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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

ACCESS SARS-CoV-2 IgG

Manufactured by Beckman Coulter, United States - https://www.beckmancoulter.com 

Device identification number
2996
CE Marking
Yes
HSC common list (RAT)
×No
Format
Automated
Target type
IgG
Targets
spike protein
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Anti-Nuclear Antibody, Cytomegalovirus (CMV), Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Influenza A, Influenza B
Information on antigen epitope targeted by the antibodies used in the design of the device
receptor-binding domain (RBD) of the Spike protein
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The Access SARS-CoV-2 IgG assay is a paramagnetic particle, chemiluminescent immunoassay intended for the qualitative detection of IgG antibodies to SARS-CoV-2 in human serum and plasma using the Access Immunoassay Systems.
Assay Type
Immuno-Antibody
Self Test
No
Reader Required
No
Method
CLIA
Measurement
Qualitative
Time
31 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.21 % (Three false positive out of a total of 1,400 negative specimens)
False negatives
One false negative for specimens collected from positive subjects >/= 14days from PCR to collection
Precision
Not evaluated
Accuracy
99.1 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
99.1 % (95% CI: 95,0%-99,8%)
Clinical Specificity
99.8 % (95% CI: 99,4%-99.9%)
Type of antigen
Spike 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