Reproducibility of low galactomannan enzyme immunoassay index values tested in multiple laboratories.
Reproducibility of low galactomannan enzyme immunoassay index values tested in multiple laboratories.
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在多个实验室测试的低半乳甘露聚糖酶免疫测定指数值的再现性。
DOI：
10.1128/jcm.43.9.4796-4800.2005
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发表时间：
2005
期刊：
影响因子：
--
通讯作者：
Marr,KierenA
中科院分区：
文献类型：
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作者：
Upton,Arlo;Gugel,Anja;Leisenring,Wendy;Limaye,Ajit;Alexander,Barbara;Hayden,Randall;Marr,KierenA
半乳甘露聚糖酶免疫分析法是一种市售的非培养诊断侵袭性曲霉病的方法。最近，已采取步骤提高敏感性；具体来说，低（0.5 - 0.7）半乳甘露聚糖指数（GMI）值确定阳性已被多个小组验证。我们在三个不同的微生物实验室使用三个不同的试剂盒批次，在三个不同的日子，评估了低指数水平下的测定内和测定间的重复性。临床血清和加标血清均采用盲法，并与半乳甘露聚糖酶免疫测定试剂盒（EIA）一起送到参与试验的实验室。我们还前瞻性地收集了2003年9月1日至2004年7月21日在华盛顿大学医学中心微生物实验室进行的所有半乳甘露聚糖环境影响评价的数据，以评估“实时”分析临床样品的可重复性。从多实验室研究中，共有836个结果可供评估。实验室间和不同日期的重复性极好。不同批次/批次之间存在显著差异，这可能部分与不同试剂盒中不同的阈值控制值有关。在前瞻性分析的1410份临床样本中，168份（90%）经重复检测确认为阳性（GMI≥0.5）。在19例（10.2%）未在重复检测中确认的初始阳性样本中，大多数在检测阈值处具有GMI（在0.5至0.7之间）。结果表明，半乳甘露聚糖免疫分析法具有良好的重复性。然而，当使用不同试剂盒批次时GMI水平的变化，以及低阳性（GMI为0.5至0.7）指数的单个样品，应谨慎解释。
The Platelia galactomannan enzyme immunoassay is a commercially available nonculture method for diagnosing invasive aspergillosis. Recently, steps have been taken to improve sensitivity; specifically, a low (0.5 to 0.7) galactomannan index (GMI) value to determine positivity has been validated by multiple groups. We evaluated the intra-assay and interassay reproducibility at low index levels using three different kit lots on three different days in three different microbiology laboratories. Clinical and spiked sera were blinded and sent with galactomannan enzyme immunoassay (EIA) kits to the participating laboratories. We also prospectively collected data on all galactomannan EIAs performed between 1 September 2003 and 21 July 2004 at the University of Washington Medical Center microbiology laboratory to assess reproducibility of clinical samples analyzed in “real time.” From the multilaboratory study, a total of 836 results were available for evaluation. Reproducibility was excellent between laboratories and on different days. Significant variability was seen between runs/lots, which may in part be associated with different threshold control values in different kits. Among the 1,410 clinical samples that were prospectively analyzed, 168 (90%) were confirmed to be positive on repeat testing (GMI, ≥0.5). Among the 19 (10.2%) initially positive samples not confirmed on repeat testing, the majority had a GMI at the threshold of the assay (between 0.5 and 0.7). Our findings suggest that the Platelia galactomannan immunoassay has good reproducibility. However, changes in GMI levels when different kit lots are used, and single samples with low-positive (GMI of 0.5 to 0.7) indices, should be interpreted with caution.