COVID-19 Antibody Rapid Test Device

Detect the presence of SARS-CoV-2 IgM and IgG antibodies instantly from a whole blood sample collected from a minimally-invasive fingerstick blood collection process.

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CLIA Waived

FDA EUA Point of Care COVID-19 Test

This test is authorized for use with point-of-care finger stick whole blood specimens. Father IgM/IgG for COVID-19 within 15 minutes at the point of care/collection. Patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance or Certificate of Accreditation are authorized to use the COVID-19 rapid testing solution.

Find out how the COVID-19 testing solution can work for your healthcare practice or to learn more about how to obtain the correct certification contact us at: (757) 398-8400 or sales@kermamedical.com

COVID-19 Facts

antibody igg igm rapid testing covid test
The COVID-19 Antibody Rapid test will detect antibodies 5 to 7 days after symptoms first appear.
The test will show clear results in 15 minutes, unlike a PCR test, which can take hours.
The COVID-19 Antibody Rapid Test is cost effective, at approx. 5% of the cost of a PCR test.

Test Procedure

antibody test procedure instructions steps IFU

Result Interpretation

antibody test results

Detection Window

antibody test results

Clinical Data

antibody clinical data chart
IgG IgM assay results

Additional information:

  • This test has been authorized by FDA under an EUA for use by authorized laboratories.
  • This test has not been FDA cleared or approved.
  • This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens.
  • This test 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 Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.
  • Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
  • This product is intended for professional use and not for home use.
  • Not for the screening of donated blood.