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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 Test Kit

Manufactured by Chongqing M&D Biotechnology Co. Ltd, China - www.MDfastcheck.com 

Device identification number
2150
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Lateral flow
Target
Antigen
Specimen
Nasopharyngeal swab
Pathogens detected
Adenovirus, Adenovirus 3, Adenovirus 7, Adenovirus Subtype B, Adenovirus Subtype C, 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), Influenza A H1N1, Influenza A H3N2, Influenza B Victoria, Influenza B Yamagata, MERS-CoV, Mumps Virus (MuV), Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, 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, SARS-CoV, Varicella Zoster Virus (VZV)
Commercial Status
Commercialised
Last Update
2021-10-20 12:50:54 CET
Comments
The M&D 2019-nCoV Antigen Test Kit is a rapid and convenient lateral flow immunochromatographic assay for the qualitative detection of SARS-CoV-2 nucleocapsid protein from nasopharyngeal swab samples obtained from individuals suspected of COVID-19 by their healthcare provider within five-seven days of symptom onset and /or epidemiological criteria. The rapid test device is for professional use only and is intended to be used as an aid in the diagnosis of SARS-COV-2 infection.
Assay Type
Immuno-Antigen
Method
Immunochromatography
Time
15 minutes
Subclass
Membrane-based
LOD
1 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
8.47 %
Fn
0 %
Precision
Evaluated
Accuracy
98.11 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
91.53 %
Clinical Specificity
100 % ((Antigen))
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