In certain situations it may be appropriate to use biopsy or other emerging ancillary techniques as a reference standard. The study arm evaluating the device should replicate intended use conditions in order to properly assess cytotechnologist and pathologist performance with respect to sensitivity and specificity. For an illustrative example of the effects of how machine error can compound human error, see table at the end of this document. Improving the Quality of Clinician Pap Smear Technique and Management, Client Pap Smear Education, and the Evaluation of Pap Smear Laboratory Testing. Sept. 1989, pp A3-A7.
More detailed explanations are also available from member societies or working group members.