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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 Antigen Saliva Test Kit

Manufactured by Assure Tech (Hangzhou) Co. Ltd., China - www.diareagent.com 

Device identification number
1579
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Target type
Antigen
Specimen
Saliva
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), Bordetella Pertussis, Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, Mumps Virus (MuV), 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
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, P.1 (Gamma)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
N/A
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
0 AU
Analysis of cross reactivity
Evaluated
Precision
Evaluated
Accuracy
96 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
89.1 %
Clinical Specificity
99.4 %

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