This product has not been FDA cleared or approved; but has been authorized by FDA under an EUA; This product has been authorized only for the detection of proteins from SARS- CoV-2, not for any other viruses or pathogens; and, The emergency use of this product is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Federal Food, Drug and Cosmetic Act, 21 U.S.C. § 360bbb-3(b)(1), unless the declaration is terminated or authorization is revoked sooner.
- The Well BioTech COVID-19 IgG/IgM Rapid Test Device is authorized for use in laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet requirements to perform high, moderate or waived complexity tests. This test is also 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 to test fingerstick whole blood specimens.
- Please refer to the Well BioTech COVID-19 IgG/IgM Rapid Test Device instructions for use for additional information.
- Test kits come in box of 20 ($10.95/test, $219/box)
- 20 cases/pallet
- The COVID-19 IgG/IgM Rapid test Device is a simple lateral flow immunoassay for the direct detection of anti-SARS-CoV-2 IgG/IgM antibody
- The rapid test will provide a presumptive diagnosis of COVID-19 in a mere 15 minutes
- Test either whole blood, plasm, or serum
- IgG and IgM combined test – both have a 95% confidence interval
- Use COVID-19 IgG/IgM Rapid Test Kits under professional supervision
What does it mean if the specimen tests positive for antibodies against the virus that causes COVID-19?
A positive test result with the SARS-CoV-2 antibody test indicates that antibodies to SARS-CoV-2 were detected, and the individual has potentially been exposed to COVID-19.
Antibodies to SARS-CoV-2 are generally detectable in blood several days after initial infection. Individuals may have detectable virus present for several weeks following seroconversion. If IgG antibodies are present, it
often indicates a past infection but does not exclude recently infected patients who are still contagious.