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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 Test

Manufactured by Gaobeidian PRISES Biotechnology Co. Ltd., China - www.prisesbio.com 

Device identification number
2781
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasopharyngeal swab
Cross-reactivity (pathogens tested)
SARS-CoV
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This product is used for in vitro qualitative detection of the antigen of novel coronavirus in human nasopharyngeal swabs. SARS-COV-2 Antigen Rapid Test is a test and provides a preliminary test result to aid in the diagnosis of infection with novel Coronavirus. Any interpretation or use of this preliminary test result must also rely on other clinical findings as well as on the professional judgment of health care providers. Alternative test method(s) should be considered to confirm the test result obtained by this test. It is valid for 24 months from date of manufacturing.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunochromatography
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich, Double
Calibration
Not evaluated
Analysis of cross reactivity
Not evaluated
False positives
0.83 % (2/240)
False negatives
7.5 % (6/80)
Precision
Evaluated
Accuracy
97.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.5 %
Clinical Specificity
99.2 %
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