Novel Coronavirus (2019-nCoV) Antigen Rapid Test
Manufactured by Bioscience(Tianjin) Diagnostic Technology Co. Ltd., China - https://www.bioscience-tj.com
Device identification number
2623
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Card, Lateral flow
Target type
Antigen
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
Adenovirus, 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 H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), Mycoplasma Pneumoniae, Respiratory Syncytial V (RSV), Rhinovirus, Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
This kit is used for in vitro qualitative detection of novel coronavirus (2019-CoV) antigens in human anterior nasal swab samples, and is used for clinical auxiliary diagnosis of novel coronavirus infection. For professional IVD use only.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Validity test kit
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
1000 TCID50/ml
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
1.73 %
False negatives
1.59 %
Precision
Evaluated
Accuracy
98.38
Reproducibility
Not evaluated
Robustness
Not evaluated
Clinical Sensitivity
96.67 %
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