EDITORIAL
The reference standard has been defined as “the best available method for establishing the presence or absence of the target condition” (1). When a new test is compared to the reference standard, the results can be used to calculate estimates of sensitivity and specificity. What should you do when comparing a new test to a non-reference standard? Read the comic strip to find out.
The views expressed in this Editorial do not necessarily reflect the views of the journal or of ASM.
REFERENCE
- 1.U.S. Food and Drug Administration. 2007. Guidance for industry and FDA staff: statistical guidance on reporting results from studies evaluating diagnostic tests. U.S. Food and Drug Administration, Silver Spring, MD: https://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm071287.pdf. [Google Scholar]