Human papilloma virus (HPV) molecular diagnostics

Abstract

Human Papilloma Virus (HPV) is becoming a menace worldwide, especially to the developing world, due to its involvement in a variety of malignancies, with cervical cancer being the most important and prevalent. There are many HPV types; HPV 16/18 are the most carcinogenic but few others are also characterized as high-risk (HR). They can cause a variety of low- or high-grade cellular abnormalities, most frequently detected in a routine Pap test. Most infections clear within 2 years, however, a minority persists and potentially could progress to cervical cancer. Molecular tests detecting HPV DNA, RNA or proteins are now being available either commercially or in-house developed. DNA detection is nowadays an established tool for diagnosis and monitoring of HPV-related disease, however, there is lack of a reference method and standardization with reference materials. The various available test formats create confusion on which molecular test to choose and what are its limitations. Therefore, the need for lab accreditation and participation in proficiency testing has to be stressed. Novel HPV biomarkers (RNA, protein etc.) are now intensively examined for their inclusion as adjunct tools. Recently, developed prophylactic vaccines for HPV 16/18 have already proven safe and efficient and raise high expectations for the complete eradication of these types in the future.

PAX1 and SOX1 methylation as an initial screening method for cervical cancer: a meta-analysis of individual studies in Asians

“…Nevertheless, in Wang's study, the accuracy of HC2 test in triage of high-grade squamous intraepithelial lesions was unsatisfactory, in which the sensitivity and specificity were only 0.677 and 0.545, respectively (13). Despite the reported inconstant results for these methods, these techniques often lack standardization and comparability (34,35). It appears therefore that single HPV DNA testing is not recommended for screening purposes (10,11).…”

“…The sensitivity of HPV DNA testing is satisfactory, whereas the high prevalence of transient HPV infections had limited the specificity of this approach (10,11). Currently, there are several test methods for HPV DNA assay, such as PCR, hybrid capture II (HC2), strip test (for E6 detection) as well as other novel techniques (5,(12)(13)(14)(15)34,35), Among these evaluation tools, PCR and HC2 tests remain the most commonly used techniques (34,35). Notwithstanding, single HPV DNA testing using PCR or HC2 method seems to yield inconstant results for the detection of cervical precancerous lesions (CIN2 or worse).…”

Trends in Laboratory Test Volumes for Medicare Part B Reimbursements, 2000–2010

“…20 Current evidence has shown superiority of HPV testing over cervical cytology as a more-sensitive screening method and for follow-up of women treated for cervical intraepithelial neoplasia. 75 Detection of HPV DNA has become an established tool for diagnosis and monitoring of HPVrelated disease, 76 given that persistent infection with HPV has been recognized as a significant risk factor for most precancerous lesions and cancers of the cervix. 77 Although testing for HPV DNA in cervical specimens is more sensitive than the Papanicolaou test in detecting high-grade cervical lesions, HPV testing is less specific than cervical cytology, 78 and it should be reserved for the more labor-efficient task of triaging patients with HPV þ test results because most HPV þ tests contain relevant abnormalities that can be evaluated by cervical cytology with sufficient accuracy.…”

Laboratory medicine and medical oncology: the tale of two Cinderellas

“…Another aspect of laboratory medicine of importance in clinical practice is the detection of infection by oncogenic viruses, e.g., human papilloma viruses that cause carcinoma of the uterine cervix as well as other tumors, including anal cancer and some cases of head and neck carcinomas [52,53] . Among other biomarkers, the detection of parameters associated with angiogenesis, one of the hallmarks of cancer, is being slowly introduced into the laboratory and the clinic [54] .…”