Imperfect gold standards for biomarker evaluation

Sushrut S. Waikar; Rebecca A. Betensky; Sarah C. Emerson; Joseph V. Bonventre

doi:10.1177/1740774513497540

Imperfect gold standards for biomarker evaluation

Sushrut S. Waikar, Rebecca A. Betensky, Sarah C. Emerson, Joseph V. Bonventre

Global Public Health

Research output: Contribution to journal › Article › peer-review

Abstract

Background 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 KI; 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. Conclusions 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. Clinical Trials 2013; 10: 696700. http://ctj.sagepub.com.

Original language	English (US)
Pages (from-to)	696-700
Number of pages	5
Journal	Clinical Trials
Volume	10
Issue number	5
DOIs	https://doi.org/10.1177/1740774513497540
State	Published - Oct 2013

ASJC Scopus subject areas

Pharmacology

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@article{9f3edb03a3b440db9b02e2f939da8a67,

title = "Imperfect gold standards for biomarker evaluation",

abstract = "Background 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 KI; 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. Conclusions 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. Clinical Trials 2013; 10: 696700. http://ctj.sagepub.com.",

author = "Waikar, {Sushrut S.} and Betensky, {Rebecca A.} and Emerson, {Sarah C.} and Bonventre, {Joseph V.}",

note = "Funding Information: This research was supported by R33DK074099, K23DK075941, R01CA075971, and T32NS048005. This research was conducted with support from Harvard Catalyst – The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award 8UL1TR000170-05, and financial contributions from Harvard University and its affiliated academic health care centers). ",

year = "2013",

month = oct,

doi = "10.1177/1740774513497540",

language = "English (US)",

volume = "10",

pages = "696--700",

journal = "Clinical Trials",

issn = "1740-7745",

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TY - JOUR

T1 - Imperfect gold standards for biomarker evaluation

AU - Waikar, Sushrut S.

AU - Betensky, Rebecca A.

AU - Emerson, Sarah C.

AU - Bonventre, Joseph V.

N1 - Funding Information: This research was supported by R33DK074099, K23DK075941, R01CA075971, and T32NS048005. This research was conducted with support from Harvard Catalyst – The Harvard Clinical and Translational Science Center (National Center for Research Resources and the National Center for Advancing Translational Sciences, National Institutes of Health Award 8UL1TR000170-05, and financial contributions from Harvard University and its affiliated academic health care centers).

PY - 2013/10

Y1 - 2013/10

N2 - Background 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 KI; 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. Conclusions 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. Clinical Trials 2013; 10: 696700. http://ctj.sagepub.com.

AB - Background 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 KI; 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. Conclusions 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. Clinical Trials 2013; 10: 696700. http://ctj.sagepub.com.

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JO - Clinical Trials

JF - Clinical Trials

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Imperfect gold standards for biomarker evaluation

Abstract

ASJC Scopus subject areas

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