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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

TestNOW® - COVID-19 Antigen Test

Manufactured by Affimedix, Inc., United States - www.affimedix.com 

Device identification number
2130
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Anterior nasal swab, Nasopharyngeal swab
Pathogens detected
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Human Metapneumovirus (HMPV), Influenza A H1N1, Influenza A H3N2, Influenza B, MERS-CoV, Mycoplasma Pneumoniae, Parainfluenza Virus Type, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV) Type A, Respiratory Syncytial V (RSV) Type B, Rhinovirus A
Commercial Status
Commercialised
Last Update
2021-11-08 09:46:42 CET
Comments
Digital Result option available with a Reader.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Self Test
No
Reader Required
No
Subcategory
Sample collection device
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
126 TCID50/ml
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.6 %
Fn
3.9 %
Precision
Evaluated
Accuracy
98.4 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.1 % (Anterior Nasal Swab)
Clinical Sensitivity
95 % (Nasopharyngeal Swab)
Clinical Specificity
100 % (Anterior Nasal Swab)
Clinical Specificity
99.2 % (Nasopharyngeal Swab)
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