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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Rapid and sensitive detection of SARS-CoV-2 RNA using the Simplexaâ„¢ COVID-19 direct assay

DOI
10.1016/j.jcv.2020.104416 
Detection Principle
NucleicAcid-PCR based
Target
S gene and ORF1ab
Testing Method Category
RT-PCR
Testing Method
SimplexaTM COVID-19 Direct assay
Testing Method - Additional Info
Comparison of the all-in -one method with the WHO pro0tocol
Reported Performance
LOD S gene: 3.2 (CI: 2.9–3.8) log10 cp/ mL and 0.40 (CI: 0.2–1.5) TCID50/mL . LOD ORF1ab: 3.2 log10 (CI: 2.9–3.7) log10 cp/mL and 0.4 (CI: 0.2–1.3) TCID50/mL
Sample Size
278 specimens
Peer-reviewed
yes

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