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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
Yes
HSC mutual recognition
Yes
Format
Near POC / POC, Other
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Other
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-13 05:43:08 CET
Comments
The Bioperfectus Technologies Novel Corona Virus(SARS-CoV-2) Ag Rapid Test Kit is a rapid chromatographic immunoassay intended for the qualitative detection of SARS-CoV-2 nucleocapsid antigens in nasal swab specimens, nasopharyngeal swab specimens or oropharyngeal swab specimens from symptomatic individuals who are suspected of COVID-19 or asymptomatic individuals who have had contact with confirmed COVID-19 patients but didn't show any symptoms.
Assay Type
Immuno-Antigen
Reader Required
No
Subcategory
Other
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
Nucleoprotein

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