Cary P L, Johnson C A, Folsom T M, Bales W R
Toxicology & Drug Monitoring Laboratory, University Hospital & Clinics, Columbia, Missouri 65203.
J Anal Toxicol. 1992 Jan-Feb;16(1):48-51. doi: 10.1093/jat/16.1.48.
Immunoassay drug testing methods, that have been modified from the manufacturers' recommended procedure to be used for the analysis of federally regulated specimens or other forensic samples require evaluation to ensure their scientific validity. These validation studies must demonstrate the accuracy, precision, and linearity of the modified immunoassay around the cutoff concentration, substantiate adequate rate separation, and verify the ability of the assay to differentiate positive and negative samples. Modification of the EMIT d.a.u. phencyclidine assay in order to achieve the federally mandated cutoff concentration of 25 ng/mL is common. This study describes the validation of a modified EMIT phencyclidine assay and a protocol that allows for the evaluation of similarly modified immunoassays.
免疫分析药物检测方法，若已对制造商推荐程序进行修改，以用于分析联邦监管的样本或其他法医样本，则需要进行评估，以确保其科学有效性。这些验证研究必须证明修改后的免疫分析在临界浓度附近的准确性、精密度和线性，证实有足够的速率分离，并验证该分析区分阳性和阴性样本的能力。为达到联邦规定的25 ng/mL临界浓度而对EMIT d.a.u.苯环利定分析进行修改很常见。本研究描述了一种修改后的EMIT苯环利定分析的验证以及一种可用于评估类似修改后的免疫分析的方案。
