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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

FASTEP COVID-19 Antigen Rapid Test Device

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

Device identification number
2364
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Chlamydia Pneumoniae, Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A, Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B, Influenza B Victoria, Influenza B Yamagata, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2021-10-04 08:55:51 CET
Comments
PEI EVALUATED
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
501 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.86 % (A total of 1036 SARS-CoV-2 negative samples were tested, 9 samples were positive by this test)
Fn
2.3 % (A total of 128 SARS-CoV-2 positive samples were tested, 3 samples were negative by this RDT)
Precision
Evaluated
Accuracy
99 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
97.7 %
Clinical Specificity
99.1 %
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