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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

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

Device identification number
1696
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
Commercial Status
Commercialised
Last Update
2022-03-14 09:42:40 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
LOD
0 AU
Calibration
not evaluated
Crossreactivity
evaluated
Fp
2 % IgG
Fp
4 % IgM
Fp
3.7 % (IgG, IgM)
Fn
15 % IgM
Fn
0 % IgG
Fn
3.1 % (IgG, IgM)
Precision
evaluated
Accuracy
92.9 % IgM
Accuracy
96.4 % (IgG, IgM)
Accuracy
98.6 % IgG
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
85 % IgM
Clinical Sensitivity
96.9 % (IgG, IgM)

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