Background BioRad is a major provider of QC materials in the US with robust peer data, and Technopath has emerged as a recent competitor, especially on cost. While many factors are considered when selecting QC materials, primary considerations include commutability, matrix effects, decision levels, and acceptability limits. A couple studies comparing BioRad and Technopath QC performance were published in recent years. However, none have compared performance to patient-pooled samples. We undertook a comparison of BioRad/Technopath QC performance, with the addition of patient-pooled samples in order to assess potential matrix effects. Methods We compared precision for 20 high-volume chemistry/immunoassay tests (Table 1) across two levels of BioRad and Technopath QC and a patient pooled sample over 7 days on 2 Abbott Alinity-i and 4 Alinity-C instruments. Each immunoassay control level was run 5 times/day across 10 tests and 7 days per instrument, (i.e., 700 results/level), and the same for chemistry controls (1,400 results/level). Lithium-heparin plasma patient-pool was prepared by obtaining sufficient volume and preparing daily frozen aliquots (i.e., 1400 immunoassay and 2800 chemistry results). Results BioRad and Technopath Chemistry QCs were highly comparable with all levels demonstrating <1% CV difference. Notably, CO2, B12, FT4 pooled-patient CVs were >2% lower than the best performing high control. Additionally, greater differences in performance were observed across immunoassay controls with high BioRad QC performing better for 7 tests. Conclusions Chemistry QC for Technopath and BioRad are largely comparable (i.e., CV differences <1%). Overall, BioRad immunoassay control performance was slightly to somewhat better (i.e., B12, CA125, and CA15-3). B12 and CO2 were particularly unstable (as reflected by patient-pool CVs). That said, differences in performance were not untenable and could be handled based on a tailored approach of extending QC limits if assay/instrument performance allows, and/or changing control material or reagents on a tighter schedule.

中文翻译：

---

A-107 样品基质很重要：对 20 种高容量化学和免疫测定中的 BioRad、TechnoPath 和患者混合样品进行精确研究


背景 BioRad 是美国 QC 材料的主要供应商，拥有可靠的同行数据，而 Technopath 已成为最近的竞争对手，尤其是在成本方面。虽然选择质量控制材料时要考虑许多因素，但主要考虑因素包括可互换性、矩阵效应、决策水平和可接受性限制。近年来发表了几项比较 BioRad 和 Technopath QC 性能的研究。然而，没有人将性能与患者合并样本进行比较。我们对 BioRad/Technopath QC 性能进行了比较，并添加了患者合并样本，以评估潜在的基质效应。方法 我们比较了 BioRad 和 Technopath QC 两个级别的 20 次大容量化学/免疫测定测试（表 1）的精度，以及 7 天内在 2 台 Abbott Alinity-i 和 4 台 Alinity-C 仪器上收集的患者样本。每个免疫测定对照水平每天运行 5 次，每台仪器运行 7 天，进行 10 次测试（即 700 个结果/水平），化学对照也是如此（1,400 个结果/水平）。通过获得足够的体积并制备每日冷冻等分试样（即1400个免疫测定和2800个化学结果）来制备肝素锂血浆患者池。结果 BioRad 和 Technopath Chemistry QC 的所有水平都具有高度可比性，显示 <1% CV 差异。值得注意的是，CO2、B12、FT4 合并患者 CV 比表现最佳的高对照低 >2%。此外，在免疫测定对照中观察到更大的性能差异，高 BioRad QC 在 7 项测试中表现更好。结论 Technopath 和 BioRad 的化学 QC 在很大程度上具有可比性（即 CV 差异 <1%）。总体而言，BioRad 免疫测定对照性能稍好一些（即 B12、CA125 和 CA15-3）。 B12 和 CO2 特别不稳定（如患者库 CV 所示）。也就是说，性能差异并非站不住脚，并且可以基于定制方法进行处理，如果测定/仪器性能允许，可以根据扩展QC限制和/或在更严格的时间表上改变控制材料或试剂。