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
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
Fact Sheet For Healthcare Providers
Fact Sheet For Patients
IFU (Instructions for use)
FDA EMERGENCY USE AUTHORIZATION