Evaluation of the ARCHITECT urine NGAL assay: Assay performance, specimen handling requirements and biological variability

Grenier, Frank C.; Ali, Salman; Syed, Hina; Workman, Ryan; Martens, Frans; Liao, Ming; Wang, Y.; Wong, Pui-Yuen

doi:10.1016/j.clinbiochem.2009.12.008

Cited by 122 publications

(109 citation statements)

References 29 publications

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“…Levels of uNGAL were determined with a commercially available assay that used a noncompetitive sandwich format with chemiluminescent signal detection (ARCHITECT NGAL Assay, Abbott, Abbott Park, IL, USA). 17 …”

Section: Patientsmentioning

confidence: 99%

Untitled

Qurashi

Ghamdi²,

Jaradat³

et al. 2014

Exp Clin Transplant

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Objectives: To investigate the predictive value of urinary neutrophil gelatinase-associated lipocalin in the occurrence of delayed graft function after kidney transplant. Materials and Methods: In this prospective cohort study of 67 consecutive patients who received a living-related (40 patients [61%]) or deceased-donor kidney transplant (27 patients [39%]), urinary neutrophil gelatinase-associated lipocalin was determined in the first 100 mL perfusate of the donor kidney and in urine at 6 hours after transplant. Patients were followed (11 ± 7 mo) for changes in estimated glomerular filtration rate and delayed graft function. Results: The mean urinary neutrophil gelatinaseassociated lipocalin level at 6 hours after transplant was significantly higher after deceased-donor (781 ± 452 ng/mL) than living-donor transplant (229 ± 223 ng/mL; P ≤ 0.001). The decrease in estimated glomerular filtration rate from 6 to 12 months after transplant was positively correlated with the urinary neutrophil gelatinase-associated lipocalin levels in the perfusate in living-donor transplant. A significant correlation was noted between the occurrence of delayed graft function and the urinary neutrophil gelatinase-associated lipocalin level at 6 hours after living-donor transplant. In the deceased-donor group, the occurrence of delayed graft function was correlated with urinary neutrophil gelatinase-associated lipocalin levels in the perfusate. In deceased-donor kidney transplant, the mean urinary neutrophil gelatinase-associated lipocalin level in the perfusion fluid was significantly greater from donors who had terminal serum creatinine > 150 μmol/L, and urinary neutrophil gelatinase-associated lipocalin level at 6 hours after transplant was significantly greater in transplants with longer cold ischemia time and donors who had hypertension. Conclusions: Urinary neutrophil gelatinase-associated lipocalin levels in the donor kidney perfusate and 6 hours after transplant may be a useful predictor of delayed graft function and decreased graft function from 6 to 12 months after transplant.

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Section: Patientsmentioning

confidence: 99%

Untitled

Qurashi

Ghamdi²,

Jaradat³

et al. 2014

Exp Clin Transplant

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“…All biomarkers were measured from frozen aliquots that did not undergo any additional freeze-thaw cycles. 34,35 Additional details on repeat biomarker measurements and assay performance and stability have been previously described. 17 …”

Section: Aki Biomarker Measurementsmentioning

confidence: 99%

Biomarkers Predict Progression of Acute Kidney Injury after Cardiac Surgery

Koyner

Garg

Coca

et al. 2012

Journal of the American Society of Nephrology

244

218

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Being able to predict whether AKI will progress could improve monitoring and care, guide patient counseling, and assist with enrollment into trials of AKI treatment. Using samples from the Translational Research Investigating Biomarker Endpoints in AKI study (TRIBE-AKI), we evaluated whether kidney injury biomarkers measured at the time of first clinical diagnosis of early AKI after cardiac surgery can forecast AKI severity. Biomarkers included urinary IL-18, urinary albumin to creatinine ratio (ACR), and urinary and plasma neutrophil gelatinaseassociated lipocalin (NGAL); each measurement was on the day of AKI diagnosis in 380 patients who developed at least AKI Network (AKIN) stage 1 AKI. The primary end point (progression of AKI defined by worsening AKIN stage) occurred in 45 (11.8%) patients. Using multivariable logistic regression, we determined the risk of AKI progression. After adjustment for clinical predictors, compared with biomarker values in the lowest two quintiles, the highest quintiles of three biomarkers remained associated with AKI progression: IL-18 (odds ratio=3.0, 95% confidence interval=1.3-7.3), ACR (odds ratio=3.4, 95% confidence interval=1.3-9.1), and plasma NGAL (odds ratio=7.7, 95% confidence interval=2.6-22.5). Each biomarker improved risk classification compared with the clinical model alone, with plasma NGAL performing the best (category-free net reclassification improvement of 0.69, P,0.0001). In conclusion, biomarkers measured on the day of AKI diagnosis improve risk stratification and identify patients at higher risk for progression of AKI and worse patient outcomes.

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“…No additives or protease inhibitors were added. We measured uNGAL using the ARCHITECT i2000 platform (Abbott Diagnostics, Abbott Park, IL) (19) and quantified as absolute concentration, urine creatinine-normalized concentration, and absolute excretion rate. The normalized uNGAL concentration was derived by dividing the absolute concentration by the urine creatinine concentration (millimole per liter), measured by the enzymatic method on the ARCHITECT C16000 platform.…”

Section: Urine Sampling and Ungal Measurementmentioning

confidence: 99%

Predictive Performance of Urine Neutrophil Gelatinase-Associated Lipocalin for Dialysis Requirement and Death Following Cardiac Surgery in Neonates and Infants

Bojan¹,

Vicca

Lopez-Lopez³

et al. 2014

Clinical Journal of the American Society of Nephrology

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SummaryBackground and objectives Urine neutrophil gelatinase-associated lipocalin (uNGAL) has been shown to accurately predict and allow early detection of AKI, as assessed by an increase in serum creatinine in children and adults. The present study explores the accuracy of uNGAL for the prediction of severe AKI-related outcomes in neonates and infants undergoing cardiac surgery: dialysis requirement and/or death within 30 days.Design, setting, participants, & measurements Prospective, observational cohort study conducted in a tertiary referral pediatric cardiac intensive care unit, including 75 neonates and 125 infants undergoing surgery with cardiopulmonary bypass between August 1, 2010, and May 31, 2011. Urine samples were collected before surgery and at median of five time points within 48 hours of bypass. Urine NGAL was quantified as absolute concentration, creatinine-normalized concentration, and absolute excretion rate, and a clusterization algorithm was applied to the individual uNGAL kinetics. The accuracy for the prediction of the outcome was assessed using receiver-operating characteristic areas, likelihood ratios, diagnostic odds ratios, net reclassification index, integrated reclassification improvement, and number needed to screen.Results A total of 1176 urine samples were collected. Of all patients, 8% required dialysis and 4% died. Three clusters of uNGAL kinetics were identified, including patients with significantly different outcomes. The uNGAL level peaked between 1 and 3 hours of bypass and remained high in half of all patients who required dialysis or died. The uNGAL levels measured within 24 hours of bypass accurately predicted the outcome and performed best after normalization to creatinine, with varying cutoffs according to the time elapsed since bypass. The number needed to screen to correctly identify the risk of dialysis or death in one patient varied between 1.5 and 2.6 within 12 hours of bypass.Conclusions uNGAL is a valuable predictive tool of dialysis requirement and death in neonates and infants with AKI after cardiac surgery.

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Evaluation of the ARCHITECT urine NGAL assay: Assay performance, specimen handling requirements and biological variability

Cited by 122 publications

References 29 publications

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Untitled

Biomarkers Predict Progression of Acute Kidney Injury after Cardiac Surgery

Predictive Performance of Urine Neutrophil Gelatinase-Associated Lipocalin for Dialysis Requirement and Death Following Cardiac Surgery in Neonates and Infants

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