Gottheil E, Caddy G R, Austin D L
JAMA. 1976 Aug 30;236(9):1035-8.
Urine specimens containing five different drugs, each at three levels of concentration with zero to five drugs in a specimen, were sent to two "approved" laboratories. In only 46.9% and 13.8%, respectively, were all drugs present correctly identified and no false-positive results reported. With some allowances, the results improved to 53.8% and 49.4%. If these tests are to be continued then (1) the fallibility of these tests should be known by all treatment personnel, (2) laboratories should be licensed rather than merely approved, and (3) maintenance of the license should be made contingent on passing "blind" proficiency tests.
含有五种不同药物的尿液样本,每种药物有三个浓度水平,且每个样本中药物数量从零到五种不等,这些样本被送到了两家“获批”实验室。结果发现,所有药物均被正确识别且未报告假阳性结果的比例分别仅为46.9%和13.8%。若给予一定宽容度,结果分别提升至53.8%和49.4%。如果要继续进行这些检测,那么(1)所有治疗人员都应了解这些检测的易出错性;(2)实验室应获得许可而非仅仅是获批;(3)许可证的维持应取决于通过“盲法”能力验证测试。