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

BMC Infectious Diseases

Thomas Iftner¹  Peter Martus²  Reinhard von Wasielewski³  Juliane Haedicke¹  Barbara Holz¹  Angelika Iftner¹  Lisa Wang²  Gerd Boehmer³ 

[1] Division of Experimental Virology, Institute of Medical Virology, University Hospital Tübingen, Elfriede-Aulhorn-Str. 6, Tübingen, 72076, Germany;Clinical Epidemiology and Applied Biometry, University Hospital Tübingen, Tübingen, Germany;German Clinic Bad Münder, Bad Münder, Germany

关键词: Cervical cancer screening;    HPV;    Hybrid capture;    Cervista;   

Others  :  1118094
DOI  :  10.1186/s12879-014-0674-1

 received in 2014-05-15, accepted in 2014-12-01,  发布年份 2014

【 摘 要 】

Background

High-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.

Methods

We 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.

Results

The 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.

Conclusions

Performance 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.

【 授权许可】

   
2014 Boehmer et al.; licensee BioMed Central.

【 图 表 】

Figure 1.

Figure 2.

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