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

Abstract

Context.-College of American Pathologists (CAP) surveys are used to establish national benchmarks for laboratories.Objective.-To investigate human papillomavirus (HPV) genotyping testing practice patterns in laboratories in 2014.Design.-Data were analyzed from the CAP HPV Genotyping Practices Supplemental Questionnaire distributed to 749 laboratories participating in the CAP Human Papillomavirus (High Risk) for Cytology Program.Results.-Six hundred four of 749 laboratories (80.6%) responded to the survey. More laboratories offered HPV genotyping testing and performed in-house HPV genotyping testing as compared to previous surveys. The Roche cobas HPV test was the most commonly used genotyping method (37.0%; 160 of 433), followed by Hologic Aptima HPV16 18/45 (26.1%; 113 of 433) and Hologic Cervista HPV16/18 (14.3%; 62 of 433). Most laboratories (287 of 399; 71.9%) offered HPV genotyping for high-risk HPV cases regardless of Papanicolaou (Pap) test results and patient age; this pattern was more common in laboratories using cobas. The remaining laboratories specifically offered testing to women with a negative Pap test result at age 30 years and older (65.2%, 73 of 112) or all ages (37.5%, 42 of 112). The median reporting rates of HPV16 and/or HPV18 positivity were 20.6%, 25.7%, 21.1%, and 57.4% for women with positive high-risk HPV adjunctive negative Pap results, atypical squamous cells of undermined significance, low-grade squamous intraepithelial lesion, and high-grade squamous lesion, respectively.Conclusions.-Human papillomavirus genotyping testing has increased. Roche cobas and Hologic Aptima genotype methods were the most common, and laboratories using cobas usually offered genotyping regardless of Pap test result and age. The data provide a baseline and trend of HPV genotyping test practices in

Role of HPV genotyping in risk assessment among cytology diagnosis categories: analysis of 4562 cases with cytology–HPV cotesting and follow-up biopsies

“…Roche Cobas and Hologic Aptima are the two most commonly used high-risk HPV testing platforms in the USA18 and employ different techniques targeting very different high-risk HPV molecules. The Cobas test detects viral DNA of 14 high-risk HPV genotypes with concurrent genotyping of HPV16 and 18, whereas Aptima is a target amplification test for detection of viral E6/E7 mRNA from 14 high-risk HPV genotypes, with optional genotyping of HPV16 and 18/45.…”

Performance of Aptima and Cobas HPV testing platforms in detecting high‐grade cervical dysplasia and cancer

“…For example, fewer women in our cohort were tested on the Aptima platform than on the Cobas platform, as noted in our current results. This is generally coincident with recent CAP survey data indicating that Cobas is the leading HPV genotyping test followed by other HPV tests, including Aptima . Clinicians may select HPV tests based on many considerations or preferences.…”

“…This is generally coincident with recent CAP survey data indicating that Cobas is the leading HPV genotyping test followed by other HPV tests, including Aptima. 11 Clinicians may select HPV tests based on many considerations or preferences. The Aptima HPV test was implemented in our laboratory much later than the well established Cobas system, and many of our clinicians were just getting familiar with the new Aptima test at the time of the data collection.…”

“…Among the 4 US Food and Drug Administration‐approved HPV tests in the United States, 3 are DNA‐based tests: Cobas HPV test (Cobas 4800; Roche Molecular Diagnostics [Roche], Pleasanton, Calif), Hybrid Capture 2 (HC2) (Qiagen, Gaithersburg, Calif), and Cervista (Hologic, Bedford, Mass); whereas 1 test detects E6/E7 messenger RNA (mRNA) (Aptima; Hologic/Gen‐Probe, San Diego, Calif). According to a 2014 College of American Pathologists (CAP) survey of laboratories, the most commonly used platforms for HPV genotyping are Roche Cobas (37%) and Hologic Aptima (26%) …”

“…According to a 2014 College of American Pathologists (CAP) survey of laboratories, the most commonly used platforms for HPV genotyping are Roche Cobas (37%) and Hologic Aptima (26%). 11 In view of the critical role of E6/E7 overexpression after HPV genome integration in the development of cervical malignancy, direct testing of hrHPV E6/E7 mRNA in cervical samples may be more specific than hrHPV DNA testing for the detection of high-grade cervical lesions. Direct comparative data with regard to the performance of the 2 different testing methods in clinical practice are limited.…”