[HPV primary test in the cervical cancer screening: reproducibility assessment and investigation on cytological outcome of Hybrid Capture 2 borderline samples]
| Autor: | Elena, Burroni, Cristina, Sani, Simonetta, Bisanzi, Cristina, Ocello |
|---|---|
| Rok vydání: | 2016 |
| Předmět: |
Adult
Vaginal Smears Papillomavirus Infections Nucleic Acid Hybridization Reproducibility of Results Uterine Cervical Neoplasms Middle Aged Sensitivity and Specificity Human Papillomavirus DNA Tests Italy Molecular Diagnostic Techniques Predictive Value of Tests Humans Female Early Detection of Cancer Retrospective Studies |
| Zdroj: | Epidemiologia e prevenzione. 40(3-4) |
| ISSN: | 1120-9763 |
| Popis: | to evaluate the reproducibility of the High-Risk Hybrid Capture 2 (HC2-HR, Qiagen) test within the frame of cervical cancer screening with HPV, for samples with values very close to the cut-off (borderline), that is 0.80≤RLU/CO≤0.99 (RLU/CO: relative light units/cut-off) and to assess any possible presence of high grade lesions.all borderline samples collected from January 2014 to August 2015 were repeated with HR-HC2 test within two weeks from the first test. For HPV-positive samples, cytology and colposcopy results (if present) were analysed.national and international directions recommend the use of HPV testing as a primary test for cervical cancer screening for women aged 30/34-64 years. In Tuscany Region (Central Italy) the primary screening with HPV test was introduced in 2013 and the HPV test currently used, HR-HC2, has a positive cut-off≥1 RLU/CO.proportion of HPV-positive tests at repetition, then stratified by type of material (ThinPrep, STM) and for the following subclasses of RLU/CO: 0.80-0.89 and 0.90-0.99.253 samples were borderline at first test with HR-HC2 (about 0.4% of all samples tested). About 83% (209/253) of the samples was confirmed to be negative at the HPV test repetition: 88% for RLU/CO=0.80-0.89 and 76% for RLU/CO=0.90-0.99 (p-value=0.014). Median RLU/CO value of 44 HPV-positive samples at repetition is 1.4, with a maximum RLU/CO value of 16.7. In addition, 90% of HPV-positive samples at repetition has a RLU/CO values below or equal to 3.6. Even the used sampling system affects reproducibility: 26.4% (33/125) of the samples resulted positive at the repetition were in ThinPrep vs. 8.6% (11/128) of those in STM (p-value0.001). The cytology result of HPV positive samples at repetition showed 84% (37/44) of normal samples and 7 low-grade lesions. No high-grade lesion was found in people who performed a colposcopy.as expected, the reproducibility decreases for values closest to the cut-off (0.90-0.99), confirming the intrinsic limit to all analytical methods near to the cut-off. Moreover, even if the difference in reproducibility between the two systems of sampling is statistically significant, in samples that resulted positive at repetition high-grade lesions were not found at the time of HPV screening test. |
| Databáze: | OpenAIRE |
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