Departments of Pathology and Medicine, Johns Hopkins University School of Medicine, Baltimore, MD, United States.
Johns Hopkins Hospital, Baltimore, MD, United States.
Clin Chim Acta. 2022 Feb 1;526:1-5. doi: 10.1016/j.cca.2021.12.013. Epub 2021 Dec 18.
Evaluation of specimen suitability for downstream analytical testing and identification of potential interferents in the clinical laboratory is critical for the generation of actionable clinical results. Within the clinical laboratory, hemolysis, icterus, and lipemia are commonly assessed spectrophotometrically. While clinical laboratories rely on analyte-specific quality control (QC) materials to monitor test or instrument performance, QC materials evaluating specimen integrity checks are infrequently implemented.
Using commercially available specimen integrity materials, we evaluated the Bio-Rad Liquichek™ Serum Indices product on Roche cobas® c701 analyzers at a large academic medical center. Target arbitrary values for the hemolysis, icterus, and lipemia QC materials were 200, 20, and 500, respectively. Means, standard deviations (SD), and coefficients of variation (%CV) were established for hemolysis, icterus, lipemia, and non-interfered QCs, and performance was monitored over a 60-day period.
Across four c701 instruments, all QC materials performed well, with %CVs ≤ 1.76%, 4.51%, and 3.46% for hemolysis, icterus, and lipemia QC, respectively.
The Bio-Rad Liquichek Serum Indices product can serve as an effective means of monitoring specimen integrity checks in a manner congruous with existing QC programs.
评估标本是否适合下游分析测试，并识别临床实验室中的潜在干扰物，对于生成可操作的临床结果至关重要。在临床实验室中，通常通过分光光度法评估溶血、黄疸和脂血。虽然临床实验室依赖于针对分析物的质量控制 (QC) 材料来监测测试或仪器性能，但很少实施评估标本完整性检查的 QC 材料。
我们使用市售的标本完整性材料，在一家大型学术医疗中心的罗氏 cobas® c701 分析仪上评估了伯乐 Bio-Rad Liquichek™ 血清指数产品。溶血、黄疸和脂血 QC 材料的目标任意值分别为 200、20 和 500。为溶血、黄疸、脂血和未受干扰的 QC 建立了平均值、标准差 (SD) 和变异系数 (%CV)，并在 60 天内监测性能。
在四台 c701 仪器上，所有 QC 材料的性能都很好，溶血、黄疸和脂血 QC 的 CV 值分别为 ≤1.76%、4.51%和 3.46%。
伯乐 Bio-Rad Liquichek 血清指数产品可以作为一种有效的方法，以与现有 QC 计划一致的方式监测标本完整性检查。
