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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

COVID-19 In Vitro Diagnostic Medical Device - detail

genesig(R) Coronavirus (COVID-19) Rt-PCR assay

Manufactured by Primerdesign Novacyt, United Kingdom - www.primerdesign.co.uk 

Device identification number
1156
CE Marking
Yes
HSC common list (RAT)
×No
Format
Manual
Target type
Nucleic acid
Specimen
Nasopharyngeal swab, Oropharyngeal swab, Saliva, Sputum
Commercial Status
Commercialised
Last Update
2022-08-24 09:08:01 CET
Comments
A real-time PCR assay for the specific and exclusive detection of SARS-CoV-2 from human nasopharyngeal swabs, oropharyngeal swabs, sputum, raw saliva and preserved saliva specimens. Open platform chemistry with a range of validated instruments including the most abundant on the market. https://www.genesig.com/products/10039-coronavirus-covid-19-ce-ivd
Assay Type
Nucleic acid-PCR
Method
RT-PCR
Time
90 minutes
LOD
0.18 cpu
Positive control
Synthetic RNA, complimentary to amplicon
Negative control
DNase/RNase free water
Analytical Sensitivity
100 %
Analytical Specificity
100 %
Clinical Sensitivity
100 %
Clinical Specificity
100 %
Throughput
96 samples/run

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