Healgen COVID-19 & SARS-CoV-2 Antibody Tests

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

Positive Percent Agreement (PPA)
95.7%
Negative Percent Agreement (NPA)
99.6%
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

Sensitivity
100%
Specificity
97.5%

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

Healgen COVID-19 Antibody Test Instruction Video

In-Home Saliva PCR KIt

E. Randy Eckert, MD
Medical Director

Need Bio

Brenda Thompson,
Vice President of Human Resources

With over 20 years of Human Resource and Operations experience, Brenda brings her expertise and specialized skill set to Dental Health Management Solutions, AnyPlace MD and AnyPlace Audiology.  Her successful career includes working as an Executive Director in senior living communities and advancing her Human Resources career to Vice President of Human Resources. Brenda has a specific style and approach to balance risk-management and employee satisfaction.

Shane Stevens
CEO/Owner

Throughout my career, I have served and volunteered with several organizations including serving as an advisory board member for Concordia University Texas, an annual participant and supporter of Hounds for Heroes, the Special Olympics, and many others. I have also served as a deacon at the Austin Baptist Church since 2009. Shane earned a BS in Long-Term Health Care Administration from Texas State University in San Marcos.