COVID-19 IgA
Manufactured by DIA.PRO Diagnostic Bioprobes Srl, Italy - www.diapro.it
Device identification number
2455
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Physical Support
Microplate
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.1.526.1, 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
Enzyme ImmunoAssay (ELISA) for the determination of IgA antibodies to COVID19 in human plasma and sera. The IgA assay is recommended, in addition to IgG and IgM, to: a) monitor the global immunological response of patients undergoing an acute infection and their follow-up to full recovery; b) test patients with symptoms of the gastro enteric form of COVID-19 infection, expected to generate IgA in a quite early stage of infection.
Assay Type
Immuno-Antibody
Method
ELISA
Measurement
Semiquantitative
Time
105 minutes
LOD
2 AU
Calibration
Not evaluated
Analysis of cross reactivity
Evaluated
False positives
0 % 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
100 %
Clinical Specificity
98 %
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