Prior high-risk human papillomavirus testing and Papanicolaou test results of 70 invasive cervical carcinomas diagnosed in 2012: results of a retrospective multicenter study.

CONTEXT: Persistent high-risk human papillomavirus (hrHPV) infection is essential for the development of cervical cancer and its precursor lesions. High-risk HPV testing has a higher sensitivity than cytology does for detecting cervical epithelial lesions. However, a large study from a single institution showed 31% of patients with invasive cervical cancer had negative baseline hrHPV testing within 5 years preceding the diagnosis. OBJECTIVE: To investigate the limitation of hrHPV testing in detecting invasive cervical cancer. DESIGN: Cases from 2012 with a histologic diagnosis of invasive cervical carcinoma were retrieved from multiple institutions. From those records, prior hrHPV testing and Papanicolaou test results in the 5 years before the cancer diagnosis were recorded. RESULTS: Seventy patients with cervical carcinoma were included in the study. Negative HPV test result rates were 9% (5 of 53), 23% (6 of 26), and 25% (2 of 8) during the periods of less than 1 year, 1 to 3 years, and 3 to 5 years before the histologic diagnoses, respectively. Negative Papanicolaou testing results in the same time intervals were 3.4% (2 of 59), 33% (10 of 30), and 40% (6 of 15). Although the HPV(-) rate seemed to be different among different HPV test methods, no statistical significance was detected because of small sample size. Negative hrHPV rates in patients with adenocarcinoma were similar to those in patients with squamous cell carcinoma. CONCLUSIONS: These data expose limitations for the potential use of primary HPV testing. In addition, current screening guidelines recommending cotesting at 5-year intervals should be evaluated further with additional historic data collection because there are women with negative results for both Papanicolaou tests and hrHPV testing within the period of 3 to 5 years before an invasive carcinoma diagnosis.

American Society of Cytopathology workload recommendations for automated Pap test screening: developed by the productivity and quality assurance in the era of automated screening task force.

Based on current literature and the best available research to date, the current FDA workload limits for automated image-assisted screening, including the ThinPrep Imaging System and the FocalPoint GS, of 100 slides/day (imaged only slides counted as 0.5) are extremely high and may be associated with significant reduction in sensitivity. This task force has proposed six recommendations relating to cytotechnologist (CT) workload in automated image-guided Pap test screening, which have already been endorsed by major pathology professional societies. These evidence-based recommendations, however, pertain only to gynecologic specimens with image-assisted screening, as there is no current available data to justify modifying screening practices regarding non-gynecologic specimens. The proposed recommendations are as follow: 1) CT workday should not include more than 7 hours of Pap test screening in a 24-hr period, and an 8-hr shift day must include at least 2 paid mini-breaks of 15 minutes each and a 30-minute lunch break. 2) Future Studies examining CT workload should use actual hours of screening rather than lesser number of hours extrapolated to 8-hour days. 3) Average laboratory CT workload should NOT exceed 70 slides/day (slides counted per 2010 FDA bulletin). 4) Proportion of imaged slides that undergo full manual review should be at least either 15%, or twice (2×) the epithelial cell abnormality (ECA) rate, whichever is greater. 5) ECA-adjusted workload measure is a promising method for calculating and monitoring CT workload, but further studies of this method are necessary before full endorsement. 6) CT productivity and workload limits are just one aspect of a good quality assurance program in a cytology laboratory, so other quality indicators to assess CT performance are essential.

Implementation of the ThinPrep imaging system in a high-volume metropolitan laboratory.

The Papanicolaou test has proven to be the most effective cancer screening test ever developed. However, with a declining number of skilled cytotechnologists, there is an increased need for computer assistance in cervical cancer screening. The ThinPrep Imaging System (Cytyc Corporation, Marlborough, MA) is a unique system that combines computer imaging technology and human interpretive expertise in the review of ThinPrep Pap test slides. The purpose of this study is to report on the introduction and validation of this technology and present data related to the performance and productivity in our laboratory. Following completion of the ThinPrep Imaging System validation protocol, all imaged ThinPrep Pap test results were tracked and compared with year-2003 manually screened results to identify whether the Imaging System was effective in aiding human interpretive skills. Cases rescreened in the 10% random quality control (QC) program from the negative population that showed abnormal cells consistent with low-grade squamous intraepithelial lesion (LSIL) and above were compared with imaged versus non-imaged cases to establish an estimated laboratory false-negative (F/N) rate. The study compared results of 82,063 manually screened ThinPrep Pap tests in 2003 with 84,473 imaged ThinPrep Pap tests in 2004. Results demonstrated a significant increase in LSIL (37%) and high-grade squamous intraepithelial lesion (HSIL) (42%) detection on the Imager cohort. The F/N rate was reduced by half. The evaluation period after validation of the Imager showed a significant increase in LSIL and HSIL detection with the ThinPrep Imaging System compared to manual screening. These results demonstrate that the Imager has the potential to allow the cytotechnologists to detect more disease and reduce the false-negative rate for the laboratory. Although not evaluated in this study, cytotechnologists reported increased job satisfaction.