Outcome of SurePath™ cervical samples reported as borderline nuclear change by cytological subtype and high-risk HPV status

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The average borderline rate in cervical cytology samples for English laboratories was 3.8% with the range being 2.0-6.8% at the time of the present study, which was undertaken in order to determine the association between different subtypes of borderline nuclear change (BNC), high-grade cervical intraepithelial neoplasia (CIN) and high-risk human papillomavirus (hrHPV) status. Of 68,551 SurePath(TM) cervical samples reported in one laboratory over a period of 2 years, 2335 (3.4%) were reported as BNC. hrHPV status was known in 1112 cases (47.6%). The outcome was known only for women with hrHPV-positive BNC, who were recommended for colposcopy under the National Health Service Cervical Screening Programme sentinel site protocol. Women with hrHPV-negative BNC were returned to 3-yearly recall. The cases were subdivided into BNC, high-grade dyskaryosis cannot be excluded (B-HG; 105 cases); BNC with koilocytosis (B-K; 421 cases); BNC with other features of HPV (B-HPV; 160 cases); and BNC, not otherwise specified (B-NOS; 426 cases) and were correlated with the histological outcome where available. The study population age ranged from 23 to 65 years. Cases that tested positive for hrHPV by Qiagen HCII assay comprised 78.1%, 81.0%, 73.1% and 67.8% of B-HG, B-K, B-HPV and B-NOS categories, respectively. CIN2 or worse (CIN2+) was found in 64.6%, 10.0%, 19.7% and 20.1% of hrHPV-positive cases of B-HG, B-K, B-HPV and B-NOS, respectively, which was significantly higher in the B-HG category (P < 0.001) and lower in the B-K category compared with B-NOS (p < 0.001) and B-HPV (p = 0.006) respectively. CIN3+ comprised 55.6%, 6.3%, 26.3% and 19.1% of biopsies in the same categories, respectively. Subtyping BNC is useful, especially B-K and B-HG, which, respectively, had the lowest and highest rates of detection of both CIN2+ and CIN3+, confirming that koilocytosis is likely to be associated with transient HPV infection. Women with B-HG should be referred to colposcopy in the absence of HPV triage.