Biohit 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

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 within 15 minutes.
Dual band results for simple interpretation.
Multi-variable analysis of immunoglobin IgG & IgM.
Room temperature storage or refrigerated (2-30°C / 36-86°F).
Detection Window (IgM): begins to form 3-5 days post infection.
Results compared to ELISA: 99% specificity and 95% sensitivity.
Whole blood, Serum or Plasma.
Do not use beyond labeling on package.

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 Validation

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.

More Info

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

• 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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