Promotor SARS-CoV-2 RT-PCR Test Kit
Manufactured by ACON Laboratories Inc., United States - www.aconlabs.com
Device identification number
1799
CE Marking
✓Yes
HSC common list (RAT)
×No
Format
Automated
Physical Support
Microplate
Target type
Nucleic acid
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
500 copies/ml
Positive control
1 AU
Negative control
1 AU
Analytical Sensitivity
99.91 %
Analytical Specificity
94.72 %
Clinical Sensitivity
99.71 %
Clinical Specificity
98.29 %
Throughput
96 %
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