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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In the United States:
– This test has not been FDA cleared or approved;
– This test has been authorized by FDA under a EUA for use by authorized laboratories;
– This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens; and
– This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of the emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under section 564(b)(1) of the Act, 21 U.S.C. § 360bbb- 3(b)(1) unless the authorization is terminated or revoked sooner.