Francesc Alameda1, Leia Garrote, Sergi Mojal, Carlos Sousa, Mercè Muset, Belen LLoveras, Beatriz Bellosillo, Conceçao Saldanha, Ramon Carreras, Sergi Serrano. 1. From the Departments of Pathology (Drs Alameda, Garrote, Muset, LLoveras, Bellosillo, and Serrano) and Obstetrics and Gynecology (Dr Carreras), Hospital del Mar, Barcelona, Spain; the Departments of Anatomic Pathology (Drs Alameda and Serrano) and Obstetrics and Gynecology (Dr Carreras), Autonomous University of Barcelona, Barcelona, Spain; Consulting Biomedical Research, Hospital del Mar Medical Research Institute, Barcelona, Spain (Dr Mojal); and Laboratorio de Anatomia Patologica Lda, Porto, Portugal (Mr Sousa and Dr Saldanha).
Abstract
CONTEXT: Almost all cervical cancers are related to the human papillomavirus (HPV). Future strategies for cervical cancer screening will be based on HPV detection. The Hybrid Capture 2 (HC2) test is currently the most widely used method to screen for HPV. OBJECTIVE: To test the performance of the Cervista HPV HR test for cervical screening. DESIGN: We examined 875 cervical samples by HC2 and Cervista. Of these, 64 were high-grade cervical intraepithelial neoplasia (CIN 2+) cases and were used to test the sensitivity of the assay. The remaining 811 were non-CIN 2+ cases, which were used to compare specificity. The noninferiority score test was used, with at least 0.90 for sensitivity and 0.98 for specificity and with a κ value of 0.7. RESULTS: Sensitivity and specificity were, respectively, 100% and 86.4% for the HC2 test, and 98.4% and 85.2% for the Cervista test. The agreement between the two assays was 91.7% (802 of 875; κ = 0.743; 95% confidence interval, 0.688-0.798). The noninferiority score test (relative sensitivity of 90%, T = 2.85, P = .002; and relative specificity of 98%, T = 2.75, P = .003) demonstrated that the Cervista results were not inferior to those of the HC2 test. Intralaboratory and interlaboratory reproducibility was determined by evaluating 513 and 507 samples, respectively. These reproducibilities showed κ values of 0.886 (95% confidence interval, 0.845-0.927) and 0.907 (95% confidence interval, 0.886-0.948), respectively. CONCLUSIONS: Our results demonstrate that the Cervista HPV HR test shows the same specificity as the HC2 assay. We therefore conclude that the Cervista HPV HR test is suitable for cervical cancer screening purposes.
CONTEXT: Almost all cervical cancers are related to the human papillomavirus (HPV). Future strategies for cervical cancer screening will be based on HPV detection. The Hybrid Capture 2 (HC2) test is currently the most widely used method to screen for HPV. OBJECTIVE: To test the performance of the Cervista HPV HR test for cervical screening. DESIGN: We examined 875 cervical samples by HC2 and Cervista. Of these, 64 were high-grade cervical intraepithelial neoplasia (CIN 2+) cases and were used to test the sensitivity of the assay. The remaining 811 were non-CIN 2+ cases, which were used to compare specificity. The noninferiority score test was used, with at least 0.90 for sensitivity and 0.98 for specificity and with a κ value of 0.7. RESULTS: Sensitivity and specificity were, respectively, 100% and 86.4% for the HC2 test, and 98.4% and 85.2% for the Cervista test. The agreement between the two assays was 91.7% (802 of 875; κ = 0.743; 95% confidence interval, 0.688-0.798). The noninferiority score test (relative sensitivity of 90%, T = 2.85, P = .002; and relative specificity of 98%, T = 2.75, P = .003) demonstrated that the Cervista results were not inferior to those of the HC2 test. Intralaboratory and interlaboratory reproducibility was determined by evaluating 513 and 507 samples, respectively. These reproducibilities showed κ values of 0.886 (95% confidence interval, 0.845-0.927) and 0.907 (95% confidence interval, 0.886-0.948), respectively. CONCLUSIONS: Our results demonstrate that the Cervista HPV HR test shows the same specificity as the HC2 assay. We therefore conclude that the Cervista HPV HR test is suitable for cervical cancer screening purposes.