SIMPLE/STICK Ag SARS-CoV-2
Manufactured by OPERON S.A., Spain - https://operondx.com/molecular-diagnostics/
Device identification number
2170
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC, Semi-automated
Physical Support
Cassette, Lateral flow, Strip
Target type
Antigen
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
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 OPERON LF reader LOD: 6 x 10^2 TCID50/mL (1.63 x 10^5 copias/mL) SENSIBILIDAD Y ESPECIFIDAD DIAGNÓSTICA: Ref: SARS-CoV-2 Rapid Antigen Test de Roche Concordancia total : 99.4% Concordancia Sensibilidad: 96.4% Concordancia Especificidad: 100% Ref: RT-PCR (Real SARS-CoV-2, OPERON S.A.) Concordancia total: 95.1% Concordancia Sensibilidad: 77.5% • Para Ct≤30: 96.7% • Para Ct≤25: >99.9% Concordancia Especificidad: 100% Ref: Diagnóstico clínico Sensibilidad diagnóstica: 95.0% Especificidad diagnóstica: 100%
Assay Type
Immuno-Antigen
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Sandwich
LOD
600 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
0 %
False negatives
3 %
Precision
Evaluated
Accuracy
99.4 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
96.4 %
Clinical Specificity
100 %
Type of antigen
Nucleoprotein
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