Cytopathology Department, Altnagelvin Hospital, Western Health and Social Care Trust, Londonderry, Northern Ireland.
Northern Ireland Centre for Stratified Medicine, School of Biomedical Sciences, Ulster University, Londonderry, Northern Ireland.
Am J Clin Pathol. 2018 Oct 24;150(6):512-521. doi: 10.1093/ajcp/aqy073.
While cervical cytology is accepted triage for human papillomavirus (HPV)-positive women, the efficiency of cervical screening could be improved by exploiting disease markers with higher specificity.
CINtec PLUS triage alone and combined with HPV 16/18 genotyping was performed on ThinPrep samples from HPV-positive women. Clinical performance and the potential to reduce or expedite colposcopy referrals were evaluated.
The 2-year sensitivity and specificity for cervical intraepithelial neoplasia grade 3 or worse (CIN3+) were 90% and 42%, respectively. Specificity was improved over HPV testing in equivocal cytology and could cut the referral rate by about 40%. When combined with HPV 16/18 genotyping, CINtec PLUS triage of the 12 other high-risk HPV genotypes generally demonstrated better sensitivity for CIN3+ than separate triage of non-type-specific HPV-positive women. This strategy could reduce colposcopy referrals by 31%.
These findings highlight the potential of CINtec PLUS to improve management pathways in HPV-positive women. CINtec PLUS cytology represents a sensitive and efficient triage in HPV-positive women. The clinical performance of the dual-stain was most notable in women younger than 25 years and could potentially improve management pathways.
虽然宫颈细胞学检查被认为是 HPV 阳性女性的一种有效的分流方法，但通过利用具有更高特异性的疾病标志物，可以提高宫颈筛查的效率。
对 HPV 阳性女性的 ThinPrep 样本进行 CINtec PLUS 单独和联合 HPV 16/18 基因分型的分流。评估其临床性能和减少或加快阴道镜转诊的潜力。
2 年时，CIN3+（宫颈上皮内瘤变 3 级或更高级别）的敏感性和特异性分别为 90%和 42%。在细胞学结果不确定的情况下，特异性优于 HPV 检测，可以将转诊率降低约 40%。当与 HPV 16/18 基因分型联合使用时，CINtec PLUS 对其他 12 种高危 HPV 基因型的单独分流通常比单独对非 HPV 阳性女性进行分流具有更高的 CIN3+敏感性。这种策略可以将阴道镜转诊率降低 31%。
这些发现突出了 CINtec PLUS 在 HPV 阳性女性中改善管理途径的潜力。CINtec PLUS 细胞学检查是 HPV 阳性女性敏感且有效的分流方法。双染的临床性能在年龄小于 25 岁的女性中最为显著，可能会改善管理途径。
