Healgen Scientific LLC, COVID-19 IgG/IgM Rapid Test Cassette

Achieve fast and accurate COVID-19 antibody results with the one-step Healgen Lateral Flow Sars-CoV-2 IgM/IgG Rapid Test. This FDA Emergency Use Authorized (EUA) test features dual IgM/IgG antibody detection to aid in identifying patients with an immune response indicating a recent or prior COVID-19 infection. This test provides results in 10 minutes and can be stored at room temperature.

SKU: GCCOV-402a Category:

Description

Achieve fast and accurate COVID-19 antibody results with the one-step Healgen Lateral Flow Sars-CoV-2 IgM/IgG Rapid Test. This FDA Emergency Use Authorized (EUA) test features dual IgM/IgG antibody detection to aid in identifying patients with an immune response indicating a recent or prior COVID-19 infection. This test provides results in 10 minutes and can be stored at room temperature.

Product Features:

  • Small sample size (5 uL Serum/Plasma, 10uL Whole Blood)
  • Results in 10 minutes
  • Room temperature storage
  • Detects both IgM and IgG antibodies
  • FDA Emergency Use Authorized (EUA) for moderate complexity

Clinical, Operational and Financial Outcomes:

Clinical Outcomes

  • Fast results (10 mins)
  • Sensitivity
    • 99% IgM; 96.7% IgG; 99% Combined
  • Specificity
    • 99% IgM; 97.5% IgG; 97.5% Combined

Operational Outcomes

  • Small sample size (5 uL Serum/Plasma, 10uL Whole Blood)
  • Intuitive w/minimal training
  • Room temperature storage

Financial Outcomes

  • Competitively priced

Ordering Information:

Product Description Catalog #
FDA EUA Authorized COVID-19 IgG/IgM Rapid Test Cassette GCCOV-402a

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.

For more information about test performance, please see the attached independent evaluation report published by the Frederick National Laboratory for Cancer Research (FNLCR), a Federally Funded Research and Development Center (FFRDC) sponsored by the National Cancer Institute (NCI) as well as Healgen’s Instruction for Use.

Fact Sheet for Healthcare Providers

Fact Sheet for Recipients