COVID-19 SPIKE QUANTITATIVE VIRCLIA® IgG MONOTEST
Manufactured by Vircell s.l., Spain - WWW.VIRCELL.COM
Device identification number
2081
CE Marking
✓Yes
HSC common list (RAT)
×No
Target type
Antibody, IgG
Specimen
Plasma, Serum
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.1.526.1, B.1.526.2, B.1.616, B.1.617.1 (Kappa), B.1.617.2 (Delta), B.1.617.3, B.1.621 (Mu), C.36, C.37 (Lambda), P.1 (Gamma), P.2 (Zeta), P.3 (Theta)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
all variants detected but not discriminated
Assay Type
Immuno-Antibody
Method
Immunoassay
Time
60 minutes
LOD
3.11 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % IgG
False negatives
Inactivated samples: 3; Non-inactivated samples: 0
Precision
Evaluated
Accuracy
VIRCLIA®: Bias (trueness / accuracy) = 14.50% VIRCLIA® LOTUS: Bias (trueness / accuracy) = 16.50%
Reproducibility
Evaluated
Robustness
Not evaluated
Clinical Sensitivity
96 % IgG (Inactivated samples: 96% Non-inactivated samples: 100%)
Clinical Specificity
100 % IgG (Inactivated samples: 100% Non-inactivated samples: 100%)
Type of antigen
Other (spike)
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