背景:对于在多种仪器上进行的非放弃测定,需要进行两年一次的仪器相关性研究。
目的:确定使用美国病理学家学院(CAP)质量交叉检查化学和治疗药物监测(CZQ)评估多种分析仪之间仪器相关性的可行性,分析器模型,和临床实验室改进修正案(CLIA)许可55种独特的分析物。
方法:对9种雅培建筑仪器进行了仪器相关性研究(c4000[n=4],c8000[n=2],和c16000[n=3])超过3个使用CZQ材料的CLIA许可证。平均值(SD),浓度差,百分比偏差,每个单独的分析仪确定每个单独的CZQ水平的对等数据。每种分析物的可接受的浓度和百分比使用来自CAP或其他有信誉的来源(例如美国生物分析协会或澳大利亚皇家病理学家学院)的标准来设定。同行数据由CAP和CZQ试剂盒提供。
结果:使用CZQ材料的相关性显示,所研究的94.5%的测定仅通过偏差百分比在可接受性标准内,而98.2%的测定通过浓度差异在可接受性标准内。
结论:CZQ的使用为不同CLIA许可证内和跨不同CLIA许可证的仪器之间的标准化相关性研究提供了支持。然而,由于对基质效应的担忧,CZQ的广泛采用可能会受到限制,分析物范围,便于数据分析。
BACKGROUND: Biannual instrument-correlation studies are required for nonwaived assays performed on multiple instruments.
OBJECTIVE: To determine the feasibility of using College of American Pathologists (CAP) Quality Cross Check-Chemistry and Therapeutic Drug Monitoring (CZQ) to assess instrument correlations among multiple analyzers, analyzer models, and Clinical Laboratory Improvement Amendments (
CLIA) licenses for 55 unique analytes.
METHODS: Instrument correlation studies were performed on 9 Abbott ARCHITECT instruments (c4000 [n = 4], c8000 [n = 2], and c16000 [n = 3]) over 3
CLIA licenses using CZQ materials. The mean (SD) values, concentration difference, percent bias, and peer data for each individual level of CZQ were determined for each individual analyzer. Acceptable concentration and percentage for each analyte were set using criteria from CAP or other reputable sources such as the American Association of Bioanalysts or the Royal College of Pathologists of Australasia. Peer data were provided by CAP with the CZQ kit.
RESULTS: Correlations using CZQ materials showed that 94.5% of assays studied were within the acceptability criteria by percent bias only and 98.2% were within acceptability criteria by concentration difference.
CONCLUSIONS: The use of CZQ provides support to standardized correlation studies among instruments within and across separate
CLIA licenses. However, widespread adoption of CZQ may be limited due to concerns regarding matrix effects, analyte ranges, and ease of data analysis.