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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV Antigen Rapid Test Cassette

Manufactured by Beijing Applied Biological Technologies Co. Ltd., China - https://www.x-abt.com/ 

Device identification number
3068
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cartridge, Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein
Specimen
Anterior nasal swab
Cross-reactivity (pathogens tested)
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, Epstein-Barr Virus (EBV), Hemophilus Influenzae, Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus, Varicella Zoster Virus (VZV)
Lineages detected
AT.1, B.1.1.529 (Omicron), B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), C.37 (Lambda), P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
other pathogens tested for cross-reactivity: enterovirus, Measles virus, Human cytomegalovirus, Legionella, Staphylococcus aureus, Streptococcus pneumoniae, Streptococcus pyogenes, Klebsiella pneumoniae, Aspergillus fumigatus, Candida albicans, Candida glabrata, Cryptococcus neoformans
Assay Type
Immuno-Antigen
Self Test
Yes
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
200 TCID50/ml
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
5.53 %
False negatives
9.9 %
Precision
Evaluated
Accuracy
94.47 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.1 %
Clinical Specificity
99.07 %
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