FDA Grants EUA To GenBody COVID-19 Antigen Test

South Korea-based GenBody has received Emergency Use Authorization from the FDA for its GenBody COVID-19 Ag antigen test.

The product is an immunochromatographic rapid diagnostic test that can identify the SARS-CoV-2 antigen in direct nasopharyngeal or anterior nasal swab specimens from individuals within the first six days of symptom onset.

The test is authorized for use in patient care settings, but test analysis is limited to laboratories certified under the Clinical Laboratory Improvement Amendments (CLIA) to perform moderate, high or “waived” complexity tests. Under CLIA, waived tests are simple tests with a low risk for an incorrect result.