SARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit
Manufactured by Jiangsu Mole Bioscience Co. Ltd., China - http://en.molechina.com/
Device identification number
2329
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgA, IgG, IgM
Specimen
Plasma, Serum, Whole blood, Whole blood with anti-coagulants
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 IgM-IgG-IgA Combined Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of IgG, IgM and IgA antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
5 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.88 % IgA
False positives
2.02 % IgM
False positives
2.04 % IgG
False negatives
3.96 % IgA
False negatives
8.41 % IgG
False negatives
7.55 % IgM
Precision
Evaluated
Accuracy
98 % IgG
Accuracy
98 % IgM
Accuracy
97 % IgA
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.12 % IgA
Clinical Sensitivity
97.98 % IgM
Clinical Sensitivity
97.96 % IgG
Clinical Specificity
91.58 % IgG
Clinical Specificity
92.45 % IgM
Clinical Specificity
96.04 % IgA
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