1. U.S. Department of Health and Human Services, Food and Drug Administration Center for Devices and Radiological Health. Policy for coronavirus disease-2019 tests during the public health emergency (revised) [Internet]. Silver Spring, MD: Center for Devices and Radiological Health;2020. May. [cited 2020 Nov 30]. Available from
https://www.fda.gov/media/135659/download.
2. Toft N, Jørgensen E, Højsgaard S. Diagnosing diagnostic tests: evaluating the assumptions underlying the estimation of sensitivity and specificity in the absence of a gold standard. Prev Vet Med. 2005; 68:19–33.
Article
3. Garrett ES, Eaton WW, Zeger S. Methods for evaluating the performance of diagnostic tests in the absence of a gold standard: a latent class model approach. Stat Med. 2002; 21:1289–307.
Article
4. Florkowski CM. Sensitivity, specificity, receiver-operating characteristic (ROC) curves and likelihood ratios: communicating the performance of diagnostic tests. Clin Biochem Rev. 2008; 29 Suppl 1:S83–7.
5. Cardoso JR, Pereira LM, Iversen MD, Ramos AL. What is gold standard and what is ground truth? Dental Press J Orthod. 2014; 19:27–30.
Article
6. Pepe MS. The Statistical Evaluation of Medical Tests for Classification and Prediction. New York, NY: Oxford University;2003.
7. Eusebi P. Diagnostic accuracy measures. Cerebrovasc Dis. 2013; 36:267–72.
Article
8. U.S. Food and Drug Administration. Guidance for Industry and FDA Staff: Statistical Guidance on Reporting Results from Studies Evaluating Diagnostic Tests. Silver Spring, MD: U.S. Food and Drug Administration;2007.
9. Zhou XH, Obuchowski NA, McClish DK. Statistical Methods in Diagnostic Medicine. New York, NY: John Wiley;2002.