For Emergency Use Authorization Only | For in vitro diagnostic use | Rx Only
The RapCov™ Rapid COVID-19 Test is a lateral flow immunoassay intended for the qualitative detection of IgG antibodies to the SARS-CoV-2 virus in human fingerstick whole blood samples. The Test is intended for use to identify individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.
Testing of fingerstick whole blood specimens 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 high, moderate, or waived complexity tests. Testing of fingerstick whole blood specimens is also authorized for use at the Point of Care (POC), i.e., inpatient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
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