COVID-19 Detection Kit
COVID-19 Detection Kit
DISCOVID-branded COVID-19 IgM/IgG Antibody Test Kit is discontinued under the policy stated in Section IV.D of the FDA’s Policy for Coronavirus Disease-2019 Tests.
DISCOVID has been evaluated at the Clinical Microbiology Laboratories, Beth Israel Deaconess Medical Center, Harvard Medical School, Boston, Massachusetts, with 93% sensitivity and 95.9% specificity in patients that have symptom onset ≥ 7 days.
DISCOVID is also being evaluated by National Institutes of Health’s National Cancer Institute (NIH/NCI).
In response to the quick detection of SARS-CoV-2 infection, we developed a rapid yet simple kit, DISCOVID, that takes <5 minutes to get the results. DISCOVID detects the presence of COVID-19 disease-specific IgM and IgG antibodies in a small drop of patient’s blood. The result of the test can be read/recorded without the need for expensive equipment during the test.
COVID-19 IgM/IgG Antibody Test Kit (Colloidal Gold)
INTENDED USE & LIMITATIONS
- DISCOVID is used by CLIA laboratories for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human serum, plasma or venous whole blood specimens suspected of having COVID-19.
- For professional in vitro diagnostic use only, and not for home testing.
- Test results from DISCOVID should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status, and must be considered with other clinical information available to the physicians.
- 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.
- DISCOVID is not for the screening of donated blood.
- The reference value of serological antibody detection is limited for the immune-compromised patients or patients who receive immunosuppressive therapy.
- Use appropriate personal protective equipment when collecting and handling the specimens.
- Optimal results may be obtained when starting to test >7-10 days after symptom onset. If symptom persists while no or weak G/M band appears, repeat the test in 2-3 days.
- For Emergency Use Authorization (EUA) Only.
The external positive and negative controls should be tested to ensure the proper performance of DISCOVID. The controls are not provided within the kit but can be purchased as accessory reagents.