Clinical performance of the APTIMA HPV Assay for the detection of high-risk HPV and high-grade cervical lesions.

摘要: ABSTRACT Background Human papillomavirus (HPV) DNA testing is widely used in conjunction with Papanicolaou (Pap) cervical cancer screening programs to improve the detection of high-grade lesions. While HPV test sensitivity good, an improvement specificity desired. Detection mRNA may specificity. The APTIMA® Assay detects 14 high-risk types liquid-based cytology specimens. Objective To evaluate APTIMA performance for and intraepithelial neoplasia (CIN) compared Qiagen's Hybrid Capture 2 (HC2) test. Study design Liquid Pap specimens were collected from 800 women referred colposcopy tested HC2 Complete results available 753 subjects. A subset samples (n = 393) typed using Roche's Linear Array Genotyping Test. Results Sensitivity >92% 99% 93% 82% Clinical 91% >55% CIN 2+, 98% 53% 3+ Assay; values 95% 47% 44% 3+. Conclusions: sensitive very specific HPV. had similar clinical disease but higher than test, which patient management reduce cost care.