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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
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