A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-offReportar como inadecuado




A population-based observational study comparing Cervista and Hybrid Capture 2 methods: improved relative specificity of the Cervista assay by increasing its cut-off - Descarga este documento en PDF. Documentación en PDF para descargar gratis. Disponible también para leer online.

BMC Infectious Diseases

, 14:674

Sexually transmitted diseases

Abstract

BackgroundHigh-risk human papillomavirus HR HPV testing has been shown to be a valuable tool in cervical cancer screening for the detection of cervical pre-cancer and cancer.

MethodsWe report a purely observational study evaluating HR HPV prevalences in residual liquid-based cytology LBC samples using both the Cervista™ HPV HR Test and the Digene Hybrid Capture 2 High-Risk HPV DNA Test HC2 in a sample of 1,741 women aged ≥30 years of a German routine screening population of 13,372 women. Test characteristics were calculated and a novel method for measuring test performances was applied by calculating ratios of sensitivity or specificity.

ResultsThe overall agreement of both tests for detection of HR HPV was excellent κ = 0.8. Relative sensitivities for the detection of histologically confirmed severe cervical intraepithelial dysplasia CIN3+ were similar for both HPV-tests, which was confirmed by the ratio analysis. However, discrepancy analysis between the Cervista HPV HR test and HC2 revealed a high false positive rate of the Cervista HPV HR test in the cytology normal category.

ConclusionsPerformance of the Cervista HPV test in cervical specimens with abnormal cytology is comparable to HC2 as both tests were highly sensitive and specific for the detection of high grade cervical disease. We also demonstrate evidence that modification of the cut-off values drastically reduces the false positive rate in the cytology normal category without affecting the detection of CIN3+, which ultimately improved specificity of the Cervista HPV HR assay.

KeywordsCervista Hybrid capture HPV Cervical cancer screening Electronic supplementary materialThe online version of this article doi:10.1186-s12879-014-0674-1 contains supplementary material, which is available to authorized users.

Gerd Boehmer, Lisa Wang contributed equally to this work.

Download fulltext PDF



Autor: Gerd Boehmer - Lisa Wang - Angelika Iftner - Barbara Holz - Juliane Haedicke - Reinhard von Wasielewski - Peter Martus - Th

Fuente: https://link.springer.com/







Documentos relacionados