Bethesda 2014 Implementation and Human Papillomavirus Primary Screening: Practices of Laboratories Participating in the College of American Pathologists PAP Education Program

Abstract

Context.— Cervical cancer screening laboratory practices may evolve with new terminology and technologies. Objective.— To investigate changes in cervical cytopathology practice resulting from the 2014 Bethesda System updates and screening technologies. Design.— Questionnaires accompanied 2016 and 2017 mailings of the College of American Pathologists PAP Education program. Results.— In 2016, most laboratories surveyed had adopted or were planning to adopt 2014 Bethesda System updates, and the majority (53%; 365 of 689) used an age cutoff of 45 for reporting benign-appearing endometrial cells. However, 51.3% (354 of 690) of laboratories used the term low-grade squamous intraepithelial lesion, cannot exclude high-grade squamous intraepithelial lesion, for cases with indeterminate features, and 44.9% (298 of 664) of laboratories used a 5000-cell cutoff for minimum squamous cellularity for posthysterectomy and posttherapy specimens. Reporting rates for cervical cytology metrics changed very little from 2013 to 2016, and the median ratio of atypical squamous cells to squamous intraepithelial lesion cases was 1.9 for ThinPrep and 1.8 for SurePath preparations. Most laboratories (59.4%; 389 of 655) did not offer stand-alone primary human papillomavirus (HPV) testing in 2017, and primary HPV testing accounted for a low proportion of HPV testing volumes. The Roche Cobas method was the most common platform for HPV primary screening. Conclusions.— These questionnaire surveys provide data about the current status of cervical cytology screening, including changes related to the 2014 Bethesda System updates and the adoption of HPV primary screening techniques.

Diagnostic Yield and Performance of a Large Population-Based Cervical Cancer Screening Program in High-Risk Rural China

“…40,000 research subjects were recruited exclusively from the cervical cancer high-risk Jiexiu and Yangqu counties in Shanxi province within six months period. Overall abnormal cytological results was 6.76% (2702/40,000), including 5.76% (2304/40,0000) reported ASC-US, which was higher but consistent with the benchmark data of most recent College of American Pathologist survey (median rate: 5.6%; range: 1.1-13.3%) [17] . The total reporting rate of combined ASC-H, LSIL, HSIL, AGC and SCCa was 1.01%, much lower than 7.1% reported by Pan et al [11] .…”

“…The total reporting rate of combined ASC-H, LSIL, HSIL, AGC and SCCa was 1.01%, much lower than 7.1% reported by Pan et al [11] . Likewise, AGC rate of both Yangqu and Jiexiu counties was only 0.03% (10/40,000), much lower than AGC rate in CAP survey in US population (median rate: 0.2%, range: 0-1%) and also lower than that of recent nationwide survey in China (median rate: 0.05%; range: 0-1%) [17,18] . Similarly, Pan et al analyzed patients of community setting from other areas of Shanxi Province and reported 0.2-0.8% AGC rate, in which authors drew the conclusion of low incidence rate of cervical adenocarcinoma in Shanxi women population [11] .…”

Cervical cancer screening for individuals at average risk: 2020 guideline update from the American Cancer Society

“…Two primary HPV tests are FDA‐approved specifically for primary screening in the United States. As of 2017, primary HPV testing was available only in a limited number of US laboratories, 134 and it may take time and financial resources for laboratories currently using other HPV testing platforms to add platforms using the tests approved for primary screening 135 …”

“…Since 2012, several RCTs have been published on the effectiveness of primary HPV testing for cervical cancer screening that include subsequent rounds of screening, 43 and there are now FDA‐approved tests for primary screening. Although the FDA approved the first test for primary HPV screening in 2014, as of 2017, only 40.6% percent of laboratories reported that they offered primary HPV screening, and, among those that did, primary HPV screening was a very small fraction of all HPV‐associated testing 134 . Furthermore, the survey reported variability in the settings where HPV genotyping (for management of positive results, not primary HPV screening) was available.…”

“…Laboratories in public health agencies or affiliated with local, state, or federal agencies represented the lowest numbers offering HPV testing 22 . The 2016 to 2017 survey 134 did not include questions related to all HPV testing, so it is unclear at this time whether access has increased. However, although we expect that laboratory capacity has increased with the increase in FDA‐approved tests and several guidelines endorsing primary HPV screening, we may continue to see the availability of FDA‐approved HPV testing being location‐dependent and small laboratories and those in lower resource settings transitioning to full access later than larger laboratories and those in health care systems with greater resources.…”