Cervista HPV HR Test for Cervical Cancer Screening: A Comparative Study in the Catalonian Population

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 2þ) cases and were used to test the sensitivity of the assay. The remaining 811 were non-CIN 2þ 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 j 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; j ¼ 0.743; 95% confidence interval, 0.688-0.798). The noninferiority score test (relative sensitivity of 90%, T ¼ 2.85, P ¼ .002; and relative specificity of 98%, T ¼ 2.75, P ¼ .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 j 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. (Arch Pathol Lab Med. 2015;139:241-244; doi: 10.5858/ arpa.2014-0012-OA) N early all cervical cancers are related to the human papillomavirus (HPV). Persistent cervical infection with certain types of HPV is a prerequisite for the development of cervical cancer through precursor lesion, namely, cervical intraepithelial neoplasia (CIN) 3.1,2 The most important carcinogenic HPV genotypes are HPV16 and HPV18. The detection of high-risk HPV (HR HPV) in cervical samples, together with abnormal cytologic findings, is crucial in cervical cancer screening.3 It is essential to improve screening strategies to avoid unnecessary clinical follow-up, diagnostic procedures, and treatment of healthy women. 4 In Catalonia, the HPV test has been used in the cervical cancer screening protocol since 2006 as a complementary test to cytology in 3 circumstances: atypia on squamous cells of undetermined significance, monitoring after treatment for high-grade CIN (CIN 2þ), and screening of women older than 40 years who have not had a cytologic test in the previous 5 years.Hybrid Capture 2 (HC2; Qiagen, Hilden, Germany) is currently the most widely used HPV method to determine the presence of HR HPV in cytologic samples. It shows greater clinical sensitivity than other methods and acceptable specificity. 5,6 A group of experts in 2009 published recommendations for the validation of n...

Food and drug administration — approved molecular methods for detecting human papillomavirus infection

“…In comparison to cytological and histopathological tests, the molecular HPV tests described show different correlations between pathological changes in the cervix and HPV-positive results. Differentiation of correlation between CIN2 + and positive HPV test result is as follows: HC2 test shows 93.4% detection of CIN2+ lesions, Cevrista HPV HR 98.4%, Cervista HPV 16/18 77%, COBAS 95%, APTIMA HPV 89.4%, Onclarity 98% [10,21,27,30,33,35]. The literature does not provide this data for the APTIMA 16 16/45 test. Each of the tests described has both advantages and disadvantages.…”

“…In comparison to the PCR method, the overall positive and negative percentages of compliance were 94% and 85%, respectively [24]. The disadvantage is the cross-reactivity with HPV 31; however, it only occurs at high concentrations of this genotype in the sample [21,22].…”

“…The Cervista™ HPV HR test is characterized by high analytical sensitivity, comparable to the sensitivity of the HC2 test [19]. Compared to the HC2 test, the advantages of the test are: the Cervista includes an internal control, requires lower sample volume and involves hands-free time, because there is a possibility for automation [21,22]. Because the test requires a small-volume sample, the collected material can be used for a greater amount of analysis, e.g.…”

“…The Cervista™ HPV 16/18 test is based on the same reactions as the Cervista™ HPV HR test, however, it contains oligonucleotides complementary only to the two most oncogenic HPV strains: 16 and 18, so it is used to detect only these two types [23]. The test can be used alone or in combination with Cervista™ HPV HR, which is recommended in the case of squamous cells with indeterminate significance (ASC-US) [21]. The advantages of the test are high analytical sensitivity and analytical specificity [24].…”

Modernas metodologías diagnosticas para la detección del Virus del Papiloma Humano y prevención del cáncer de cuello uterino

“…Permite detectar por reacción cruzada a VPH 66 además de los capturados por Hybrid Capture 2. Posee el mismo procedimiento ya descrito 26,27 . Cervista HPV 16/18: hecho también por Hologic® y aprobado el mismo año (2009) fue diseñado para la identificación específica de los genotipos VPH 16 y VPH 18 24 .…”