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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 IgG/IgM Test

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

Device identification number
2132
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus OC43 (HCoV-OC43), Coronaviruses (HCoV), Enterovirus A71 (EV-A71), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Influenza A H1N1, Influenza A H3N2, MERS-CoV, 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, Rhinovirus A
Lineages detected
B.1.1.7 (Alpha), B.1.351 (Beta), B.1.427 (Epsilon), B.1.429 (Epsilon),
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
Digital Result reading with a Reader
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
0 AU 0
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
N.A.
Fn
N.A.
Precision
Evaluated
Accuracy
96.8 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98.3 %
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