SARS-CoV-2 Nucleic acid detection kit based on Cartridge Real-Time PCR platform
Manufactured by Tellgen Corporation, China - en.tellgen.com/
Device identification number
1979
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Cassette
Target type
Nucleic acid
Specimen
Nasopharyngeal swab
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
Characteristic: Sample in, Result out, Random testing, Close system - SARS CoV 2 PCR Cartridge - The only manual operation step is adding sample - Inserting the Cartridge and start automated PCR processing - Real time PCR 4 channels, random testing TAT is 1.5 hours
Assay Type
Nucleic acid-PCR
Reader Required
Yes
Method
RT-PCR
Measurement
Quantitative
Time
75 minutes
Subclass
JRC-S
LOD
100 cpr
Positive control
97.87 %
Negative control
95.41 %
Analytical Sensitivity
95 %
Analytical Specificity
100 %
Clinical Sensitivity
95.96 %
Clinical Specificity
98.08 %
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