For Emergency Use Authorization Only | For in vitro diagnostic use | Rx Only
Product Overview
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.
Products Benefits
Related Information
* Check out the Instructions for Use and Quick Reference Instructions for more details about this product.
* Read the Flyer for our product highlights.
* Read the NCI/NIH Evaluation Report for our data and results.
* Download our Letters of Authorization (Original, Revised) from FDA.
* Download our healthcare provider fact sheet and patient fact sheet.
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