Accuracy of mRNA HPV Tests for Triage of Precursor Lesions and Cervical Cancer: A Systematic Review and Meta-Analysis.

OBJECTIVE: This systematic review evaluates the accuracy of the mRNA HPV biomarker in cervical smears to identify cervical intraepithelial neoplasia (CIN) 2 or 3 and cervical cancer. DATA SOURCE: Eligible studies were identified by performing a search of electronic databases on Medline via Pubmed, Lilacs, Cochrane Library, Embase, and Grey literature for papers published between January 1990 and June 2018. STUDY ELIGIBILITY CRITERIA: As no randomized studies were identified, this review focuses on observational studies in which the mRNA HPV diagnostic test was compared to a histopathology reference standard. We analyzed studies that included women screened for cervical cancer using mRNA HPV. STUDY APPRAISAL AND SYNTHESIS METHODS: After screening, 61 studies including 29,674 patients met the inclusion criteria and were analyzed. Dichotomization was performed by defining CIN2 or worse (CIN2+) versus CIN1, HPV infection, and normal (CIN 1-). The analysis was discriminated by the following tests: Aptima, PreTect HPV Profeer, NucliSens EasyQ HPV, OncoTect, and Quantivirus. RESULTS: Analyzing by technique, Aptima, with 28 studies, exhibited superior performance, showing for the outcomes CIN2+ and CIN3+ an AUC of 0.88 (0.82-0.95) and 0.91 (0.84-0.99), a pooled sensitivity of 92.8% (95%CI 91.9-93.7) and 95.6% (95%CI 94.5-96.5), and a pooled specificity of 60.5% (95%CI 59.8-61.3) and 61.9% (95%CI 61.1-62.7), respectively. CONCLUSION: This study supports the current hypothesis that the mRNA HPV assay is an adequate tool for secondary cervical cancer screening.

Accuracy of Messenger RNA Human Papillomavirus Tests for Diagnostic Triage of Minor Cytological Cervical Lesions: A Systematic Review and Meta-Analysis.

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.

Accuracy of mRNA HPV tests as a predictor of recurrence of precursor lesions and cervical cancer after conization: a systematic review and meta-analysis.

Objective: This systematic review evaluates the accuracy of mRNA HPV biomarker for the identification of cervical intra-epithelial neoplasia (CIN) or cervical cancer during a follow-up after conization, taking histopathology as reference standard. Methods: A search of electronic databases was performed, for studies published until June 2018. As results, after screening, five studies including 1148 patients met the inclusion criteria. Dichotomization was performed by CIN2+ versus CIN1-. By analyzing all five studies, a sensitivity of 62.4% (95% CI: 54.8-69.7), specificity of 91.9% (95% CI: 90.0-93.5) and area under the curve of 0.5685 were revealed. Conclusion: mRNA HPV assay presents a high specificity and is an adequate tool for cervical cancer screening in the follow-up after conization.