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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 Rapid Test Device (Nasopharyngeal swab, Oropharyngeal swab)

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

Device identification number
2350
CE Marking
Yes
HSC common list (RAT)
Yes
Format
Manual, Near POC / POC
Physical Support
Lateral flow
Target type
Antigen
Antibody type
Monoclonal
Targets
nucleocapsid protein,
Specimen
Nasopharyngeal swab, Oropharyngeal swab
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), 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)
Pathogens detected
SARS-CoV
Lineages detected
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), P.1 (Gamma), P.2 (Zeta), P.3 (Theta), B.1.1.529 (Omicron), C.37 (Lambda),
Commercial Status
Commercialised
Last Update
2022-05-02 09:29:21 CET
Comments
update Variants detected information
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
LOD
2×10^2.4 TCID50/mL
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