Human Papillomavirus Testing and Reporting Rates in 2012: Results of a College of American Pathologists National Survey

Abstract

Context College of American Pathologists (CAP) surveys are used to establish national benchmarks for laboratory parameters. Objective To evaluate changes in laboratory human papillomavirus (HPV) testing patterns in laboratories incorporating HPV testing with Papanicolaou tests in 2012. Design Data were analyzed from the CAP HPV Supplemental Questionnaire distributed to 1771 laboratories participating in either CAP HPV or CAP Papanicolaou proficiency testing in 2013. Results A total of 1022 laboratories (58%) responded. There were more high-risk (HR) HPV tests performed per institution as compared to previous surveys. There were more HPV tests performed within an institution as compared to previous surveys. Hybrid Capture 2 (HC2) remains the most common method (42.4%, 239 of 564); Cervista and cobas methods are used in 37.2% (210 of 564) and 14.9% (84 of 564) of laboratories, respectively. Human papillomavirus testing is offered as a reflex test after a Papanicolaou test result of atypical squamous cells of undetermined significance (ASC-US) in 89.6% of laboratories (476 of 531); as a cotest for women aged 30 years and older in 60.3% (404 of 531); as reflex testing after atypical squamous cells, cannot exclude high-grade squamous intraepithelial lesion (ASC-H) in 42.7% (320 of 531); and as reflex testing after atypical glandular cells (AGC) in 27.3% (145 of 531). The HPV-positive rates for ASC-US and ASC-H were similar in 2012 and 2006. Cervista (49.2%, 88 of 179) and Roche cobas (27.4%, 49 of 179) are the most common methods used for genotyping. Most laboratories use the CAP Human Papillomavirus for Cytology Program for proficiency testing. Conclusions There was an increase in annual volume of HR-HPV testing with a shift toward in-house HR-HPV testing. Genotyping volumes also increased. HC2 and Cervista are most commonly used, with an increasing volume of Roche cobas testing. The most common indication for HPV testing among all laboratories was ASC-US reflex testing, but an increase in HPV cotesting was observed. The data provide an update into persisting and newer trends in HPV testing practices.

Human Papillomavirus Genotyping Testing Practice in 2014: Results of a College of American Pathologists National Survey

“…Hologic Cervista HPV16/18 assay, Roche cobas HPV test, and polymerase chain reaction/others were used for HPV genotyping in 49.2% (88 of 179), 27.4% (49 of 179), and 3.5% (6 of 179) of laboratories, respectively, in 2012. 8 For women aged 30 years and older who had cotesting (HPV testing concordant with a Pap test), the median reporting rate of HR-HPV positivity was 6.0% (mean: 8.5%, 150 laboratories) in 2014, similar to that in 2012 (median: 6.5%, mean: 10.9%, 81 laboratories).…”

“…As compared to our previous 2012 survey, more laboratories offered HPV genotyping and more laboratories performed in-house HPV genotyping testing, indicating a trend of adopting HPV genotyping testing into the laboratories. 8 The total volume of HPV tests and genotyping tests continues to increase while the total volume of Pap tests continues to decrease, suggesting an increase in HPV genotyping tests with an expansion of its use in more clinical settings, and increased use of recently approved HPV test platforms. The changes in percentage of methods from 2012 to 2014 reflect the adoption of newly FDAapproved methods on the market.…”

“…8 The cobas 4800 HPV Test simultaneously detects a total of 14 HR-HPV types: HPV16 individually, HPV18 individually, and 12 pooled HR-HPV genotypes (31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68). 10 Roche cobas HPV testing reports both HR-HPV results and genotyping results even if genotyping testing is not ordered, which likely explains why it is the most commonly used HPV genotyping method, and why HPV genotyping test was most commonly offered to women with a positive HPV test result regardless of Pap test results and patient age.…”

“…[3][4][5][6][7] One recent CAP survey in 2012 demonstrated that there was an increase in annual volume of both HR-HPV testing and HPV genotyping volumes. 8 The specific goal of the 2015 CAP HPV Genotyping Practices Supplemental Questionnaire was to evaluate current practices in those laboratories incorporating HPV genotyping testing with the Pap test, to compare the results with previous survey results, 8 and to identify trends in HPV genotyping testing.…”

A Suggested Approach to Simplify and Improve Cervical Screening in the United States

“…While it is widely acknowledged that positive HPV tests require triage rather than universal, immediate colposcopic referral, the optimal triage methods are undecided and quite varied. Possible triage methods include cytology (3, 9–13) and related methods (e.g., p16/Ki67 dual staining)(14), HPV genotyping in various configurations (8, 10, 15), and other promising novel technologies including redesigned automated cytology (as presented by Schiffman et al at the 30 th International Papillomavirus Conference in 2015) and biomarkers like methylation (16–18). The multiple screening/triage combinations need to be better validated in large prospective studies and, in the absence of sufficient information, they have not been addressed in formal guidelines.…”