SARS-COV-2 RT-qPCR Assay
Manufactured by CITEST DIAGNOSTICS Inc., Canada - www.citestdiagnostics.com
Device identification number
1388
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Lab-based
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Rapid Diagnostic
No
Method
RT-PCR
Time
100 minutes
LOD
200 AU
Positive control
RAN Pseudovirus
Negative control
DEPC-Treated Water
Analytical Sensitivity
100 %
Analytical Specificity
99.14 %
Clinical Sensitivity
100 %
Clinical Specificity
99.14 %
Throughput
96 samples/run
Notes
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