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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test Kit

Manufactured by Beijing Jinwofu Bioengineering Technology Co.,Ltd., China - jwfbio.com 

Device identification number
2072
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target
Antigen
Specimen
Anterior nasal swab, Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Cytomegalovirus (CMV), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV), Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A, Rhinovirus B
Commercial Status
Commercialised
Last Update
2021-07-13 05:54:34 CET
Comments
)Do not use this kit beyond the expiration date printed on the outside carton. 2)This test has been authorized only for the detection of proteins from SARS-CoV-2, not for any other viruses or pathogens; 3)To avoid erroneous results, specimens must be processed as indicated in the test procedure section.Proper specimen collection, storage and transport are critical to the performance of this test 4)The used Jinwofu Novel Coronavirus (SARS-CoV-2) Antigen Rapid Test cards should be treated as hazardous waste. 5)Our company's novel coronavirus detection kit is a product developed for novel coronavirus nucleoprotein, which only detects nucleoprotein, but cannot detect spike protein and its variation structure. Therefore, spike protein and UK variant do not affect the detection ability and accuracy (sensitivity and specificity) of our company's novel coronavirus antigen detection kit for novel coronavirus.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
30 minutes
Subclass
Sandwich, Double
LOD
100 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0 %
Fn
3.125 %
Precision
Evaluated
Accuracy
98.82 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
% 96.88%
Clinical Specificity
100 %
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