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

Boehmer G, Wang L, Iftner A, Holz B, Haedicke J, von Wasielewski R, Martus P, Iftner T - BMC Infect. Dis. (2014)

Bottom Line: Test characteristics were calculated and a novel method for measuring test performances was applied by calculating ratios of sensitivity or specificity.The overall agreement of both tests for detection of HR HPV was excellent (κ = 0.8).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.

View Article: PubMed Central - PubMed

Affiliation: German Clinic Bad Münder, Bad Münder, Germany. Boehmer@izd-hannover.de.

ABSTRACT

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.

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Ratio of specificities of Cervista and HC2 as a function of HR HPV prevalence.
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Fig2: Ratio of specificities of Cervista and HC2 as a function of HR HPV prevalence.

Mentions: As only women with high grade abnormal cytology were referred to colposcopy and considering the low sensitivity of cytology in detecting CIN3+ [25], the true extent of high grade CIN in the Pap I/II and IIw categories remains unknown. This lack of data prevents the application of conventional clinical sensitivity and specificity calculations. However, by calculating the ratio of the sensitivity or specificity of two tests, we developed a method, which yields a value that measures relative performance. The ratio of sensitivity between Cervista HPV HR test and HC2 is 0.977 (0.69, 1.27). The ratio of specificity also contained 1 over all prevalence possibilities. Figure 2 shows the ratio of specificity given a range of prevalences. As a result, there is no statistical difference between clinical sensitivity and specificity of the Cervista HPV HR test and HC2 for the detection of high grade disease at the 95% confidence level.Figure 2


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

Boehmer G, Wang L, Iftner A, Holz B, Haedicke J, von Wasielewski R, Martus P, Iftner T - BMC Infect. Dis. (2014)

Ratio of specificities of Cervista and HC2 as a function of HR HPV prevalence.
© Copyright Policy - open-access
Related In: Results  -  Collection

License 1 - License 2
Show All Figures
getmorefigures.php?uid=PMC4279999&req=5

Fig2: Ratio of specificities of Cervista and HC2 as a function of HR HPV prevalence.
Mentions: As only women with high grade abnormal cytology were referred to colposcopy and considering the low sensitivity of cytology in detecting CIN3+ [25], the true extent of high grade CIN in the Pap I/II and IIw categories remains unknown. This lack of data prevents the application of conventional clinical sensitivity and specificity calculations. However, by calculating the ratio of the sensitivity or specificity of two tests, we developed a method, which yields a value that measures relative performance. The ratio of sensitivity between Cervista HPV HR test and HC2 is 0.977 (0.69, 1.27). The ratio of specificity also contained 1 over all prevalence possibilities. Figure 2 shows the ratio of specificity given a range of prevalences. As a result, there is no statistical difference between clinical sensitivity and specificity of the Cervista HPV HR test and HC2 for the detection of high grade disease at the 95% confidence level.Figure 2

Bottom Line: Test characteristics were calculated and a novel method for measuring test performances was applied by calculating ratios of sensitivity or specificity.The overall agreement of both tests for detection of HR HPV was excellent (κ = 0.8).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.

View Article: PubMed Central - PubMed

Affiliation: German Clinic Bad Münder, Bad Münder, Germany. Boehmer@izd-hannover.de.

ABSTRACT

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.

Show MeSH
Related in: MedlinePlus