Performance of proex c and pretect hpv‐proofer e6/e7 mrna tests in comparison with the hybrid capture 2 hpv dna test for triaging ascus and lsil cytology |
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Authors: | Reza Alaghehbandan M.D. M.Sc. Daniel Fontaine M.D. James Bentley M.D. Nicholas Escott M.D. Prafull Ghatage M.D. Adrian Lear M.D. Francois Coutlee M.D. Samuel Ratnam Ph.D. MPH |
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Affiliation: | 1. Department of Anatomic Pathology, Faculty of Medicine, Memorial University, , St. John's, Newfoundland and Labrador, Canada;2. Department of Anatomical Pathology, Faculty of Medicine, University of Calgary, , Calgary, Alberta, Canada;3. Department of Obstetrics and Gynecology, Queen Elizabeth II Health Sciences Centre, , Halifax, Nova Scotia, Canada;4. Department of Pathology, Regional Health Sciences Centre, , Thunder Bay, Ontario, Canada;5. Department of Gynecology, Tom Baker Cancer Centre, , Calgary, Alberta, Canada;6. Department of Oncology, Dr. Bliss H. Murphy Cancer Centre, , St. John's, Newfoundland and Labrador, Canada;7. Département de Microbiologie et Infectiologie, Centre Hospitalier de l'Université de Montréal et Université de Montréal, , Montréal, Québec, Canada;8. Public Health Laboratory, Department of Health, Faculty of Medicine, Memorial University, , St. John's, Newfoundland and Labrador, Canada |
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Abstract: | The clinical usefulness of the ProEx C (Becton Dickinson) and PreTect HPV‐Proofer E6/E7 mRNA tests (Proofer; Norchip) for the triage of ASCUS and LSIL cytology was determined in comparison with the Hybrid Capture 2 HPV DNA test (HC2; Qiagen). The study population consisted of women with a history of abnormal cytology referred to colposcopy. Histology‐confirmed CIN 2+ served as the disease endpoint. The study was based on 1,360 women (mean age 30.7 years), of whom 380 had CIN 2+. Among 315 with ASCUS (CIN 2+, n = 67), the sensitivities of ProEx C, Proofer, and HC2 to detect CIN 2+ were, 71.6, 71.6, and 95.5%, respectively, with a corresponding specificity of 74.6, 74.2, and 35.1%. Among 363 with LSIL (CIN 2+, n = 108), the sensitivities of ProEx C, Proofer, and HC2 were, 67.6, 74.1, and 96.3%, respectively, with a corresponding specificity of 60, 68.2, and 18.4%. Among 225 HC2‐positive ASCUS (CIN 2+, n = 64), 105 tested positive by ProEx C, reducing colposcopy referral by 53.3% and detecting 71.9% of CIN 2+; Proofer was positive in 112/225, reducing colposcopy referral by 50.2% and detecting 75.0% of CIN 2+. Among 312 HC2‐positive LSIL (CIN 2+, n = 104), 160 tested positive by ProEx C, reducing coloposcopy referral by 48.7% and detecting 66.3% of CIN 2+; Proofer was positive in 159/312, reducing colposcopy referral by 49.0% and detecting 75.0% of CIN 2+. In conclusion, both ProEx C and Proofer have a similar performance profile with a significantly higher specificity but lower sensitivity than HC2 for the detection of CIN 2+. Consequently, although they can reduce colposcopy referral, they will miss a proportion of CIN 2+ cases. This is a major limitation and should be taken into account if these tests are considered for ASCUS or LSIL triage. Diagn. Cytopathol. 2013;41:767–775. © 2013 Wiley Periodicals, Inc. |
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Keywords: | ProEx C PreTect HPV‐proofer HC2 ASCUS triage LSIL triage CIN 2+ |
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