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Accuracy of Messenger RNA Human Papillomavirus Tests for Diagnostic Triage of Minor Cytological Cervical Lesions

A Systematic Review and Meta-Analysis

Macedo, Ana Cristina L., PhD*; Bavaresco, Daniela Vicente, MS*; Gonçalves, João Carlos N., MS*; Grande, Antônio José, PhD; da Rosa, Maria Inês, PhD*

Sexually Transmitted Diseases: May 2019 - Volume 46 - Issue 5 - p 297–303
doi: 10.1097/OLQ.0000000000000970
Original Studies

Objectives The main objective of this systematic review and meta-analysis is to specify the accuracy of messenger RNA human papillomavirus (HPV) tests among women with previous minor cervical lesion cytology to detect high-grade squamous intraepithelial lesions (CIN2+ and CIN3+) compared with a histopathological reference standard. The secondary objective is to compare messenger RNA HPV test accuracies and the DNA high-risk HPV test among these women.

Methods Eligible studies were identified by searching the electronic databases with medical subject headings.

Main Results Among the 2052 studies identified, 20 primary studies were included. Two tests were mainly identified: Aptima and PreTect HPV-Proofer. Aptima, with 10 studies, had better performance, considering atypical squamous cells of undetermined significance (ASC-US) and low-grade squamous intraepithelial lesion together, with a pooled sensitivity of 90.5% (95% confidence interval [CI], 88.1–92.6) and specificity of 55.1% (95% CI, 53.5–56.8) for CIN2+. For the ASC-US sample, Aptima had a pooled sensitivity of 90.1% (95% CI, 87.1–92.7) and specificity of 59.3% (95% CI, 57.5–61.1).

Conclusions Messenger RNA HPV tests, mainly Aptima assay, can be recommended to triage women with ASC-US and low-grade squamous intraepithelial lesion because it has higher specificity with a small loss of sensitivity than Hybrid Capture 2 assay; this finding is promising as a means to reduce the overmanagement of minor cytological abnormalities.

This review contained 20 primary studies. Two tests were mainly identified: Aptima, which had a better area under the curve in all analyses and the best sensitivity, and PreTect HPV-Proofer, which had the best specificity.

From the *Translational Biomedicine Laboratory, Graduate Program in Health Sciences, University of Southern Santa Catarina, Criciúma, SC; and

Laboratory of Evidence in Health, Medicine and Health Sciences, University of State of Mato Grosso do Sul, Campo Grande, MS, Brazil

Acknowledgment: The authors acknowledge generous funding from the University of Extremo Sul Catarinense–University of Southern Santa Catarina.

Conflict of Interest and Sources of Funding: The present study has no conflict of interest. This study was supported in part by grants from “Conselho Nacional de Desenvolvimento Científico e Tecnológico” (CNPq-Brazil). M.I.R. is recipient of CNPq (Brazil) Productivity Fellowships.

Correspondence: Maria Inês da Rosa, PhD, Translational Biomedicine Laboratory, Graduate Program in Health Sciences, University of Southern Santa Catarina, Criciúma, SC 88806000, Brazil. E-mail:

Received for publication July 3, 2018, and accepted December 24, 2018.

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© Copyright 2019 American Sexually Transmitted Diseases Association