Biohit SARS-CoV-2 IgM/IgG Antibody Test


The Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Qty.: 25 TESTS

This test has been authorized by FDA under an EUA for use by authorized laboratories.

Manufacturer

Biohit HealthCare Co. Ltd. was formed in 2013 and is one of China’s leading lateral flow assay developers. Receiving ISO13485, Biohit has sold its SARS-CoV-2 antibody and antigen tests to countries across the world.

Clinical Studies

  • 98.9% Sensitivity, 95.0% Specificity (N>1000, including FDA Study)
  • Specificity testing: No cross-reaction with other species
  • Interference testing: No interfering drugs or other factors identified

*FDA clinical study. See Instructions for Use for additional clinical data.

Specifications

Intended Use
Lateral flow immunoassay intended for the qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2.

Who Can Perform Testing
CLIA-certified laboratories qualified to perform medium or high complexity tests.

Time to Result
10-15 minutes

Sample Types

  • Whole blood
  • Plasma from anti-coagulated blood (heparin/EDTA/sodium citrate)
  • Serum

Controls
Internal control lines appear when test is ready to be read.

Components
Individually sealed test cassettes in aluminum foil pouch with desiccant. Each cassette contains an IgM strip and an IgG strip, side-by-side. Buffer solution diluent.

Storage & Handling
Cap and store the serum or plasma samples at 2-8°C for no more than 24 hours prior to testing. For long-term storage, freeze the serum or plasma samples at -20°C. Avoid multiple freeze-thaw cycles. Mix thawed samples thoroughly by low speed vortexing or by inverting 10 times. Bring samples to room temperature prior to testing for at least 30 minutes. Visually inspect the samples. If layering or stratification is observed, continue mixing until samples are visibly homogeneous.

FDA Disclaimer

  • • 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.