Sykes P H, Harker D Y, Miller A, Whitehead M, Neal H, Wells J E, Peddie D
Department of Obstetrics and Gynaecology, University of Otago, Christchurch, New Zealand.
BJOG. 2008 Oct;115(11):1375-81. doi: 10.1111/j.1471-0528.2008.01865.x.
The objective of this study was to compare the sensitivity of cervical cytology using conventional smears and SurePath liquid-based cytology (LBC).
Prospective randomised evaluation of diagnostic test.
A single institution colposcopy clinic.
Women attending first visit colposcopy appointments were offered entry into the study.
Cervical cytology samples from 913 women of age 16-75 years were randomly processed as SurePath LBC or conventional smears. Conventional smears were taken for 453 women and a SurePath LBC taken for 451 women. Cytology results were correlated with colposcopic findings and histology from colposcopic biopsies, treatment and follow up.
To compare the sensitivity of SurePath LBC and conventional smears for histologically proven abnormality. Other outcome measures include a comparison of their sensitivity for high-grade abnormalities and their satisfactory rate.
Accounting for all randomised samples, there was a trend towards improved sensitivity for SurePath LBC (79.1 versus 73.7%, P = 0.1). However, excluding unsatisfactory cytology (and samples not taken) eliminated this trend; the sensitivity for both LBC and conventional smears for any epithelial abnormality was 81%. With a threshold of atypical squamous cells of uncertain significance (ASC-US), both SurePath LBC and conventional smears had a sensitivity of 92% for high-grade lesions. SurePath LBC was less likely to be reported as unsatisfactory (2.7 versus 9.1%, P < 0.0001).
In this context, with a threshold of ASC-US, both SurePath LBC and conventional smears offer high sensitivity for the detection of CIN2/3, but SurePath LBC is less likely to be reported as unsatisfactory.
本研究的目的是比较传统涂片和SurePath液基细胞学（LBC）用于宫颈细胞学检查的敏感性。
诊断试验的前瞻性随机评估。
单一机构的阴道镜诊所。
首次就诊接受阴道镜检查的女性被邀请参加本研究。
对913名年龄在16 - 75岁的女性的宫颈细胞学样本随机采用SurePath LBC或传统涂片处理。453名女性采用传统涂片，451名女性采用SurePath LBC。细胞学结果与阴道镜检查结果以及阴道镜活检的组织学检查、治疗和随访情况相关。
比较SurePath LBC和传统涂片对组织学证实异常的敏感性。其他观察指标包括比较它们对高级别异常的敏感性及其满意度。
考虑所有随机样本，SurePath LBC有敏感性提高的趋势（79.1%对73.7%，P = 0.1）。然而，排除不满意的细胞学检查结果（以及未采集的样本）后，这种趋势消失；LBC和传统涂片对任何上皮异常的敏感性均为81%。以意义不明确的非典型鳞状细胞（ASC-US）为阈值，SurePath LBC和传统涂片对高级别病变的敏感性均为92%。SurePath LBC被报告为不满意的可能性较小（2.7%对9.1%，P < 0.0001）。
在此情况下，以ASC-US为阈值，SurePath LBC和传统涂片对CIN2/3的检测均具有高敏感性，但SurePath LBC被报告为不满意的可能性较小。
