Carothers A, McGoogan E, Vooijs P, Bird C, Colquhoun M, Eason P, McKie M, Nieuwenhuis F, Pitt P, Rutovitz D
MRC Human Genetics Unit, Western General Hospital, Edinburgh, UK.
Anal Cell Pathol. 1994 Dec;7(4):261-74.
We report a test of an experimental system for machine-aided screening in cervical cytology, comprising the 'CYTOPRESS' semi-automatic slide preparation system (Nijmegen) and the 'CERVIFIP' interactive scanner (Edinburgh). Material from women attending clinics in Edinburgh and Nijmegen was stratified according to the severity of the conventional laboratory diagnosis and selected randomly within strata for inclusion in the test. Monolayered slides were prepared by CYTOPRESS from cervical scrape material remaining after preparation of conventional smears and scanned by CERVIFIP to determine the positions of the most 'suspicious' objects. The test was based on a set of 701 monolayers, divided equally between 'negatives' and 'abnormals' of various grades, of which 585 (83.4%) were passed automatically as adequate for machine-aided analysis. Approximately 15% of adequate slides were passed as 'negative' without operator interaction. In the remaining 85%, the suspicious objects were inspected by a human operator and a decision was then made either to refer each monolayer for conventional microscopic analysis, or to pass it as 'negative'. Where discrepancies occurred between the conventional laboratory and the system results, a consensus diagnosis was reached by taking into account all relevant information including clinical data. Of those with a consensus diagnosis of CIN 3 or worse an estimated 9.3 +/- 4.1% were passed by the system as 'negative'. Closer investigation of these false-negatives revealed that most, and perhaps all, were preventable by system improvements either planned or in progress. Corresponding false-negative rates for those graded 'CIN 1 or 2' and 'negative-early recall' were estimated, respectively as 18.9 +/- 5.3% and 22.9 +/- 3.1%. Of those with a 'negative-routine recall' consensus, 19.4 +/- 2.5% were referred for conventional microscopic analysis, a level well within acceptable limits for cost-effectiveness. Women whose initial laboratory smears were negative, but whose consensus diagnosis was 'negative-early recall' or CIN, are being investigated further to determine whether cervical abnormalities were in fact present. Over two-thirds of this group were referred by the machine-aided system for conventional microscopic analysis.
我们报告了一项用于宫颈细胞学机器辅助筛查的实验系统测试，该系统包括“CYTOPRESS”半自动玻片制备系统（奈梅亨）和“CERVIFIP”交互式扫描仪（爱丁堡）。来自爱丁堡和奈梅亨诊所的女性样本，根据传统实验室诊断的严重程度进行分层，并在各层内随机选取纳入测试。CYTOPRESS 从传统涂片制备后剩余的宫颈刮片材料制备单层玻片，然后由 CERVIFIP 进行扫描以确定最“可疑”物体的位置。该测试基于一组 701 个单层玻片，在不同等级的“阴性”和“异常”之间平均分配，其中 585 个（83.4%）被自动判定为适合机器辅助分析。约 15%的合格玻片在无操作员干预的情况下被判定为“阴性”。在其余 85%的情况下，可疑物体由人工操作员检查，然后决定是将每个单层玻片送去进行传统显微镜分析，还是判定为“阴性”。当传统实验室结果与系统结果出现差异时，通过考虑包括临床数据在内的所有相关信息达成共识诊断。在共识诊断为 CIN 3 或更严重的病例中，估计有 9.3±4.1%被系统判定为“阴性”。对这些假阴性结果的进一步调查显示，大多数（也许所有）可以通过已计划或正在进行的系统改进来避免。对于分级为“CIN 1 或 2”和“阴性 - 早期召回”的病例，相应的假阴性率分别估计为 18.9±5.3%和 22.9±3.1%。在达成“阴性 - 常规召回”共识的病例中，19.4±2.5%被送去进行传统显微镜分析，这一水平在成本效益可接受的范围内。初始实验室涂片为阴性，但共识诊断为“阴性 - 早期召回”或 CIN 的女性正在接受进一步调查，以确定是否实际上存在宫颈异常。该组中超过三分之二的人被机器辅助系统送去进行传统显微镜分析。
