GCdia™ COVID-19 Fast Detection Kit
Manufactured by Genes Laboratories, South Korea - http://www.geneslabs.com/
Device identification number
2656
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Cross-reactivity (pathogens tested)
Coronaviruses (HCoV)
Commercial Status
Commercialised
Last Update
2022-12-02 09:22:17 CET
Comments
GCdia™ COVID-19 Fast Detection Kit is a real-time RT-PCR (reverse transcriptase polymerase chain reaction) test intended for the qualitative detection of nucleic acids from SARS-CoV-2 in nasopharyngeal swab, oropharyngeal swab and sputum specimens collected from any individuals suspected of COVID-19 by their healthcare providers.
Assay Type
Unknown
Reader Required
No
Method
RT-PCR
Measurement
Qualitative
Time
35 minutes
LOD
5 cpr
Positive control
Positive control provided in the kit
Negative control
Nuclease-free water provided in the kit
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
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