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      ImmunoDip ®: An Improved Screening Method for Microalbuminuria

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          Abstract

          Background: It is important to test for microalbuminuria in patients with diabetes, hypertension and possible insulin resistance syndrome. Current screening methods are suboptimal. This study evaluates a new office screening test for microalbuminuria that utilizes a monoclonal antibody against human serum albumin (ImmunoDip<sup>®</sup>). Methods: 182 urine samples were collected from patients attending diabetes, nephrology or hypertension clinics. The ImmunoDip<sup>®</sup> screening test was carried out in the 182 samples after which albumin and creatinine concentrations were measured quantitatively in a reference laboratory. Results: Screening the 182 patient samples with ImmunoDip<sup>®</sup> and designating an albumin:creatinine ratio of ≧30 µg/mg as positive yielded a sensitivity of 96%, a specificity of 80%, a positive predictive value (PPV) of 66% and a negative predictive value (NPV) of 98%. The reduced specificity and PPV were not due to an intrinsic inaccuracy with ImmunoDip<sup>®</sup> screening of these samples, but rather was shown to be due to the discordance between the accepted upper limits of normal for the albumin:creatinine ratio (30 µg/mg) and the albumin concentration (20 mg/l), the latter corresponding to a ratio of 20 µg/mg. In 35 samples with albumin concentrations of 20–50 mg/l, ImmunoDip<sup>®</sup> screening yielded only one false negative (FN) result. Conclusions: ImmunoDip<sup>®</sup> is an excellent screening tool for microalbuminuria.

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          Most cited references 3

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          Effect of captopril on progression to clinical proteinuria in patients with insulin-dependent diabetes mellitus and microalbuminuria. European Microalbuminuria Captopril Study Group.

          To study the effect of angiotensin converting enzyme inhibition on the rate of progression to clinical proteinuria and the rate of change of albumin excretion rates in patients with insulin-dependent diabetes mellitus and persistent microalbuminuria. Randomized, double-blind, placebo-controlled clinical trial of 2 years' duration at 12 hospital-based diabetes centers. Ninety-two patients with insulin-dependent diabetes mellitus and persistent microalbuminuria but no hypertension. The patients were randomly allocated in blocks of two to receive either captopril, 50 mg, or placebo twice per day. Albumin excretion rate, blood pressure, glycosylated hemoglobin level, and fructosamine level every 3 months; urinary urea nitrogen excretion every 6 months; and glomerular filtration rate every 12 months. Twelve patients receiving placebo and four receiving captopril progressed to clinical proteinuria, defined as an albumin excretion rate persistently greater than 200 micrograms/min and at least a 30% increase from baseline (P = .05). The probability of progression to clinical proteinuria was significantly reduced by captopril therapy (P = .03 by log-rank test). Albumin excretion rate rose from a geometric mean (95% confidence interval) of 52 (39 to 68) to 76 (47 to 122) micrograms/min in the placebo group but fell from 52 (41 to 65) to 41 (28 to 60) micrograms/min in the captopril group, a significant difference (P < .01). Mean blood pressure was similar at baseline in the two groups and remained unchanged in the placebo group but fell significantly, by 3 to 7 mm Hg, in the captopril group. Glycosylated hemoglobin levels and glomerular filtration rate remained stable in the two groups. Captopril therapy significantly impeded progression to clinical proteinuria and prevented the increase in albumin excretion rate in nonhypertensive patients with insulin-dependent diabetes mellitus and persistent microalbuminuria.
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            Randomised placebo-controlled trial of lisinopril in normotensive patients with insulin-dependent diabetes and normoalbuminuria or microalbuminuria

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              Long-term renoprotective effect of angiotensin-converting enzyme inhibition in non-insulin-dependent diabetes mellitus. A 7-year follow-up study.

              Diabetic nephropathy is the leading cause of end-stage renal disease in developed countries. Duration of diabetes, blood pressure values, and metabolic status are the major determinants of the course of nephropathy, and microalbuminuria is the hallmark of its onset. Angiotensin-converting enzyme inhibitors offer important renoprotection to hypertensive and normotensive patients with insulin-dependent diabetes mellitus and non-insulin-dependent diabetes mellitus. Our study extends previous observations for duration and the effect of angiotensin-converting enzyme inhibition on advanced nephropathy. Double-blinded (first phase) and open (second phase) randomized controlled study of 7 years. Ninety-four normotensive patients with non-insulin-dependent diabetes mellitus whose serum creatinine levels were lower than 123.76 mumol/L (1.4 mg/dL) and who had microalbuminuria (30 to 300 mg/24 h) were given enalapril maleate, 10 mg/d, or placebo, for 5 years. For 2 more years they were followed up openly and given the choice to receive enalapril or no treatment. In the enalapril-treated patients, albuminuria remained stable for 7 years. An increase from (mean +/- SD) 123 +/- 58 to 310 +/- 167 mg/24 h occurred in the untreated group after 5 years, and a further increase to (mean +/- SD) 393 +/- 223 mg/24 h occurred after 7 years. Reciprocal creatinine was unchanged in treated patients for 7 years; in the untreated patients, the mean decline was 13% at 5 years and 16% at 7 years. Treatment with enalapril resulted in an absolute risk reduction of 42% for nephropathy to develop during 7 years (95% confidence interval, 15% to 69%; P < .001, Student's t test). Glycosylated hemoglobin and body mass index remained unchanged. Angiotensin-converting enzyme inhibition offers long-term protection against the development of nephropathy in normotensive patients with noninsulin-dependent diabetes mellitus who have microalbuminuria, and it stabilizes renal function in previously untreated patients with impaired renal function. Discontinuation of treatment results in renewed progression of nephropathy.
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                Author and article information

                Journal
                AJN
                Am J Nephrol
                10.1159/issn.0250-8095
                American Journal of Nephrology
                S. Karger AG
                0250-8095
                1421-9670
                2004
                June 2004
                06 July 2004
                : 24
                : 3
                : 284-288
                Affiliations
                aClinical Trials Unit, Charles R. Drew University, Los Angeles, Calif.; bEPISTAT, Charles R. Drew University, LosAngeles, Calif.; cRush Hypertension, Clinical Research Center, Chicago, Ill.; dUSC Clinical Diabetes Programs, LosAngeles, Calif. and eUSC Division of Nephrology, Los Angeles, Calif., USA
                Article
                77854 Am J Nephrol 2004;24:284–288
                10.1159/000077854
                15087587
                © 2004 S. Karger AG, Basel

                Copyright: All rights reserved. No part of this publication may be translated into other languages, reproduced or utilized in any form or by any means, electronic or mechanical, including photocopying, recording, microcopying, or by any information storage and retrieval system, without permission in writing from the publisher. Drug Dosage: The authors and the publisher have exerted every effort to ensure that drug selection and dosage set forth in this text are in accord with current recommendations and practice at the time of publication. However, in view of ongoing research, changes in government regulations, and the constant flow of information relating to drug therapy and drug reactions, the reader is urged to check the package insert for each drug for any changes in indications and dosage and for added warnings and precautions. This is particularly important when the recommended agent is a new and/or infrequently employed drug. Disclaimer: The statements, opinions and data contained in this publication are solely those of the individual authors and contributors and not of the publishers and the editor(s). The appearance of advertisements or/and product references in the publication is not a warranty, endorsement, or approval of the products or services advertised or of their effectiveness, quality or safety. The publisher and the editor(s) disclaim responsibility for any injury to persons or property resulting from any ideas, methods, instructions or products referred to in the content or advertisements.

                Page count
                Figures: 1, Tables: 2, References: 32, Pages: 5
                Product
                Self URI (application/pdf): https://www.karger.com/Article/Pdf/77854
                Categories
                Original Report: Laboratory Investigation

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