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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 Rapid Test Kit

Manufactured by Triplex International Biosciences (China) Co., LTD., China - www.tibchina.com 

Device identification number
2074
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Card
Target
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Saliva
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, 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, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-10-21 11:54:15 CET
Comments
The SARS-CoV-2 Antigen Rapid Test Kit is a colloidal gold enhanced double antibody sandwich immunoassay for the qualitative determination of nucleocapsid protein (N protein) from SARS-CoV-2 antigen.The types of test samples are Nasal swab,Nasopharyngeal swab,Oropharyngeal swab,or Saliva.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
40 TCID50/ml (40-100TICD 50/ml)
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
1.49 %
Fn
0.09 %
Precision
Evaluated
Accuracy
99.54 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.51 %
Clinical Specificity
99.91 %
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