Diagnostic Automation, Inc. SARS-CoV-2 RT-PCR Kit
Manufactured by Diagnostic Automation/Cortez Diagnostics Inc., United States - www.rapidtest.com
Device identification number
1194
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated, Manual
Target type
Nucleic acid
Targets
nucleocapsid protein/gene
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
LOD
12.5 GE/reaction; 1100 GE/ml specimen&CFX96 Touch Real-Time PCR Detection System: 10 GE/reaction; 860 GE/ml specimen
Clinical Sensitivity
100 %
Clinical Specificity
96.7 %
Throughput
48 samples/run
Type of antigen
SARS-CoV-2 viral nucleoprotein antigens.
Notes
3 target-system minimizes potential for reduced detection of new SARS-CoV-2 variantsMultiplex format allows for single-well detection of 3 different targets. Compatible with multiple PCR instruments after proper validationCompatible with multiple RNA extraction kits after proper validation.
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