Evaluation of careHPV, Cervista Human Papillomavirus, and Hybrid Capture 2 Methods in Diagnosing Cervical Intraepithelial Neoplasia Grade 2+ in Xinjiang Uyghur Women.

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. ©AlphaMed Press.