Section of Clinical Biochemistry, University of Verona, Verona, Italy.
Department of Laboratory Medicine, Paracelsus Medical University, Salzburg, Austria.
PLoS One. 2018 Jul 6;13(7):e0200088. doi: 10.1371/journal.pone.0200088. eCollection 2018.
Automatic assessment of hemoglobin (H), lipaemia (L) and icterus (I) in serum or plasma (HIL indices) is the mainstay for evaluating sample quality. We planned this study to verify whether in-house prepared internal quality control (IQC) materials may be suitable for quality assurance of HIL indices. Pools containing different values of each of the three HIL indices were prepared from routine plasma samples, divided in aliquots and frozen at -20°C. Stability of frozen materials was assessed by thawing one aliquot of each pool after different days of freezing (1, 4, 8, 15, 22 and 29), and by measuring HIL indices on baseline fresh samples and frozen-thawed aliquots with Roche Cobas c702. Five fresh liquid IQCs materials were also measured at the same time points. Intra-assay and inter-assay imprecision of HIL indices calculated with commercial IQC materials ranged between 1.1-2.0% and 1.6-3.3%, respectively. When target values of HIL indices were calculated using frozen-thawed aliquots, the inter-assay imprecision of in-house prepared materials was optimal, even better than that of commercial liquid IQCs (H-index, 0.8% versus 1.6%; L-index, 2.2% versus 2.5%; I-index, 0.8% versus 3.3%). In conclusion, in-house prepared IQC materials are cost-effective alternatives to commercial liquid IQCs for HIL quality assurance.
自动评估血清或血浆中的血红蛋白（H）、脂血（L）和黄疸（I）（HIL 指数）是评估样本质量的主要方法。我们计划进行这项研究，以验证内部自制质控（IQC）材料是否可用于 HIL 指数的质量保证。从常规血浆样本中制备含有三种 HIL 指数中每一种不同值的混合液，分装并在-20°C 下冷冻。通过解冻每个混合液的一份冻存样本，评估冷冻材料的稳定性，分别在冻存后 1、4、8、15、22 和 29 天进行解冻，使用罗氏 Cobas c702 测量 HIL 指数在基线新鲜样本和冻融样本中的值。同时在相同时间点也测量了五种新鲜的液体 IQC 材料。使用商业 IQC 材料计算 HIL 指数的批内和批间精密度分别在 1.1-2.0%和 1.6-3.3%之间。当使用冻融样本计算 HIL 指数的靶值时，自制材料的批间精密度最佳，甚至优于商业液体 IQC（H 指数，0.8%比 1.6%；L 指数，2.2%比 2.5%；I 指数，0.8%比 3.3%）。总之，内部自制的 IQC 材料是用于 HIL 质量保证的经济有效的商业液体 IQC 替代品。
