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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Novel Coronavirus (2019-nCoV) Antigen Rapid Detection kit

Manufactured by Bioscience(Tianjin) Diagnostic Technology Co., Ltd.., China - https://www.bioscience-tj.com 

Device identification number
2858
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antigen
Specimen
Nasal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
A.23.1 AT.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), B.1.1.529 (Omicron), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Product is positively evaluated by PEI with the bfarm number AT805/21
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
Method
RT-PCR
Measurement
Other
Time
20 minutes
Subclass
Sandwich
LOD
1000 TCID50/ml
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
3.4 % (4 out of 120)
Fn
0 % 2 out of 250
Precision
Evaluated
Accuracy
98.38 % (95%CI:96.52-99.41%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.67 % (95%CI:91.31%-98.94%)
Clinical Specificity
99.2 % (95%CI:96.83%-99.86)
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