ABSTRACT 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.
Abuduxikuer et al. (Wed,) studied this question.