title: Negative computer-imaged ThinPrep Pap test and positive hybrid capture2 HPV co-testing results: A quality assurance review.
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).
authors.affiliation: Department of Pathology & Laboratory Medicine, New York Presbyterian Hospital, Weill Cornell Medical College, New York.
authors.forename: Rema
authors.initials: R
authors.lastname: Rao
authors.affiliation: Department of Pathology & Laboratory Medicine, New York Presbyterian Hospital, Weill Cornell Medical College, New York.
authors.forename: David
authors.initials: D
authors.lastname: Molina
authors.affiliation: Department of Pathology & Laboratory Medicine, New York Presbyterian Hospital, Weill Cornell Medical College, New York.
authors.forename: Allison M
authors.initials: AM
authors.lastname: Halligan
authors.affiliation: Department of Pathology & Laboratory Medicine, New York Presbyterian Hospital, Weill Cornell Medical College, New York.
authors.forename: Behzad
authors.initials: B
authors.lastname: Vakil
authors.affiliation: Department of Pathology & Laboratory Medicine, New York Presbyterian Hospital, Weill Cornell Medical College, New York.
authors.forename: Susan A
authors.initials: SA
authors.lastname: Alperstein
authors.affiliation: Department of Pathology & Laboratory Medicine, New York Presbyterian Hospital, Weill Cornell Medical College, New York.
authors.forename: Rana S
authors.initials: RS
authors.lastname: Hoda
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D004279:DNA, Viral / Q000235:genetics; D005260:Female; D052162:Human papillomavirus 16 / Q000235:genetics*; D052161:Human papillomavirus 18 / Q000235:genetics*; D006801:Humans; D007090:Image Interpretation, Computer-Assisted; D008403:Mass Screening / Q000379:methods; D008875:Middle Aged; D065006:Papanicolaou Test; D027383:Papillomaviridae / Q000235:genetics; D030361:Papillomavirus Infections / Q000175:diagnosis; D011785:Quality Assurance, Health Care; D065310:Squamous Intraepithelial Lesions of the Cervix / Q000175:diagnosis* / Q000473:pathology; D002583:Uterine Cervical Neoplasms / Q000175:diagnosis* / Q000473:pathology; D014626:Vaginal Smears; D055815:Young Adult; D002578:Uterine Cervical Dysplasia / Q000175:diagnosis* / Q000473:pathology
chemical_list: D004279:DNA, Viral
keywords: ThinPrep Pap test; computer-imaged ThinPrep Pap test; hybrid capture2 HPV test