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J Clin Virol. 2015 Jun;67:59-66. doi: 10.1016/j.jcv.2015.04.004. Epub 2015 Apr 7.

Comparing triage algorithms using HPV DNA genotyping, HPV E7 mRNA detection and cytology in high-risk HPV DNA-positive women.

Author information

1
VU University Medical Center, Department of Pathology, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: r.luttmer@vumc.nl.
2
VU University Medical Center, Department of Epidemiology & Biostatistics, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: h.berkhof@vumc.nl.
3
VU University Medical Center, Department of Pathology, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: mg.dijkstra@vumc.nl.
4
VU University Medical Center, Department of Pathology, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: f.vankemenade@erasmusmc.nl.
5
VU University Medical Center, Department of Pathology, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: pjf.snijders@vumc.nl.
6
VU University Medical Center, Department of Pathology, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: dam.heideman@vumc.nl.
7
VU University Medical Center, Department of Pathology, PO Box 7057, 1007 MB Amsterdam, The Netherlands. Electronic address: cjlm.meijer@vumc.nl.

Abstract

BACKGROUND:

High-risk human papillomavirus (hrHPV) DNA positive women require triage testing to identify those with high-grade cervical intraepithelial neoplasia or cancer (≥CIN2).

OBJECTIVE:

Comparing three triage algorithms (1) E7 mRNA testing following HPV16/18/31/33/45/52/58 genotyping (E7 mRNA test), (2) HPV16/18 DNA genotyping and (3) cytology, for ≥CIN2 detection in hrHPV DNA-positive women.

STUDY DESIGN:

hrHPV DNA-positive women aged 18-63 years visiting gynecology outpatient clinics were included in a prospective observational cohort study. From these women a cervical scrape and colposcopy-directed biopsies were obtained. Cervical scrapes were evaluated by cytology, HPV DNA genotyping by bead-based multiplex genotyping of GP5+6+-PCR-products, and presence of HPV16/18/31/33/45/52/58 E7 mRNA using nucleic acid sequence-based amplification (NASBA) in DNA positive women for respective HPV types. Sensitivities and specificities for ≥CIN2 were compared between E7 mRNA test and HPV16/18 DNA genotyping in the total group (n=348), and E7 mRNA test and cytology in a subgroup of women referred for non-cervix-related gynecological complaints (n=133).

RESULTS:

Sensitivity for ≥CIN2 of the E7 mRNA test was slightly higher than that of HPV16/18 DNA genotyping (66.9% versus 60.9%; ratio 1.10, 95% CI: 1.0002-1.21), at similar specificity (54.8% versus 52.3%; ratio 1.05, 95% CI: 0.93-1.18). Neither sensitivity nor specificity of the E7 mRNA test differed significantly from that of cytology (sensitivity: 68.8% versus 75.0%; ratio 0.92, 95% CI: 0.72-1.17; specificity: 59.4% versus 65.3%; ratio 0.91, 95% CI: 0.75-1.10).

CONCLUSION:

For detection of ≥CIN2 in hrHPV DNA-positive women, an algorithm including E7 mRNA testing following HPV16/18/31/33/45/52/58 DNA genotyping performs similar to HPV16/18 DNA genotyping or cytology.

KEYWORDS:

Cervical cancer; Cytology; E7 mRNA; Genotyping; Human papillomavirus; Triage

PMID:
25959161
DOI:
10.1016/j.jcv.2015.04.004
[Indexed for MEDLINE]

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