BioHit SARS-CoV-2 Antigen Rapid Test Kit (25 count)


This test was manufactured by BioHit Healthcare (Hefei) Co., Ltd. for in vitro detection of the antibodies associated with SARS-CoV-2, the virus causing coronavirus disease 2019 (“COVID-19”). In response to SARS-CoV-2 infection, your body produces specific immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies. This test is designed to confirm the presence of IgM and/or IgG antibodies in your blood. A study of 226 samples from BioHit Healthcare (Hefei) Co., Ltd has shown the test to be relatively precise in detecting the presence of IgM and/or IgG antibodies based on a clinical experiment conducted under strict controls and designed with blinded and controlled features. (Please see the en- closed Clinical Examination Results Sheet for a more detailed description of the study and its results.)

SKU: TKITGEN25-1 Categories: , Tag:


Test kits in stock and ship directly from our center of excellence in Golden, CO.

Storage and Stability

Store as packaged in the sealed pouch at room temperature or refrigerated (4-30℃ or 40-86℉). The test device is stable through the expiration date printed on the sealed pouch.

The test must remain in the sealed pouch until use.


Do not use beyond the expiration date.

Test cassette is stable for 12 months from the date of production when stored properly in unopened aluminum foil pouches with desiccant.

Download FDA EUA letter of authorization here.

FDA Disclaimer: Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals. Results from antibody testing should not be used as the sole basis to diagnose or exclude SARS-CoV-2 infection or to inform infection status. 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.Not for the screening of donated blood.

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