Comparing the Cervista HPV HR Test and Hybrid Capture 2 Assay in a Dutch Screening Population: Improved Specificity of the Cervista HPV HR Test by Changing the Cut-OffBoers, A., Slagter-Menkema, L., van Hemel, B. M., Belinson, J. L., Ruitenbeek, T., Buikema, H. J., Klip, H., Ghyssaert, H., van der Zee, A. G. J., de Bock, G. H., Wisman, G. B. A. & Schuuring, E., 22-Jul-2014, In : PLoS ONE. 9, 7, 9 p., 101930.
Research output: Contribution to journal › Article › Academic › peer-review
The diagnostic performance of the widely-used Cervista HPV HR test was compared to the Hybrid Capture 2 (HC2) test in a Dutch population-based cervical cancer screening program. In 900 scrapings of women with normal cytomorphology, specificity was 90% (95%CI: 87.84-91.87) for the Cervista HPV HR test and 96% (95%CI: 94.76-97.37) for the HC2 test with 93% agreement between both tests (κ = 0.5, p<0.001). The sensitivity for CIN2+ using 65 scrapings of women with histological-confirmed CIN2+ was 91% (95%CI: 80.97-96.51) for the Cervista HPV HR test and 92% (95%CI: 82.94-97.43) for the HC2 test with 95% agreement between both tests (κ = 0.7, p<0.001). Fifty-seven of 60 HC2 negative/Cervista positive cases tested HPV-negative with PCR-based HPV assays; of these cases 56% were defined as Cervista triple-positive with FOZ values in all 3 mixes higher than the second cut-off of 1.93 (as set by manufacturer). By setting this cut-off at 5.0, specificity improved significantly without affecting sensitivity. External validation of this new cut-off at 5.0 in triple-positive scrapings of women selected from the SHENCCASTII database revealed that 22/24 histological normal cases now tested HPV-negative in the Cervista HPV HR test, while CIN2+ lesions remained HPV-positive. The intra-laboratory reproducibility of the Cervista HPV HR test (n = 510) showed a concordance of 92% and 93% for cut-off 1.93 and 5.0 (κ = 0.83 and κ = 0.84, p<0.001) and inter-laboratory agreement of the Cervista HPV HR test was 90% and 93% for cut-off 1.93 and 5.0 (κ = 0.80 and κ = 0.85, p<0.001). In conclusion, the specificity of the Cervista HPV HR test could be improved significantly by increasing the second cut-off from 1.93 to 5.0, without affecting the sensitivity of the test in a population-based screening setting.
|Number of pages||9|
|Publication status||Published - 22-Jul-2014|
- HIGH-RISK HPV, HUMAN-PAPILLOMAVIRUS DNA, CERVICAL-CANCER, WOMEN, CYTOLOGY, PERFORMANCE, VALIDATION, PREVENTION, GUIDELINES, EXPERIENCE
Dataset: Inter-laboratory agreement of the Cervista HPV HR test with a second cut-off at default setting of 1.93 (A) and at new setting of 5.0 (B)
Boers, A. (Creator), Slagter-Menkema, L. (Creator), Hemel, van, B. (Creator), Belinson, J. L. (Creator), Ruitenbeek, T. (Creator), Buikema, H. J. (Creator), Klip, H. (Creator), Ghyssaert, H. (Creator), Zee, van der, A. (Creator), Bock, de, T. (Creator), Schuurs-Wisman, B. (Creator), Schuuring, E. (Creator), University of Groningen, 22-Jul-2014