Biohit Healthcare SARS-CoV-2 Antigen Test Kit (25-pk)

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What is a COVID-19 antigen test

The SARS-CoV-2 Antigen Rapid Test is used to detect the nucleocapsid protein in the SARS-CoV-2 virus, which causes the disease COVID-19. With clear results in 15 minutes without the need for a laboratory, you can know if you have been exposed to the SARS-CoV-2 virus. This test is most accurate in detecting antigen levels in patients after at least 3 days after suspected exposure.

Antigen test vs. Antibody test

While antibodies and antigens are both typically proteins, a positive antigen test reflects an active infection, while a positive antibody test reflects recent or past infection.

CLINICAL DATA (N = 139):

Specificity (these high rates minimize false positives): 100%

Sensitivity: 91.2%

NOTE: For in vitro diagnostic use only

 

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CERTIFICATION STATUS

Pending approval by the U.S. FDA for Emergency Use Authorization (EUA) under the provisions outlined in Section D of Policy for Diagnostic Tests for Coronavirus Disease-2019

European CE certified

Australian TGA approved

  • This test has not been reviewed by the FDA
  • 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.

ABOUT THE MANUFACTURER

Founded in 1988, Finnish biotechnology company Biohit Oyj develops in vitro diagnostic technology used routinely in clinical laboratories, endoscopy units and practice clinics as well as in academic and clinical research settings to promote early diagnosis. In June 2018, Biohit HealthCare (Hefei) Co. Ltd acquired Finnish Biohit Oyj and became the largest shareholder of the listed company. Biohit Oyj supplies the necessary raw materials and reagents used to produce serology test kits at the ISO 13485-certified manufacturing facility in China. On March 18, 2020, Biohit SARS-CoV-2 IgM/IgG Antibody Rapid Test Kit passed the European CE certification and export qualifications. On June 18th 2020, Biohit SARS-CoV-2 IgM/IgG Antibody Test Kit (Colloidal Gold Method) was granted U.S. Food and Drug Administration (FDA) Emergency Use Authorization (EUA).