Antibody Testing Information

The COVID-19 IgG/IgM Rapid Test Cassette is a lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2. The Test Cassette is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

  • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 10 minutes
  • Shelf Life: 24 months from the date of manufacture

Performance

Antibody
Performance Measure
Estimate of Performance
95 Confidence Interval
IgM Sensitivity 100% (30/30) (88.7%; 100%)
IgM Specificity 100% (80/80) (95.4%; 100%)
IgG Sensitivity 96.7% (29/30) (83.3%; 99.4%)
IgG 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 at prevalence = 5% 67.8% (35.0%; 88.4%)
Combined NPV at prevalence = 5% 100% (99.4%; 100%)

Results

INTERPRETATION OF RESULTS

NEGATIVE:
The colored line in the control line region (C) changes from blue to red. No line appears in the test line regions M or G. The result is negative.

IgM POSITIVE:
The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region M. The test result indicates the presence of IgM anti-SARS-Cov-2 antibodies.

IgG POSITIVE:
The colored line in the control line region (C) changes from blue to red, and a colored line appears in test line region G. The test result indicates the presence of IgG anti-SARS-CoV-2 antibodies

IgG and IgM POSITIVE:
The colored line in the control line region (C) changes from blue to red, and two colored lines appear in test line regions M and G. The test results indicate the presence of IgM and IgG anti-SARS-CoV-2 antibodies.

INVALID:
The Control line is partially red and fails to completely change from blue to red. Insufficient specimen volume or incorrect procedural techniques are the most likely reasons for control line failure. Review the procedure and repeat the test with a new test cassette. If the problem persists, discontinue using the test kit immediately and contact your local distributor.

Limitations

This test has been authorized by FDA under an EUA for use by authorized laboratories.
This test has not been FDA cleared or approved.
This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
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.
Not for the screening of donated blood.

Product Information

Fact Sheets

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Please note the tests are not for private use. Tests should be performed by trained healthcare personnel.