National Serology Reference Laboratory Australia, Victoria, Australia.
Vox Sang. 2009 Nov;97(4):309-16. doi: 10.1111/j.1423-0410.2009.01218.x. Epub 2009 Aug 4.
Laboratories screening for blood-borne virus infections in blood and blood products are required by international standards and guidelines to ensure that their testing processes remain within control. An effective means of ensuring this aim is through participation in a quality control programme. Analyses of results from a quality control (QC) programme conducted for the Abbott PRISM (PRISM) assays are reported.
Laboratories participating in the National Serology Reference Laboratory, Australia's PRISM QC programme were provided with aliquots of a multimarker QC sample which were tested regularly in each PRISM subchannel. Test results were submitted to a single database using an Internet-based QC monitoring system, EDCNet. The QC test results submitted between 15 October 2001 and 5 March 2006 for each PRISM instrument and each lot of PRISM reagent were analysed to determine the imprecision and bias in each test system.
A total of 157,404 test results from approximately 47,000 test runs submitted into the EDCNet database were analysed. Six batches of the multimarker QC samples were tested in 454 PRISM reagent lots. The coefficient of variation of QC sample test results ranged from 9.17 to 15.83%, 8.29 to 9.44%, 10.50 to 15.38% and 7.05 to 10.32% when tested in the PRISM anti-hepatitis C virus, anti-human immunodeficiency virus, anti-human T-cell lymphotrophic virus and hepatitis B surface antigen assays, respectively. Analysis of QC test results reported from testing in the anti-HTLV assay detected one lot of reagent (10572HN00) which was identified to be an outlier using Tukey's filter.
Analysis of test results of an external QC sample can be used as a statistical process control through ongoing measurement of imprecision. When laboratories test the same QC sample in the same assay and submit test results to a single database, the results can be compared and a measure of bias can be calculated. The resulting QC programme can offer detection of unexpected variation in the testing processes and the source of variation investigated.
国际标准和准则要求血液和血液制品筛查血液传播病毒感染的实验室，以确保其检测过程处于控制之中。确保这一目标的有效方法是通过参与质量控制计划。本文报告了为 Abbott PRISM（PRISM）检测进行的质量控制（QC）计划的结果分析。
参与澳大利亚国家血清学参考实验室 PRISM QC 计划的实验室提供了多标志物 QC 样本的等分样本，这些样本在每个 PRISM 子通道中定期进行测试。使用基于 Internet 的 QC 监测系统 EDCNet 将测试结果提交到一个单独的数据库中。分析了 2001 年 10 月 15 日至 2006 年 3 月 5 日期间每个 PRISM 仪器和每个 PRISM 试剂批次提交的 QC 测试结果，以确定每个测试系统的不精密度和偏差。
共分析了约 47000 次测试运行中提交到 EDCNet 数据库的 157404 次测试结果。对 6 批多标志物 QC 样本进行了 454 批 PRISM 试剂的测试。当在 PRISM 抗丙型肝炎病毒、抗人类免疫缺陷病毒、抗人类 T 细胞淋巴嗜病毒和乙型肝炎表面抗原检测中测试时，QC 样本测试结果的变异系数分别为 9.17%至 15.83%、8.29%至 9.44%、10.50%至 15.38%和 7.05%至 10.32%。对在抗 HTLV 检测中报告的 QC 测试结果的分析检测到一种试剂（10572HN00）是一个异常值，使用 Tukey 的过滤器可以识别。
对外部 QC 样本的测试结果进行分析可以作为一种统计过程控制，通过持续测量不精密度来实现。当实验室在同一检测中测试相同的 QC 样本并将测试结果提交到单个数据库时，可以对结果进行比较，并计算出偏差的度量值。由此产生的 QC 计划可以检测到测试过程中的意外变化，并调查变化的来源。
