

CARESTART™
COVID-19
IgM/IgG
Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab
ORDERING INFO


ACCESS BIO’S CARESTART™ COVID-19 lgM/lgG
RAPID COVID-19 Testing TOOL
NOW FDA EMERGENCY USE AUTHORIZED
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.
- CE certified.
TEST PRINCIPLES
The CareStart™ Covid 19 IgM/IgG Rapid Diagnostic Test for the Detection of SARS-CoV-2 IgM/IgG Ab is a lateral flow immunochromatographic assay which can differentiate SARS-CoV-2 Immunoglobin IgM and IgG antibodies in human blood specimens in a single test within 10 minutes.
PROCEDURE
Procedure
1Add 10µl of the sample (whole blood, serum, or plasma).
2Add 1 drop of Assay
Buffer3Read the test results after 10 minutes.
RESULTS INTERPRETATION
Results Interpretation
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Covid-19 Positive
-
Covid-19 Negative
-
Invalid
-
ORDERING INFORMATION
Order Information
Cat. No.
RCHM-02071
PACKAGE UNIT
20 Tests / Kit
Kit Component
20 Test devices
20 Assay buffer
20 Extraction vials and caps
20 Specimen collection swabs
1 Positive and 1 negative control swabs
1 Instructions for UsePRODUCT DOCUMENTATION