utilizing lateral flow technology that is used for the qualitative, differential detection of both anti-SARS-CoV-2 IgM and IgG antibodies. In general, antibodies can be detected 1-3 weeks after infection. This test is intended to screen patients for COVID-19. Combining RNA and Antibody tests can significantly raise the sensitivity for detecting COVID-19 in infected individuals.
Can I freeze the device for long-term storage?
The device should never be frozen. If refrigerated, allow the buffer, specimen and device to reach room temperature before use.
What is the significance of the various test results?
IgM negative, IgG negative:
Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.
IgM positive, IgG positive/negative:
Acute or recent infection.
IgM negative, IgG positive:
Previous, distant infection.
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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
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.
This product is intended for professional use and not for home use.
|Antibody||Performance Measure||Estimate of Performance||95% Confidence Interval
|lgM||Sensitivity||100% (30/30)||(88.7%; 100%)
|lgM||Specificity||98.8% (79/80)||(93.3%; 99.8%)
|lgG||Sensitivity||90.0% (27/30)||(74.4%; 96.5%)
|lgG||Specificity||100% (80/80)||(95.4%; 100%)
|Combined||Sensitivity||100% (30/30)||(88.7%; 100%)
|Combined||Specificity||98.8% (79/80)||(93.3%; 99.8%)
|Combined||PPV per prevalence = 5%||80.8%||(40.9%; 96.0%)
|Combined||NPV per prevalence = 5%||100%||(99.4%; 100%)