ACCESS SARS-CoV-2 IgG (1st IS)
Manufactured by Beckman Coulter, United States - https://www.beckmancoulter.com
Device identification number
2994
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Target type
IgG
Targets
spike protein
Specimen
Plasma, Serum
Cross-reactivity (pathogens tested)
Adenovirus, Alpha Coronavirus 229E (HCoV-229E), Alpha Coronavirus Nl63 (HCoV-Nl63), Anti-Nuclear Antibody, Beta Coronavirus HKU1 (HCoV-HKU1), Beta Coronavirus OC43 (HCoV-OC43), Enterovirus A71 (EV-A71), Epstein-Barr Virus (EBV), Hemophilus Influenzae, Hepatitis B Virus (HBV), Hepatitis C Virus (HCV), Human Immunodeficiency Virus (HIV), Human Metapneumovirus (HMPV), Influenza A, Influenza B, Mycobacterium Tuberculosis, Mycoplasma Pneumoniae, Parainfluenza Virus Type 1, Parainfluenza Virus Type 2, Parainfluenza Virus Type 3, Parainfluenza Virus Type 4, Respiratory Syncytial V (RSV)
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 (1st IS) assay is a paramagnetic particle, chemiluminescent immunoassay intended for the quantitative and 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
Quantitative
Time
30 minutes
Subclass
Sandwich
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0.21 % (three false positives out of a total of 1400 negative samples)
False negatives
0 % Zero false negatve for specimens collectedfrom positive subjects >/= 14 days post symptom onset
Precision
Evaluated
Accuracy
100 % IgG
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
100 % (95% CI: 92,7-100,0%)
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