Document Detail


Interest of Clinitek Microalbumin in screening for microalbuminuria: results of a multicentre study in 302 diabetic patients.
MedLine Citation:
PMID:  11240444     Owner:  NLM     Status:  MEDLINE    
Abstract/OtherAbstract:
A prospective survey was performed in 302 consecutive diabetic outpatients from 3 French diabetic centres to study the sensitivity and specificity of screening for microalbuminuria using Clinitek Microalbumin. Urinary samples with positive (at least one +) proteinuria, hematuria, leucocyturia, or nitrates using the Multistix strip were excluded from the study. Results obtained with Clinitek Microalbumin were compared to those observed with the reference method of the biological laboratory of the centre on the same urinary sample. A positive result was defined as an albumin-to-creatinine ratio > or =30 mg/g. Results were described in terms of sensitivity, specificity, positive and negative predictive values and likelihood ratio. Agreement rates were compared with the Kappa test. In the study population, 48 patients (17%) had a positive microalbuminuria with reference assay. However, different rates were found in each site (25%, 11%, and 15%, respectively, p<0.001). Using the Clinitek Microalbumin, a positive result was found among 86 patients (29%), (39%, 26%, and 23%, respectively). A good agreement was observed in the population as a whole (81%, K=0.47 +/- 0.06) and in each site (77%, 81%, 84%, respectively). Sensitivity was 79% (82%, 80%, 75%), specificity 81% (76%, 81%, 85%), positive predictive value 46% (53%, 35%, 46%), negative predictive value 95% (93%, 97%, 95%), and positive likelihood ratio 4.2 (3.4, 4.3, 5.0, respectively). Due to the excellent negative predictive value, these results suggest that Clinitek Microalbumin is a good screening test for microalbuminuria. Positive results should be confirmed using a reference assay.
Authors:
J P Le Floch; M Marre; M Rodier; P Passa
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Publication Detail:
Type:  Comparative Study; Journal Article; Multicenter Study    
Journal Detail:
Title:  Diabetes & metabolism     Volume:  27     ISSN:  1262-3636     ISO Abbreviation:  Diabetes Metab.     Publication Date:  2001 Feb 
Date Detail:
Created Date:  2001-03-12     Completed Date:  2001-05-03     Revised Date:  2006-11-15    
Medline Journal Info:
Nlm Unique ID:  9607599     Medline TA:  Diabetes Metab     Country:  France    
Other Details:
Languages:  eng     Pagination:  36-9     Citation Subset:  IM    
Affiliation:
Clinique de Villecresnes, 94440 Villecresnes. jean-pierre.lefloch@uni-medecine.fr
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MeSH Terms
Descriptor/Qualifier:
Albuminuria / diagnosis*,  epidemiology
Creatinine / urine
Diabetes Mellitus / urine*
Diabetic Nephropathies / diagnosis*,  epidemiology
France
Hematuria
Hospitals, University
Humans
Mass Screening / instrumentation,  methods
Nitrates / urine
Outpatients
Predictive Value of Tests
Proteinuria
Reagent Strips
Reference Values
Reproducibility of Results
Sensitivity and Specificity
Chemical
Reg. No./Substance:
0/Nitrates; 0/Reagent Strips; 60-27-5/Creatinine

From MEDLINE®/PubMed®, a database of the U.S. National Library of Medicine


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