DirectDetect SARS-CoV-2 Detection Kit (PCR-Fluorescence Probe)
Manufactured by Coyote Bioscience Co. Ltd., China - www.coyotebio.com/gykyd
Device identification number
1866
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Manual
Physical Support
Microplate
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
The DirectDetect SARS-CoV-2 Detection Kit is a real-time RT-PCR test intended for the qualitative detection of nucleic acid from severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) in nasopharyngeal/oropharyngeal swabs
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Quantitative
Time
100 minutes
LOD
400 cpm
Positive control
non-infectious armored RNA with the ORF1ab and N gene sequence of SARA-CoV-2 in sample stor
Negative control
non-infectious armored RNA with RNP sequence in sample storage solution
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