• KOTEX

Access Bio, Antibody COVID-19, Corona Test Kits

Updated: Dec 8, 2020

CareSart COVID-19 IgM/IgG


Approved FDA (U.S Food & Drug Administration) Emergency Use Authorization

Type: Antibody COVID-19 Diagnostic kits

Result: within 10 mins

Manufacturer/origin: USA


SARS-CoV-2, A highly contagious novel virus, had severely impacted the U.S. and global healthcare system and economy. A rapid in vitro testing is a key component to identify and mitigate the spread. The CareStart™ Covid 19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab provides a fast and easy diagnostic tool for COVID-19 in the limited testing environment.


  • Fast and easy to use in a qualified CLIA setting

  • Detect and differentiate IgM/IgG antibody specific to SARS-CoV-2.

  • Requires small sample volume (10 uL of venous whole blood, serum, or plasma).

  • Results available in 10 minutes.

  • No equipment or training required.

  • Identify and monitor individual’s previous infection history and immune response to COVID-19.

  • Clinical performance (NIH/NCI) of 100% sensitivity and 97.5% specificity.

  • FDA and CE certified.

Purchasing or more information

chang@kotexsupplies.com







Fact Sheet For Healthcare Providers

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.
Download • 222KB

Fact Sheet For Patients

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.
Download • 173KB

IFU (Instructions for use)

5-EUA201309-Access-Bio-IFU-Serology-07-2
.
Download • 7.31MB

FDA EMERGENCY USE AUTHORIZATION

EUA201309-Access-Bio-Letter-of-Authoriza
.
Download • 274KB

Download Brochures

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.PDF
Download PDF • 3.13MB




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