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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

2019-nCoV IgG/IgM Rapid Test Cassette (Whole Blood/Serum/Plasma)

Manufactured by Acro Biotech Inc, United States - www.acrobiotech.com 

Device identification number
2434
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG, IgM
Specimen
Plasma, Serum, Whole blood
Cross-reactivity (pathogens tested)
Adenovirus, Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B, Parainfluenza Virus Type, Respiratory Syncytial V (RSV)
Lineages detected
A.23.1 AT.1 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.1.617.2 (Delta), B.1.621 (Mu), C.36 P.1 (Gamma), P.2 (Zeta), P.3 (Theta), C.37 (Lambda), B.1.616 B.1.526.1 B.1.526.2
Commercial Status
Commercialised
Last Update
2022-04-20 12:09:38 CET
Comments
The 2019-nCoV IgG/IgM Rapid Test Cassette is a lateral flow chromatographic immunoassay for the qualitative detection of IgG and IgM antibodies to 2019-nCoV in human whole blood, serum or plasma specimen.
Assay Type
Immuno-Antibody
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
100 AU
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.15 AU ((IgM);)
Fp
0 AU (IgG);
Fp
0.031 AU ((2019-nCoV IgG/IgM ))
Fn
0.02 AU ((IgG);)
Fn
0.04 AU ((IgM);0.037(2019-nCoV IgG/IgM ))
Fn
0.04 AU ((IgM);0.037(2019-nCoV IgG/IgM ))
Precision
Evaluated
Accuracy
96.4 % ((IgG/IgM)(2019-nCoV IgG/IgM ))
Accuracy
92.9 % ((IgG/IgM)(IgM);)
Accuracy
98.6 % ((IgG/IgM)(IgG);)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
85 % ((IgG/IgM)(IgM);)
Clinical Sensitivity
96.9 % ((IgG/IgM)(2019-nCoV IgG/IgM ))
Clinical Sensitivity
100 % ((IgG/IgM)(IgG);)
Clinical Specificity
96 % ((IgG/IgM)(IgM);)
Clinical Specificity
96.3 % ((IgG/IgM)(2019-nCoV IgG/IgM ))
Clinical Specificity
98 % ((IgG/IgM)(IgG);)
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