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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

CHIL COVID-19 Antigen Rapid Test (Nasopharyngeal / Oropharyngeal Swab-Casette)

Manufactured by Chil Tıbbi Malzeme Sanayi ve Ticaret Limited Şirketi, Turkey - https://www.chil.com.tr 

Device identification number
1691
CE Marking
Yes
HSC common list
Yes
HSC mutual recognition
Yes
Format
Manual, Near POC / POC
Physical Support
Cassette
Target
Antigen
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Pathogens detected
SARS-CoV
Commercial Status
Commercialised
Last Update
2021-11-08 10:34:17 CET
Comments
The CHIL® COVID-19 antigen rapid test is an immunochromatographic in-vitro test for the qualitative detection of nucleocapsid protein antigen from SARS-CoV-2 in direct nasopharyngeal and oropharyngeal swabs directly from people. This product is intended exclusively for professional use in the laboratory and at the point of care.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Subcategory
N.A.
Method
Immunoassay
Measurement
Qualitative
Time
15 minutes
Subclass
Sandwich
LOD
30 %
Calibration
evaluated
Crossreactivity
evaluated
Fp
0.49 % (2 False Positives out of 405)
Fn
0.85 % (4 False Negatives out of 466)
Precision
evaluated
Accuracy
99.54 %
Reproducibility
evaluated
Robustness
evaluated
Clinical Sensitivity
99.01 %
Clinical Specificity
99.57 %
Type of antigen
Nucleocapsid protein

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