Pre-EUA Antigen test
The Rapid COVID-19 Antigen Test is an in-vitro immunochromatographic assay for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal (NP) swab specimens directly from individuals who are suspected of COVID-19 by their healthcare provider. It is intended to aid in the rapid diagnosis of SARS-CoV-2 infections. The Rapid COVID-19 Antigen Test does not differentiate between SARS-CoV and SARS-Cov-2.
COVID-19
Healgen Rapid cOVID-19 Antigen Test
USFDA Emergency Use Authorization pending for POC; For Use only by high Complex laboratories
- Highly specific, and selective for SARS-CoV-2 nucleocapsid protein
- Simple, visual results within 15 minutes
- Specimen Type: Direct Nasopharyngeal Swab*
- No instrument required
Clinical Evaluation
Warning
- This test has not been reviewed by the FDA
- Negative results do not rule out SARS-CoV-2 infection, particularly those who have been in contact with the virus. Follow up testing with a molecular diagnostic test should be considered to rule out infection in these individuals.
- Use of this test is limited to laboratories certified to perform high complexity testing, including testing at point-of-care when the site is covered by the laboratory’s CLIA certificate of high-complexity testing.
- This test is not for home-use or at-home specimen collection.
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COVID-19
Healgen Rapid cOVID-19 Antibody Test
Healgen COVID-19 Antibody Test
The COVID-19 IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma) is authorized for the detection of IgG and IgM antibodies against SARS-CoV-2 in human serum, plasma (EDTA, lithium heparin, and sodium citrate), or venous whole blood. This test detects human SARS-CoV-2 IgM and IgG that are generated as part of the human adaptive immune response to the COVID-19 virus and is to be performed only by using human serum, plasma, or venipuncture whole blood specimens.
For Use only by high Complex laboratories
Clinical Evaluation
Warning
- 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.
- The antibody test cannot be promoted for Fingerstick use
