Negative computer-imaged ThinPrep Pap test and positive hybrid capture2 HPV co-testing results: A quality assurance review

Diagn Cytopathol. 2015 Sep;43(9):763-9. doi: 10.1002/dc.23303. Epub 2015 Jul 15.

Abstract

Women ≥30 years of age with negative (-) Pap tests and positive (+) HPV co-test results have a higher prevalence and cumulative risk of developing high-grade cervical intraepithelial neoplasia (CIN 2+). Thus, the current management in these women is to repeat co-test in 12 months or immediate reflex genotyping for HPV16 or HPV 16/18. If genotyping is not an option, timely quality assurance (QA) rescreen of such Pap tests may be a valuable alternative. All ThinPrep Pap tests (TPPT) interpreted as negative for intra epithelial lesion (NILM) or NILM with reactive cellular changes (NILM/RCC) and a (+) high-risk HPV [Hybrid Capture 2 (HC2), Qiagen, Hilden, Germany] co-test result over a 45-month period (10/2009-06/2013) underwent monthly QA review. The TPPT were screened by the TP Imaging System [TIS, Hologic Inc., Bedford, MA]. Twenty five thousand six hundred and seventy five (18%) NILM and NILM/RCC TPPT of a total of 141,548 TPPT underwent HPV co-test. HPV test was (+) in 2,300 (8.9%) TPPT cases. HPV (+) cases by age group were <30 years, 486 (21%), and ≥30 years, 1,814 (79%). Upon QA review, 10 cases (0.4%) were reclassified, with significant findings in three cases in ≥30 years. Two cases showed high-grade squamous intraepithelial lesion (HSIL) on repeat Pap, and one case showed endocervical adenocarcinoma in situ (AIS) on biopsy. Timely QA review of HPV (+) Pap (-) co-tests is a valuable monitor. Ninety percentage of reclassified cases were in ≥30 age group and 70% were originally signed out by using TIS 22 Field of View (FOV) only. Three reclassified cases had significant findings on follow up (F/U).

Keywords: ThinPrep Pap test; computer-imaged ThinPrep Pap test; hybrid capture2 HPV test.

Publication types

  • Review

MeSH terms

  • Adolescent
  • Adult
  • Aged
  • Aged, 80 and over
  • DNA, Viral / genetics
  • Female
  • Human papillomavirus 16 / genetics*
  • Human papillomavirus 18 / genetics*
  • Humans
  • Image Interpretation, Computer-Assisted
  • Mass Screening / methods
  • Middle Aged
  • Papanicolaou Test
  • Papillomaviridae / genetics
  • Papillomavirus Infections / diagnosis
  • Quality Assurance, Health Care
  • Squamous Intraepithelial Lesions of the Cervix / diagnosis*
  • Squamous Intraepithelial Lesions of the Cervix / pathology
  • Uterine Cervical Dysplasia / diagnosis*
  • Uterine Cervical Dysplasia / pathology
  • Uterine Cervical Neoplasms / diagnosis*
  • Uterine Cervical Neoplasms / pathology
  • Vaginal Smears
  • Young Adult

Substances

  • DNA, Viral