False-positive rate of AKI using consensus creatinine–based criteria

Jennie Lin, Hilda Fernandez, Michael G.S. Shashaty, Dan Negoianu, Jeffrey M. Testani, Jeffrey S. Berns, Chirag R. Parikh, F. Perry Wilson

Research output: Contribution to journalArticle

Abstract

Background and objectives Use of small changes in serumcreatinine to diagnose AKI allows for earlier detection but may increase diagnostic false–positive rates because of inherent laboratory and biologic variabilities of creatinine. Design, setting, participants,&measurements We examined serum creatinine measurement characteristics in a prospective observational clinical reference cohort of 2267 adult patientswith AKI by Kidney Disease Improving Global Outcomes creatinine criteria and used these data to create a simulation cohort to model AKI false– positive rates. We simulated up to seven successive blood draws on an equal population of hypothetical patients with unchanging true serum creatinine values. Error terms generated from laboratory and biologic variabilities were added to each simulated patient’s true serum creatinine value to obtain the simulated measured serum creatinine for each blood draw.We determined the proportion of patients who would be erroneously diagnosed with AKI by Kidney Disease Improving Global Outcomes creatinine criteria. Results Within the clinical cohort, 75.0% of patients received four serum creatinine draws within at least one 48- hour period during hospitalization. After four simulated creatinine measurements that accounted for laboratory variability calculated from assay characteristics and 4.4% of biologic variability determined from the clinical cohort and publicly available data, the overall false–positive rate for AKI diagnosis was 8.0% (interquartile range =7.9%–8.1%), whereas patients with true serum creatinine ≥1.5 mg/dl (representing 21% of the clinical cohort) had a false–positive AKI diagnosis rate of 30.5% (interquartile range =30.1%–30.9%) versus 2.0% (interquartile range =1.9%–2.1%) in patients with true serum creatinine values <1.5 mg/dl (P<0.001). Conclusions Use of small serum creatinine changes to diagnose AKI is limited by high false–positive rates caused by inherent variability of serum creatinine at higher baseline values, potentially misclassifying patients with CKD in AKI studies.

Original languageEnglish (US)
Pages (from-to)1723-1731
Number of pages9
JournalClinical Journal of the American Society of Nephrology
Volume10
Issue number10
DOIs
StatePublished - Oct 7 2015

ASJC Scopus subject areas

  • Epidemiology
  • Critical Care and Intensive Care Medicine
  • Nephrology
  • Transplantation

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    Lin, J., Fernandez, H., Shashaty, M. G. S., Negoianu, D., Testani, J. M., Berns, J. S., Parikh, C. R., & Perry Wilson, F. (2015). False-positive rate of AKI using consensus creatinine–based criteria. Clinical Journal of the American Society of Nephrology, 10(10), 1723-1731. https://doi.org/10.2215/CJN.02430315