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首页> 外文期刊>The journal of applied laboratory medicine. >Analytical Performance and Quality Indicators of Fully Automated Immunoassays for sFlt-1 and PIGF
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Analytical Performance and Quality Indicators of Fully Automated Immunoassays for sFlt-1 and PIGF

机译：分析性能和质量指标全自动免疫测定sFlt-1和PIGF

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摘要

Background:The ratio of the antiangiogenic factor, soluble fms-like tyrosine kinase 1 (sFlt-1), to the proangiogenic factor, placental growth factor (PlGF), is associated with increased risk of preeclampsia. Here, we describe an analytical evaluation of the Elecsys sFlt-1 and PlGF assays at the first North American site in which they were clinically implemented.Methods:The analytical evaluation included short- and long-term imprecision, method comparison, accuracy, linearity, sample stability, limit of quantification verification, and measurement uncertainty. Quality indicators were also evaluated, including turnaround time and repeat test frequency.Results:Short-term (13-day) and long-term (12-month) imprecision for sFlt-1 and PlGF were ?0.99 and bias 38, >85, and >110) exhibited negative percent agreement and positive percent agreement of 100%, respectively (n?=?40). During the first 12?months, 257 orders were placed, repeat test frequency was 17.5%, mean time between repeat orders was 23?days, and 72.0% of results were reported within 2?h from sample receiptwhen quality control was run continuously.Conclusions:We describe analytical performance parameters and quality indicators of the Elecsys sFlt-1 and PlGF assays, which was the first North American clinical laboratory site to implement these assays in support of the institution’s high-risk obstetrical unit.
机译：背景:反血管增生的比例因子,可溶性fms-like酪氨酸激酶1 (sFlt-1)proangiogenic因素,胎盘生长因子(PlGF)与风险增加有关子痫前期。评估Elecsys sFlt-1 PlGF化验他们在第一个北美网站是临床实施。包括短期和分析评价长期的不精确,方法比较,准确性、线性样本稳定性,限制的量化验证和测量不确定性。评估,包括周转时间和重复测试频率。长期(12个月)为sFlt-1和不精确PlGF CV ? 0.99和偏差 > 85年,> 110)表现出负的协议和积极的百分比协议百分比分别为100% (n = ? 40)。12？频率为17.5%,平均间隔时间重复订单是23吗?报道在2 ?质量控制管理不断。性能参数和质量指标的Elecsys sFlt-1 PlGF化验,这是第一个北美临床实验室网站实现这些化验的支持机构的高危产科单位。

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