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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail



Novel Corona Virus (SARS-CoV-2) Ag Rapid Test Kit

Manufactured by Jiangsu Bioperfectus Technologies Co., Ltd., China - https://www.bioperfectus.com/ 

Device identification number
2107
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Near POC / POC, Other
Physical Support
Cassette, Lateral flow
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.429 (Epsilon), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), P.1 (Gamma), C.37 (Lambda),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
AU 100
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
Past medical history and other diagnostic information is necessary to determine infection status.
Fn
Negative results should be treated as presumptive and confirmed with other diagnostic techniques.
Precision
Evaluated
Accuracy
98.79 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.06 %
Clinical Specificity
99.15 %
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