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ORALVEQ:口腔液中滥用药物的外部质量评估方案:2007年第一轮评估结果

ORALVEQ: external quality assessment scheme of drugs of abuse in oral fluid: results obtained in the first round performed in 2007.

作者信息

Ventura M, Ventura R, Pichini S, Leal S, Zuccaro P, Pacifici R, Langohr K, de la Torre R

机构信息

Grup de Recerca en Bioanàlisi i Serveis Analítics, Programa de Recerca en Neuropsicofarmacologia, IMIM-Hospital del Mar, Barcelona, Spain.

出版信息

Forensic Sci Int. 2008 Nov 20;182(1-3):35-40. doi: 10.1016/j.forsciint.2008.09.016. Epub 2008 Nov 11.

DOI:10.1016/j.forsciint.2008.09.016
PMID:19004584
Abstract

The Institut Municipal d'Investigació Mèdica IMIM-Hospital del Mar (Barcelona, Spain) in cooperation with the Istituto Superiore di Sanità (Rome, Italy) organized an external quality assessment scheme to assess the reliability of analytical laboratories when analyzing drugs of abuse in oral fluid (ORALVEQ). For the first round of ORALVEQ, performed in February 2007, three different samples (S1, S2 and S3) were sent to 21 participating international laboratories. S1 was a blank sample and S2 and S3 were prepared by addition of drugs at known concentrations to pre-screened drug-free oral fluid (containing sodium azide) and diluted up to 50% with acidic buffer. S2 contained 6-monoacetyl morphine, morphine, cocaine and benzoylecgonine and S3 contained 3,4-methylendioxymethamphetamine and 3,4-methylendioxyamphetamine. Results were evaluated from a qualitative and quantitative point of view. Whereas only half laboratories performed screening analysis, all of them reported a quantitative result for almost all analytes. Eighteen false-positive and 3 false-negative results were reported by 8 (from a total of 21) laboratories. The quantitative evaluation was performed measuring dispersion (% coefficient of variation, CV%) and accuracy (% error, ERR%) of results and calculating the z-score values (using robust statistics). ERR% between 2% and 20% and CVs% around 40% were obtained for all analytes. In terms of z-score, a high percentage of adequate results (between 85 and 95%) was obtained. In general, the participating laboratories had a satisfactory performance. The number of false-negatives reported was very low, the false-positives were reported by a reduced number of laboratories and the scatter in the quantitative results was principally due to a few outlying values; since applying robust statistics, there was no rejection of outliers.

摘要

西班牙巴塞罗那的市立医学研究中心IMIM-海洋医院与意大利罗马的高等卫生研究院合作,组织了一项外部质量评估计划,以评估分析实验室在分析口腔液中滥用药物时的可靠性(ORALVEQ)。在2007年2月进行的第一轮ORALVEQ中,向21个参与的国际实验室发送了三种不同的样本(S1、S2和S3)。S1是空白样本,S2和S3是通过向预先筛选的无药物口腔液(含叠氮化钠)中添加已知浓度的药物并以酸性缓冲液稀释至50%制备而成。S2含有6-单乙酰吗啡、吗啡、可卡因和苯甲酰爱康宁,S3含有3,4-亚甲基二氧甲基苯丙胺和3,4-亚甲基二氧苯丙胺。从定性和定量的角度对结果进行了评估。虽然只有一半的实验室进行了筛查分析,但所有实验室都报告了几乎所有分析物的定量结果。8个(共21个)实验室报告了18例假阳性和3例假阴性结果。通过测量结果的离散度(变异系数百分比,CV%)和准确性(误差百分比,ERR%)并计算z分数值(使用稳健统计)进行定量评估。所有分析物的ERR%在2%至20%之间,CV%约为40%。就z分数而言,获得了较高比例的合格结果(85%至95%)。总体而言,参与实验室的表现令人满意。报告的假阴性数量非常少,假阳性由少数实验室报告,定量结果的离散主要是由于一些异常值;由于应用了稳健统计,没有剔除异常值。

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