DIA.CHEMILUX SARS-CoV-2 NCP IgA
Manufactured by DIA.PRO Diagnostic Bioprobes Srl, Italy - www.diapro.it
Device identification number
2477
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Fully automated (robot)
Physical Support
Cartridge
Target type
IgA
Specimen
Plasma, Serum
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
The kit is intended for monitoring of infected patients. In addition, the kit may be used when testing the population and health-care workers looking for potentially infective “pauci” or a-symptomatic individuals in the early phase of infection, in combination with SARS-COV-2 molecular tests. The device has been adapted for the use in exclusive combination with the Dia.Pro CLIA random access instrument named SARA.
Assay Type
Immuno-Antibody
Method
CLIA
Time
35 minutes
Detection Principle
Chemiluminescence
LOD
2 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
Common autoantibodies in Autoimmune Diseases did not generate false positive results
False negatives
0 % No false negative result was found
Precision
Evaluated
Accuracy
100 %
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
98 %
Clinical Specificity
99 %
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