Senior Medical Laboratory Scientist, New Zealand Blood Service, 71 Great South Road,Epsom, Auckland, 1051, Private Bag 92071, Auckland Mail Centre, Auckland, 1142, New Zealand.
Medical Director, Transfusion Medicine, Abbott Laboratories, 3 Fraser St 2 #23-28, Duo Tower, Singapore 189352.
Diagn Microbiol Infect Dis. 2024 Oct;110(2):116451. doi: 10.1016/j.diagmicrobio.2024.116451. Epub 2024 Jul 17.
Sigma metric analysis was conducted across two New Zealand Blood Services (NZBS) laboratories (Auckland and Christchurch) to optimize quality control (QC) procedures. We evaluated five assays (anti-HCV, HIV Ag/Ab combo, HTLV-I/II, HBsAg, and Syphilis) using internal quality control (IQC) and third-party daily QC data extracted from four Architect i2000SR instruments during Jan 2 -31st, 2023. Mean, standard deviation (SD), and coefficient of variation (CV%) were calculated, assuming zero bias. Sigma metrics were determined using the Total Allowable Error (TEa %) based on difference between positive control mean and signal-to-cutoff (s/co) cut-off. Most assays exhibited CV% values ≤10 % except for HBsAg IQC (18.5 %) and anti-HCV third-party QC (13.4 %) at Christchurch. TEa % ranged from 38 % to 90 %. Overall, the assays demonstrated Six Sigma performance (σ > 6), except for HBsAg IQC (3.97) and anti-HCV third-party QC (5.46) at Christchurch. These high-quality serology assays can benefit from simplified QC design without compromising blood safety.
在新西兰血液服务中心（NZBS）的两个实验室（奥克兰和克赖斯特彻奇）进行了西格玛度量分析，以优化质量控制（QC）程序。我们使用内部质量控制（IQC）和 2023 年 1 月 2 日至 31 日从四台 Architect i2000SR 仪器中提取的第三方日常 QC 数据评估了五个检测项目（抗 HCV、HIV Ag/Ab 组合、HTLV-I/II、HBsAg 和梅毒）。假设无偏倚，计算平均值、标准差（SD）和变异系数（CV%）。西格玛度量值使用总允许误差（TEa%）确定，TEa% 基于阳性对照平均值与信号与截止值（s/co）之间的差异。除了克赖斯特彻奇的 HBsAg IQC（18.5%）和抗 HCV 第三方 QC（13.4%）外，大多数检测项目的 CV% 值均≤10%。TEa% 范围从 38%到 90%。总体而言，除了克赖斯特彻奇的 HBsAg IQC（3.97）和抗 HCV 第三方 QC（5.46）外，所有检测项目均表现出六西格玛性能（σ>6）。这些高质量的血清学检测项目可以简化 QC 设计，而不会影响血液安全性。
