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COVID-19 In Vitro Diagnostic Devices and Test Methods Database

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

Discrimination of False Negative Results in RT-PCR Detection of SARS-CoV-2 RNAs in Clinical Specimens by Using an Internal Reference

Detection Principle
NucleicAcid-PCR based
Target
ORF1, N genes
Testing Method Category
PCR_KIT
Testing Method
WHO-1 RT-PCR (Bojie Ltd, Shanghai, China)
Testing Method - Additional Info
identification of Ct cutoff values for internal reference RPP30 RT-PCR which predicted false negative results for SARS-CoV-2 RT-PCR
Reported Performance
Sensitivity: 95.03% (ORF1ab, sputum), 95.10% (N, sputum), 95.26% (ORF1ab, throat swab), 95.14% (N, throat swab) ; Specificity: 91.40% (ORF1ab, sputum), 88.16% (N, sputum), 83.72% (ORF1ab, throat swab), 98.55% (N, throat swab)
Sample Size
161 patients
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