Impact of proficiency testing on results of the microscopic agglutination test for diagnosis of leptospirosis
Impact of proficiency testing on results of the microscopic agglutination test for diagnosis of leptospirosis
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DOI：
10.1128/jcm.42.12.5484-5488.2004
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发表时间：
2004-12-01
影响因子：
9.4
通讯作者：
Hartskeerl, RA
中科院分区：
文献类型：
--
作者：
Chappel, RJ;Goris, M;Hartskeerl, RA
2002年（第一轮）向23个国家的37个实验室提供了钩端螺旋体病显微镜凝集试验能力测试计划，2003年（第二轮）向34个国家的60个实验室提供了该计划。34个实验室参加了这两轮活动。每组由5份兔血清样品组成，其中4份是针对钩端螺旋体致病血清型产生的抗血清。其中一个样本是两种不同抗血清的混合物。假阴性结果的发生率（基于血清群内的血清型将发生交叉反应的假设计算）为11%（第1轮）和14%（第2轮）。假阴性率存在地区差异。实验室对相同血清型的相同样本进行检测后报告的滴度差异很大。先前参与第1轮的实验室在第2轮报告的假阴性结果比新参与者少（分别为10%和21%[P = 0.002]），每个参与者报告0.56个假阴性结果，而新参与者报告每个参与者1.23个假阴性结果（P = 0.041）。之前参与的实验室在第2轮中报告的假阴性结果也比第1轮少，当时检测了两轮共有的样本（分别为5%和15%[P = 0.028]）。平均而言，新参与者报告的滴度低于先前参与的实验室报告的滴度（P = 0.019），并且差异显著（P = 0.001）。对这些结果的分析表明，能力验证对参与实验室的检测性能产生了积极影响。
A proficiency testing scheme for the leptospirosis microscopic agglutination test was provided to 37 laboratories in 23 countries in 2002 (round 1) and to 60 laboratories in 34 countries in 2003 (round 2). Thirty-four laboratories participated in both rounds. Each panel consisted of five rabbit serum samples, four of which were antisera raised against pathogenic serovars of Leptospira. One of these samples was a mixture of two different antisera. The rates of false-negative results, calculated on the basis of the assumption that serovars within a serogroup will cross-react, were 11% for round 1 and 14% for round 2. There were regional differences in the rates of false-negative results. The titers reported by laboratories testing for the same sample with the same serovar varied widely. Laboratories that had previously participated in round 1 reported fewer false-negative results in round 2 than new participants (10 and 21%, respectively [P = 0.002]) and reported 0.56 false-negative results per participant, whereas new participants reported 1.23 false-negative results per participant (P = 0.041). Laboratories that had previously participated also reported fewer false-negative results in round 2 than in round 1 when samples common to both rounds were tested (5 and 15%, respectively [P = 0.028]). The titers reported by the new participants were, on average, lower than those reported by the laboratories that had participated previously (P = 0.019) and were significantly more variable (P = 0.001). Analysis of these results suggests a positive impact of proficiency testing on the testing performance of the participating laboratories.