Waikar Sushrut S, Betensky Rebecca A, Emerson Sarah C, Bonventre Joseph V
aRenal Division, Department of Medicine, Brigham and Women's Hospital, Harvard Medical School, Boston, MA, USA.
Clin Trials. 2013 Oct;10(5):696-700. doi: 10.1177/1740774513497540. Epub 2013 Sep 3.
Serum creatinine has been used as the diagnostic test for acute kidney injury (AKI) for decades despite having imperfect sensitivity and specificity. Novel tubular injury biomarkers may revolutionize the diagnosis of AKI; however, even if a novel tubular injury biomarker is 100% sensitive and 100% specific, it may appear inaccurate when using serum creatinine as the gold standard.
In general, the apparent diagnostic performance of a biomarker depends not only on its ability to detect injury but also on disease prevalence and the sensitivity and specificity of the imperfect gold standard. Apparent errors in diagnosis using a new biomarker may be a reflection of errors in the imperfect gold standard itself rather than poor performance of the biomarker.
几十年来，血清肌酐一直被用作急性肾损伤（AKI）的诊断检测指标，尽管其敏感性和特异性并不理想。新型肾小管损伤生物标志物可能会彻底改变AKI的诊断方式；然而，即使一种新型肾小管损伤生物标志物的敏感性和特异性均为100%，以血清肌酐作为金标准时，它可能看起来并不准确。
一般来说，生物标志物的表观诊断性能不仅取决于其检测损伤的能力，还取决于疾病患病率以及不完善的金标准的敏感性和特异性。使用新生物标志物时出现的表观诊断错误可能反映了不完善的金标准本身存在的错误，而非生物标志物的性能不佳。
