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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ECOTEST COVID-19 Antigen Nasal Test Kit

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

Device identification number
2277
CE Marking
Yes
HSC common list
×No
HSC mutual recognition
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Other
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Bordetella Pertussis, Chlamydia Pneumoniae, Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, 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 A, Rhinovirus B, SARS-CoV
Commercial Status
Commercialised
Last Update
2021-07-22 10:16:11 CET
Comments
None
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich, Double
LOD
251 AU
Calibration
Not evaluated
Crossreactivity
Evaluated
Fp
0 % none, 100% specific
Fn
0 % no false negatives occurred on antigen level at 370 pg/mL or virus level at 1×10 2.4 TCID50/mL
Precision
Evaluated
Accuracy
98.7 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.1 %
Clinical Specificity
99.8 %
Type of antigen
Nucleoprotein

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