Abstract
Insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) have demonstrated significantly improved diagnostic performance in assessing risk for acute kidney injury (AKI) compared with existing biomarkers. We present the findings of a multi-site trial to determine the reference intervals for these biomarkers in apparently healthy adults and those with stable chronic morbid conditions without AKI. A urine specimen was collected from apparently healthy subjects (N=378) and subjects with at least one stable chronic morbidity (N=372). Specimens were kept frozen until analysis with the NephroCheck® Test (Astute Medical). The test is comprised of fluorescence immunoassays for IGFBP7 and TIMP-2 and is used with the Astute140® Meter which quantifies the concentration of each biomarker. The meter multiplies the concentrations of IGFBP7 and TIMP-2 and displays the result as a numerical value ([IGFBP7]∙[TIMP-2]) expressed in (ng/ml)(2)/1000 which is called the AKIRisk™ Score. The reference intervals (inner 95%) for [IGFBP7]∙[TIMP-2] in all subjects (N=750), apparently healthy subjects, and subjects with stable chronic morbidities were 0.04-2.22, 0.04-2.25, and 0.05-2.20 (ng/ml)(2)/1000 respectively. There was no statistical difference between reference intervals for apparently healthy and chronic stable morbid cohorts (p=0.42). Our investigation showed that urine [IGFBP7]∙[TIMP-2] values were not elevated in patients with stable chronic morbidities who did not have AKI.
Highlights
Acute kidney injury (AKI) is a disease with multiple etiologies that lacks an effective specific treatment in current clinical practice [1]
This is the first report of the observed values of [Insulin-like growth factor-binding protein 7 (IGFBP7)]∙[tissue inhibitor of metalloproteinases-2 (TIMP-2)] in urine where a large group of subjects including apparently healthy individuals and individuals with stable chronic morbidities were studied in order to determine how these biomarkers varied in different patient populations that were not acutely ill and did not have signs or clinical findings of acute kidney injury (AKI)
The NEPHROCHECK® Test is an FDA cleared [22] in-vitro diagnostic test that quantitatively measures IGFBP7 and TIMP-2 in human urine on the ASTUTE140® Meter, a bench/table-top analyzer [23]. It is a single-use cartridge comprised of sandwich immunoassays for IGFBP7 and TIMP-2 on a membrane test strip enclosed in a plastic housing
Summary
Insulin-like growth factor-binding protein 7 (IGFBP7) and tissue inhibitor of metalloproteinases-2 (TIMP-2) have demonstrated significantly improved diagnostic performance in assessing risk for acute kidney injury (AKI) compared with existing biomarkers. We present the findings of a multi-site trial to determine the reference intervals for these biomarkers in apparently healthy adults and those with stable chronic morbid conditions without AKI. Methods: A urine specimen was collected from apparently healthy subjects (N = 378) and subjects with at least one stable chronic morbidity (N = 372). Results: The reference intervals (inner 95%) for [IGFBP7]∙[TIMP-2] in all subjects (N = 750), apparently healthy subjects, and subjects with stable chronic morbidities were 0.04–2.22, 0.04–2.25, and 0.05–2.20 (ng/ml)2/1000 respectively. There was no statistical difference between reference intervals for apparently healthy and chronic stable morbid cohorts (p = 0.42). Conclusions: Our investigation showed that urine [IGFBP7]∙[TIMP-2] values were not elevated in patients with stable chronic morbidities who did not have AKI
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