Comparison among different measurement systems for fibrinogen using fresh samples and frozen samples
Comparison among different measurement systems for fibrinogen using fresh samples and frozen samples
复制标题
使用新鲜样品和冷冻样品进行纤维蛋白原不同测量系统的比较
DOI：
10.1016/j.cca.2020.06.030
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发表时间：
2020
影响因子：
5
通讯作者：
Peng Mingting
中科院分区：
文献类型：
--
作者：
Li Chenbin;Sun Zhuoyi;Liu Yanhong;Zhou Wenbin;Wang Yu;Peng Mingting
中国的许多实验室都有几种类型的凝血分析仪。不同系统间纤维蛋白原结果的差异可能导致不适当的医疗决策。我们的目的是建立可比性评价标准，并评估使用新鲜和冷冻样品的不同纤维蛋白原测量系统的可比性。方法对国内外有关纤维蛋白原生物学变异（BV）的文献进行综述。基于可靠的BV数据和外部质量评价（EQA）标准，结合总误差设定允许限值。如果从不同系统获得的结果具有可比性，则样品的符合率应至少达到80%。采用三种测量系统对57个冻融前后试样进行了测量，计算了试样的顺应率。结果允许限量为11.3%。新鲜样品的合格率为78.2-84.2%，冷冻样品的合格率为54.5-93.0%。两种样品的可比性结果不同。结论基于BV和技术水平设定可比性允许限是可行的；建议采用新鲜样品评价系统的可比性。可比性的结果与样品的浓度分布有关，其范围应超过常规实验室检测的浓度范围。
BackgroundMany laboratories in China have several types of coagulation analyzers. Differences in fibrinogen results among different systems may cause inappropriate medical decisions. Our aim was to set the comparability evaluation criteria and evaluate comparability of different fibrinogen measurement systems using fresh and frozen samples.MethodsBiological variation (BV) publications on fibrinogen were reviewed. Total error based on reliable BV data and external quality assessment (EQA) criteria were combined to set allowable limit. The compliance rate of samples for the limit should achieve at least 80% if the results obtained from different systems were comparable. Fifty-seven samples before and after freeze–thaw were measured by three measurement systems and the percentage of compliant samples was calculated.ResultsThe allowable limit was 11.3%. The compliance rates of fresh samples were 78.2–84.2%, and the rates of frozen samples were 54.5–93.0%. The comparability results were different using two kinds of samples.ConclusionsIt is feasible to set allowable limits of comparability based on BV and state of the art; and fresh samples are recommended for evaluating systems comparability. The results of comparability are related to samples’ concentrations distribution, which should range over the concentration ranges in routine laboratory tests.