__
May 2021
QIAreach
®
Anti-SARS-
CoV-2 Total Test
Instructions for Use
(Handbook)
For
in vitro
diagnostic use
For Emergency Use Authorization Only
Rx Only
Version 1
R3
645033
QIAGEN GmbH, QIAGEN Strasse 1, D
-40724 Hilden
L1121905EN
Sample to Insight
Contents
Intended Use .............................................................................................................................. 4
Summary and Explanation of the Test ..................................................................................... 5
Principles of the assay.................................................................................................. 5
Time required for performing the assay ...................................................................... 7
Pipet use......................................................................................................................... 7
Kit Contents ............................................................................................................................... 8
Materials Required but not Provided........................................................................................ 9
Equipment required but not provided........................................................................... 9
Storage and Handling................................................................................................................ 9
Kit reagents.................................................................................................................... 9
Stability........................................................................................................................... 9
Warnings ........................................................................................................................11
Precautions ....................................................................................................................11
Procedures ...............................................................................................................................14
Preparing samples .......................................................................................................14
Detection assay.............................................................................................................15
Results Analysis and Test Interpretation............................................................................... 22
Quality control of test .................................................................................................. 22
Interpretation of results.............................................................................................. 24
Limitations.................................................................................................................... 24
Conditions of Authorization for the Laboratory ......................................................... 26
Performance Characteristics................................................................................................. 29
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
2
Clinical performance ................................................................................................... 29
Independent evaluation of clinical performance........................................................ 30
Cross-reactivity........................................................................................................... 32
Interference.................................................................................................................. 34
Matrix equivalency....................................................................................................... 34
Technical Information.............................................................................................................. 35
Clotted plasma samples.............................................................................................. 35
eHub display icons....................................................................................................... 36
Error codes.................................................................................................................. 37
Troubleshooting Guide ............................................................................................................ 43
QIAreach Anti-SARS-CoV-2 Total Test troubleshooting ........................................... 43
Additional user warnings ............................................................................................ 43
Contact Information..................................................................................................................... 44
References............................................................................................................................... 45
Symbo ls.................................................................................................................................... 48
Ordering Information............................................................................................................... 49
Document Revision History..................................................................................................... 50
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
3
Intended Use
The QIAreach™ Anti-SARS-CoV-2 Total Test is a rapid, digital lateral flow serological test,
using nanoparticle fluorescence, intended for qualitative detection of total antibodies to
SARS-CoV-2 in human serum and plasma (sodium heparin, lithium heparin, dipotassium
EDTA, and tripotassium EDTA). The QIAreach™ Anti-SARS-CoV-2 Total Test is intended for
use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2,
indicating recent or prior infection. The QIAreach™ Anti-SARS-CoV-2 Total Test should not
be used to diagnose or exclude acute SARS-CoV-2 infection. At this time, it is unknown for
how long antibodies persist following infection and if the presence of antibodies confers
protective immunity. Testing is limited to laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C §263a, that meet
requirements to perform moderate or high complexity tests.
Results are for the detection of SARS CoV-2 antibodies. Antibodies to SARS-CoV-2 are
generally detectable in blood several days after initial infection, although the duration of
time antibodies are present post-infection is not well characterized. Individuals may have
detectable virus present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all results
to the appropriate public health authorities.
The sensitivity of the QIAreach™ Anti-SARS-CoV-2 Total Test early after infection is
unknown. Negative results do not preclude acute SARS-CoV-2 infection. If acute infection
is suspected, direct testing for SARS-CoV-2 is necessary.
False-positive results for the QIAreach™ Anti-SARS-CoV-2 Total Test may occur due to
cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of
false positive results, confirmation of positive results should be considered using a second,
different SARS-CoV-2 antibody test.
The QIAreach™ Anti-SARS-CoV-2 Total Test is only for use under the Food and Drug
Administration’s Emergency Use Authorization.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
4
Summary and Explanation of the Test
COVID-19 (coronavirus disease 2019) is the disease caused by SARS-CoV-2 (severe acute
respiratory syndrome coronavirus 2) viral infection.
1
The virus is readily transmitted from
both symptomatic and presymptomatic
2-4
individuals via respiratory droplets, aerosols, and
upper respiratory secretions.
5-6
The incubation period is estimated to be 4.6–5.8 days with
a median of ~5 days.
7
The symptoms of COVID-19 are non-specific, ranging from
asymptomatic to severe pneumonia and death.
8
Fever and cough are the most common
clinical symptoms but also include shortness of breath, fatigue, muscle aches, headache,
new loss of smell or taste, sore throat, congestion or runny nose, diarrhea, and vomiting,
which typically appear between 2–14 days following exposure to the virus.
8-10
Roughly 20%
of those infected with SARS-CoV-2 will experience severe symptoms, including Acute
Respiratory Distress Syndrome (ARDS) that often requires mechanical ventilation.
11
The standard medical practice for definitive diagnosis of active SARS-CoV-2 infection relies
on the molecular detection of viral RNA.
12-14
Typically, IgA and IgM production occur
simultaneously and shortly after viral infection with IgM ebbing rapidly in convalescence.
15-
16
IgG antibody responses occur after IgM and IgA seroconversion and are longer
sustained.
17
The QIAreach™ Anti-SARS-CoV-2 Total Test detects total antibodies to SARS-
CoV-2 and is an indirect test for indicating recent or prior infection in populations of
interest. The clinical and public health applications of serologic assays may include support
to clinical assessment in persons suspected of having a post-infectious syndrome and
understanding transmission dynamics in populations.
18
Principles of the assay
The QIAreach™ Anti-SARS-CoV-2 Total Test is a rapid, qualitative serological test that
detects total antibody responses to expressed SARS-CoV-2 viral antigens, in serum or
plasma (sodium heparin, lithium heparin, dipotassium EDTA and tripotassium EDTA).
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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Antibodies are detected on a single-use, lateral flow, digital detection cartridge (eStick) v ia
nanoparticle fluorescence. The eStick contains state-of-the-art optoelectronic technology
and a microprocessor that converts a fluorescent signal into a qualitative readout for the
presence of SARS-CoV-2 specific antibodies in patient test samples.
The QIAreach™ Anti-SARS-CoV-2 Total Test is performed by inserting the eStick into an
QIAreach™ eHub (sold separately). The QIAreach™ eHub (referred to as eHub hereafter) is
a connection hub that provides power to perform multiple QIAreach™ Anti-SARS-CoV-2
Total Tests simultaneously. The eHub acts as a power source and features a rechargeable
lithium battery to allow QIAreach Anti-SARS-CoV-2 Total Tests to be performed when a
continuous power supply is not available.
To perform the test, QIAreach Diluent Buffer is first added to the QIAreach Processing Tube
and reconstitutes a SARS-CoV-2 viral S1 protein-fluorescent nanoparticle conjugate that
is spray dried on an immobilized accretion pad within the tube. Patient serum or plasma is
then added to the Processing Tube and mixed with the resuspended conjugate using a
pipette. If anti-SARS-CoV-2 antibodies are present in the sample, they will bind to the
SARS-CoV-2 S1 antigen-nanoparticle conjugate. The sample is then transferred from the
Processing Tube to the eStick sample port.
Once in the eStick, the test sample migrates on a nitrocellulose membrane and across the
test line. The migrating anti-SARS-CoV-2 antibodies will bind to immobilized SARS-CoV-2
viral S1 protein at the test line, where they will bridge the two SARS-CoV-2 S1 viral proteins
on the test line and in the conjugate. A photosensor will detect light emitted from the
fluorescent nanoparticles in the presence of excitation light filtered onto the test line.
Signal is interpreted on the eStick firmware and transmitted to the eHub, which then
communicates a positive or negative test result to the user by means of a visual display.
QIAreach™ Anti-SARS-CoV-2 Total test results are determined as Positive or Negative
according to the assay result algorithm on the eStick firmware.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
6
Software is available to backup test results, generate test reports, and support online data
transfer.
Time required for performing the assay
The time required to perform the QIAreach Anti-SARS-CoV-2 Total Test is estimated below.
The time of testing multiple samples when batched is also indicated.
Digital detection: Approx. 10 minutes for one test
(1 individual)
<20 minutes labor in total
Add up to 3 minutes for each extra eStick
Pipet use
This assay requires use of an adjustable volume pipet. Users should familiarize themselves
with pipet use prior to performing the QIAreach™ Anti-SARS-CoV-2 Total Test.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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Kit Contents
QIAreach™ Anti-SARS-CoV-2
Total Test
Catalog number 645033
Number of tests/pack
60
QIAreach Anti-SARS-CoV-2 Total
Test Detection System
Components*
QIAreach e Stic k Packaged together with Processing Tube in foil
wrapper
Contains recombinant S ARS-CoV-2 S1 pr otein
and human serum albumin
QIAreach P roc essing Tube Packaged together with eStick in foil wrapper
Contains an accretion pad that contains spray
dried fluorescent nanoparticles conjugated to
SARS-CoV-2 S1 v iral prote in and bovine serum
albumin, along with maltose.
QIAreach Diluent Buffer Contains bovine serum albumin and ProClin®
300
3 x 10 ml
*See Warnings and Precautions for precautions and hazard statements.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
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Materials Required but not Provided
Collection tubes for patient serum and plasma (lithium heparin, sodium heparin,
dipotassium EDTA, tripotassium EDTA)
QIAreach™ eHub (including USB adapter and cable)*- Catalogue# 9003063
QIAreach
®
Anti-SARS-CoV-2 Controls (Catalogue # 647030)
Equipment required but not provided
Calibrated pipets* for delivery of 50 µl, 150 µl, and 300 µl with disposable tips
Optional: Centrifuge for isolating patient serum or plasma
Optional: QIAreach Software (Catalogue# 1118894)
Storage and Handling
Kit reagents
Store kit reagents at 2–30°C for up to 4 months.
Stability
The test must be initiated within 60 minutes of opening the foil-wrapped eStick and
Processing Tube.
The QIAreach
TM
Anti-SARS-CoV-2 Total Test should be performed in a test
environment with ≤ 65% relative humidity.
Refer to the expiration date printed on the device labeling for component shelf life.
* See Warnings and Precautions for precautions and hazard statements.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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QIAreach Diluent Buffer should be used within 3 months after opening the bottle.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
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Warnings and Precautions
Warnings
For prescription use only. For in vitro diagnostic use only. For Emergency Use
Authorization Only.
This test has not been FDA cleared or approved but has been authorized for
emergency use by FDA under an EUA for use by authorized laboratories certified
under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C.
263a, that meet the requirements to perform moderate or high complexity tests.
This test has been authorized only for detecting the presence of total antibodies to
SARS-CoV-2, not for any other viruses or pathogens.
The emergency use of this test is only authorized for the duration of the declaration
that circumstances exist justifying the authorization of emergency use of in vitro
diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the
Federal Food, Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
declaration is terminated or authorization is revoked sooner.
Do not use kits or reagents after the expiration dates shown on the labels.
Ensure test is run away from direct sunlight.
Do not use damaged test kit. Do not reuse the test kit.
Human serum and plasma samples should be considered as potentially infectious.
Operators should wear protective clothing, masks, gloves and take other appropriate
safety precautions to avoid or reduce the risk of infection.
Precautions
When working with chemicals, always wear a suitable lab coat, disposable gloves, and eye
protection goggles. For more information, please consult the appropriate safety data sheets
(SDSs).
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
11
CAUTION Handle all human blood serum, and plasma as if potentially (C1)
infectious. Observe relevant blood and blood product
handling guidelines. Dispose of samples and materials in
contact with blood or blood products in accordance with
federal, state, and local regulations.
The following hazards and precautionary statements apply to components of the
QIAreach
TM
Anti-SARS-CoV-2 Total Test kit.
Hazard statements
WARNING QIAreach Diluent Buffer (W1)
Contains: Mixture of 2-methyl-1,2-thiazol-3(2H)-one, and 5-
chloro-2-methyl-1,2-thiazol-3(2H)-one. Warning! May cause
an allergic skin reaction. Harmful to aquatic life with long
lasting effects. Wear protective gloves/ protective clothing/
eye protection/ face protection.
WARNING QIAreach™ eHub (W2)
Do not open the eHub. No serviceable parts inside. Opening of
the eHub device could lead to electric shock or damage of the
device.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
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CAUTION QIAreach eStick (C2)
Do not open the eStick. No serviceable parts inside. Opening
of the eStick could lead to user exposure of infectious patient
body fluids. Opening the eStick could also damage the eStick
device.
Further information
Deviations from the
QIAreach™ Anti-SARS-CoV-2 Total Test Instructions for Use
may
yield erroneous results. Please read the instructions carefully before use.
Important: Inspect materials prior to use. Do not use kit if the Diluent Buffer,
Processing Tube, or eStick show signs of damage or leakage, or if the seals have
been compromised prior to use. Do not handle broken eSticks.
Discard used or unused materials and biological samples in accordance with local
and government regulations.
Do not use the QIAreach™ Anti-SARS-CoV-2 Total Test kit after the expiration date.
Do not mix consumables and reagents from multiple lots.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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Procedures
Preparing samples
Note: The QIAreach™ Anti-SARS-CoV-2 Total Test requires 50 µl of serum or plasma for
an individual test.
Follow all instructions provided by the manufacturer of the sample collection device when
collecting test specimens. Collect all specimens using standard procedures. Refer to the
following guidelines
19
for handling of samples prior to performing the QIAreach™ Anti-
SARS-CoV-2 Total Test.
Samples that require fractionation from red blood cells should be isolated by
appropriate means (e.g. centrifugation using a gel separator) prior to analysis.
Samples collected in serum tubes should be allowed to clot prior to serum
separation.
Samples should optimally be tested as soon as possible following collection and may
be held at room temperature (17–27°C) for up to 8 hours prior to testing.
Samples may be stored for up to 2 days at 2–8°C prior to testing.
Samples that require long term storage prior to testing may be stored at ≤ –20°C.
Specimens may be frozen and thawed once.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
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Detection assay
Materials required
QIAreach Processing Tube (packaged together with eStick in foil wrapper)
QIAreach eStick (packaged together with Processing Tube in foil wrapper)
QIAreach Diluent Buffer
QIAreach™ eHub (with associated power cable and adapter), sold separately
Important points before starting
All samples and reagents (if stored in the refrigerator), must be brought to room
temperature (17–27°C) before use. Allow at least 60 minutes for sample equilibration
to room temperature. Any clots visible in the samples may be removed by
centrifugation.
The eStick and Processing Tube are packaged together in a foil wrapper. The
packaging should only be opened before performing the assay.
Important: The QIAreach™ Anti-SARS-CoV-2 Total Test must be startedwithin 60
minutes of removing the components from the packaging.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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Figure 1. Contents of foil wrapper packaging – QIAreach Processing Tube and eStick.
The eStick is a single use device. It is recommended to label the eStick with test
information using a permanent marker or by applying a label directly on the eStick. If
a label is applied to the eStick, ensure that the label is not placed over the sample
port or the sloped front end (with arrow) of the eStick as this could affect the
connection between the eStick and eHub.
There is a small white pad contained within the Processing Tube that is critical
component of the QIAreach™ Anti-SARS-CoV-2 Total Test. DO NOT remove the pad
from the Processing Tube. This pad will not be dislodged or come loose during
pipetting.
If not connected to a power source, the eHub should have sufficient battery power to
complete the test. A fully charged eHub should maintain internal battery power for 8
hours. The QIAreach™ Anti-SARS-CoV-2 Total Test should not be performed if the
eHub battery power is less than 10% and is not connected to a power source. The
battery LED indicator will display the battery status. The battery level can also be
checked by connecting the eHub to a laptop via the provided USB cable and launching
the software. The software displays the level of battery charge in the bottom right
hand corner of the screen. Refer to the
QIAreach™ eHub User Manual
and software
guide (provided with the optional QIAreach software) for details.
The eHub comes with a cover to protect the internal ports from dust buildup and
contamination. The cover should be placed over the front panel of the eHub when the
eHub is not in use.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
16
Figure 2. eHub layout. Note: The cover shouldbe in place whenthe eHub is not in use.
Note: It is recommended to fully charge the eHub in a switched off state overnight
(when not in use) or to charge for 4 hours before use. To charge the unit, connect the
eHub to a power outlet using the provided USB power adapter and USB cable. We also
recommend that the eHub is connected to a USB power source (either a USB adapter
or PC) during operation.
Figure 3. Side panel view of eHub with dust cover, ON/OFF switch and USB connection port.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
17
Procedure
1. Remove the dust cover from the front panel of the eHub and set aside.
2. Press the ON/OFF switch on the right side of the eHub to turn it on.
3. Remove the eStick from the packaging, label with patient identifier, and insert into the
eHub.
Note: The test sample must be added to the eStick sample port within 60 minutes of
removal from the foil packaging.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
18
4. Remove the Processing Tube from the packaging and insert into the empty tube slot
directly in line with the eStick.
5. Add 300 µl of QIAreach Diluent Buffer to the Processing Tube using a pipet.
6. Carefully remove 50 µl of the patient sample (serum or plasma) from the sample tube
using a pipet.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
19
7. Add the patient sample to the Processing Tube containing the QIAreach Diluent Buffer.
8. With the pipette set to 150 µl, mix the contents of the Processing Tube by pipetting up
and down at least 4 times. Take care to not introduce foam while pipetting.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
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9. Remove 150 μl of the mixed sample from the Processing Tube and dispense into the
sample port of the inserted eStick.
10. The test will start automatically within approximately 30 seconds following sample
addition, signaled by a countdown timer on the display. Do not remove the inserted
eStick until the test is complete and a result is displayed.
11. After completion of the test, the result will be displayed on the eHub.
Positive Negative
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
21
Results Analysis and Test Interpretation
The standard time from sample addition to the eStick to the test result is 10 minutes. The
time to result will be less than 10 minutes for positive samples containing elevated anti-
SARS-CoV-2 antibody levels. The time to test result will be displayed on the eHub following
a positive result.
QIAreach Anti-SARS-CoV-2 Total Test raw data is analyzed on the eStick firmware, which
then interprets a positive or negative QIAreach™ Anti-SARS-CoV-2 Total Test result based
on an internal algorithm. The result is transmitted to the eHub, which displays the result.
If the optional QIAreach software (Catalogue# 1118894) is used, the eHub will transfer the
test result to a computer for data backup and report printing. Please refer to the QIAreach
software user manual for detailed instructions about how to use the QIAreach software
with the QIAreach Anti-SARS-CoV-2 Total Test.
Quality control of test
All eSticks have built-in controls to ensure reliable performance of the eStick
optoelectronics and lateral flow strip and also monitor procedural steps after sample
addition to confirm suitability. A failure alert will be communicated to the user in the form
of a test error if any fault conditions are detected on the eStick firmware.
Mechanical performance controls are in place to confirm that the eStick components are
functioning correctly and are not compromised due to improper handling or transport. Once
the sample is added to the eStick, the eStick will continually monitor progress, including
the proper flow rate of sample across the strip as well as the correct range of detector
particles in the sample. The eStick has at least 48 unique controls built into the firmware
to alert the user if the test has not been successfully completed or if the test strip has been
compromised, providing an additional level of control over standard lateral flow tests that
rely on a single control line.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
22
External positive and negative controls are required but not supplied with this kit; and are
available for purchase separately from QIAGEN (QIAreach® Anti-SARS-CoV-2 Controls,
Catalog # 647030). External controls should be run as outlined in the procedure for testing
the samples. Positive and negative controls are required to be tested each time when a
new lot is used, when a new operator performs the test, or when the test is run in a new
room/laboratory, etc. as a good laboratory practice to confirm the test procedure and to
verify proper test performance.
If the test is invalid, an error code will be displayed on the eHub. The test should be repeated
if there is ≥ 50 μl of patient sample remaining. See Table 7 in the Technical Information
section for the list of QIAreach Anti-SARS-CoV-2 Total test error codes.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
23
Interpretation of results
Assessment of QIAreach Anti-SARS-CoV-2 Total Test results is to be performed after the
positive and negative controls have been examined, as recommended in Quality Control
section above, and determined to be valid and acceptable. If the controls are not valid, the
results cannot be interpreted.
QIAreach Anti-SARS-CoV-2 Total Test results are interpreted using the following criteria:
Table 1. Interpretation of QIAreach™ Anti-SARS-CoV-2 Total Test results
QIAreach Anti-SARS-CoV-2 Total Test result Report/Interpretation
Positive (+)
Positive for antibodies for SARS-CoV-2
Negative (-)
Negative for antibodies for SARS-CoV-2
QIAreach Anti-SARS-CoV-2 Total Test results should not be used to diagnose or exclude
acute infection. Results are not intended to be used as the sole basis for patient
management decisions. Test results should be interpreted in conjunction with clinical
observations, patient history, epidemiological information, and other laboratory findings.
Important: Laboratories within the United States and its territories are required to report
all results to the appropriate public health authorities.
If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
Limitations
• This test is only to be used in CLIA certified laboratories that meet requirements
to perform moderate or high complexity testing and not in point-of-care or at-
home testing settings.
• This test can only be used for the analysis of serum and plasma (sodium heparin,
lithium heparin, dipotassium EDTA and tripotassium EDTA) samples. Do not use
with venous or fingerstick (capillary) whole blood samples.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
24
• The test is limited to the qualitative detection of total antibodies specific for the
SARS-CoV-2 virus.
• Results from antibody testing should not be used to diagnose acute SARS-CoV-2
infection or to inform infection status. An assay that directlydetects the virus
should be used to evaluate symptomatic patients for acute COVID-19.
• It is unknown at this time if the presence of antibodies to SARS-CoV-2 confers
immunity to infection.
• False negative results may occur for immune-compromised individuals or
individuals who receive immunosuppressive therapy.
• Antibodies to SARS-CoV-2 are generally detectable in blood several days after
initial infection, although the duration of time antibodies are present post-infection
is not well characterized. Individuals may have detectable virus present for
several weeks following seroconversion.
• Negative results do not preclude SARS-CoV-2 infection and should not be used as
the sole basis for patient management decisions. Antibodies may not be detected
in the first few days of infection; The sensitivity of QIAreach™ Anti-SARS-CoV-2
Total Test early after infection is unknown. Negative results do not preclude acute
SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-
CoV-2 is necessary.
• False positive results may occur due to cross-reactivity from pre-existing
antibodies or other possible cause. Positive results may be due to past or present
infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1,
NL63, OC43, or 229E.
• A negative result can occur if the quantity of the anti-SARS-CoV-2 antibodies
present in the specimen is below the detection limits of the assay, or the
antibodies that are detected are not present during the stage of disease in which
a sample is collected.
• A positive result may not indicate previous SARS-CoV-2 infection. Consider other
information, including clinical history and local disease prevalence, in assessing
the need for a second, different serology test to confirm an adaptive immune
response.
• Significantly hemolyzed (reddish brown) samples can potentially interfere with
the QIAreach™ Anti-SARS-CoV-2 Total Test optical measurement system. The
eStick firmware features built-in controls to determine unacceptably high levels
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
25
of hemolysate (> 5mg/ml) and will return an invalid result in the form of an error
code if interference is present. Refer to the troubleshooting section if observing
elevated hemolysate in samples.
• Not to be used for the screening of donated blood.
• Note: Unreliable results may occur due to deviations from the procedure
described in this handbook.
• The performance of this test has not been established in individuals that have
received a COVID-19 vaccine. The clinical significance of a positive or negative
antibody result following COVID-19 vaccination has not been established, and the
result from this test should not be interpreted as an indication or degree of
protection from infection after vaccination.
• The performance of this test was established based on the evaluation of a limited
number of clinical specimens. The specimens for the negative agreement studies
were collected in Pennsylvania, USA between July 2019 and September 2019 and
in Florida, USA between August 2018 and October 2019. The specimens for the
positive agreement studies were collected in Florida, Louisiana, Texas, and the
state of Washington, USA between April 2020 and June 2020 and in Lima, Peru in
May 2020. The clinical performance has not been established in all circulating
variants but is anticipated to be reflective of the prevalent variants in circulation
at the time and location of the clinical evaluation. Performance at the time of
testing may vary depending on the variants circulating, including newly emerging
strains of SARS-CoV-2 and their prevalence, which change over time.
Conditions of Authorization for the Laboratory
The QIAreach™ Anti-SARS-CoV-2 Total Test Letter of Authorization, along with the
authorized Fact Sheet for Healthcare Providers, the authorized Fact Sheet for Recipients,
and authorized labeling are available on the FDA website:
https://www.fda.gov/medical-
devices/coronavirus-disease-2019-covid-19-emergency-use-authorizations-medical-
devices/vitro-diagnostics-euas. Authorized laboratories using the QIAreach™ Anti-SARS-
CoV-2 Total Test (referred to as “your product” in the conditions below), must adhere to
the Conditions of Authorization indicated in the Letter of Authorization as listed below:
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
26
• Authorized laboratories using your product must include with test result reports,
all authorized Fact Sheets. Under exigent circumstances, other appropriate
methods for disseminating these Fact Sheets may be used, which may include
mass media.
• Authorized laboratories must use your product as outlined in the authorized
labeling. Deviations from the authorized procedures, including the authorized
instruments, authorized clinical specimen types, authorized control materials,
authorized other ancillary reagents and authorized materials required to use
your product are not permitted.
• Authorized laboratories that receive your product must notify the relevant public
health authorities of their intent to run your product prior to initiating testing.
• Authorized laboratories using your product must have a process in place for
reporting test results to healthcare providers and relevant public health
authorities, as appropriate.
• Authorized laboratories must collect information on the performance of your
product and report to DMD/OHT7-OIR/OPEQ/CDRH (via email: CDRH-EUA-
Reporting@fda.hhs.gov) and to you (techservice-na@qiagen.com) any suspected
occurrence of false positive or false negative results and significant deviations
from the established performance characteristics of your product of which they
become aware.
• All laboratory personnel using your product must be appropriately trained in
immunoassay techniques and use appropriate laboratory and personal
protective equipment when handling this kit and use your product in accordance
with the authorized labeling. All laboratory personnel using the assay must also
be trained in and be familiar with the interpretation of results of the product.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
27
• Authorized distributors, and authorized laboratories using your product will
ensure that any records associated with this EUA are maintained until otherwise
notified by FDA. Such records will be made available to FDA for inspection upon
request.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
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Performance Characteristics
Clinical performance
Positive Percent Agreement (PPA)/Sensitivity
PPA/Sensitivity was estimated by evaluating serum and plasma samples from study
subjects with PCR-confirmed symptomatic SARS-CoV-2 infection. A total of 65 previously
collected samples from 65 subjects, collected from April 2020 to July 2020 in the United
States (43 samples) and Peru (22 samples), were tested using the QIAreach Anti-SARS-
CoV-2 Total Test.
The following table describes the positive percent agreement by time of sampling after
onset of symptoms.
Table 2. Clinical sensitivity by days post-symptom onset
Number of days
after symptom
onset
Number of
samples tested
Number of
QIAreach™ Anti-
SARS-CoV-2 Total
Test positive results
Positive percent
agreement
95% confidence
interval
0 – 7 days 3 2 66.67 % 9.43 – 99.16 %
8 – 14 days 13 12 92.31 % 63.97 – 99.81 %
≥ 15 days 49 47 95.92 % 86.02 – 99.50 %
All 65 61 93.85 % 84.99 – 98.30 %
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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Negative Percent Agreement/Specificity
NPA/Specificity was estimated by evaluating samples collected before the start of the
SARS-CoV-2 pandemic (before December 2019). A total of 230 previously collected serum
and plasma samples from 230 subjects in the United States were tested using the QIAreach
Anti-SARS-CoV-2 Total Test. The following table shows the negative percent agreement.
Table 3. Negative Percent Agreement
Number of Number of QIAreach™ Negative percent 95% confidence
samples tested Anti-SARS-CoV-2 Total agreement interval
Test negative results
230
225
97.83 %
95.00 – 99.29 %
Independent evaluation of clinical performance
The QIAreach Anti-SARS-CoV-2 Total Test was tested on December 10, 2020 at the
Frederick National Laboratory for Cancer Research (FNLCR) sponsored by the National
Cancer Institute (NCI). Tests were from lot number 86652. The test was evaluated against
“Panel 3” which is a panel of previously frozen samples consisting of 30 SARS-CoV-2
antibody-positive serum samples and 80 antibody-negative serum and plasma samples.
Each of the 30 antibody-positive samples were confirmed with a nucleic acid amplification
test (NAAT) and both SARS-CoV-2 IgM and IgG antibodies were confirmed to be present in
all 30 samples. The presence of antibodies in the samples was confirmed by several
orthogonal methods prior to testing with the QIAreach Anti-SARS-CoV-2 Total Test. The
presence of SARS-CoV-2 antibodies specifically was confirmed by one or more comparator
methods. Antibody-positive samples were selected at different antibody titers.
All antibody-negative samples were collected prior to 2020 and include i) seventy (70)
samples selected without regard to clinical status, “Negatives” and ii) Ten (10) samples
selected from banked serum from HIV+ patients, “HIV+”. Testing was performed by one
operator using 1 lot of QIAreach Anti-SARS-CoV-2 Total Test. Confidence intervals for
sensitivity and specificity were calculated per a score method described in CLSI EP12-A2
(2008).
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
30
For the evaluation of cross-reactivity with HIV+, it was determined whether an increased
false positive rate among antibody-negative samples with HIV was statistically higher than
the false positive rate among antibody-negative samples without HIV (for this, a confidence
interval for the difference in false positive rates was calculated per a score method
described by Altman). The results and data analysis are shown in the following tables:
Table 4. Summary Results
Comparator Method Collected pre-2020 Total
Antibody Positive Antibody Negative
QIAreach Anti- SARS-CoV-2
Total Test
IgM+,
IgG+
IgM+,
IgG-
IgM-,
IgG+
Negative HIV+ Total
Pan Ig+ 30 2 32
Pan Ig- 68 10 78
Total 30 70 10 110
Table 5. Summary Statistics
Measure Estimate Confidence Interval
Pan Ig Sensitivity 100% (30/30) (88.7%; 100%)
Pan Ig Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined Sensitivity 100% (30/30) (88.7%; 100%)
Combined Specificity 97.5% (78/80) (91.3%; 99.3%)
Combined PPV for prevalence = 5.0% 67.8% (35.0%; 88.4%)
Combined NPV for prevalence = 5.0% 100% (99.4%; 100%)
Combined NPV for prevalence = 5.0% 100% (99.4%, 100%)
Cross-reactivity with HIV+ 0.0% (0/10), not detected
Important limitations:
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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1. Samples were not randomly selected, and sensitivity and specificity estimates
may not be indicative of the real-world performance of the device
2. These results are based on serum and ACD plasma samples only and may not be
indicative of performance with other sample types, such as whole blood, including
finger stick blood.
3. The number of samples in the panel is a minimally viable sample size that still
provides reasonable estimates and confidence intervals for test performance, and
the samples used may not be representative of the antibody profile observed in
patient populations.
Cross-reactivity
QIAreach™ Anti-SARS-CoV-2 Total Test was evaluated for potential cross-reactivity with
antibodies to the pathogens listed below. All samples were collected from SARS-CoV-2
negative individuals prior to November 2019 (pre-pandemic). A total of 167 individual
specimens were tested. No cross-reactivity was observed.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
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Table 6. Cross-reactivity summary for QIAreach™ Anti-SARS-CoV-2 Total test*
Pathogen Sample type N
Number of
cross-
reactive
Number of
non-
reactive
Adenovirus Plasma 28 0 28
Anti-nuclear Antibody (ANA) Serum 5 0 5
Bordetella pertussis Plasma 31 0 31
Chlamydia pneumoniae Plasma 42 0 42
CoV 229E Serum 17 0 17
CoV HKU1 Serum 5 0 5
CoV NL63 Serum 5 0 5
CoV OC43 Serum 14 0 14
Dengue Serum 10 0 10
Enterovirus Plasma 20 0 20
Haemophilus influenzae Plasma 5 0 5
Hepatitis B- HBc Serum 5 0 5
Hepatitis B- HBs Serum 5 0 5
Hepatitis C Serum 5 0 5
Influenza A Plasma 63 0 63
Influenza A Serum 5 0 5
Influenza B Plasma 72 0 72
Legionella pneumophila Plasma 12 0 12
Mycoplasma pneumoniae Plasma 81 0 81
Parainfluenza Plasma 103 0 103
Respiratory Syncytial Virus (RSV) Plasma 76 0 76
Respiratory Syncytial Virus (RSV) Serum 5 0 5
* This table evaluatescross-reactivity separately for each pathogen category. With several specimens, containing
antibodies to multiple pathogens, somespecimens are listed more than once,but in separate pathogen categories.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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Interference
The effect of potentially interfering substances on QIAreach™ Anti-SARS-CoV-2 Total Test
was evaluated by spiking endogenous and exogenous interferents at CLSI recommende d
high level concentrations into SARS-CoV-2 negative plasma and negative plasma spiked
with low titer SARS-CoV-2 antibody. No significant interference was observed at the
following concentrations:
Bilirubin, conjugated 0.4 mg/ml
Bilirubin, unconjugated 0.4 mg/ml
Hemoglobin* 5 mg/ml
Prednisolone 0.12 mg/ml
Triglycerides 15 mg/ml
* Hemoglobin levels above 5 mg/ml (reddish brown colored samples) can potentially
interfere with the QIAreach™ Anti-SARS-CoV-2 Total Test optical measurement
system. The eStick firmware features built-in controls to determine unacceptably
high levels of hemolysate and will return an invalid result in the form of an error
code if interference is present. See Troubleshooting Guide for more information.
Matrix equivalency
QIAreach Anti-SARS-CoV-2 Total Test performance was evaluated in serum, lithium
heparin plasma, sodium heparin plasma, dipotassium EDTA plasma, and tripotassium EDTA
plasma by obtaining each sample matrix in a single blood collection from each of five
negative donors and one positive donor. Low and Medium level positive samples were
contrived by diluting the positive subject sample into each of the negative subject samples,
with each sample matrix diluted into the same matrix that was being assessed in order to
maintain matrix integrity. The contrived Low and Medium positive samples were tested in
parallel with uncontrived negative samples, with 2 replicates tested at each concentration
level. QIAreach Anti-SARS-CoV-2 Total Test results were evaluated against the expected
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
34
Negative result for uncontrived samples and the expected Positive result for Low and
Medium level contrived positive samples. Result agreement is shown in Table 7.
Table 7. Sample matrix equivalency test agreement to expected result
Sample matrix Negative
agreement
(n=10)
Low positive
agreement
(n=10)
Med positive
agreement
(n=10)
Overall
agreement
(n=40)
Serum 10/10 (100%) 10/10 (100%) 10/10 (100%) 30/30 (100%)
Lithium Heparin 10/10 (100%) 10/10 (100%) 10/10 (100%) 30/30 (100%)
Sodium Heparin 10/10 (100%) 10/10 (100%) 10/10 (100%) 30/30 (100%)
Dipotassium EDTA 10/10 (100%) 10/10 (100%) 10/10 (100%) 30/30 (100%)
Tripotassium EDTA 10/10 (100%) 10/10 (100%) 10/10 (100%) 30/30 (100%)
Technical Information
Clotted plasma samples
Should fibrin clots occur with long-term storage of plasma samples at or below –20°C, the
samples may be centrifuged to sediment clotted material and to facilitate pipetting of
plasma.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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eHub display icons
Table 8. eHub display icons
Icon ID Description
Please Insert The eHub port is availablefor eStick use.
Self-test The eStick has been inserted and a self-testis being performed.
Add sample
The eStick is ready for sample addition to thedetection port. The sample
must be added within 60 minutes of removing the eStick from the foil
packaging.
Processing
The eStick has detected sample andis processing the test. A test
countdown timer is displayed. Do notremove the eStick until a result is
displayed. The test will take up to 10 m inutes .
Positive Anti-SARS-CoV-2 antibody present
Negative Anti-SARS-CoV-2 antibody NOT present
Error
The eStick has encountered an error. The letter below the symbol de notes
the type and the numbers are code for the error. Refer to the error code
section for more information.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
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Error codes
The following table lists the error codes in the QIAreach Anti-SARS-CoV-2 test:
Table 9. QIAreach™ Anti-SARS-CoV-2 Total test error codes categories – general description
Error type Error code format Description
Self-Test A-[Error code] eStick electronic failure
Algorithm B-[Error code] Run error or user workflow error
Communication/
Other
C-[Error code]
Invalid data or missed
communication betweeneStick
and eHub
Table 10. “A” error codes
Error code Description Recommended action
A-1 Used eStick Discard and use new eStick.
A-2 Metadata error Discard and use new eStick.
A-4 Metadata error Discard and use new eStick.
A-8 Voltage Failure Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-16 Voltage Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-32 Voltage Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-64 Voltage Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-128 Frequency Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
Table continued on next page
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
37
Table continued from previous page
Table 10. “A” error codes (cont’d)
Error code Description Recommended action
A-256 Frequency Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-512 Frequency Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-1024 Frequency Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-2048 LED Current Failure Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-4096 LED Current Failure Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-8192 LED Current Failure Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-16384 LED Current Failure Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-32768 Dark Frequency Failure Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
A-65535 Unknown value
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
QIAreach™ Anti-SARS-CoV2Total Test Instructions for Use 02/2021
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Table 11. “B” error codes
Error code Description Recommended action
B-0 No result Discard and use new eStick.
B-8 Conjugate Wave Too Early
Ensure eStick is inserted prior to
adding sample. Discard and use
new eStick.
B-9 Conjugate Wave Too Early
Check color of sample*. Discard
and use new eStick.
B-10 High Dark Frequency Ensure test is run away from
direct sunlight. Discard anduse
new eStick.
B-12 No Frequency Discard and use new eStick.
B-13 No Frequency Discard and use new eStick.
B-14 No Conjugate Wave (Timeout)
Run test within 60 minutes of
removing eStick from foil. Check
color of sample. Discard and use
new eStick.
B-15 Frequency Out of Range Discard and use new eStick.
B-16 Low Frequency
Ensure sample is mixed well in
processing tube prior to adding
test sample to eStick. D is c ard a nd
use new eStick.
B-17 High Frequency Discard and use new eStick.
B-18 Frequency Out of Range Discard and use new eStick.
B-19 Low Frequency Ensure sample is mixed well in
processing tube prior to adding
test sample to eStick. D is c ard a nd
use new eStick.
B-21 Peak Data Failure Check color of sample*. Discard
and use new eStick.
Table continued on next page
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
39
Table continued from previous page
Table 11. “B” error codes (cont’d)
Error code Description Recommended action
B-22 Result Timeout Discard and use new eStick.
B-23 Baseline Issue Discard and use new eStick.
B-24 Baseline Issue Discard and use new eStick.
B-25 Signal Noise Discard and use new eStick.
B-255 Test Removed Early Wait for test completion before
removing eStick. Discard and use
new eStick.
* See Troubleshooting Guide section of applicable kit Instructions for Use regarding optical interference.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
40
Table 12. “C” error codes
Error code Description Recommended action
C-0 Connection Error
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
C-1 Expired eStick
Test is past expiry date. Use an
eStick within expiration.
C-2 Sample Not Detected Run test within 60 minutes of
removing eStick from foil. Discard
and use new eStick.
C-3 Start Not Ac knowl edged
Remove and re-insert the eStick. If
error persists, discard and use
new eStick. If errorpersists with
new eStick, discontinue use of
eHub port.
C-4 Self Test Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick. If errorpersists with
new eStick, discontinue use of
eHub port.
C-5 Metadata Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick. If errorpersists with
new eStick, discontinue use of
eHub port.
C-6 Measurement Data Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick. If errorpersists with
new eStick, discontinue use of
eHub port.
C-9 Algorithm Failure
Remove and re-insert the eStick. If
error persists, discard and use
new eStick. If errorpersists with
new eStick, discontinue use of
eHub port.
Table continued on next page
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
41
Table continued from previous page
Table 12. “C” error codes (cont’d)
Error code Description Recommended action
C-10 Unexpected Result Time
Remove and re-insert the eStick. If
error persists, discard and use
new eStick. If error persists with
new eStick, discontinue use of
eHub port.
C-11 eStick Timeout
Run test within 60 minutes of
removing eStick from foil. D iscard
and use new eStick.
C-12 Test Removed Too Early
Wait for test completion before
removing eStick. Discard and use
new eStick.
C-13 Connection Error
Remove and re-insert the eStick. If
error persists, discard and use
new eStick. If error persists with
new eStick, discontinue use of
eHub port.
C-14 eHub Low Battery Charge eHub or connect to main
power prior to repeating test.
Remove and re-insert the eStick. If
error persists, discard and use
new eStick.
C-15 eHub Internal Error The eHub can no longer be used.
Contact QIAGEN Customer
Support.
C-16 eHub RTC Failure The eHub can no longer be used.
Contact QIAGEN Customer
Support.
* The eHub does not have to be fully charged before running a test, but we recommend ke eping the eHub plugged in
to a power source and charging at all times, if possible.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
42
Troubleshooting Guide
This troubleshooting guide may be helpful in solving any problems that may arise. For more
information, see also the Frequently Asked Questions page at our Technical Support Center:
www.qiagen.com/FAQ/FAQList.aspx
. The scientists in QIAGEN Technical Services are
always happy to answer any questions you may have about either the information or
protocols in this handbook (for contact information, see back cover or visit
www.qiagen.com).
QIAreach Anti-SARS-CoV-2 Total Test troubleshooting
See Table 9-12 in Technical Information section for the list of QIAreach Anti-SARS-CoV-2
Total Test error codes.
Significantly hemolyzed (reddish brown) samples can potentially interfere with the
QIAreach™ Anti-SARS-CoV-2 Total Test optical measurement system. The eStick firmware
features built-in controls to determine unacceptably high levels of hemolysate and will
return an invalid result in the form of an error code if interference is present. If a reddish-
brown test sample results in a “B” error code or if the sample is added to the eStick and
the test will not start within 1 minute, then the sample may contain elevated levels of
hemoglobin that interfere with the test. Causes of in vitro hemolysis may include improper
sample collection from the patient and improper storage / handling of the sample prior to
analysis. See Preparing samples for guidelines and for pre-analytical specimen stability
and follow the sample collection device manufacturer’s recommendations for sample
collection and centrifugation.
Additional user warnings
When cleaning, avoid any deliberate water ingress deep into the test ports. The eHub
can be cleaned using mild detergent, 10% bleach or 70% EtOH.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
43
Only use the eHub with the USB cable and USB adapter supplied with the device.
Contact Information
For technical assistance and more information, please see our Technical Support Center at
www.qiagen.com/support, call 800-344-3631, email techservice-na@qiagen.com, or
contact one of the QIAGEN Technical Service Departments or local distributors (see back
cover or visit www.qiagen.com).
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
44
References
1. Coronaviridae Study Group of the International Committee on Taxonomy of
Viruses. The species Severe acute respiratory syndrome-related coronavirus:
classifying 2019-nCoV and naming it SARS-CoV-2. Nat Microbiol. 2020; 5(4): 536-
44
2. He, X., Lau, E.H.Y., Wu, P. et al. Temporal dynamics in viral shedding and
transmissibility of COVID-19. Nat Med 26, 672-675 (2020).
https://doi.org/10.1038/s41591-020-0869-5
3. Payne DC, Smith-Jeffcoat SE, Nowak G, et al. SARS-CoV-2 Infections and
Serologic Responses from a Sample of U.S. Navy service Members -USS Theodore
Roosevelt, April 2020. MMWR Morb Mortal Wkly Rep 2020:69;714-721
4. Lei Huang, Xiuwen Zhang, Xinyue Zhang, Zhijian Wei, Lingli Zhang, Jingjing Xu,
Peipei Liang, Yuanhong Xu, Chengyuan Zhang, Aman Xu Rapid asymptomatic
transmission of COVID-19 during the incubation period demonstrating strong
infectivity in a cluster of youngsters aged 16-23 years outside Wuhan and
characteristics of young patients with COVID-19: A prospective contact-trac ing
study, J Infect. 2020 Jun; 80(6): e1-e13. Published online 2020 Apr 10. doi:
10.1016/j.jinf.2020.03.006
5. CDC, Clinical Questions about COVID-19: Questions and Answers
https://www.cdc.gov/coronavirus/2019-
ncov/hcp/faq.html#Transmissionhttps://www.who.int/emergencies/diseas
es/novel-coronavirus-2019/question-and-answers-hub
6. Kampf, G. et al. (2020). J Hosp Infect. 104(3), 246-251
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
45
7. Lauer SA, Grantz KH, Bi Q, et al. The Incubation Period of Coronavirus Disease 2019
(COVID-19) From Publicly Reported Confirmed Cases: Estimation and Application.
Ann Intern Med. 2020;172(9):577-582. doi:10.7326/M20-0504
8. Xu G, Yang Y, Du Y, et al. Clinical Pathway for Early Diagnosis of COVID-19: Updates
from Experience to Evidence-Based Practice. Clin Rev Allergy Immunol.
2020;59(1):89-100. doi:10.1007/s12016-020-08792-8
9. CDC Symptoms of Coronovirus, https://www.cdc.gov/coronavirus/2019-
ncov/symptoms-testing/symptoms.html accessed August 6, 2020
10. Burke RM, Killerby ME, Newton S, et al. Symptom Profiles of a Convenience
Sample of Patients with COVID-19 – United States, January–April 2020. MMWR
Morb Mortal Wkly Rep 2020;69:904–908. DOI
http://dx.doi.org/10.15585/mmwr.mm6928a2
11. Wu C, Chen X, Cai Y, Xia J, Zhou X, Xu S, et al. Risk Factors Associated With Acute
Respiratory Distress Syndrome and Death in Patients With Coronavirus Disease
2019 Pneumonia in Wuhan, China. JAMA Intern Med. 2020;10:1001.
12. World Health Organization. Laboratory testing strategy recommendations for
COVID-
19. March 2020. Available here:
https://apps.who.int/iris/bitstream/handle/10665/331509/WHO-COVID-19-
lab_testing-2020.1-eng.pdf
13. CDC. (2020). Overview of Testing for SARS-CoV-2
https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
14. ECDC. (2020).
https://www.ecdc.europa.eu/sites/default/files/documents/Overview-
rapid-test-situationfor-COVID-19-diagnosis-EU-EEA.pdf.
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
46
https://www.ecdc.europa.eu/sites/default/files/documents/Overview-
rapid-test-situation-for-COVID-19-diagnosis-EU-EEA.pdf
15. Ma, H., Zeng, W., He, H. et al. Serum IgA, IgM, and IgG responses in COVID-19. Cell
Mol Immunol 17, 773-775 (2020). https://doi.org/10.1038/s41423-020-0474-z,
16. Padoan A, Sciacovelli L, Basso D, et al. IgA-Ab response to spike glycoprotein of
SARS-CoV-2 in patients with COVID-19: A longitudinal study. Clin Chim Acta.
2020;507:164-166. doi:10.1016/j.cca.2020.04.026
17. Hsueh PR, Huang LM, Chen PJ, Kao CL, Yang PC. Chronological evolution of IgM,
IgA, IgG and neutralisation antibodies after infection with SARS-associated
coronavirus. Clin Microbiol Infect. 2004;10(12):1062?1066. doi:10.1111/j.1469-
0691.2004.01009 2. Wang G, Jin X. The progress of 2019 Novel Coronavirus (2019-
nCoV) event in China. J Med Virol. 2020; 92(5): 468-72
18. US CDC. Overview of testing for SARS-CoV-2.
https://www.cdc.gov/coronavirus/2019-ncov/hcp/testing-overview.html
19. Hodgkinson VS, Egger S, Betsou F, et al. Preanalytical Stability of Antibodies to
Pathogenic Antigens. Cancer Epidemiol Biomarkers Prev. 2017;26(8):1337-1 3 44.
doi:10.1158/1055-9965.EPI-17-0170
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
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Symbols
The following symbols may appear on the packaging and labelling:
Symbol Symbol definition
Use by date
Temperature limitation
Catalog number
Material number
Manufacturer
Protect from light
Consult instructions for use
Caution
Do not open electrical unit
Do not reuse
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
48
Ordering Information
Product
Contents
Cat. no.
645033
9003063
1118894
647030
QIAreach™ Anti-SARS-CoV-2 60 QIAreach eSticks / Processing
Total Test Kit Tubes
3 x 10 ml QIAreach Diluent Buffer
Related Products
QIAreach™ eHub
QIAreach™ eHub, power adapter and
USB connector cable
QIAreach™ Software n/a
QIAreach
®
Anti-SARS-CoV-2 QIAreach Anti-SARS-CoV-2 Positive
Controls
Control and the QIAreach Anti-SARS-
CoV-2 Negative Control
For up-to-date licensing and product-specific disclaimers, see the respective QIAGEN kit
handbook or user manual. QIAGEN kit handbooks and user manuals are available at
www.qiagen.com or can be requested from QIAGEN Technical Services or your local
distributor.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
49
Document Revision History
Date Changes
R1, August 2020 Initial release
R2, December 2020 Rebranding from Access to QIAreach™
Updated clinical agreement section for sensitivity, specificity and predictive
value
Updated available sample matrices study
Updated Error Codes Table
R3, May 2021
Updated to include QIAreach
®
Anti-SARS-CoV-2 Co ntr ol s. Corrected eHub
catalog number
QIAreach™ Anti-SARS-CoV2 Total Test Instructions for Use 02/2021
50
Limited License Agreement for QIAreach™ Anti-SARS-CoV-2 Total Test
Use of thi s pr oduct si gni fies the agreement of any purchaser or user of the product to the followi ng ter ms:
1. The product may be used sol ely i n accordance wi th the pr otocols pr ovi ded w i th the pr oduct and thi s handbook and for use wi th components contained in
the ki t only. QIAGEN grants no li cense under any of i ts intellectual property to use or i ncor por ate the enclosed components of thi s ki t wi th any components
not included within this kit except as described in the protocols provided with the product, this handbook, and additional protocols avai lable at
www.qiagen.com. Some of these addi tional pr otocols have been provi ded by QIAGE N user s for QIAGEN users. These protocols have not been thor oughl y
tested or optimized by QI AGEN. QIAGE N neither guarantees them nor w arr ants that they do not i nfr i nge the ri ghts of thi r d-parties.
2. Other than expr essly stated li censes, QIAGEN makes no w ar r anty that thi s ki t and/or i ts use(s) do not i nfri nge the ri ghts of thi r d-parties.
3. This kit and its components are licensed for one-ti me use and may not be r eused, refurbi shed, or resold.
4. QIAGE N specifi cally disclaims any other licenses, expr essed or implied other than those expressly stated.
5. The purchaser and user of the ki t agr ee not to take or permi t anyone else to take any steps that could lead to or facilitate any acts prohibited above.
QI AGEN may enfor ce the pr ohibitions of this Limi ted License Agreement i n any Court, and shall r ecover all i ts i nvesti gative and Cour t costs, includi ng
attorney fees, i n any action to enforce this Limited License Agreement or any of its intellectual property rights relating to the kit and/or its components.
For updated l i cense terms, see www.qiagen.com.
Tr ademarks: QIAr each™, QIAGEN
®
, Sample to I nsi ght
®
, (QIAGEN Group). Regi stered names, trademarks, etc. used i n thi s document, even when not specifically
marked as such, are not to be considered unprotected by law.
1121905 12-2020 © 2020 QIAGEN, all rights r eser ved.
QIAreach™ Anti-SA RS -CoV2 Total Test Instructions for Use 02/2021
51
__
May 2021
QIAreach™ eHub
User Manual
For
in vitro
diagnostic use
For Emergency Use Authorization Only
Rx Only
9003063
QIAGEN GmbH, QIAGEN Strasse 1, D
-40724 Hilden
1118891EN
R1
Sample to Insight
QIAreach eHub User Manual 05/2021
2
Contents
1 Introduction.............................................................................................................................5
1.1 About this user manual ...............................................................................................5
1.2 General Information ....................................................................................................6
1.3 Intended use of the QIAreach™ eHub .........................................................................7
1.4 Symbols on the QIAreach™ eHub ...............................................................................8
2 Safety Information ................................................................................................................ 10
2.1 Proper use ..................................................................................................................11
2.2 Electrical safety..........................................................................................................11
2.3 Chemical safety..........................................................................................................11
2.4 Biological safety .........................................................................................................11
2.5 Waste disposal........................................................................................................... 12
3 General Description.............................................................................................................. 13
3.1 System description.................................................................................................... 13
3.2 QIAreach™ eHub description..................................................................................... 13
4 Installation Procedures........................................................................................................ 15
4.1 Site requirements...................................................................................................... 15
4.2 QIAreach™ eHub delivery and compone nts ............................................................. 16
4.3 Unpacking and installing the QIAreach™ eHub ........................................................ 18
5 Operating the QIAreach™ eHub ............................................................................................ 19
5.1 Setting up the QIAreach™ eHub for use ................................................................... 19
5.2 Running a test on the QIAreach™ eHub.................................................................... 21
5.3 Shutting down the QIAreach™ eHub .........................................................................22
6 QIAreach™ eHub Functions ..................................................................................................23
6.1 Display screen icons .................................................................................................23
6.2 Battery LED indicator................................................................................................24
7 Maintenance ..........................................................................................................................25
7.1 Cleaning the QIAreach™ eHub after use ..................................................................25
8 Troubleshooting ....................................................................................................................26
8.1 General information ..................................................................................................26
QIAreach eHub User Manual 05/2021
3
8.2 Contacting QIAGEN Technical Services....................................................................26
8.3 QIAreach™ eHub error codes....................................................................................26
9 Technical Specifications.......................................................................................................28
9.1 Electromagnetic compatibility (EMC).................................................................29
9.2 Electrical Safety .......................................................................................................29
9.3 Cybersecurity ...........................................................................................................29
9.4 Software Validation ................................................................................................29
10 Appendix A – Technical Data................................................................................................30
10.1 FCC Compliance: Supplier’s Declaration of Conformity .....................................30
10.2 Waste Electrical and Electronic Equipment (WEEE)...........................................32
10.3 Disclaimer of warranties......................................................................................32
11 Ordering Information ............................................................................................................33
12 Document Revision History..................................................................................................34
QIAreach eHub User Manual 05/2021
4
1 Introduction
This manual describes how to operate the QIAreach™ eHub (also referred to as eHub herein).
Before using the QIAreach™ eHub, it is essential that you read this user manual carefully and
pay particular attention to the safety information. The instructions and safety information in the
user manual must be followed to ensure safe operation of the instrument and to maintain the
instrument in a safe condition.
1.1 About this user manual
This user manual provides information about QIAreach™ eHub in the following sections:
Introduction
Safety Information
General Description
Installation Procedures
Operation
System Functions
Maintenance
Troubleshooting
Technical Specifications
The Appendix section contains the following information:
Declaration of Conformity
Waste Electrical and Electronic Equipment (WEEE)
Disclaimer of warranties
QIAreach eHub User Manual 05/2021
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1.2 General Information
This test has not been FDA cleared or approved but has been authorized for emergency
use by FDA under an EUA for use by authorized laboratories certified under the Clinical
Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C 263a, that meet
requirements to perform moderate or high complexity tests.
This test has been authorized only for detecting the presence of total antibodies to SARS-
CoV-2, not for any other viruses or pathogens.
The emergency use of this test is only authorized for the duration of the declaration that
circumstances exist justifying the authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug,
and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or
authorization is revoked sooner.
1.2.1 Technical assistance
At QIAGEN
®
, we pride ourselves on the quality and availability of our technical support. Our
Technical Services Departments are staffed by experienced scientists with extensive practical
and theoretical expertise in molecular biology and the use of QIAGEN products. If you have any
questions or experience any difficulties regarding the QIAreach™ eHub or QIAGEN products in
general, do not hesitate to contact us.
For technical assistance and more information, please see our Technical Support Center at
www.qiagen.com/support/technical-support or call one of the QIAGEN Technical Service
Departments or local distributors (see back cover or visit www.qiagen.com).
When contacting QIAGEN Technical Services about errors, please have the following information
ready:
QIAreach™ eHub serial number
Test type and test kit lot number
Error code (if applicable)
Timestamp when the error occurred for the first time
Frequency of error occurrence (i.e., intermittent or persistent error)
Photo of error, if possible
QIAreach eHub User Manual 05/2021
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1.2.2 Policy statement
It is the policy of QIAGEN to improve products as new techniques and components become
available. QIAGEN reserves the right to change specifications at any time.
In an effort to produce useful and appropriate documentation, we appreciate your comments on
this user manual. Please contact QIAGEN Technical Services.
1.3 Intended use of the QIAreach™ eHub
The QIAreach™ eHub is intended for use in conjunction with QIAreach™ Anti-SARS-CoV-2 Total
Test. QIAreach™ technology on the digital detection eStick provides diagnostic results that are
displayed to the user on the QIAreach™ eHub visual display.
The QIAreach™ eHub and QIAreach™ Anti-SARS-CoV-2 Total test are intended for professional
use only and not intended for self-testing. The QIAreach™ Anti-SARS-CoV-2 Total test is for in
vitro diagnostic use, for Emergency Use Authorization Only, and for prescription use only.
1.3.1 Limitations of use
The QIAreach™ eHub can only be used with eSticks according to the instructions contained
in this user manual and in the Instructions for Use for the QIAreach™ Anti-SARS-CoV-2
Total Test.
When powering the QIAreach™ eHub or connecting to a computer, use only the USB cable
supplied with this product.
When charging the QIAreach™ eHub, use only the USB charger and USB cable supplied with
this product.
The QIAreach™ eHub should only be operated on a flat, horizontal surface with no angles or
tilts.
Do not re-run an eStick if it has already been used successfully or if it has been associated
with an error or an incomplete run.
Ensure that the QIAreach™ eHub is positioned away from any air conditioning outlets,
heaters, or sources of intense light.
Do not move the QIAreach™ eHub while a test is running.
Do not remove an eStick from the QIAreach™ eHub before the run has completed.
QIAreach eHub User Manual 05/2021
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1.4 Symbols on the QIAreach™ eHub
The following symbols may appear on the packaging or labelling.
Symbol Location Description
Type plate and outer box label
of the
QIAreach™ eHub
CE mark
Type plate on the bottom of the QIAreach™
eHub
FCC Mark
Type plate and outer box label
of the
QIAreach™ eHub
WEEE Mark for Europe
Type plate and outer box label
of the
QIAreach™ eHub
Legal Manufacturer
Type plate and outer box label
of the
QIAreach™ eHub
Catalog Number
Type plate and outer box label
of the
QIAreach™ eHub
Serial Number
Type plate and outer box label
of the
QIAreach™ eHub
Global Trade Item Number
Outer box label of the QIAreach™ eHub Fragile
Type plate
and outer box label of the
QIAreach™ eHub
Electrical Safety
Regulatory Compliance
Mark (Australia and New
Zealand)
Type plate and outer box label of the
QIAreach™ eHub
Consult Instructions for
Use
QIAreach eHub User Manual 05/2021
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Type plate and outer box label of the
QIAreach™ eHub
Attention
QIAreach eHub User Manual 05/2021
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2 Safety Information
Before using the QIAreach™ eHub, it is essential that you read this user manual carefully and
pay particular attention to the safety information. The instructions and safety information in the
user manual must be followed to ensure safe operation of the QIAreach™ eHub and to maintain
a safe working condition.
Possible hazards that could harm the user or result in damage to the instrument are clearly
stated at the appropriate places throughout this user manual.
If the QIAreach™ eHub is used in a manner not specified by the manufacturer, the protection
provided by the equipment may be impaired.
The following types of safety information appear throughout the
QIAreach™ eHub User Manual
.
WARNING
The term WARNING is used to inform you about situations that could result
in personal injury to you or others.
Details about these circumstances are given in a box like this one.
CAUTION
The term CAUTION is used to inform you about situations that could result
in damage to the QIAreach™ eHub or to other equipment.
Details about these circumstances are given in a box like this one.
Important
The term Important is used to highlight information that is critical for the
completion of a task or optimal performance of the system.
Note
The term Note is used for information that explains or clarifies a specific
case or task.
The guidance provided in this manual is intended to supplement, not supersede, the normal
safety requirements prevailing in the user’s country.
QIAreach eHub User Manual 05/2021
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2.1 Proper use
Use the QIAreach™ eHub according to this user manual. We recommend you carefully read
and become acquainted with the Instructions for Use before running a QIAreach™ Anti-
SARS-CoV-2 Total Test.
Improper use of the QIAreach™ eHub may cause personal injuries or damage to the
QIAreach™ eHub.
The QIAreach™ eHub must only be operated by qualified and appropriately trained QIAGEN
personnel.
2.2 Electrical safety
Observe all general safety precautions that apply to electrical instruments. This device has been
tested for compliance with electrical safety requirements as per IEC 61010-1: Safety
requirements for electrical equipment for measurement, control, and laboratory use - Part 1:
General requirements.
WARNING/
CAUTION
Do not open the QIAreach™ eHub. No user-serviceable parts inside.
Opening of the QIAreach™ eHub device could lead to user injury or
damage of the device.
(W1)
2.3 Chemical safety
Safety Data Sheets (SDSs) for QIAreach™ Anti-SARS-CoV-2 Total Test kit materials are available
and can be requested from QIAGEN. Used eSticks should be disposed of in accordance with all
national, state, and local health and safety regulations and laws.
2.4 Biological safety
Samples tested on the QIAreach™ eHub may contain infectious agents. Users should be aware
of the health hazard presented by such agents and should use, store and dispose of such
samples according to the required safety regulations. Wear personal protective equipment when
handling reagents or samples, and wash hands thoroughly thereafter.
QIAreach eHub User Manual 05/2021
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Always observe safety precautions as outlined in relevant guidelines. Avoid contamination of
the QIAreach™ eHub and workspace by handling samples and eSticks with care. In the event of
contamination, clean and decontaminate the affected area of the QIAreach™ eHub.
For instructions on cleaning and decontaminating the QIAreach™ eHub, see Maintenance.
2.5 Waste disposal
For disposal of waste electrical and electronic equipment (WEEE), see Waste Electrical and
Electronic Equipment (WEEE).
QIAreach eHub User Manual 05/2021
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3 General Description
3.1 System description
The QIAreach™ eHub, in combination with eSticks, provides a simplified workflow for multiple in
vitro diagnostic tests, using state-of-the-art nanoparticle fluorescence detection technology.
The eSticks are single-use tests that include a lateral flow strip and optoelectronics that
perform test measurements and interpret results. The QIAreach™ eHub provides power to the
eStick to run the test when the eStick is connected to any one of the eHub-eStick ports. The
QIAreach™ eHub visually communicates test progress and results to the user via a display
screen specific to each QIAreach™ eHub port.
Optional QIAreach software is not provided with the QIAreach™ eHub and can be purchased
separately from Qiagen (Catalog # 1118894). The QIAreach™ eHub will transmit test information
and results when connected to a computer running QIAreach™ software.
3.2 QIAreach™ eHub description
The QIAreach™ eHub is a connection hub that provides power to perform multiple QIAreach™
Anti-SARS-CoV-2 Total Tests simultaneously. The QIAreach™ eHub is connected to a power
source using the provided connection cable and features a rechargeable lithium battery to allow
QIAreach™ Anti-SARS-CoV-2 Total Test to be performed when a continuous power supply is not
available. QIAreach™ Anti-SARS-CoV-2 Total Test results are interpreted on the eStick
firmware, and results are transmitted to the QIAreach™ eHub which then communicates to the
user by means of a visual display.
The QIAreach™ eHub USB charger and USB cable allow the QIAreach™ eHub to be powered from
either an electrical outlet or from a computer equipped with USB ports. Use of the optional
QIAreach™ software (Catalogue# 1118894) requires the QIAreach™ eHub to be connected to a
computer. For instructions on how to use the software, refer to the QIAreach™ software user
guide (available separately),
The QIAreach™ eHub includes the following elements:
eStick connection ports for up to eight (8) separate tests
Visual display screen centered above each individual eStick connection port
QIAreach processing tube holder slot positioned directly behind each visual display screen
QIAreach eHub User Manual 05/2021
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Sample tube holder slot positioned directly behind each processing tube holder slot, to be
used for QIAreach™ Anti-SARS-CoV-2 Total Test
USB-C port for connection to a USB charger (supplied) or computer
Battery LED indicator
Figures 1 and 2 show the location of various QIAreach™ eHub features.
Figure 1. Front view of QIAreach™ eHub.
Figure 2. Side view of QIAreach™ eHub.
QIAreach eHub User Manual 05/2021
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4 Installation Procedures
4.1 Site requirements
Select a flat, dry, and clean workbench space for the QIAreach™ eHub. Make sure that the space
is free of excessive moisture and dust, protected from direct sunlight, large temperature
fluctuations, heat sources, vibration and electrical interference. Refer to Section 9 for the weight
and dimensions of the QIAreach™ eHub and the correct operating conditions (temperature and
humidity). There should be sufficient clearance on the workbench to allow unimpeded access to
the eStick connection ports, USB port, and ON/OFF button.
Note: Before installing and using the QIAreach™ eHub, see Operating the QIAreach™ eHub to
become familiar with the QIAreach™ eHub operating conditions.
CAUTION
Do not place the QIAreach™ eHub in close proximity to sources of (C2)
strong electromagnetic radiation (e.g., unshielded intentional RF
sources), as these can interfere with proper operation. For more
information, see
FCC Compliance: Supplier’s Declaration of
Conformity.
QIAreach eHub User Manual 05/2021
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4.2 QIAreach™ eHub delivery and components
The QIAreach™ eHub is delivered in a single box and includes all the necessary components for
setting up and connecting the QIAreach™ eHub. The contents of the box are described below:
Note: QIAreach™ Anti-SARS-CoV-2 Total Test kits (sold separately) are required to perform
testing on QIAreach™ eHub devices.
Components Description
1x QIAreach™ eHub
1x Dust cover
1x USB drive containing QIAreach™ software
1x USB-C – USB-A Cable, 1.5m length
1x USB Charger Power adapter with region
specific plugs
QIAreach eHub User Manual 05/2021
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The following components are required for testing but are provided separately in the QIAreach™
Anti-SARS-CoV-2 Total Test kit (Cat#645033).
Components Description
QIAreach eStick
QIAreach Processing Tube
QIAreach Diluent Buffer
QIAreach eHub User Manual 05/2021
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4.3 Unpacking and installing the QIAreach™ eHub
The QIAreach™ eHub is delivered ready for use and does not require any hands-on assembly
procedures.
Remove the QIAreach™ eHub from its delivery box and place on a flat, level surface.
The QIAreach™ eHub should be charged prior to use. To charge the QIAreach™ eHub, connect
the USB cable from the QIAreach™ eHub USB port to either the supplied power adapter or to a
computer.
Figure 3. Connecting the USB cable to the QIAreach™ eHub USB port.
Note: The QIAreach™ eHub will charge more quickly when charged through the supplied USB
charging adapter, compared to when it is charged through a computer USB port.
The QIAreach™ eHub comes with a dust cover to protect the internal ports from dust buildup and
contamination. The cover should always be placed over the front panel of the QIAreach™ eHub
when not in use. When ready to operate the QIAreach™ eHub, the dust cover can be removed
from the front panel and set aside.
QIAreach eHub User Manual 05/2021
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5 Operating the QIAreach™ eHub
5.1 Setting up the QIAreach™ eHub for use
1. Remove the dust cover from the front panel of the QIAreach™ eHub and set aside.
Figure 4. Removing the dust cover from the front ofQIAreach™eHub prior to use.
2. Ensure that the provided USB cable is connected to the QIAreach™ eHub and an adequate
power source (power outlet or computer).
Note: We recommend to fully charge the QIAreach™ eHub in a switched off state overnight
(when not in use). We also recommend that you connect the QIAreach™ eHub to a USB
power source (either a USB adapter or computer) during operation. If testing is performed
without the use of associated QIAreach™ software, then we recommend connecting the
QIAreach™ eHub to a power outlet (if available) through the provided USB power adapter
and USB cable.
3. To turn on the QIAreach™ eHub, press ON/OFF on the side of the unit until the visual
display screen lights up.
Figure 5. Press the ON/OFF switch to turn on the QIAreach™ eHub.
4. Check battery LED indicator to ensure that the QIAreach™ eHub has sufficient charge for
the test operation. For different battery LED indicator states, see Battery LED indicator.
QIAreach eHub User Manual 05/2021
19
Once the QIAreach™ eHub is ready for use, the visual display screen above each available eStick
connection port will display the “Insert eStick” icon shown below.
Figure 6. Insert eStick icon. This signifies that an QIAr each™ eHub po rt is av ail abl e for us e.
QIAreach eHub User Manual 05/2021
20
5.2 Running a test on the QIAreach™ eHub
Important: The steps described in this section are general test workflow cues provided on the
QIAreach™ eHub visual display screen. Refer to the QIAreach™ Anti-SARS-CoV-2 Total Test
Instructions for Use for instructions on performing a test with the QIAreach™ eHub.
Note: Each of the connection ports on the QIAreach™ eHub operates separately. Up to eight (8)
QIAreach™ Anti-SARS-CoV-2 Total tests can be run simultaneously.
1. When an eStick has been inserted in an eHub-eStick connection port, the self-test icon will
be displayed while the eStick performs a self-test.
Figure 7. Self-test screen display.
2. Once the eStick self-test has successfully completed, the “Add sample” icon will be
displayed, signifying the eStick is ready for sample addition.
Figure 8. Add sample screen display.
3. After the test sample has been added to the eStick, the “Processing” icon will be displayed
along with a test countdown timer.
Important: The eStick must not be removed from the QIAreach™ eHub until the test has
been completed
.
Figure 9. Processing screen display and countdown timer.
4. Once the QIAreach™ Anti-SARS-CoV-2 Total Test has completed, the test result will be
displayed on the screen and the eStick can be safely removed.
Figure 10. Test result screen.
QIAreach eHub User Manual 05/2021
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5. If an error occurs during the test, the error icon will appear along with a specific error
code. Refer to the Troubleshooting section of this manual for more information.
Figure 11. Error icon and associated error code.
5.3 Shutting down the QIAreach™ eHub
After use, the QIAreach™ eHub should be turned off by pressing the ON/OFF button. The
QIAreach™ eHub battery will continue to charge when turned off if connected to a power source.
After each use, clean the QIAreach™ eHub according to the instructions in Cleaning the
QIAreach™ eHub after use.
Replace the dust cover on the front panel of the QIAreach™ eHub to protect the eStick connection
ports from moisture and dust.
QIAreach eHub User Manual 05/2021
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6 QIAreach™ eHub Functions
6.1 Display screen icons
Table 1. Display screen icons
Icon ID Description
Please
The
QIAreach™ eHub port is available for eStick use.
Insert
The eStick has been inserted and a self-test is being
Self-test
performed.
The eStick is ready for sampleaddition to thedetection port. The samplemust
Add sample
be added within 60 minutes of removing the eStick from the foil packaging.
The eStick has detected sample andis processing the test. A test countdown
Processing timer is displayed. Do not removethe eStic k until a result is displayed. Test
times may v ary ac ross Access products.
Positive (varies
The test has returned a positive result.
with test)
Negative (v aries
The test has returned a negativeresult.
with test)
The test has encountered an error. The letter denotesthe type and thenumbers
Error
are code for the error. Referto the Troubleshooting sec tion for more
information.
QIAreach eHub User Manual 05/2021
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6.2 Battery LED indicator
If not connected to a power source, the QIAreach™ eHub should have sufficient battery power to
complete all in-progress QIAreach™ Anti-SARS-CoV-2 Total Tests. A fully charged QIAreach™
eHub should maintain internal battery power for at least 8 hours. QIAreach™ Anti-SARS-CoV-
2 Total tests should not be performed if the battery power is less than 10% and is not connected
to a power source. The battery level can be checked by connecting the QIAreach™ eHub to a
computer through the provided USB cable and launching the software. The software displays
the level of battery charge in the bottom right hand corner of the screen. The battery level is
also indicated by the various batteryLED states listed below.
Table 2. Battey levels
Display LED state Meaning
None off The QIAreach™ eHub is off
Flashing green Battery charging in progress
Solid green
The QIAreach™ eHub is t u rne d o n,
battery charge > 50%
Solid amber
The QIAreach™ eHub is t u rne d o n,
battery charge 10 – 50%
Solid red
The QIAreach™ eHub is t u rne d o n,
battery charge < 10%
Flashing red
The QIAreach™ eHub is t u rne d o n,
battery fault
QIAreach eHub User Manual 05/2021
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7 Maintenance
The QIAreach™ eHub does not require any service maintenance or calibration.
7.1 Cleaning the QIAreach™ eHub after use
WARNING/
CAUTION
Risk of personal injury and material damage
Disconnect the QIAreach™ eHub from all power sources before
cleaning.
Ensure the QIAreach™ eHub is turned off before cleaning.
(W2)
(C3)
CAUTION Risk of damage to the QIAreach™ eHub
When cleaning, avoid any deliberate water ingress into the eStick
(C4)
connection ports.
CAUTION Risk of damage to the QIAreach™ eHub
Avoid the use of excessive volumes of liquid that could enter the
(C5)
interior of the unit when cleaning the QIAreach™ eHub.
Only use the following materials to clean the QIAreach™ eHub exterior surfaces:
Mild detergent
Water
When cleaning the QIAreach™ eHub surface:
Wear laboratory gloves, coat, and protective glasses.
Wet a paper towel in mild detergent and wipe down the QIAreach™ eHub surface and the
surrounding workbench area. Take care not to intentionally wet the eStick connection ports
or ON/OFF button and USB port.
Dry the QIAreach™ eHub surface with a fresh paper towel.
QIAreach eHub User Manual 05/2021
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8 Troubleshooting
8.1 General information
This section provides information on some issues that may occur with the QIAreach™ eHub along
with possible causes and solutions. Specific information may vary with QIAreach™ Anti-SARS-
CoV-2 Total Tests. For troubleshooting relevant to QIAreach™ Anti-SARS-CoV-2 Total Test, see
the kit instructions for use.
8.2 Contacting QIAGEN Technical Services
When contacting QIAGEN Technical Services about an error with the QIAreach™ eHub, note the
steps leading up to the error. This information will help QIAGEN Technical Services solve the
problem.
When contacting QIAGEN Technical Services about errors, please have the following information
ready:
QIAreach™ eHub serial number
Test type and test kit lot number
Error code (if applicable)
Timepoint when the error occurred for the first time
Frequency of error occurrence (i.e., intermittent or persistent error)
Photo of error, if possible
8.3 QIAreach™ eHub error codes
If the QIAreach™ eHub displays an error code, refer to the table below specific error descriptions
and solutions.
QIAreach eHub User Manual 05/2021
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Table 2. QIAreach™ eHub error codes
Error type Format Description
eStick electronic failure
Self-Test A-[Error code]
Run error or user workflow error
Algorithm B-[Error code]
Communication/
Invalid data or missed
C-[Error code]
communication betweeneStick and
Other eHub
A-[all error codes] eStick electronic failure
Discard and use new eStick.
Repeat test.
B-8 Sample added too early
Only add sample after “Add
Sample” icon is displayed.
Repeat test.
B-14 No sample detected
Add sample within 60 min of
insertion.
Repeat test.
Baseline signal at reference Ensure solution in
B-16
line too low
processing tube is well
mixed.
Repeat test.
Baseline signal at test line
Ensure solution in
B-19
too low
processing tube is well
mixed.
Repeat test.
eStick removed too early
Remove eStick only after a
B-255
from eHub
valid test result or error
code is displayed.
B-[all other error codes] Error code specific
Repeat test.
Discard and use another eStic k f rom
C-1 Out of date, i.e. expired test
a kit within expiry.
Connect eHub to a power outl e t or
computer via USB cable*.
C-14 eHub battery charge too low
Remove and reinsert eStick.
Remove and reinsert eStick.
C-[all other error codes] Electrical contact or timing issue If issue persists, discard anduse
new eStick.
* The QIAreach™ eHub does not have tobe fully charged before running a test, but we recommend to keep theQ I Areach™
eHub plugged in to a power sourceand charging atalltimes, if possible.
QIAreach eHub User Manual 05/2021
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9 Technical Specifications
Dimensions and weight
Dimensions Width: 304 x 112 x 51 mm (12 x 4.4 x 2 in)
Weight 1000 g (2.2 lb)
Power requirements
USB Charger Power Adapter (supplied)
Voltage 90–264 VAC
Power 0.4A max
Frequency 50–60 Hz
Line regulation ± 1%
Load regulation ± 5%
Line Frequency Variation ± 3 Hz
QIAreach™ eHub device:
Voltage 5V DC
Power 1.0A
Internal Li-Ion battery (non user-seviceable):
Voltage: 3.7V nominal
Capacity: 3350 mAh nominal
Operating conditions
Air Temperature 15–30°C (59–86°F)
Relative Humidity 30–65% (non-condensing)
Place of Operation For Indoor use only
Transport conditions
Air Temperature 5–50°C (41–122°F)
Relative Humidity Maximum 70% relative humidity, non-condensing
Storage conditions
Air Temperature 15–30°C (59–86°F)
Relative Humidity 30–65% (non-condensing)
RoHS (Responsibility of Health and Safety) Compliance:
Compliant with RoHS 3 EU Directive 2015/863: Restriction of the Use of certain
Hazardous Substances in electrical and electronic equipment
QIAreach eHub User Manual 05/2021
28
9.1 Electromagnetic compatibility (EMC)
Compliant with IEC 61326-1: Electrical equipment for measurement, control and
laboratory use – EMC requirements – Part 1: General requirements
Meets the requirements of CISPR 11:2015: ISM Equipment Radiated RF Emissions as
a Group 1, Class A device
Meets the requirements of FCC Title 47 CFR Part 15 Subpart B– unintentional
radiators as a Class A device
9.2 Electrical Safety
Compliant with IEC 61010-1: Safety requirements for electrical equipment for
measurement, control, and laboratory use - Part 1: General requirements
9.3 Cybersecurity
Negligible or acceptable failure modes or hazards identified after a failure mode and
effects analysis (FMEA) of the cybersecurity risks to the test system, including the
optional QIAreach software.
Standard Windows Filesharing provides authenticated and encrypted
communication.
9.4 Software Validation
Complaint with ISO 62304: Software verification of the QIAreach software has been
done in accordance with the Ellume Quality System Design Control Procedures and
ISO 62304 on both the 32-bit and 64-bit version.
QIAreach eHub User Manual 05/2021
29
10 Appendix A – Technical Data
10.1 FCC Compliance: Supplier’s Declaration of Conformity
47 CFR § 2.1077 Compliance Information
Unique Identifier: 9002969 – QIAGEN QIAreach™ eHub
Responsible Party – U.S. Contact Information
QIAGEN Inc. - USA
19300 Germantown Road
Germantown, MD 20874
Telephone: (800-362-7737)
Email: customercare-us@qiagen.com
FCC Compliance Statement
This product has been tested and found to comply with the limits for a Class A digital device
pursuant to Part 15 of the FCC Rules. These limits are designed to provide reasonable protection
against harmful interference when the equipment is operated in a commercial environment. This
product generates, uses, and can radiate radio frequency energy and, if not installed and used
in accordance with the manufacturer’s instruction manual, may cause harmful interference with
radio communications. Operation of this product in a residential area is likely to cause harmful
interference, in which case you will be required to correct the interference at your own expense.
This device complies with Part 15 of the FCC Rules. Operation is subject to the following two
conditions:
1) This device may not cause harmful interference.
2) This device must accept any interference received, including interference that may cause
undesired operation.
QIAreach eHub User Manual 05/2021
30
Notice: The FCC regulations provide that changes or modifications not expressly approved by
QIAGEN, Inc. could void your authority to operate this equipment.
These limits are designed to provide reasonable protection against harmful interference in a
non-residential installation. However, there is no guarantee that interference will not occur in a
particular installation. If this equipment does cause harmful interference with radio or television
reception, which can be determined by turning the equipment off and on, you are encouraged to
try to correct the interference by one or more of the following measures:
• Reorient or relocate the antenna of the radio/television receiver.
• Increase the separation between this equipment and the radio/television receiver.
• Plug the equipment into a different outlet so that the equipment and the radio/television
receiver are on different power mains branch circuits.
• Consult a representative of QIAGEN or an experienced radio/television technician for additional
suggestions.
In order to maintain compliance with FCC regulations, this equipment must be used with the
supplied USB cable and USB Charger. Operation with non-approved equipment or alternate
cables may result in interference to radio and TV reception.
QIAreach eHub User Manual 05/2021
31
10.2 Waste Electrical and Electronic Equipment (WEEE)
This section provides information about disposal of waste electrical and electronic equipment
by users.
The crossed-out wheeled bin symbol (see below) indicates that this product must not be
disposed of with other waste; it must be taken to an approved treatment facility or to a
designated collection point for recycling, according to local laws and regulations.
The separate collection and recycling of waste electronic equipment at the time of disposal helps
to conserve natural resources and ensures that the product is recycled in a manner that
protects human health and the environment.
Recycling can be provided by QIAGEN upon request at additional cost. In the European Union, in
accordance with the specific WEEE recycling requirements and where a replacement product is
being supplied by QIAGEN, free recycling of its WEEE-marked electronic equipment is provided.
To recycle electronic equipment, contact your local QIAGEN sales office for the required return
form. Once the form is submitted, you will be contacted by QIAGEN either to request follow-up
information for scheduling collection of the electronic waste or to provide you with an individual
quote.
10.3 Disclaimer of warranties
EXCEPT AS PROVIDED IN QIAGEN TERMS AND CONDITIONS OF SALE FOR THE QIAREACH™
EHUB, QIAGEN ASSUMES NO LIABILITY WHATSOEVER AND DISCLAIMS ANY EXPRESS OR
IMPLIED WARRANTY RELATING TO THE USE OF THE QIAREACH™ EHUB INCLUDING LIABILITY
OR WARRANTIES RELATING TO MERCHANTABILITY, FITNESS FOR A PARTICULAR PURPOSE, OR
INFRINGEMENT OF ANY PATENT, COPYRIGHT, OR OTHER INTELLECTUAL PROPERTY RIGHT
ANYWHERE IN THE WORLD.
QIAreach eHub User Manual 05/2021
32
11 Ordering Information
Product
Contents
Cat. no.
QIAreach™ eHub
Includes 1 QIAreach™ eHub; 1 USB charging cable;
1 power adapter; 1 QIAreach™ eHub dust cover
9003063
Optional QIAreach
Software
N/A
1118894
For up-to-date licensing information and product-specific disclaimers, see the respective
QIAGEN kit handbook or user manual. QIAGEN kit handbooks and user manuals are available at
www.qiagen.com or can be requested from QIAGEN Technical Services or your local
distributor.
QIAreach eHub User Manual 05/2021
33
12 Document Revision History
Date
Changes
R1, July 2020 Initial release
R2, May 2021 Change to catalog Number
QIAreach eHub User Manual 05/2021
34
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QIAreach eHub User Manual 05/2021
35
Limited License Agreement for QIAreach™ eHub
Use of thi s pr oduct si gni fies the agreement of any purchaser or user of the product to the followi ng ter ms:
1. The product may be used sol ely i n accordance wi th the pr otocols pr ovi ded w i th the pr oduct and thi s handbook and for use wi th components contained in the kit only.
QIAGEN grants no license under any of i ts i ntell ectual property to use or i ncorpor ate the enclosed components of this ki t wi th any components not i ncluded wi thi n
thi s kit except as descr ibed i n the protocols provided w i th the pr oduct, this handbook, and additional pr otocol s available at ww w.qiagen.com. Some of these
addi tional protocols have been pr ovided by QIAGEN user s for QIAGEN users. These pr otocols have not been thoroughly tested or optimized by QIAGE N. QIAGE N
nei ther guar antees them nor w arr ants that they do not i nfri nge the ri ghts of thi r d-parties.
2. Other than expr essly stated li censes, QIAGEN makes no warranty that this ki t and/or its use(s) do not i nfr i nge the r i ghts of thi r d-parties.
3. Thi s ki t and its components are l i censed for one-ti me use and may not be r eused, refurbished, or resold.
4. QIAGE N specifi cally disclaims any other licenses, expr essed or implied other than those expressly stated.
5. The pur chaser and user of the kit agree not to take or permit anyone else to take any steps that could lead to or facilitate any acts prohibited above. QIAGEN may
enfor ce the pr ohi bitions of this Limi ted Li cense Agr eement i n any C ourt, and shal l recover all i ts i nvesti gative and Court costs, includi ng attor ney fees, i n any action
to enforce this Limited License Agreement or any of its intellectual pr operty ri ghts r elati ng to the kit and/or i ts components.
For updated l i cense terms, see www.qiagen.com.
Tr ademarks: QI AGEN
®
, Sample to Insight, (QIAGE N Group). Registered names, tr ademarks, etc. used i n this document, even when not specifically marked as such, are not to be consi der ed unprotected by law.
1118891 05-2021 © 2020 QIAGEN
®
, all rights reserved.
QIAreach eHub User Manual 05/2021
36
QIAreach™ Anti-SARS-CoV-2
Total Test
Emergency Use Authorization (EUA) only
Please be advised:
o This test has not been FDA cleared or approved, but has been
authorized for emergency use by FDA under an EUA for use by
authorized laboratories;
o This test has been authorized only for detecting the presence of
total antibodies to SARS-CoV-2, not for any other viruses or
pathogens; and
o The emergency use of this test is only authorized for the duration
of the declaration that circumstances exist justifying the
authorization of emergency use of in vitro diagnostics for
detection and/or diagnosis of COVID-19 under Section 564(b)(1)of
the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3
(b)(1), unless the declaration is terminated or authorization is
revoked sooner.
Please contact QIAGEN Technical Services (1-800-426-8157) if
you require a printed copy free of charge.
Please find the “QIAreach Anti-SARS-CoV-2 Total Test
Instructions for Use (Handbook)”, and the “QIAreach Anti-SARS-
CoV-2 Total Test Quick Reference Guide” instructions for use at
the following web address:
www.qiagen.com/us/products/diagnostics-and-clinical-
research/infectious-disease/qiareach-solutions/qiareach-anti-
sars-cov-2-total-us/#orderinginformation
Tr ademarks: QI AGEN
®
, Sample to I nsi ght
®
, QIAreach™ {QIAGEN Group);
1122741 Rev. 01
02/2021 © 2021 QIAGEN, all rights reserved.
Ordering www.qiagen.com/shop | Technical Support support .qiagen.com | Website www.qiagen.com
Sample to Insight
QIAreach
®
Anti-SARS-CoV-2 Total Test
Pre-analytical Steps
Quick Reference Guide
The QIAreach
®
Anti-SARS-CoV-2 Total Test has not
been FDA cleared or approved, but has been
authorized for emergency use by FDA under an EUA
Test Kit Contents (REF 645033)
Note: Do not use the QIAreach Anti-SARS-CoV-2 Total Test beyond
the expiration date displayed on the associated product labeling.
for use by authorized laboratories. Testing of serum
laboratories certified under CLIA that meet the requirements to
perform moderate- or high-complexity tests.
60 x QIAreach Anti-SARS-CoV-2 Total
Processing Tubes
60 x QIAreach Anti-SARS-CoV-2 Total eSticks
The QIAreach™ Anti-SARS-CoV-2 Total Test has been authorized
Centrifuge the sample per the
only for detecting the presence of total antibodies to SARS-CoV-2,
collection tube manufacturer’s
not for any other viruses or pathogens.
standard serum tube -
following phlebotomy best
practice.
specifications.
The emergency use of this test is only authorized for the duration of
the declaration that circumstances exist justifying the authorization of
emergency use of in vitro diagnostics for detection and/or
diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food,
3 x 10ml QIAreach Anti-SARS-CoV-2
Drug, and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the
Total Diluent Buffer
declaration is terminated or authorization is revoked sooner.
QIAreach eHub Setup
Due to the risk of false-positive results, confirmation of positive results
should be considered using a second, different total antibody assay.
Please study the QIAreach™ Anti-SARS-CoV-2 Total Test Instructions
for Use (Handbook) thoroughly before referring to this Quick
Reference Guide. This Quick Reference Guide is not intended as an
exhaustive instructional document.
Power USB
QIAreach eHub (REF 9003063)
Remove QIAreach Remove the dust
Connect the eHub to
eHub from its
cover from the front
power via USB (wall
For use under Emergency Use Authorization (EUA) only
Adjustable Volume Pipettes + tips
Volume/s required: 50µl, 150µl, 300µl
packaging.
of the QIAreach
plug or PC) and turn
eHub.
on by pushing the
power button.
REF 645033
Optional Step
Draw patient sample using a
plasma collection tube or
Additional Components Required
Plasma collection or serum tubes
www.qiagen.com
Minimum collection volume 1ml
NB: Refer to QIAreach eHub User
Manual for a complete guide to
800-344-3631
Technical support: techser[email protected]
device operation and troubleshooting.
Sample to Insight
Note: Refer to the QIAreach Anti-SARS-CoV-2 Total Test Instructions for Use (Handbook) for Warnings and Precautions, Directions for Use,
Results Analysis and Test Interpretation, Technical Information and Troubleshooting. For required positive and negative control testing
associated with the QIAreach Anti-SARS-CoV-2 Total Test, use the QIAreach Anti-SARS-CoV-2 Controls product; this product is sold separately
and is available from QIAGEN (Catalog Number 647030). External controls should be run as outlined in the procedure for testing the
Test Procedure
samples. Positive and negative controls are required to be tested each time when a new lot is used, when a new operator performs the test, or
when the test is run in a new room/laboratory, etc. as a good laboratory practice to confirm the test procedure and to verify proper test
Ensure the QIAreach eHub is
1
turned on then insert the
QIAreach Processing Tube and
eStick. Samples and reagents
must be brought to room
temperature.
2
performance.
Transfer 300 µl of QIAreach
Diluent Buffer solution into
QIAreach Processing Tube.
3
Draw 50 µl of serum or plasma
sample from collection tube.
Refer to the instructions for use
for further detail.
Transfer the plasma sample to
4
QIAreach Processing Tube.
Allowance for 13 mm
collection tubes
300 μl
50 μL
Record patient
**eStick must be
information
used within 1hr
of unwrapping**
With the pipette set to 150 µl, mix the
5
contents at least 4 times to mix the
sample in the QIAreach Processing
Tube.
150 μl
6
Transfer 150 µl from the
QIAreach Processing Tube to the
eStick.
7
The test will run automatically
and display a result within
approximately 10 minutes.
Anti-CoV2
Anti-CoV2
or
09:59
Positive Negative
Summary of Limitations:
- QIAreach Anti-SARS-CoV-2 results should not be
used to diagnose or exclude acute infection. Results
are not intended to be used as the sole basis for
patient management decisions. Test results should be
interpreted in conjunction with clinical observations,
patient history, epidemiological information, and
other laboratory findings.
- Negative results do not rule out SARS-CoV-2
infection, particularly in those who have been in
contact with the virus. Follow-up testing with a
molecular diagnostic should be considered to rule out
infection in these individuals.
- Positive results may be due to past or present
infection with non-SARS-CoV-2 coronavirus strains,
such as coronavirus HKU1, NL63, OC43, or 229E.
150 μl
Wait for result before
removing the eStick
Trademarks: QIAGEN
®
, Sample to Insight
®
, QIAreach
®
, (QIAGEN Group). Registered names, trademarks, etc. used in this document, even when
not specifically marked as such, are not to be considered unprotected by law.
1122620 Rev. 02, © 2021 QIAGEN, all rights reserved.
Sample to Insight
__
QIAreach
®
Anti-SARS-CoV-2 Controls Package Insert
For use under Emergency Use Authorization (EUA) only
For In Vitro Diagnostic Use
Rx Only
647030
Intended use
QIAGEN
19300 Germantown Road
For use with the QIAreach
®
Anti-SARS-CoV-2 Total Test (Cat# 645033)
Germantown, MD 20874
USA
Consult Instructions for Use
The QIAreach Anti-SARS-CoV-2 Controls are intended for use as
positive and negative external quality controls to assess the
1124356
performance of the QIAreach Anti-SARS-CoV-2 Total Test (Cat#
645033). The QIAreach Anti-SARS-CoV-2 Controls are provided to
R1
assist laboratories with training new operators and qualifying
individual lots of the QIAreach Anti-SARS-CoV-2 Total Test.
The QIAreach Anti-SARS-CoV-2 Controls are designed for quality
assurance purposes, and should be used when:
Training new operators
Qualifying new lots or shipments of the QIAreach Anti-SARS-CoV-2 Total Test.
Identifying systematic issues at a particular lab or testing site.
External controls are deemed necessary by organizational quality control procedures, and/or in accordance with
Local, State and Federal regulations or accreditation requirements.
Summary and explanation
The QIAreach Anti-SARS-CoV-2 Controls test kit consists of the QIAreach Anti-SARS-CoV-2 Positive Control and the
QIAreach Anti-SARS-CoV-2 Negative Control. The Negative Control contains SARS-CoV-2 seronegative human serum
and the Positive Control contains SARS-CoV-2 antibodies in a human serum matrix diluted to a low reactive level.
Principles of the procedure
The QIAreach Anti-SARS-CoV-2 Controls are provided frozen in single-use vials and are substituted with the patient
sample in the QIAreach Anti-SARS-CoV-2 Total Test workflow. For instructions on how to perform the test, refer to the
QIAreach Anti-SARS-CoV-2 Total Test Instructions For Use (Handbook)
.
Sample to Insight
Kit contents
QIAreach Anti-SARS-CoV-2 Controls
Catalog no. 647030
QIAreach Anti-SARS-CoV-2 Positive Control Contains anti-SARS-CoV-2 antibodies in human serum 4 ea
(100 µl)
QIAreach Anti-SARS-CoV-2 Negative Control Contains SARS-CoV-2 seronegative human serum 4 ea
(100 µl)
Store QIAreach Anti-SARS-CoV-2 Controls at –30 to –15°C. Do not use after the expiration date printed on the labelling.
Each control vial is single use only and should be used within 4 hours of thawing to room temperature.
Warnings and Precautions
When working with chemicals, always wear a suitable lab coat, disposable gloves, and eye protection goggles. For more
information, please consult the appropriate safety data sheets (SDSs). Refer to the
QIAreach Anti-SARS-CoV-2 Total Test
Instructions For Use (Handbook)
for further safety information.
Important: Inspect vials prior to use. Do not use control vials that show signs of damage or if the vial cap has been
compromised. Do not handle broken vials. Take appropriate safety precautions to dispose of vials safely.
1. For Emergency Use Authorization only.
2. For
in vitro
diagnostic use only.
3. For professional use only.
4. This test has not been FDA cleared or approved, but has been authorized for emergency use by FDA under an EUA
for use by authorized laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA),
42 U.S.C §263a, that meet requirements to perform moderate or high complexity tests.
5. This test has been authorized only for detecting the presence of total antibodies to SARS-CoV-2, not for any other
viruses or pathogens.
6. The emergency use of this test is only authorized for the duration of the declaration that circumstances exist
justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under
Section 564(b)(1) of the Federal Food Drug and Cosmetic Act, 21 U.S.C. § 360bbb3(b)(1), unless the declaration is
terminated or authorization is revoked sooner.
7. All specimens of human origin should be considered potentially infectious and handled with care.
Procedure
1. Equilibrate all controls to room temperature (15–30°C) prior to use. Controls should be used within 4 hours of
thawing. Do not refreeze vials after thawing.
2. Controls are substituted with the patient sample in the QIAreach Anti-SARS-CoV-2 Total Test workflow and 50 µl of
control sample should be used in the assay workflow.
3. Discard opened vials after use in accordance with the local and government regulations.
Expected results
The QIAreach Anti-SARS-CoV-2 Positive Control should return a Positive result and the QIAreach Anti-SARS-CoV-2
Negative Control should return a Negative result in the QIAreach Anti-SARS-CoV-2 Total Test. Control test results that
do not match with the expected results may identify a potential issue with operator training, laboratory handling
procedures or witha specific QIAreach Anti-SARS-CoV-2 Total Test lot or shipment. If the control results do not match
the expected results then patient results should not be reported.
For up-to-date licensing information and product-specific disclaimers, see the respective QIAGEN kit handbook or user
manual. QIAGEN kit handbooks and user manuals are available at www.qiagen.com or can be requested from QIAGEN
Technical Services or your local distributor.
Tr ademarks: QI AGEN
®
, Sample to Insight
®
, QIAreach
®
(QIAGEN Group). Register ed names, trademarks, etc., used in thi s document, even when not specifi call y marked as such, are not to be considered unprotected by
law.
05/2021 © 2021 QI AGE N, all rights reserved.
Ordering
www.qiagen.com/contact | Technical Support support.qiagen.com | Website www.qiagen.com
