Rowe Leslie R, Marshall C Jay, Bentz Joel S
Institute for Clinical and Experimental Pathology, LLC, Associated Regional and University Pathologists Laboratories, Inc., Salt Lake City, Utah, USA.
Cancer. 2002 Dec 25;96(6):325-9. doi: 10.1002/cncr.10883.
Quality control (QC) of Papanicolaou (Pap) smear testing focuses on the identification of screening errors by 10% random, rapid, or thorough manual rescreening of some portion of negative smears. One hundred percent thorough manual rescreening has been reported to be the most effective method of identifying screening errors in conventional Pap smears (CP), but to the authors' knowledge no experience with this QC method has been reported for the ThinPrep Pap test (TP). The current study reports the estimated screening error rate of TP as determined by a QC program using 100% thorough rescreening.
All TP samples received at the study institution between January 1, 1999 and December 31, 2000 and initially screened as negative underwent thorough manual QC rescreening.
A total of 53,419 TP samples were received during the study period. Of these, 5,368 cases (10%) initially were interpreted as abnormal. A total of 47,247 cases (88.4%) were rescreened. Abnormalities were identified in 804 additional cases, for a screening error rate of 13.0%. Of the 804 cases, 678 (84.3%) were atypical squamous cells of undetermined significance, 116 (14.4%) were low-grade squamous intraepithelial lesions, and 10 (1.2%) were high-grade squamous intraepithelial lesions. No tumors were identified on rescreening.
In the current study, 100% thorough rescreening of TP samples was found to result in the detection of a significant number of abnormalities that would have been missed by routine random 10% QC rescreening. The screening error rate determined by 100% thorough QC rescreening of TP is comparable to that reported for CP QC rescreening.
巴氏涂片检测的质量控制（QC）重点在于通过对部分阴性涂片进行10%的随机、快速或全面人工复查来识别筛查错误。据报道，100%全面人工复查是识别传统巴氏涂片（CP）筛查错误的最有效方法，但据作者所知，尚未有关于这种质量控制方法在薄层液基细胞学检测（TP）中的应用经验报道。本研究报告了通过100%全面复查的质量控制程序确定的TP筛查错误率估计值。
对1999年1月1日至2000年12月31日期间在研究机构收到的所有最初筛查为阴性的TP样本进行全面人工质量控制复查。
研究期间共收到53419份TP样本。其中，5368例（10%）最初被判定为异常。共复查了47247例（88.4%）。另外在804例中发现了异常，筛查错误率为13.0%。在这804例中，678例（84.3%）为意义不明确的非典型鳞状细胞，116例（14.4%）为低级别鳞状上皮内病变，10例（1.2%）为高级别鳞状上皮内病变。复查时未发现肿瘤。
在本研究中，发现对TP样本进行100%全面复查可检测出大量常规10%随机质量控制复查会遗漏的异常情况。通过对TP进行100%全面质量控制复查确定的筛查错误率与CP质量控制复查报告的错误率相当。
