ACCESS SARS-CoV-2 IgG II
Manufactured by Beckman Coulter, United States - https://www.beckmancoulter.com
Device identification number
2995
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Target type
IgG
Targets
spike protein
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Adenovirus, 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 II assay is a paramagnetic particle, chemiluminescent immunoassay intended for the semi-quantitative and qualitative determination 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
Semiquantitative
Time
30 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.13 % (Two false positive out of a total of 1448 negative specimens)
False negatives
9 false negative for specimens collected from positive subjects >/= 15 days, 8 from >/= 60 days
Precision
Not evaluated
Accuracy
98.8 %
Reproducibility
Not evaluated
Robustness
Evaluated
Clinical Sensitivity
98.9 % (95% CI: 94,1%-99,8%)
Clinical Specificity
99.9 % (95% CI: 99,5%-100,0%)
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