INGEZIM COVID 19 SPIKE CROM
Manufactured by EUROFINS INGENASA, Spain - https://ingenasa.eurofins-technologies.com
Device identification number
2458
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Lateral flow
Target type
Antibody
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
detection of antibodies specific of protein S of SARS-CoV-2
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
15 minutes
Subclass
Enzyme-linked
Calibration
Evaluated
Analysis of cross reactivity
Evalauted
False positives
3.7 %
False negatives
2.78 %
Precision
Evalauted
Accuracy
96 %
Reproducibility
Evaluated
Robustness
Evalauted
Clinical Sensitivity
97.22 % ((day 15 after vaccination))
Clinical Specificity
96.3 %
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