London L, Thompson M L, Sacks S, Fuller B, Bachmann O M, Myers J E
Department of Community Health, University of Cape Town, Observatory, South Africa.
Occup Environ Med. 1995 Jan;52(1):57-64. doi: 10.1136/oem.52.1.57.
To evaluate a spectrophotometric field kit (Test-Mate-OP) for repeatability and validity in comparison with reference laboratory methods and to model its anticipated sensitivity and specificity based on these findings.
76 farm workers between the age of 20 and 55, of whom 30 were pesticide applicators exposed to a range of organophosphates in the preceding 10 days, had blood taken for plasma cholinesterase (PCE) and erythrocyte cholinesterase (ECE) measurement by field kit or laboratory methods. Paired blinded duplicate samples were taken from subgroups in the sample to assess repeatability of laboratory and field kit methods. Field kits were also used to test venous blood in one subgroup. The variance obtained for the field kit tests was then applied to two hypothetical scenarios that used published action guidelines to model the kit's sensitivity and specificity.
Repeatability for PCE was much poorer and for ECE slightly poorer than that of laboratory measures. A substantial upward bias for field kit ECE relative to laboratory measurements was found. Sensitivity of the kit to a 40% drop in PCE was 67%, whereas that for ECE was 89%. Specificity of the kit with no change in mean of the population was 100% for ECE and 91% for PCE.
Field kit ECE estimation seems to be sufficiently repeatable for surveillance activities, whereas PCE does not. Repeatability of both tests seems to be too low for use in epidemiological dose-response investigations. Further research is indicated to characterise the upward bias in ECE estimation on the kit.
评估一种分光光度法现场检测试剂盒(Test-Mate-OP)与参考实验室方法相比的重复性和有效性,并根据这些结果模拟其预期的敏感性和特异性。
选取76名年龄在20至55岁之间的农场工人,其中30人在过去10天内接触过多种有机磷农药,采集他们的血液,通过现场检测试剂盒或实验室方法测量血浆胆碱酯酶(PCE)和红细胞胆碱酯酶(ECE)。从样本中的亚组采集配对的盲法重复样本,以评估实验室和现场检测试剂盒方法的重复性。还使用现场检测试剂盒对一个亚组的静脉血进行检测。然后将现场检测试剂盒测试获得的方差应用于两个假设场景,这两个场景使用已发表的行动指南来模拟试剂盒的敏感性和特异性。
PCE的重复性比实验室测量差得多,ECE的重复性略差。发现现场检测试剂盒ECE相对于实验室测量存在明显的正向偏差。该试剂盒对PCE下降40%的敏感性为67%,而对ECE的敏感性为89%。在总体均值无变化的情况下,该试剂盒对ECE的特异性为100%,对PCE的特异性为91%。
现场检测试剂盒ECE估计对于监测活动似乎具有足够的重复性,而PCE则不然。两种检测的重复性似乎都太低,无法用于流行病学剂量反应调查。需要进一步研究来表征该试剂盒ECE估计中的正向偏差。