Tuerxun Gulixian, Yukesaier Awaguli, Lu Ling, Aierken Kailibinuer, Mijiti Patiman, Jiang Yujie, Abulizi Axianguli, Zhang Yuanyuan, Abuduxikuer Guzhanuer, Abulizi Guzhalinuer, Li Hua
Fifth Department of Gynecology, Affiliated Tumor Hospital of Xinjiang Medical University, Urumqi, Xi'anjiang Uygur, People's Republic of China.
Department of Gynecology, 12th Hospital of Xi'an City, Xi'an, Shaanxi, People's Republic of China.
Oncologist. 2016 Jul;21(7):825-31. doi: 10.1634/theoncologist.2015-0447. Epub 2016 Jun 17.
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.
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.
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+.
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.
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.
本研究旨在评估Cervista人乳头瘤病毒（HPV）检测、第二代杂交捕获法（HC-2）检测及careHPV检测在诊断新疆维吾尔族女性宫颈上皮内瘤变2级（CIN2）及更严重病变中的价值。
采用不同组合方式，在两个不同人群中研究三种高危型人乳头瘤病毒（HR-HPV）检测方法；同时获取细胞学标本。任何一项检测结果异常均需转诊至阴道镜检查，并进行宫颈活检。
在人群1中，HC-2检测和Cervista检测的HR-HPV阳性率分别为57.6%和54.3%；HC-2检测和Cervista检测一致性检验的κ值为0.892（p < 0.001）。HC-2检测和Cervista检测诊断CIN2+的受试者工作特征曲线下面积（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探针可检测6种HPV亚型，包括HPV16、HPV31、HPV33、HPV35、HPV52和HPV58。若这些亚型中一种或多种呈阳性，则A9呈阳性。Cervista检测诊断为A9类与病理诊断结果相关（χ² = 43.063，p < 0.001）。在人群2中，HC-2检测和careHPV检测的HR-HPV阳性率分别为40.1%和34.4%；两项检测的κ值为0.779（p < 0.001）。HC-2检测诊断CIN2+的AUC为0.895（95% CI：0.849∼0.940，p < 0.001），careHPV检测的AUC为0.841（95% CI：0.770∼0.899，p < 0.001）。
HC-2检测与Cervista检测之间以及HC-2检测与careHPV检测之间均显示出良好的一致性。在检测CIN2+时，Cervista检测的特异性优于HC-2检测，且A9亚组的判读显示出较高的预测价值。HC-2检测在检测CIN2+时的敏感性优于careHPV检测。HC-2检测、Cervista检测及careHPV检测可作为对醋酸/卢戈氏碘染色阳性或薄层液基细胞学检测阳性女性进行分流检测的方法。careHPV检测相对经济高效，可能更适合像新疆这样资源有限的地区。
本研究旨在评估Cervista人乳头瘤病毒（HPV）检测、第二代杂交捕获法（HC-2）检测及careHPV检测在诊断新疆维吾尔族女性宫颈上皮内瘤变2级（CIN2）及更严重病变（CIN2+）中的价值。结果显示，HC-2检测与Cervista检测之间以及HC-2检测与careHPV检测之间均具有良好的一致性。在检测CIN2+时，Cervista检测的特异性高于HC-2检测，而对A9亚组的分析具有较高的预测价值。（A9探针可检测6种HPV亚型，包括HPV16、HPV31、HPV33、HPV35、HPV52和HPV58。若这些亚型中一种或多种呈阳性，则A9呈阳性。）HC-2检测在检测CIN2+时的敏感性优于careHPV检测。HC-2检测、Cervista检测及careHPV检测可作为对醋酸/卢戈氏碘染色阳性或薄层液基细胞学检测阳性女性进行分流检测的方法。careHPV检测相对经济高效，可能更适合像新疆这样资源有限的地区。
