评估Revvity sFlt-1和PlGF方法用于子痫前期评估的分析性能

摘要(中文译文)

血管生成生物标志物胎盘生长因子（PlGF）和可溶性fms样酪氨酸激酶-1（sFlt-1）的检测正日益用于支持子痫前期（PE）在常规临床实践中的预测和诊断。可用于分析这些标志物的方法越来越多，但显示其分析可比性的数据有限。本研究对Revvity公司的PlGF和sFlt-1检测方法进行了评估，并与牛津当前临床实践中使用的Roche方法进行了比较。研究开展了不精密度和配对分析比较研究，并针对数值一致性以及与制造商推荐的PE纳入和排除阈值相关的一致性对数据进行了评价。根据评估期间分析的质量控制材料计算得出的Revvity PlGF和sFlt-1方法的不精密度估计值为3.2至9.0 CV%。Revvity方法从581份双份分析的临床标本中得出的精密度概况显示，PlGF的CV%中位数为1.8%，四分位距为2.3%；sFlt-1的CV%中位数为1.1%，四分位距为1.5%。在437份临床标本中与Roche PlGF和sFlt-1方法的比较显示，PlGF的总体Passing-Bablok回归关系为y = -23.4 + 0.73x（r = 0.983），sFlt-1为y = -87.7 + 0.40x（r = 0.971）。然而，两种方法及计算比值均存在具有统计学显著性的浓度依赖性相对偏倚。sFlt-1:PlGF比值相对于制造商特定纳入和排除阈值的一致性为95.2%。Revvity的PlGF和sFlt-1方法精密度良好，且与Roche方法具有相关性。然而，数值一致性不足以支持结果互换使用以及采用共同的纳入和排除阈值。临床实践中应使用制造商特定的阈值。尚需进一步研究以了解方法差异如何影响临床结局及其原因。

Abstract

The measurement of the angiogenic biomarkers placental growth factor (PlGF) and soluble fms-like tyrosine kinase-1 (sFlt-1) are increasingly used to support the prediction and diagnosis of preeclampsia (PE) in routine clinical practice. There are an increasing number of methods available for the analysis of these markers but data showing their analytical comparability is limited. The assays for PlGF and sFlt-1 from Revvity were evaluated and compared against Roche methods that are used in current clinical practice in Oxford. Imprecision and paired analytical comparisons studies were undertaken and data evaluated for numeric agreement and concordance relative to manufacturer recommended rule-in and rule-out thresholds for PE. Imprecision estimates for the Revvity PlGF and sFlt-1 methods calculated from quality control material analysed during the evaluation were between 3.2 and 9.0 CV%. Revvity method precision profiles derived from 581 clinical specimens analysed in duplicate had a median CV% for PlGF of 1.8%, IQR 2.3% and for sFlt-1 a median CV% of 1.1%, IQR 1.5%. Comparison against the Roche PlGF and sFlt-1 methods in 437 clinical specimens showed an overall Passing-Bablok regression relationship for PlGF of y = -23.4 + 0.73x (r = 0.983) and for sFlt-1, y = -87.7 + 0.40x (r = 0.971). However, there was statistically significant () concentration dependant relative bias for both methods and the calculated ratio. Concordance of the sFlt-1:PlGF ratio relative to manufacturer specific rule-in and rule-out thresholds was 95.2%. The Revvity methods for PlGF and sFlt-1 are precise and correlate with the Roche methods. However, numeric agreement precludes result interchangeability and the use of common rule-in and rule-out thresholds. The manufacturer specific thresholds should be applied in clinical practice. Further work is required to understand how method differences impact clinical outcomes and their causes.

如何引用

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