Jones Heidi E, Mansukhani Mahesh M, Tong Guo-Xia, Westhoff Carolyn L
Department of Obstetrics & Gynecology, Columbia University Medical Center, New York, New York, United States of America ; Epidemiology & Biostatistics Program, City University of New York School of Public Health and Hunter College, New York, New York, United States of America.
Department of Pathology and Cell Biology, Columbia University Medical Center, New York, New York, United States of America.
PLoS One. 2013 Dec 20;8(12):e82115. doi: 10.1371/journal.pone.0082115. eCollection 2013.
Self-sampling could increase cervical cancer screening uptake. While methods have been identified for human papillomavirus (HPV) testing, to date, self-sampling has not provided adequate specimens for cytology. We piloted the validity and reliability of using a self-lavaging device for cervical cytology and HPV testing. We enrolled 198 women in New York City in 2008-2009 from three ambulatory clinics where they received cervical cancer screening. All were asked to use the Delphi Screener™ to self-lavage 1-3 months after clinician-collected index cytological smear (100 normal; 98 abnormal). Women with abnormal cytology results from either specimen underwent colposcopy; 10 women with normal results from both specimens also underwent colposcopy. We calculated sensitivity of self-collected cytology to detect histologically confirmed high grade lesions (cervical intraepithelial neoplasia, CIN, 2+); specificity for histology-negative (CIN 1 or lower), paired cytology negative, or a third cytology negative; and kappa for paired results. One hundred and ninety-seven (99.5%) women self-collected a lavage. Seventy-five percent had moderate to excellent cellularity, two specimens were unsatisfactory for cytology. Seven of 167 (4%) women with definitive results had CIN2+; one had normal and six abnormal cytology results with the self-lavage (sensitivity = 86%, 95% Confidence Interval, CI: 42, 100). The kappa for paired cytology was low (0.36; 95% CI: 0.25, 0.47) primarily due to clinician specimens with atypical squamous cells of undetermined significance (ASC-US) and low grade squamous intraepithelial lesion (LSIL) coded as normal using Screener specimens. However, three cases of HSIL were coded as ASC-US and one as normal using Screener specimens. Seventy-three women had paired high-risk HPV tests with a kappa of 0.66 (95% CI: 0.49, 0.84). Based on these preliminary findings, a larger study to estimate the performance of the Screener for co-testing cytology and HPV or for HPV testing with cytology triage is warranted.
ClinicalTrials.gov NCT00702208.
自我采样可提高宫颈癌筛查的接受率。虽然已确定了人乳头瘤病毒（HPV）检测方法，但迄今为止，自我采样尚未提供足够的细胞学标本。我们对使用自我灌洗装置进行宫颈细胞学检查和HPV检测的有效性和可靠性进行了试点。2008年至2009年，我们在纽约市的三家门诊诊所招募了198名接受宫颈癌筛查的女性。所有女性均被要求在临床医生采集索引细胞学涂片后1至3个月使用Delphi Screener™进行自我灌洗（100例正常；98例异常）。任何一种标本细胞学结果异常的女性均接受阴道镜检查；10例两种标本结果均正常的女性也接受了阴道镜检查。我们计算了自我采集细胞学检测组织学确诊的高级别病变（宫颈上皮内瘤变，CIN，2级及以上）的敏感性；组织学阴性（CIN 1级或更低）、配对细胞学阴性或第三次细胞学阴性的特异性；以及配对结果的kappa值。197名（99.5%）女性进行了自我灌洗。75%的标本细胞量为中等至良好，两份标本细胞学检查不满意。167名结果明确的女性中有7名（4%）患有CIN2级及以上；1名自我灌洗细胞学结果正常，6名异常（敏感性=86%，95%置信区间，CI：42，100）。配对细胞学的kappa值较低（0.36；95%CI：0.25，0.47），主要是因为临床医生采集的标本中意义不明确的非典型鳞状细胞（ASC-US）和低级别鳞状上皮内病变（LSIL）在使用Screener标本编码时被视为正常。然而，使用Screener标本时，3例HSIL被编码为ASC-US，1例被编码为正常。73名女性进行了配对高危HPV检测，kappa值为0.66（95%CI：0.49，0.84）。基于这些初步发现，有必要进行一项更大规模的研究，以评估Screener在联合检测细胞学和HPV或用于细胞学分流的HPV检测中的性能。
ClinicalTrials.gov NCT00702208
