Skip to main content
COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

Q-Check Rapid Lateral Flow Assay for SARS-CoV-2 Antigen Detection

Manufactured by Synbiotik Biotechnology, Turkey - https://synbiotiktr.com 

Device identification number
2884
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual, Near POC / POC
Physical Support
Cassette
Target type
Antigen
Targets
nucleocapsid protein
Specimen
Nasal swab, Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Beta Coronavirus OC43 (HCoV-OC43), Influenza A H1N1, Influenza A H3N2, Influenza A H5N1, Influenza B Victoria, Influenza B Yamagata, Respiratory Syncytial V (RSV)
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Rapid Lateral Flow Assay is designed to qualitatively detect the presence of Nucleocapsid protein (N protein), an antigen that is specific to SARS-CoV-2 in patients' swab samples. This test is developed to diagnose the presence of Nucleocapsid protein in human swab samples during the SARS-CoV-2 infection. Designed for in vitro diagnosis only.
Assay Type
Immuno-Antigen
Rapid Diagnostic
Yes
Reader Required
No
Method
Immunoassay
Measurement
Qualitative
Time
20 minutes
Subclass
Sandwich
LOD
27 ct (Ct ≤27)
Calibration
Evaluated
Analysis of cross reactivity
Evaluated
False positives
2.6 % (8 false positive out of 300)
False negatives
2 % (6 false negative out of 300)
Precision
Evaluated
Accuracy
96.14 % (Antigen)
Reproducibility
Evaluated
Robustness
Evaluated
Clinical Sensitivity
90.7 % (Antigen)
Clinical Specificity
97.3 % (Antigen)
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