SARS-CoV-2 Total Antibody Rapid Test Kit
Manufactured by Jiangsu Mole Bioscience Co. Ltd., China - http://en.molechina.com/
Device identification number
2339
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antibody
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 Total Antibody Rapid Test Kit is a lateral flow chromatographic immunoassay for the qualitative detection of total antibodies to SARS-CoV-2 in human whole blood, serum or plasma specimen.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Membrane-based
LOD
10 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
6.31 %
False negatives
1.06 %
Precision
Evaluated
Accuracy
94 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
93.69 %
Clinical Specificity
98.94 %
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