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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography)

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

Device identification number
2704
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza B, MERS-CoV, Respiratory Syncytial V (RSV) Type B, SARS-CoV
Pathogens detected
SARS-CoV
Information on antigen epitope targeted by the antibodies used in the design of the device
clone1 binding site: INTNSSP(74-80) clone2 binding site: GTRNPANN(147-154)
Lineages detected
B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.2 (Delta), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
SARS-CoV-2 Antigen Rapid Detection Kit (Latex Chromatography) is a lateral flow chromatographic immunoassay. It has two pre-coated lines, “T” Test line and “C” Control line on the nitrocellulose membrane. Mouse monoclonal anti-SARS-CoV-2 antibodies are coated on the test line region and Goat anti-chicken IgY antibodies are coated on the control region. When the specimen is processed and added to the sample well, SARS-CoV-2 antigens in the sample interact with the SARS-CoV-2 Antibody-labeled conjugate forming antigen-antibody color particle complexs .The complexs migrate on the nitrocellulose membrane via capillary action until the test line, where they are captured by the mouse monoclonal anti-SARS-CoV-2 antibodies. A colored test line is visible in the result window if SARS-CoV-2 antigens are present in the specimen and the intensity depends upon the amount of SARS-CoV-2 antigen. When the SARS-CoV-2 antigens in the specimen does not exist or is below the detection limit, there is not a visible colored band in the Test line (T) of the device. This indicates a negative result. Neither the test line nor control line are visible in the result window prior to applying the specimen. A visible control line is required to indicate the result is valid.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other ()
Method
Chromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
28.8 (pg/ml (Nucleocapsid protein Concentration))
Analysis of cross reactivity
Evaluated
False positives
6 AU
False negatives
2 AU
Accuracy
98.4 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.9 % (Antigen)
Clinical Specificity
98.11 % (Antigen)
Type of antigen
Nucleocapsid protein
Notes
INTNSSP(74-80) clone2 binding site:GTRNPANN(147-154)

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