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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

(COVID-19) IgM/IgG Antibody Rapid Test Kit

Manufactured by Bioantibody Biotechnology Co. Ltd., China - http://www.baikangbiotech.com/index.php/product/49.html 

Device identification number
2703
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Latex
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
(COVID-19) IgM/IgG Antibody Rapid Test Kit (Latex Chromatography) is based on the principle of capture immunoassay for determination of COVID-19 IgG/IgM antibodies in human whole blood, serum and plasma. When the sample is added to the test device, the sample will be absorbed into the device by capillary action, mixing with SARS- CoV-2 recombinant antigen-color latex conjugate and flowing through the pre-coated membrane. When the COVID-19 IgG antibody or IgM antibody level in the specimen is at or above the target cutoff (the detection limit of the test), the antibodies bound to the antigen- color latex conjugate are captured by anti-human IgG antibody immobilized on the Test Region (G)of the device or anti-human IgMantibody immobilized on the Test Region(M), and This produces one or two color teststrips indicating a positive result. When theCOVID-19 IgG/IgM antibodies level in thespecimen is zero or below the target cutoff,there is not a visible colored band in the TestRegion (G M) of the device. This indicates anegative result. To serve as a procedure control, a colored linewill appear at the Control Region (C), if the testhas been performed properly.
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Method
Chromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
% 0
False negatives
% 0
Precision
Evaluated
Accuracy
100 % IgG
Accuracy
100 % IgM
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
100 % IgM
Clinical Specificity
100 % IgG
Clinical Specificity
100 % IgM
Type of antigen
Nucleocapsid protein

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