5-type HPV mRNA versus 14-type HPV DNA test: test performance, over-diagnosis and overtreatment in triage of women with minor cervical lesions.

Content Provider	Europe PMC
Author	Westre, Bjørn Giske, Anita Guttormsen, Hilde Sørbye, Sveinung Wergeland Skjeldestad, Finn Egil
Abstract	BackgroundRepeat cytology and HPV testing is used in triage of women with minor cytological lesions. The objective of this study was to evaluate 14-type HPV DNA and 5-type HPV mRNA testing in delayed triage of women with ASC-US/LSIL.MethodsWe compared a DNA test (Roche Cobas 4800) and an 5-type mRNA test (PreTect HPV-Proofer). In total 564 women were included in the study.ResultsThe sensitivity among solved cases for CIN3+ were 100 % (15/15) for both tests. The sensitivity for CIN2+ of the HPV DNA test was 100 % (38/38) relative to 79 % (30/38) for the 5-type HPV mRNA test. The corresponding estimates of specificity for CIN2+ among solved cases were 84 % (393/466; 95 % CI: 81–88) and 91 % (451/498; 95 % CI: 88–93). The positive predictive values for CIN3+ were 13.5 % (15/111) for DNA+ and 19.5 % (15/77) for 5-type mRNA+. Significantly more women screened with 5-type mRNA than DNA returned to screening (81 % vs 71 %, p < 0.01). Subsequently, significantly fewer women were referred for colposcopy/biopsies/treatment (19 % (105/564) vs 29 % (165/564), p < 0.01).Conclusions5-type HPV mRNA is more specific than 14-type HPV DNA in delayed triage of women with ASC-US/LSIL. The referral rate for colposcopy was 57 % higher for DNA+ relative to mRNA+ cases (165 vs 105), with the same detection rate of CIN3+, but the 5-type mRNA test had lower sensitivity for CIN2+. It is important to consider the trade-off between sensitivity and specificity of the diagnostic test when designing screening algorithms.
Related Links	https://europepmc.org/backend/ptpmcrender.fcgi?accid=PMC4897822&blobtype=pdf
Journal	BMC Clinical Pathology [BMC Clin Pathol]
Volume Number	16
DOI	10.1186/s12907-016-0032-x
PubMed Central reference number	PMC4897822
PubMed reference number	27279798
e-ISSN	14726890
Language	English
Publisher	BioMed Central
Publisher Date	2016-06-07
Publisher Place	London
Access Restriction	Open
Rights License	Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License (http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver (http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated. © The Author(s). 2016
Subject Keyword	HPV DNA mRNA Screening Triage CIN CIN2 CIN3 Cervical cancer
Content Type	Text
Resource Type	Article
Subject	Histology Pathology and Forensic Medicine