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
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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:

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

Real Time Monitoring of Important Biometrics
Fully Compatible with WytCote's AutobahnTM
Secure Health Data Transmissions.
Personalized Care Anywhere
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Corporate Headquarters

3 Park Plaza, Suite 480
Irvine CA 92614
(877) 472-5587

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