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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CareStart(TM) COVID-19 IgM/IgG

Manufactured by Access Bio, Inc., United States - www.accessbiodiagnostics.com 

Device identification number
2573
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Manual, Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood, Whole blood with anti-coagulants
Pathogens detected
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2021-08-25 06:22:01 CET
Comments
The kit contains the following items - 25 test devices - 1 assay buffer vial - 25 blood transfer pipettes - 1 instructions for use
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
6 AU ( (IgG-/IgM-))
Fn
0 AU (IgG+/IgM+)
Fn
1 AU ((IgG+/IgM-))
Fn
1 AU ((IgG-/IgM+))
Precision
Evaluated
Accuracy
94.2 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
91.2 %
Clinical Specificity
97.1 %
Type of antigen
Other

The database contains publicly available In Vitro Diagnostic Medical Devices for COVID-19 and it is being updated periodically. Please note that additional performance (as retrieved from manufacturers web pages) is provided only for devices commercially available with CE-IVD mark. Acknowledgements