CareStart™
EZ COVID-19
IgM/IgG
Rapid diagnostic test for the detection of COVID-19 IgM/IgG antibody
Access Bio’s CareStart™ EZ COVID-19 IgM/IgG
Rapid diagnostic test for the detection of COVID-19 IgM/IgG antibody
The CareStart™ COVID-19 IgM/IgG is an immunochromatographic lateral flow assay intended for the qualitative detection and differentiation of Immunoglobulin M (IgM) and Immunoglobulin G (IgG) antibodies to SARS-CoV-2 in human serum, plasma (sodium citrate, sodium heparin, or dipotassium EDTA), venous whole blood (sodium citrate, sodium heparin, or dipotassium EDTA) and fingerstick whole blood.
Testing of fingerstick whole blood specimens is limited to laboratories certified under the Clinical Laboratory Improvement Amendments of 1988 (CLIA), 42 U.S.C. §263a, that meet the requirements to perform high, moderate or waived complexity tests. Testing of fingerstick whole blood specimens is authorized for use at the Point of Care (POC), i.e., in patient care settings operating under a CLIA Certificate of Waiver, Certificate of Compliance, or Certificate of Accreditation.
- For in vitro diagnostic use only
- For prescription use only
- FDA use under Emergency Use Authorization only
- All-in-one type device
- Fast and easy to use in Point-of-Care setting
- Requires small sample volume (10 uL of fingerstick, venous whole blood, serum, or plasma)
- Fast results only in 15 min
- Detect and differentiate IgM/IgG antibodies specific to SARS-CoV-2
Clinical Performance for fingerstick whole blood against comparable method
- IgM PPAaand NPAb: 100% and 100%
- IgG PPAaand NPAb: 100% and 100%
- aPPA: Positive Percent Agreement, bNPA: Negative Percent Agreement
TEST PRINCIPLES
- 10 TEST DEVICES
- 10 ALCOHOL WIPES
- 10 ASSAY BUFFER VIALS
- 10 TRANSFER PIPETTE
- 1 PACKAGE INSERT
- 1 QUICK REFERENCE INSTRUCTIONS