Effectiveness of the SurePath liquid‐based Pap test in automated screening and in detection of HSIL

Abstract

We have shown that SurePath when compared to conventional Paps fails to increase HSIL detection. In this study, assessment of test performance characteristics for the FocalPoint showed that sensitivity was 96% when manual screening was used as the "gold standard." When cervical biopsy, however, was used as the "gold standard" FocalPoint sensitivity decreased to 93%, which was the same as manual screening. Examination of the FocalPoint "no further review" cases showed that 4/296 were SIL. To understand better the implication of an SIL diagnosis, cervical biopsies generated from SurePath and conventional Paps were compared. Conventional Paps diagnosed as LSIL had a biopsy LSIL:HSIL ratio of 3.1/1, while SurePath Paps had a biopsy LSIL:HSIL ratio of 1.5/1. These results indicate that when cervical biopsy is used as the "gold standard," FocalPoint and manual screening of SurePath Paps have similar test performance but that the FocalPoint can fail to detect LSIL. Importantly, LSIL in a SurePath Pap is 1.6 times more likely to be HSIL on biopsy than LSIL in a conventional Pap.

Effectiveness of Rapid Prescreening and 10% Rescreening in Liquid-Based Papanicolaou Testing

“…We hypothesize that several factors may have contributed to the UCD baseline sensitivity, with one factor being the UCD use of liquid-based and manual screening technologies. [33][34][35] Although the effectiveness of these technologies has been controversial, most published RPS data are based on conventional screening practices; this variable cannot be controlled in comparing our data with previously published data, as we do not have pretechnology RS sensitivity data for the UCD laboratory.…”

Cervical and Vaginal Cytology

“…54 The productivity gain with FPSP is modest, because in practice the FPSP archives only about 16% to 17% of Paps without full manual review. In the clinical trial, there were 10 falsenegatives (5 ASC-US, 4 LSIL, and 1 HSIL) in the 1182 cases considered no further review by FPSP, and Cengel and colleagues found 9 false-negatives (5 ASC-US and 4 LSIL) in the 296 cases considered no further review by FPSP.…”

A randomised comparison of SurePath liquid‐based cytology and conventional smear cytology in a colposcopy clinic setting

“…There are several large studies on screening populations using split samples or comparison between nonrandomised populations that report a higher sensitivity and lower unsatisfactory rates for SurePath compared with conventional slides. [4][5][6][7][8][9][10][11] However, we have been unable to identify a published, randomised study including colposcopic evaluation of cytologically negative women.…”