FDA Regulatory status of Rapcov™ COVID-19 Rapid Test
The Rapcov™ COVID-19 Rapid Test is not cleared, CLIA waived, approved, or subject to an approved investigational device exemption.
ADVAITE has completed the notification process with FDA. The FDA notification allows ADVAITE to develop and distribute the Rapcov™ COVID-19 Rapid Test for Laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high complexity tests. Link to listing of ADVAITE test on the FDA Test Notification page (See “What Laboratories and Manufacturers are Offering Tests for COVID-19?”, Question 6 – What commercial manufacturers are distributing serology test kits under the policy outlined in Section IV.D of the Policy for Coronavirus Disease-2019 Tests? (Updated 9/10))
ADVAITE has submitted an Emergency Use Authorization (EUA) request for the Rapcov™ COVID-19 Rapid Test to the FDA (EUA # 202686). The EUA request is currently under FDA review.
RapCov™ COVID-19 Rapid Test is a lateral flow immunochromatographic assay intended for the presumptive qualitative detection of IgG antibodies to the SARS-CoV-2 in fingerstick whole blood from individuals who are suspected of COVID-19 virus exposure.
The RapCov™ COVID-19 Rapid Test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. At this time, it is unknown for how long antibodies persist following infection and if the presence of antibodies confers protective immunity. Testing is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. 263a, to perform moderate and high complexity tests and/or by healthcare workers at the point-of-care, and is not recommended for at home testing. This test 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.
Results are for the detection of SARS CoV-2 IgG antibodies. IgG antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection, although the duration of time antibodies are present post-infection is not well characterized. Individuals may have detectable virus present for several weeks following seroconversion.
Laboratories within the United States and its territories are required to report all positive results to the appropriate public health authorities.
Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
False positive results for RapCov™ COVID-19 Rapid Test may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.