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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

Scientific literature on COVID-19 Test Methods and Devices - detail

Development and Evaluation of a Duo SARS-CoV-2 RT-qPCR Assay Combining Two Assays Approved by the World Health Organization Targeting the Envelope and the RNA-Dependant RNA Polymerase (RdRp) Coding Regions

Detection Principle
NucleicAcid-PCR based
Testing Method Category
Testing Method
in house (WHO-5 + WHO-2)
Testing Method - Additional Info
2 mono-target assays recommended by WHO (WHO-5: E-Sarbeco, enveloppe gene, Charite University, Berlin, Germany and WHO-2: RdRp-IP4 RdRp, Institut Pasteur, Paris, France) were selected and combined in a unique robust test
Reported Performance
LOD95: 29.3 RNA copies/µL (E-Sarbeco assay), 7.9 RNA copies/µL (RdRp-IP4)
Sample Size
69 samples

The database contains available information from scientific literature that is being updated periodically. Please note that the provided information (as retrieved from analysed papers) is provided only for devices commercially available with CE-IVD mark. Acknowledgements