NOVACHECK Diagnostic kit (collodial gold) for IgG/IgM Antibody to SARS-CoV-2
Manufactured by Novatech, Turkey - www.novadiag.com
Device identification number
1393
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Target type
Antibody, IgG, IgM
Targets
nucleocapsid protein
Specimen
Plasma, Serum, Whole blood
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
https://www.novadiag.com/files/novadiag-katalog-english.pdf
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Detection Principle
Colorimetry
LOD
0 AU
Calibration
Not evaluated
False positives
7.92 % (16 fake POSITIVE NUMBER OF PATIENTS / 202 TOTAL NUMBER OF PATIENTS) * 100: 7.92%)
False negatives
2.1 % (8 fake NEGATIVE NUMBER OF PATIENTS / 380 TOTAL NUMBER OF PATIENTS) *100: %2.10)
Accuracy
95.88 % (95 CI:%93.44-%97.2)
Clinical Sensitivity
92.08 % (95 CI:%87.52-%95.07)
Clinical Specificity
97.89 %
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