Now Available
covid-19 HEALGEN Test:
  • Results within 10 minutes.
  • Rapid test kit
  • 25 tests
  • Visual read
  • Whole blood, Serum or Plasma.
  • Cassette format
  • Lateral flow immunochromatographic assay
  • Antibody test
  • UNSPSC Code: 41116205

 

 

 

How it Works
Available to Healthcare Professionals + Labs

Wytcote's SARS-CoV-2 IgM+IgG antibody kit is only approved for sale to healthcare professionals and labs that have the appropriate licenses.

Study Valuation

In a recent study conducted at Yale University, the SARS-CoV-2 IgM + IgG detection specificity was near perfect (97-100%) and sensitivity was 94% for patients who were tested at least two weeks from initial symptom onset.

Available to CE & FDA EUA Markets

The SARS-CoV-2 IgM+IgG antibody kit is CE certified and was issued an EUA by the FDA. The test is ONLY for sale to markets and governments with appropriate laboratory or healthcare certification and is NOT currently available for personal use.

SARS-CoV-2 IgM+IgG Antibody Kit

The SARS-CoV-2 antibody kit is packaged with 25 test cassettes, 25 pipettes and 1 bottle of diluent. The test is manufactured by Biohit Healthcare in China. Lancets are sold separately and can be added to the order at time of purchase.

Download further information
Download
Letter
Download
Information For Healthcare Provider
Download
Information for recipient
Download
the serology test report
Disclaimers

• This test has been authorized by FDA under an EUA for use by authorized laboratories.
• 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 the 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

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