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The Efficacy of the Aptima HPVmRNA Assay in Comparison to the Hybrid Capture II: a systematic review

11 August 2012


Background: Cervical cancer remains a leading cause of morbidity and mortality for women worldwide. Cytological methods of screening introduced over 50 years ago remain the primary screening method. With advancing science and the understanding of the etiology of cervical cancer, new methods of screening have been introduced such as HPV DNA and HPV mRNA testing. This review of literature focuses on the comparison between the APTIMA mRNA test and the Hybrid Capture II DNA test, two promising tests approved by the FDA.

Method: An exhaustive literature search was conducted in Medline, CINAHL , Web of Science, Google Scholar, and EBMRmultifile using the search terms papilomaviridae, uterine cervical dysplasia, RNA, and sensitivity and specificity in combination and alone as well as terms known to be synonymous. No limitations were placed on the search. Excluded were articles that assessed HPV screening in the HIV population, non-cervical methods of screening, screening conducted on self-collected samples, and those studies not utilizing both the APTIMA HPV mRNA assay and the Hybrid Capture II test, as well as articles not written in the English language.

Results: Seven accuracy studies were included based on the inclusion and exclusion criteria delineated in the methods section. All studies utilized histology as the gold standard of comparison. All studies included showed the Aptima HPV mRNA assay (AHPV) to have comparable sensitivity to Hybrid Capture II DNA test (HC2) and statistically better specificity for detection of clinically significant cervical lesions classified as CIN2+. Four of the studies compared the AHPV to both HC2 and liquid based cytology (LBC) and demonstrated AHPV and HC2 to have better sensitivity for CIN2+ than LBC.

Conclusion: This systematic review clearly shows that the AHPV assay could play a promising role in the future of cervical cancer detection. The AHPV maintained high sensitivity, similar to the HC2, while showing improved specificity.

Keywords: papillomaviridae, papillomavirus, uterine cervical dysplasia, cervical intraepithelial neoplasm, uterine cervical neoplasm, RNA, and sensitivity and specificity


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