SIMPLE IgA/IgM/IgG SARS-CoV-2
Manufactured by OPERON S.A., Spain - https://operondx.com/molecular-diagnostics/
Device identification number
2171
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC, Semi-automated
Target type
Antibody, IgA, IgG, IgM
Specimen
Serum, Whole blood
Cross-reactivity (pathogens tested)
SARS-CoV
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
Interpretación de resultados: visual ó automática con el LF OPERON reader. SENSIBILIDAD Y ESPECIFICIDAD DIAGNÓSTICA > 6 días Sensibilidad: 96,3% (Ig tot); 92,5% (IgA), 91,3% (IgG), 91,3% (IgM) Especificidad: 96,7% (Ig tot); 98,4% (IgA), 100% (IgG), 98,3% (IgM) Precisión: 96,5% (Ig tot); 95% (IgA), 95% (IgG), 94,3% (IgM) >15 días Sensibilidad: 96,9% (Ig tot); 93,8% (IgA), 96,9% (IgG), 92,3% (IgM) Especificidad: 96,7% (Ig tot); 98,4% (IgA), 100% (IgG), 98,3% (IgM) Precisión: 96,8% (Ig tot); 96% (IgA), 98,4% (IgG), 95,2% (IgM)
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
0.04 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
3 % ((Ig tot))
False positives
1.7 % IgM
False positives
0 % IgG
False positives
1 % IgA
False negatives
3 % ( (Ig tot))
False negatives
7 % IgM
False negatives
3 % IgG
False negatives
6 % IgA
Precision
Evaluated
Accuracy
95 % IgM
Accuracy
96 % ((Ig tot))
Accuracy
98 % IgG
Accuracy
96 % IgA
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96 % ( (Ig tot))
Clinical Sensitivity
93
Clinical Sensitivity
96
Clinical Sensitivity
92
Clinical Specificity
96 % ( (Ig tot))
Clinical Specificity
98 % IgA
Clinical Specificity
100 % IgG
Clinical Specificity
98 % IgM
Type of antigen
Other
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