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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma)

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

Device identification number
2427
CE Marking
Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette, Lateral flow
Target type
Antibody, IgG
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.1.617.3 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 COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is a lateral flow chromatographic immunoassay for the qualitative detection of IgG antibodies to SARS-CoV-2 spike (S) protein receptor binding domain (RBD) in human whole blood, serum or plasma specimen. The COVID-19 IgG Rapid Test (Whole Blood/Serum/Plasma) is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2. False positive results may occur due to cross-reactivity from pre-existing antibodies or other possible causes. Due to the risk of false positive results, confirmation of positive results should be considered using second, different IgG assay.
Assay Type
Immuno-Antibody
Reader Required
No
Subcategory
Validity test kit
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
100
Calibration
Evaluated
Crossreactivity
Evaluated
Fp
0.071 AU ((SARS-CoV-2);)
Fp
0.015 AU ((vaccination))
Fn
0 AU (SARS-CoV-2);
Fn
0.001 AU (>0.001(vaccination))
Precision
Evaluated
Accuracy
97.4 % IgG ((SARS-CoV-2);)
Accuracy
98.9 % IgG ((vaccination).)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.9 % IgG ((SARS-CoV-2);)
Clinical Sensitivity
98.5 % IgG ((vaccination).)
Clinical Specificity
100 % IgG ((SARS-CoV-2);)
Clinical Specificity
99.9 % IgG ((vaccination))
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