门诊人群中肌酐测量的杰氏法与酶法的风险评估
A Risk Assessment of the Jaffe vs Enzymatic Method for Creatinine Measurement in an Outpatient Population.
作者信息
Schmidt Robert L, Straseski Joely A, Raphael Kalani L, Adams Austin H, Lehman Christopher M
机构信息
Department of Pathology and ARUP Laboratories, University of Utah Health Sciences Center, Salt Lake City, Utah, United States of America.
Department of Internal Medicine, Division of Nephrology, University of Utah Health Sciences Center, Salt Lake City, Utah, United States of America.
出版信息
PLoS One. 2015 Nov 24;10(11):e0143205. doi: 10.1371/journal.pone.0143205. eCollection 2015.
BACKGROUND
The Jaffe and enzymatic methods are the two most common methods for measuring serum creatinine. The Jaffe method is less expensive than the enzymatic method but is also more susceptible to interferences. Interferences can lead to misdiagnosis but interferences may vary by patient population. The overall risk associated with the Jaffe method depends on the probability of misclassification and the consequences of misclassification. This study assessed the risk associated with the Jaffe method in an outpatient population. We analyzed the discordance rate in the estimated glomerular filtration rate based on serum creatinine measurements obtained by the Jaffe and enzymatic method.
METHODS
Method comparison and risk analysis. Five hundred twenty-nine eGFRs obtained by the Jaffe and enzymatic method were compared at four clinical decision limits. We determined the probability of discordance and the consequence of misclassification at each decision limit to evaluate the overall risk.
RESULTS
We obtained 529 paired observations. Of these, 29 (5.5%) were discordant with respect to one of the decision limits (i.e. 15, 30, 45 or 60 ml/min/1.73m2). The magnitude of the differences (Jaffe result minus enzymatic result) were significant relative to analytical variation in 21 of the 29 (72%) of the discordant results. The magnitude of the differences were not significant relative to biological variation. The risk associated with misclassification was greatest at the 60 ml/min/1.73m2 decision limit because the probability of misclassification and the potential for adverse outcomes were greatest at that decision limit.
CONCLUSION
The Jaffe method is subject to bias due to interfering substances (loss of analytical specificity). The risk of misclassification is greatest at the 60 ml/min/1.73m2 decision limit; however, the risk of misclassification due to bias is much less than the risk of misclassification due to biological variation. The Jaffe method may pose low risk in selected populations if eGFR results near the 60 ml/min/1.73m2 decision limit are interpreted with caution.
背景
Jaffe法和酶法是测量血清肌酐的两种最常用方法。Jaffe法比酶法成本更低，但更容易受到干扰。干扰可能导致误诊，且干扰情况可能因患者群体而异。与Jaffe法相关的总体风险取决于错误分类的概率和错误分类的后果。本研究评估了门诊患者群体中与Jaffe法相关的风险。我们分析了基于Jaffe法和酶法测得的血清肌酐值估算的肾小球滤过率的不一致率。
方法
方法比较与风险分析。在四个临床决策界值下，比较了通过Jaffe法和酶法获得的529个估算肾小球滤过率（eGFR）。我们确定了每个决策界值下不一致的概率和错误分类的后果，以评估总体风险。
结果
我们获得了529对观察值。其中，29对（5.5%）在其中一个决策界值（即15、30、45或60 ml/min/1.73m²）上存在不一致。在29个不一致结果中的21个（72%）中，差异幅度（Jaffe法结果减去酶法结果）相对于分析变异具有显著性。差异幅度相对于生物学变异不具有显著性。在60 ml/min/1.73m²决策界值下，与错误分类相关的风险最大，因为在该决策界值下错误分类的概率和不良后果的可能性最大。
结论
Jaffe法因干扰物质（分析特异性丧失）而存在偏差。在60 ml/min/1.73m²决策界值下，错误分类的风险最大；然而，由于偏差导致的错误分类风险远小于由于生物学变异导致的错误分类风险。如果对接近60 ml/min/1.73m²决策界值的eGFR结果谨慎解读，Jaffe法在特定人群中可能风险较低。
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