CHiL COVID-19 IgG/IgM Rapid Test cassette
Manufactured by CHIL Medical Supplies Ltd., Turkey - https://www.chil.com.tr/
Device identification number
1098
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Near POC / POC
Physical Support
Cassette
Target type
Antibody, IgG, IgM
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Immuno-Antibody
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
10 minutes
Calibration
Performed (QCRSARSCoV-2QC1 - Anti-SARS-CoV-2 Quality Control 1 NIBSC code: 20/B764 is used)
Analysis of cross reactivity
0% (anti-influenza A (IgG), anti-influenza B (IgG), anti-HCV (IgG and IgM), anti-HBV (IgG and IgM), anti-229E (alpha coronavirus), anti-NL63 (alpha coronavirus), anti-OC43 (beta coronavirus), anti-HKU1 (beta coronavirus) , anti-respiratory syncytial viru
False positives
0.1 % IgG
False positives
0.8 % IgM
False negatives
0.5 % IgG
False negatives
8 % IgM
Precision
100 %
Accuracy
99.7 % IgG
Accuracy
98 % IgM
Reproducibility
100 %
Robustness
99 %
Clinical Sensitivity
100 % IgG
Clinical Sensitivity
92 % IgM
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