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4
Procedural Controls:
ID NOW COVID-19 contains an internal control that has been designed to control for sample inhibition and
assay reagent function. In positive samples where target amplification is strong, the internal control is
ignored, and the target amplification serves as the ‘control’ to confirm that the clinical sample was not
inhibitory, and that assay reagent performance was robust. At a very low frequency, clinical samples can
contain inhibitors that may generate invalid results.
Procedural Control Valid displayed on the instrument screen indicates that the assay reagents m aintained
their functional integrity and the sample did not significantly inhibit assay performance.
External Positive and Negative Controls:
Good laboratory practice suggests the use of positive and negative controls to ensure that test reagents are
working and that the test is correctly performed. ID NOW COVID-19 kits contain a Positive Con t rol Swab
and Sterile Swabs that can be used as a Negative Control Swab. These swabs will monitor the entire assay.
Test these swabs once with each new shipment received and once for each untrained operator. Further
controls may be tested in order to conform with local, state and/or federal regulations, accrediting groups,
or your lab’s standard Quality Control procedures.
CONTROL SWAB PROCEDURE
Positive and Negative Controls should be tested following the Run QC Test instructions on the ID NOW
Instrument. A Positive Control Swab is included in the kit. Use a sterile swab provided in the kit as the
Negative Control Swab. Refer to Quality Control Swab Test Procedure or Instrument User Manual for
further details.
Note: The ID NOW Instrument reports QC results as Pass or Fail.
If the correct control results are not obtained, do not perform patient tests or report patient results. Contact
Technical Support during normal business hours before testing patient specimens.
SPECIMEN COLLECTION AND HANDLING
Use freshly collected specimens for optimal test performance. Inadequate specimen collection or improper
sample handling/storage/transport may yield erroneous results. Refer to the CDC Interim Guidelines for
Collecting, Handling, and Testing Clinical Specimens from Persons for Coronavirus Disease 2019 (COVID-
19) https://www.cdc.gov/coronavirus/2019-nCoV/lab/guidelines-clinical-specimens.html
ID NOW COVID-19 is intended for testing a swab directly without elution in viral transport media as
dilution will result in decreased detection of low positive samples that are near the limit of detection of the
test.
Follow Standard Precautions when handling clinical specimens, all of which may contain potentially
infectious materials. Standard Precautions include hand hygiene and the use of personal protective
equipment (PPE), such as laboratory coats or gowns, gloves, and eye protection.
To minimize risk of contamination of PPE and swab package during sample collection, it is recommended
to widely open the package by pulling from the top down. Carefully remove the swab and perform sample
collection.
Throat Swab
For optimal test performance, use the swabs provided in the test kit. Alternatively, foam, polyester,
Hy draFlock® and nylon flocked throat swabs can be used to collect throat swab samples.
Rayon swabs are not suitable for use in this assay.
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