A CRITICAL LOOK AT PAP ADEQUECY: ARE OUR CRITERIA SATISFACTORY?

Liquid based Pap (LBP) specimen adequacy is a highly documented, yet poorly understood cornerstone of our GYN cytology practice. Each day, as cytology professionals, we make adequacy assessments and seldom wonder how the criteria we use were established. Are the criteria appropriate? Are they safe? What is the scientific data that support them? Were they clinically and statistically tested or refined to achieve optimal patient care? In this presentation, we will take a fresh look at what we know about Pap specimen adequacy and challenge some of the core assumptions of our daily practice. LBP tests have a consistent, well‐defined surface area for screening, facilitating the quantitative estimates of slide cellularity. This provides an unprecedented opportunity to establish reproducible adequacy standards that can be subjected to scientific scrutiny and rigorous statistical analysis. Capitalizing on this opportunity, the TBS2001 took the landmark step to define specimen adequacy quantitatively, and set the threshold for a satisfactory LBP at greater than 5,000 well visualized squamous epithelial cells. To date, few published studies have attempted to evaluate the validity or receiver operator characteristics for this threshold, define an optimal threshold for clinical utility or assess risks of detection failure in ‘satisfactory’ but relatively hypocellular Pap specimens. Five years of cumulative adequacy and cellularity data of prospectively collected Pap samples from the author's laboratory will be presented, which will serve as a foundation for a discussion on ‘Pap failure’. A relationship between cellularity and detection of HSIL will be presented. Risk levels for Pap failure will be presented for Pap samples of different cellularities. The effect of different cellularity criterion on unsatisfactory Pap rates and Pap failure rates will be demonstrated. Results from this data set raise serious questions as to the safety of current TBS2001 adequacy guidelines and suggest that the risk of Pap failure in specimens with 5,000 to 20 000 squamous cells on the slide is significantly higher than those assumed by the current criteria. TBS2001 designated all LBP to have the same adequacy criterion. Up to this point, it has been assumed that ThinPrep, SurePath, or any other LBP would be sufficiently similar that they should have the same adequacy criteria. Data for squamous cellularity and other performance characteristics of ThinPrep and SurePath from the author's laboratory will be compared. Intriguing data involving the recently approved MonoPrep Pap Test will be reviewed. MonoPrep clinical trial data show the unexpected finding of a strong correlation between abundance of endocervical component and the detection of high‐grade lesions, provoking an inquiry of a potential new role for a quantitative assessment of the transition zone component. The current science of LBP adequacy criteria is underdeveloped and does not appear to be founded on statistically valid methods. This condition calls us forward as a body of practitioners and scientists to rigorously explore, clarify and define the fundamental nature of cytology adequacy. As we forge this emerging science, we will improve diagnostic performance, guide the development of future technologies, and better serve the patients who give us their trust. Reference:  Birdsong GG: Pap smear adequacy: Is our understanding satisfactory? Diagn Cytopathol. 2001 Feb; 24(2): 79–81.