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

Q2 Medicine

BMC Clinical Pathology Pub Date : 2016-06-07 eCollection Date: 2016-01-01 DOI:10.1186/s12907-016-0032-x

Bjørn Westre, Anita Giske, Hilde Guttormsen, Sveinung Wergeland Sørbye, Finn Egil Skjeldestad

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引用次数: 18

Abstract

Background: Repeat 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.

Methods: We 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.

Results: The 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).

Conclusions: 5-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.

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5型人乳头瘤病毒mRNA与14型人乳头瘤病毒DNA检测:宫颈轻微病变女性分诊中的检测性能、过度诊断和过度治疗

背景:重复细胞学检查和HPV检测用于鉴别患有轻微细胞学病变的妇女。本研究的目的是评估14型HPV DNA和5型HPV mRNA检测在ASC-US/LSIL女性延迟分诊中的作用。方法:我们比较了DNA检测(Roche Cobas 4800)和5型mRNA检测(preect HPV-Proofer)。共有564名女性参与了这项研究。结果:两项检测对CIN3+的敏感性均为100%(15/15)。HPV DNA检测CIN2+的敏感性为100%(38/38)，而5型HPV mRNA检测的敏感性为79%(30/38)。CIN2+在已解决病例中的特异性估计为84% (393/466;95% CI: 81-88)和91% (451/498;95% ci: 88-93)。DNA+的CIN3+阳性预测值为13.5%(15/111)，5型mRNA+为19.5%(15/77)。接受5型mRNA筛查的女性复诊率明显高于接受DNA筛查的女性(81% vs 71%， p)。结论:在ASC-US/LSIL患者的延迟分诊中，5型HPV mRNA比14型HPV DNA更具特异性。DNA+病例的阴道镜转诊率比mRNA+病例高57% (165 vs 105)， CIN3+的检出率相同，但5型mRNA检测对CIN2+的敏感性较低。在设计筛选算法时，考虑诊断测试的敏感性和特异性之间的权衡是很重要的。

本文章由计算机程序翻译，如有差异，请以英文原文为准。

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来源期刊

BMC Clinical Pathology Medicine-Pathology and Forensic Medicine

CiteScore

3.30

自引率

0.00%

发文量

期刊介绍： BMC Clinical Pathology is an open access journal publishing original peer-reviewed research articles in all aspects of histopathology, haematology, clinical biochemistry, and medical microbiology (including virology, parasitology, and infection control). BMC Clinical Pathology (ISSN 1472-6890) is indexed/tracked/covered by PubMed, CAS, EMBASE, Scopus and Google Scholar.