COVID-19 NEUTRALISING Ab RAPID TEST
Manufactured by PRIMA Lab SA, Switzerland - primahometest.com/en/
Device identification number
1875
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
IgG
Specimen
Plasma, Serum, Venous whole blood, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The performance of the device to recognize IgG post-Vaccination have been clinically evaluated.
Assay Type
Immuno-Antibody
Reader Required
No
Method
Immunochromatography
Measurement
Qualitative
Time
10 minutes
Subclass
Neutralization Antibody (NAb)
LOD
93.75 AU
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
Possible cross-interferences were observed: Ad V IgG, Ad V IgM, RF IgG, antinuclear Ab, HCV IgG
False negatives
No hook effect has been observed
Precision
Evaluated
Accuracy
96.5 % IgG (After infection 96.5 % (Wilson 95% Cl: 94.9%-98.13%), after vaccination > 98% at 35 days, C.I. 95%)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
92.6 % IgG (Sensitivity after infection 92.6%(sensitivity after vaccination 98.3% at 35 days, C.I. 95%))
Clinical Specificity
97.4 % IgG (Specificity on pre-outbreak samples 97.4% (C.I. 95%))
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