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Healgen COVID-19 Serology Test Kits

Our rapid diagnostic test for IgM (acute stage) and IgG (recovery stage) antibodies can help determine previous exposure to SARS-CoV-2, the virus responsible for COVID-19
CALL TO ORDER
This product is only available to high and/or moderate complexity CLIA lab. You will screen the order and buyer information and ask for providing the CLIA lab certificate for verification.

Product Features

Our rapid diagnostic test for IgM (acute stage) and IgG (recovery stage) antibodies can help determine previous exposure to SARS-CoV-2, the virus responsible for COVID-19.
Results as soon as 2-10 minutes.
High sensitivity and specificity.
Detection Window (IgM): 3-5 days after incubation.
Dual band results for simple interpretation.
Multivariable analysis of immunoglobin IgG & IgM.
Room temperature storage or refrigerated (2-30⁰C / 36-86⁰F).
Procedural internal control included.
Buffer included.
All necessary reagents provided, and no equipment needed.

Test Procedure & Interpretation

What is the signification of the various test results?

  • IgM negative, IgG negative: Patient not exposed or too early. A medical professional should observe symptoms and epidemiology of patients. Retesting should be considered if symptoms appear or persist.
  • IgM positive, IgG positive/negative: Acute or recent infection.
  • IgM negative, IgG positive: Previous, distant infection.

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.

Specifications

  • Clinical Evaluation
    • Positive Percent Agreement (PPA): IgG 96.7%; IgM 86.7%; Overall 96.7%
    • Negative Percent Agreement (NPA): IgG 98.0%; IgM 99.0%; Overall 97.0%
  • Clinical Agreement with Characterized SamplesSensitivity: IgG 96.7%; IgM 100%; Combined 100%
    • Specificity: IgG 97.5%; IgM 100%; Combined 97.5%
    • Specimen: Whole Blood, Serum, Plasma
  • Time to Results: 10 minutes
  • Shelf Life: 24 months from the date of manufacture

More Info

More Information on the Healgen Antibody Test Kit can be downloaded below:
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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

This test has not been approved by the FDA

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