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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 (RAT)
Yes
Format
Near POC / POC, Other
Physical Support
Card, Other
Target type
Antigen
Targets
nucleocapsid protein,
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab, Other, Saliva
Cross-reactivity (pathogens tested)
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, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type, 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, Rhinovirus A, Rhinovirus B, SARS-CoV
Lineages detected
A.23.1 AT.1 B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon), B.1.525 (Eta), B.1.526 (Iota), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3 B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2 B.1.1.529 (Omicron),
Commercial Status
Commercialised
Last Update
2022-05-02 04:41:21 CET
Comments
Lineages detected: A.23.1; AT.1;B.1.1.7(Alpha); B.1.351 (Beta); B.1.427(Epsilon); B.1.429(Epsilon); B.1.525 (Eta); B.1.526(Iota); B.1.617.1(Kappa); B.1.617.2 (Delta); B.1.617.3;B.1.621 (Mu); C.36;P.1(Gamma); P.2(Zeta); P.3 (Theta); C.37 (Lambda); B.1.616; B.1.1.529 (Omicron); B.1.526.1; B.1.526.2;
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Other
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