Objective: The study aimed to evaluate the value of the Cervista human papillomavirus (HPV), Hybrid Capture 2 (HC-2), and careHPV tests in diagnosing cervical intraepithelial neoplasia grade 2 (CIN2) or worse in Xinjiang Uyghur women.
Methods: Three high-risk human papillomavirus (HR-HPV) detection methods were studied on two different populations by different combination modes; a cytology specimen was obtained at the same time. An abnormal result of any test resulted in referral to colposcopy. Cervical biopsy was also performed.
Results: In population 1, HR-HPV-positive rates were 57.6% and 54.3% as detected by HC-2 and Cervista, respectively; κ = 0.892 for consistency check of HC-2 and Cervista (p < .001). Area under the receiver operating characteristic curve (AUC) of HC-2 and Cervista was 0.744 (95% confidence interval [CI]: 0.664∼0.824, p < .001) and 0.786 (95% CI: 0.715∼0.858, p < .001), respectively, for diagnosing CIN2+. The A9 probe can detect six subtypes of HPV, including HPV16, HPV31, HPV33, HPV35, HPV52, and HPV58. If one or more of these subtypes are postitive, then A9 will be positive. A diagnosis of class A9 by the Cerevista test correlated with pathological interpretations (chi-square = 43.063, p < .001). In population 2, HR-HPV-positive rates were 40.1% and 34.4%, respectively, by HC-2 and careHPV; κ value was 0.779 for the two tests (p < .001). AUC of HC-2 was 0.895 (95% CI: 0.849∼0.940, p < .001), and careHPV was 0.841 (95% CI: 0.770∼0.899, p < .001) for diagnosing CIN2+.
Conclusion: Good consistency was shown between HC-2 and Cervista tests and also between the HC-2 and careHPV tests. In the detection of CIN2+, Cervista showed better specificity than HC-2, and interpretation of the A9 subgroup showed high predicted value. The HC-2 test demonstrated better sensitivity than careHPV in detection of CIN2+. HC-2, Cervista, and careHPV may be applied as a triage test for visual inspection with acetic acid/Lugol's iodine-positive or ThinPrep cytologic test-positive women. The careHPV test was comparatively economical and efficient and may be more suitable for resource-limited regions, such as Xinjiang.
Implications for practice: This study was designed to evaluate the value of the Cervista human papillomavirus (HPV), Hybrid Capture 2 (HC-2), and careHPV tests in diagnosing cervical intraepithelial neoplasia grade 2 (CIN2) or worse (CIN2+) lesions in Xinjiang Uyghur women. Results showed that there was good consistency between the HC-2 and Cervista tests, as well as between the HC-2 and careHPV tests. In detecting CIN2+, Cervista had higher specificity than HC-2, whereas analysis of the A9 subgroup had high predictive value. (The A9 probe can detect six subtypes of HPV, including HPV16, HPV31, HPV33, HPV35, HPV52, and HPV58. If one or more of these subtypes are postitive, then A9 will be positive.) The HC-2 test demonstrated better sensitivity than careHPV in detecting CIN2+. HC-2, Cervista, and careHPV could be applied as a triage test for visual inspection with acetic acid/Lugol's iodine-positive or ThinPrep cytologic test-positive women. The careHPV test was comparatively economical and efficient and may be more suitable for resource-limited regions, such as Xinjiang.
摘要
目的. 本研究旨在评价Cervista人乳头瘤病毒 (HPV) 检测、第二代杂交捕获技术 (HC-2) 和careHPV检测在诊断新疆维吾尔族妇女宫颈内瘤变2级 (CIN2) 或以上级别病变中的价值。
方法. 使用三种高危人乳头瘤病毒 (HR-HPV) 检测方法, 采用不同组合模式在两个不同人群中开展研究, 同时留取细胞学样本。发现任何检验异常结果即进行阴道镜检查。同时进行宫颈活检。
结果. 在人群1中, HC-2和Cervista检测的HR-HPV阳性率分别为57.6%和54.3% ; HC-2和Cervista的一致性检验κ=0.892 (P<0.001)。HC-2和Cervista诊断CIN2+的接受者操作特征曲线下面积 (AUC) 分别为0.744[95%置信区间 (CI) : 0.664∼0.824, P<0.001]和0.786 (95%CI : 0.715∼0.858, P<0.001)。A9探针能检测出6种亚型的 HPV, 包括HPV16、HPV31、HPV33、HPV35、HPV52和HPV58。如果其中≥1种亚型检测结果为阳性, 则A9检测结果为阳性。使用Cervista检测的A9组诊断与病理学解读具有相关性 (x2=43.063, P<0.001)。在人群2中, HC-2和careHPV检测的HR-HPV阳性率分别为40.1%和34.4%, 两种检测的κ=0.779 (P<0.001)。诊断CIN2+的AUC分别为HC-2 : 0.895 (95%CI : 0.849∼0.940, P<0.001), careHPV为0.841 (95%CI : 0.770∼0.899, P<0.001)。
结论. HC-2与Cervista检测以及HC-2与careHPV检测之间均具有良好的一致性。Cervista诊断CIN2+的特异性优于HC-2, 在A9亚组的解读中也显示出高预测值。HC-2检测CIN2+的敏感性高于careHPV。HC-2、Cervista和careHPV也许可以用于醋酸染色/Lugol碘着色肉眼观察法阳性或ThinPrep细胞学检测阳性妇女的分类检验。CareHPV检测相对较为经济高效, 可能更适用于新疆等资源有限的地区。The Oncologist 2016;21:825–831
对临床实践的提示: 本研究旨在评价Cervista人乳头瘤病毒 (HPV) 检测、第二代杂交捕获技术 (HC-2) 和careHPV检测在诊断新疆维吾尔族妇女宫颈内瘤样变2级 (CIN2) 或以上级别 (CIN2+) 病变中的应用。结果显示HC-2与Cervista检测之间以及HC-2与careHPV检测之间均有较好的一致性。Cervista检测CIN2+的特异性高于HC-2, 而在A9亚组分析中具有高预测值。(A9探针能检测出6种HPV亚型, 包括HPV16、HPV31、HPV33、HPV35、HPV52和HPV58。如其中≥1种亚型检测结果为阳性, 则A9检测结果为阳性。) HC-2检测CIN2+的病变的敏感性高于careHPV。HC-2、Cervista和careHPV也许可以作为醋酸染色/Lugol碘着色肉眼观察法阳性或ThinPrep细胞学检测阳性妇女的分类检验。CareHPV检测相对较为经济高效, 可能更适用于新疆等资源有限地区。
Keywords: Cervical cancer screening; Cervista HPV test; High-risk human papillomavirus; Hybrid Capture 2; careHPV.
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