Comparative study of the cervista and hybrid capture 2 methods in detecting high‐risk human papillomavirus in cervical lesions

Abstract

High-risk human papillomavirus (HR HPV) testing is important for the follow-up of patients with cytological abnormalities. This study was undertaken to compare the clinical value of the Cervista and hybrid capture 2 (HC2) tests for detection of HR HPV in cervical lesions. Overall 439 cervical specimens with abnormal cytology and 22 normal cervical specimens were subjected to the Cervista and HC2 tests. HPV positivity and its predictive value for high-grade cervical lesions were assessed. The Cervista and HC2 tests showed comparable HR HPV detection rates in women with all cytological and histological diagnoses, with a positive and negative percent agreement of 90.8% and 64.5%, respectively. The two methods had a same sensitivity of 90% in detecting CIN II or greater cervical lesions, while the specificity for the Cervista test and HC2 assay was 47% and 43%, respectively. The positive rate for the Cervista assay probe set A9 increased with the histological severity, ranging from 25.0% in normal specimens to 69.5% in high-grade lesions. In conclusion, the clinical performance for the Cervista test is as excellent as the HC2 test in detecting HR HPV and predicting high-grade cervical lesions.

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

“…Furthermore, discrepancy analysis revealed a high false positive rate for Cervista using the currently approved cut-off values (n = 56 for Cervista versus n = 3 for HC2; Table 5). This result, however, is not in line with previous studies demonstrating a tendency of a lower or no difference in the HR HPV prevalence rate for Cervista in comparison to HC2 in women with NILM cytology [12]-[17]. This disagreement with previous reports might, however reflect differences in study design [12],[13],[16],[17], age range of participants [12],[13],[15]-[17] or overall HR HPV prevalence rates [14].…”

“…Although relative specificity was better for the Cervista HPV HR test (15.7%) than for HC2 (9.8%), the difference was not significant (p value = 0.14), which is supported by the results obtained from our ratio analysis. Our findings confirm the results of previous publications, which compared the performances of the Cervista HPV HR test and the HC2 tests and showed no significant differences in sensitivities detecting histologically confirmed high grade lesions (CIN2+ or CIN3+) [12],[16],[17]. These studies also demonstrated differences in specificities in favour for the Cervista® HPV HR test, however only Belinson et al was able to show that this difference was of statistical significance [17].…”

“…Performance comparisons of HR HC2 and the Cervista HPV HR test have previously been performed [12]-[22]. However, only a limited number of studies present data from both assays on the same residual LBC sample in comparison to cytology and histology results [12],[16],[17],[19].…”

“…However, only a limited number of studies present data from both assays on the same residual LBC sample in comparison to cytology and histology results [12],[16],[17],[19]. The objective of this study was therefore to evaluate the Cervista HPV HR assay in comparison to HC2 regarding relative sensitivity and specificity for the detection of high grade CIN3+ in women of a German routine screening population aged ≥30 years using cervical samples collected in PreservCyt® LBC medium.…”

Hybrid Capture 2 Assay Based Evaluation of High-Risk HPV Status in Healthy Women of North-East India

“…It is advocated that the interval for repeat screening can be extended to 5 years due to the increased sensitivity with this co-testing. The HR-HPV testing may be useful for management of patients with abnormal cervical smears (Tao et al, 2013). It has been shown that a single HPV test at around 35 years of age is the most cost-effective intervention in reducing the burden of cervical cancer in countries with low or no screening coverage (Goldie et al, 2005).…”