Clinical Experience with the Cervista HPV HR Assay

Abstract

Testing for high-risk (HR) human papillomavirus (HPV) is a key component of current recommendations for cervical cancer screening. Herein is described our clinical experience using Cervista HPV HR, a testing platform recently approved by the USThe relationship of cervical cancer and cervical intraepithelial neoplasia grades 2 and 3 to persistent infection with human papillomavirus (HPV) is well established. Since the identification of HPV as the primary etiologic agent of cervical cancer, 1 14 sexually transmitted oncogenic variants have been identified. These variants, referred to as the high-risk subtypes (HPV 16,18,31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68), are responsible for most cervical cancers worldwide. [2][3][4] The remarkable success of Papanicolaou test-based cervical cancer screening programs demonstrates that cervical cancer is largely preventable. However, despite its many advantages and historical success, morphologic examination of cervical cytologic material alone has limitations as a screening test. The addition of high-risk HPV (HR-HPV) DNA testing to screening algorithms has enabled better identification of clinically significant precancerous cervical lesions and more accurate evaluation of the risk of developing cervical cancer. 5,6 HR-HPV DNA testing is currently recommended by the American Society for Colposcopy and Cervical Pathology screening guidelines in two principal clinical settings. One setting in which HR-HPV DNA testing is beneficial is when cytologic findings are ambiguous or equivocal. HR-HPV DNA testing for triage of patients with atypical squamous cells of undetermined significance (ASC-US) cytological interpretations decreases colposcopic referrals by roughly half without sacrificing screening sensitivity. 7 A second setting in which HR-HPV testing is useful is for primary screening ("co-testing," along with cytology) in patients aged 30 years or older. Women in this group with both normal cytological interpretations (ie, negative for intraepithelial lesion or malignancy [NILM]) and negative HR-HPV test results are at extremely low risk of developing cervical cancer over the next several years. 8 Accordingly, the current

Human Papillomavirus Laboratory Testing: the Changing Paradigm

“…A number of clinical trials have shown that the Cervista HPV HR test is at least comparable to HC2 in the ability to accurately detect high-risk HPV and has the advantage of significantly lower cross-reactivity to other HPV types (136,(146)(147)(148)(149)(150)(151). Discordant results are seen with specimens that test HC2 negative but are positive with all three probe pools in the Cervista HPV HR test (136,152).…”

Clinical Validation of the Cervista HPV HR Test According to the International Guidelines for Human Papillomavirus Test Requirements for Cervical Cancer Screening

“…The Cervista test has a few advantages over the HC2 test: it detects the same hrHPV types as the HC2 test plus HPV66, it requires half the sample volume of that of the HC2 test, it includes the human histone 2 gene as an internal control for sample adequacy, it demonstrates no cross-reactivity with common nononcogenic HPV types, and it has a shorter processing time. In comparative studies, the Cervista HPV HR test shows sensitivity and specificity results that are similar to those of the HC2 test (8)(9)(10)(11)(12)(13)(14)(15)(16)(17), but studies comparing both assays on the same samples in a population-based screening setting are limited (9)(10)(11). Here, we evaluated the Cervista HPV HR test according the international guidelines for HPV DNA testing in primary cervical cancer screening in women Ն30 years by performing the validation process in strict accordance with that recommended by Meijer et al (4).…”

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

“…9,15,16 The analytic agreement with HC2 was very high (91.7%). Clinical sensitivity and specificity showed noninferiority in comparison with HC2, the gold standard method.…”

“…New tests should demonstrate at least 90% sensitivity and 98% specificity of the HC2 results, as assessed by a noninferiority score test. 7,8 In this regard, here we evaluated the performance of the Food and Drug Administration-approved 9 Cervista HPV HR test (Hologic, Bedford, Massachusetts).…”