Population-Based Evaluation of a Novel E6/E7 Immunocytochemistry Assay for Cervical Cancer Screening and Triage of HPV-Positive Women.

The E6 and E7 oncoproteins are significant contributors to HPV-induced cervical cancer and promising candidates for screening methods. However, clinical evidence for detecting E6/E7 by immunocytochemistry (ICC) remains limited. This study evaluated the diagnostic accuracy of a novel E6/E7 immunocytochemistry assay for primary cervical cancer screening and triage of women with high-risk human papillomavirus (hrHPV). In this cross-sectional diagnostic study conducted in 2023, 3,108 women aged 21-81 from Moyu County, Xinjiang, China, underwent HPV testing, cytology, and E6/E7 ICC. Women with abnormal results were referred for colposcopy and biopsy as indicated, and histologically confirmed CIN2+ served as the gold standard. Among 3,049 participants with complete primary screening results, E6/E7 ICC positivity was 7.4% (n = 226), intermediate between SureX hrHPV positivity (8.5%, n = 258) and cytology ASC-US+ (6.1%, n = 185). E6/E7 positivity was strongly associated with HPV16/18 infection (OR = 20.2, 95%CI:13.1-31.0), high-grade cytology (OR = 73.4, 95%CI:20.5-262.8), and increasing histology-confirmed CIN grades (OR: 14.2 ~ 149.0). A total of 3,039 women had evaluable screening outcomes within 12 months, and 36 cases of CIN2+ were identified. The E6/E7 ICC alone detected 86.1% (31/36) of CIN2+ lesions with 93.6% specificity, yielding a 7.4% referral rate. A combined strategy-referring all HPV16/18 positive women to colposcopy and triaging other hrHPV positive women using E6/E7 ICC-detected 88.9% (32/36) of CIN2+ cases with 96.2% specificity and a 4.8% colposcopy referral rate. This first population-based, cross-sectional evaluation provides preliminary evidence that the E6/E7 ICC, particularly in combination with HPV16/18 genotyping, may be an effective strategy for cervical cancer screening and triage. Prospective studies are essential to confirm its long-term predictive value before clinical implementation.
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Abuduxikuer Abuduxikuer, Abulimiti Abulimiti, Abudurexiti Abudurexiti, Zhuo Zhuo, Muhetaer Muhetaer, Li Li, Yang Yang, Tuerxun Tuerxun, Abulizi Abulizi, Rezhake Rezhake
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