GenBody COVID-19 Rapid Ag Point of Care Test

 The GenBody COVID-19 Ag is an immunochromatographic rapid diagnostic test (RDT) intended for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) or anterior nasal (AN) swab specimens from individuals who are suspected of COVID-19 by their healthcare provider within the first six days of symptom onset, or from individuals without symptoms or other epidemiological reasons to suspect COVID-19 when tested twice over two or three days with at least 24 hours and no more than 48 hours between tests. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform moderate, high or waived complexity tests. This product is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation.

The Advin COVID-19 Antigen Test @ Home is a qualitative immunoassay test for the detection of nucleocapsid protein antigens from SARS-CoV-2 in anterior nasal swab specimens. 

This test is authorized for both CLIA Waived Point-of-Care use and non-prescription home use with self-collected anterior nasal swab samples from individuals aged 14 years or older or with adult-collected anterior nasal samples from individuals aged 2 years or older. This test is authorized for individuals with symptoms of COVID-19 within the first 7 days of symptom onset when tested at least twice over three days with at least 48 hours between tests, and for individuals without symptoms or other epidemiological reasons to suspect COVID-19, when test at least three times over five days with at least 48 hours between tests.

INDICAID® is a fast, reliable, and affordable Professional  COVID-19 Rapid Antigen Test for use by laboratories, pharmacies, urgent care clinics, nursing homes, hospitals, businesses/employers, schools, sports, events, and more, that have a CLIA certified technician to administer and/or supervise the tests.

• The INDICAID COVID-19 Antigen Test is a lateral flow immunoassay intended for the qualitative detection of nucleocapsid protein antigen from SARS-coV-2 indirect anterior nasal swab specimens from individuals who are suspected of COVID-19.
• For use with direct anterior nasal and nasopharyngeal swab specimens, non-invasive test procedures
• Rapid results within 20 minutes
• Detect SARS-CoV-2 nucleocapsid protein antigen
• Effective in Detecting Omicron Variant (B.1.1.529) and specific variants of new coronavirus.*
• Accuracy: Sensitivity 88.9%; Specificity 96.8%; Overall accuracy 95.6%

*Detectable variants include Alpha (B.1.1.7), Beta (B.1.351), Gamma (P.1), Delta (B.1.617.2), Delta Plus (AY.1 and AY.2) and Omicron (B.1.1.529)