COVID-19 IgG/IgM Rapid Test Cassette
The FDA Emergency Use Authorized Healgen COVID-19 IgG/IgM Rapid Test Cassette delivers qualitative, differential analysis of IgM and IgG antibodies in whole blood, serum and plasma specimens within 10 minutes. Results are visually read and are indicative of recent or distant exposure to SARS-CoV-2. Test performance demonstrates overall sensitivity of 100% and specificity 97.5%. This product is intended for professional use and not for home use.
Rapid COVID-19 Antigen Test
The recently launched COVID-19 Antigen Test provide qualitative, visually read results within 15 minutes. The test is intended to detect nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal swabs directly from individuals within the first 10 days of symptom onset. Interim test performance demonstrates 97.3% sensitivity and 99.6% specificity. The specimen is aliquoted directly on the device, where no instrumentation or complex sample preparation is required to perform the test. All necessary reagents and materials needed to perform the test are included within the kit.