Department of Pediatrics and Department of Environmental Medicine, New York University, School of Medicine, New York, NY, 10016, USA.
Division of Environmental Health Sciences, Wadsworth Center, New York State Department of Health, Albany, NY, 12237, USA.
Int J Hyg Environ Health. 2021 May;234:113741. doi: 10.1016/j.ijheh.2021.113741. Epub 2021 Mar 24.
A consortium of laboratories established under the Children's Health Exposure Analysis Resource (CHEAR) used a multifaceted quality assurance program to promote measurement harmonization for trace organics analyses of human biospecimens that included: (1) participation in external quality assurance (EQA)/proficiency testing (PT) programs; (2) analyses of a urine-based CHEAR common quality control (QC) pool with each analytical batch across all participating laboratories; (3) method validation against NIST Standard Reference Materials® (SRMs); and (4) analyses of blinded duplicates and other project-specific QC samples. The capability of five CHEAR laboratories in organic chemical analysis increased across the 4-year period, and performance in the external PT program improved over time - recent challenges reporting >90% analytes with satisfactory performance. The CHEAR QC pools were analyzed for several classes of organic chemicals including phthalate metabolites and environmental phenols by the participating laboratories with every batch of project samples, which provided a rich source of measurement data for the assessment of intra- and inter-laboratory variance. Within-laboratory and overall variabilities in measurements across laboratories were calculated for target chemicals in urine QC pools; the coefficient of variation (CV) was generally below 25% across batches, studies and laboratories and indicated acceptable analytical imprecision. The suite of organic chemicals analyzed in the CHEAR QC pool was broader than those reported for commercially available reference materials. The accuracy of each of the laboratories' methods was verified through the analysis of several NIST SRMs and was, for example, 97 ± 5.2% for environmental phenols and 95 ± 11% for phthalates. Analysis of blinded duplicate samples showed excellent agreement and reliability of measurements. The intra-class correlation coefficients (ICC) for phthalate metabolites analyzed in various batches across three CHEAR laboratories showed excellent reliability (typically >0.90). Overall, the multifaceted quality assurance protocols followed among the CHEAR laboratories ensured reliable and reproducible data quality for several classes of organic chemicals. Increased participation in external PT programs through inclusion of additional target analytes will further enhance the confidence in data quality.
一个由多个实验室组成的联盟,根据儿童健康暴露分析资源 (CHEAR) 建立,采用了多方面的质量保证计划,以促进人体生物样本中痕量有机物分析的测量协调,其中包括:(1) 参与外部质量保证 (EQA)/能力验证 (PT) 计划;(2) 对每个分析批次的尿液 CHEAR 共同质量控制 (QC) 池进行分析;(3) 针对 NIST 标准参考物质 ® (SRMs) 进行方法验证;(4) 分析盲样重复和其他特定项目的 QC 样本。在四年的时间里,五个 CHEAR 实验室的有机化学分析能力得到了提高,外部 PT 计划的表现也随着时间的推移而提高——最近的报告显示,有超过 90%的分析物具有令人满意的性能。参与实验室对 CHEAR QC 池中的几类有机化学物质进行了分析,包括邻苯二甲酸代谢物和环境酚类,每个批次的项目样本都进行了分析,这为评估实验室内部和实验室之间的差异提供了丰富的测量数据来源。在尿液 QC 池的目标化学物质中,计算了各实验室的批内和批间变异性;变异系数 (CV) 在各批次、研究和实验室中通常低于 25%,表明分析精密度可接受。CHEAR QC 池分析的有机化学物质种类比商业上可用的参考物质报告的更为广泛。通过分析几个 NIST SRMs,验证了每个实验室方法的准确性,例如,环境酚类的准确性为 97 ± 5.2%,邻苯二甲酸酯的准确性为 95 ± 11%。盲样重复分析显示测量结果具有极好的一致性和可靠性。在三个 CHEAR 实验室的不同批次中分析的邻苯二甲酸代谢物的组内相关系数 (ICC) 显示出极好的可靠性(通常 >0.90)。总的来说,CHEAR 实验室遵循的多方面质量保证协议确保了几类有机化学物质的可靠和可重复的数据质量。通过纳入更多的目标分析物,增加对外部 PT 计划的参与将进一步提高对数据质量的信心。