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首页> 外文期刊>Journal of clinical laboratory analysis. >The Analytical Performance Evaluation of Freelite? Human Kappa Free and Human Lambda Free on the SPAPLUS? Immunoturbidimetric Analyzer
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The Analytical Performance Evaluation of Freelite? Human Kappa Free and Human Lambda Free on the SPAPLUS? Immunoturbidimetric Analyzer

机译：Freelite的分析性能评估？ SPAPLUS上的Human Kappa Free和Human Lambda Free？免疫比浊分析仪

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BackgroundSPAPLUS™ is a turbidimetric immunoassay analyzer for detection of excess free light chain (FLC) antigens in serum. Here, we evaluated the analytical performance of Freelite™ Human Kappa Free and Lambda Free on a SPAPLUS™ instrument.MethodsWe evaluated the precision, linearity, sample carryover, and drift of the SPAPLUS™ instrument and compared it with Hitachi 7600 and BN™ II instruments. We evaluated the detection of antigen excess for 12 specimens from patients with monoclonal gammopathy.ResultsThe coefficients of variations of κFLC and λFLC were below 5.0%. Linearity was shown in the range of 9.68–152.25 mg/l for κFLC and 4.96–171.09 mg/l for λFLC, and no drift was observed. The κFLC sample carryover was statistically significant, but much smaller than the optimum allowable bias. Agreement rates with the two comparative methods were 87.1, 87.1, and 97.1% or higher for κFLC, λFLC, and the κ/λ ratio, respectively. Antigen excess signals were observed for all 12 antigen excess specimens.ConclusionsThe Freelite™ on the SPAPLUS™ exhibited appropriate precision, linearity, and relative comparability to the reagents on the other instruments. It was good at detecting specimens that had previously demonstrated the hook effect due to antigen excess.
机译：BackgroundSPAPLUS™是一种浊度免疫分析仪，用于检测血清中过量的游离轻链（FLC）抗原。在这里，我们评估了SPAPLUS™仪器上Freelite™无人Kappa和Lambda Free的分析性能。方法我们评估了SPAPLUS™仪器的精密度，线性，样品残留和漂移，并将其与Hitachi 7600和BN™II仪器进行了比较。 。我们评估了12例单克隆丙种球蛋白病患者的抗原过量检测结果。结果κFLC和λFLC的变异系数低于5.0％。线性曲线在κFLC范围内为9.68–152.25 mg / l，在λFLC范围内为4.96–171.09 mg / l，未观察到漂移。 κFLC样品的残留有统计学意义，但比最佳容许偏差小得多。两种比较方法的κFLC，λFLC和κ/λ比分别为87.1、87.1和97.1％或更高。在所有12个抗原过量样本中均观察到抗原过量信号。结论SPAPLUS™上的Freelite™与其他仪器上的试剂相比具有适当的精密度，线性和相对可比性。它擅长检测先前因抗原过量而表现出钩效应的标本。

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