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Diabetes Care 29:422-423, 2006
DOI: 10.2337/diacare.29.02.06.dc05-1080
© 2006 by the American Diabetes Association
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Pathophysiology/Complications
Brief Report

Hemocue Urine Albumin Point-Of-Care Test Shows Strong Agreement With the Results Obtained With a Large Nephelometer

Gösta Florvall1, Samar Basu, PHD2, Johanna Helmersson, PHD2 and Anders Larsson, MD, PHD1

1 Section of Clinical Chemistry, Department of Medical Sciences, Uppsala University Hospital, Uppsala, Sweden
2 Section of Clinical Nutrition Research, Department of Public Health and Caring Sciences, Uppsala University Hospital, Uppsala, Sweden

Address correspondence and reprint requests to Anders Larsson, Department of Medical Sciences, University Hospital, S-751 85 Uppsala, Sweden. E-mail: anders.larsson{at}akademiska.se

Abbreviations: ACR, albumin-to-creatinine ratio • POCT, point-of-care testing


   INTRODUCTION
TOP
 INTRODUCTION
RESEARCH DESIGN AND METHODS
 RESULTS
 CONCLUSIONS
 References
 
There is an increasing incidence of diabetic nephropathy, predominantly in patients with type 2 diabetes (1–3). Persistent microalbuminuria is a sign of ongoing glomerular injury and a strong predictor of clinical nephropathy, and screening for microalbuminuria, the earliest manifestation of diabetic nephropathy, is recommended for all diabetic patients (4).

Point-of-care testing (POCT) offers rapid test results, which facilitate the use of the results to motivate the patient to lifestyle changes and increased compliance (5–7). To achieve good compliance, it is essential that the patient and physician work together and that the patient get regular feedback on the treatment results. The feedback is considered to be more effective if the test results are available during the consultation. This has led to the development of POCT instruments for measuring urine albumin excretion.

The aim of the present study was to evaluate urine albumin analyzed by the HemoCue POCT instrument, which can provide rapid test results, in relation to urine albumin analyzed by a central laboratory instrument (ProSpec) and the albumin-to-creatinine ratio (ACR) in a group of elderly men.


   RESEARCH DESIGN AND METHODS
TOP
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
RESULTS
 CONCLUSIONS
 References
 
This study is a cross-sectional investigation of Swedish men, 77 years of age, who were participants in Uppsala Longitudinal Study of Adult Men (8). The study was approved by the ethics committee at Uppsala University. A total of 706 (103 individuals with type 2 diabetes) 24-h urine samples were analyzed.

Urine albumin
Urine albumin was analyzed with HemoCue Urine Albumin (HemoCue, Ängelholm, Sweden) and Behring BN ProSpec (Dade Behring, Deerfield, IL) analyzers. The HemoCue instrument had a measuring range of 10–150 mg/l. Urine creatinine was analyzed with a modified kinetic Jaffe reaction on an Architect Ci8200 analyzer (Abbott, Abbot Park, IL) and reported as SI units (micromoles per liter), and ACR was calculated from the Prospec results.

Statistical calculations
For the statistical analysis, urine albumin values below the detection limits were assigned the value of the detection limit. All calculations were performed with Statistica 4.5 (StatSoft, Tulsa, OK). Associations between variables were tested with Spearman’s rank correlation analysis.


   RESULTS
TOP
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
CONCLUSIONS
 References
 
Correlation between urine albumin and ACR assays
There was a strong correlation between duplicate tests (n = 100) analyzed with the HemoCue instrument (R2 = 0.999). The total coefficient of variation calculated on duplicate samples was 3.9%. There was good agreement between the urine albumin methods (Fig. 1). In general, the Prospec gave slightly higher values. There were 555 samples with urine albumin <20 mg/l on the HemoCue. Nineteen of these samples showed values >20 mg/l on the ProSpec, and of these, only 4 were >25 mg/l. The correlation in the 10- to 150-mg/l range (n = 184) was also good (R2 = 0.956). There was also a strong correlation between urine albumin and ACR (R2 = 0.937). A total of 147 (20.7%) of the tested male subjects had urine albumin >20 mg/l and 130 (18.4%) urine albumin >25 mg/l with the HemoCue instrument. One hundred fifty-two (21.5%) of the tested male subjects had ACR >2.5 mg/mmol creatinine and 139 (19.7%) ACR >3 mg/mmol creatinine.


Figure 1
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  		Figure 1— Bland-Altman plot showing correlation between urine albumin analyzed with the HemoCue and Prospec analyzers in the 10- to 150-mg/l range.

 

   CONCLUSIONS
TOP
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
 CONCLUSIONS
References
 
Screening for microalbuminuria is usually performed by one of following methods: measurement of total urine albumin in a 12- or 24-h collection, measurement of the ACR in morning urine or random sample, or measurement of urine albumin in morning urine (9). Urine albumin concentrations are standardized for concurrent creatinine excretion, thus obtaining ACR. Repeated measurements have shown that albuminuria is twice as variable as creatininuria (10). However, ACRs often do not take into account diet, sex differences, or the effect of reduced muscle mass, especially in elderly patients. The analytical quality of the creatinine method will influence ACR, and there is also an economical aspect of the question, as ACR requires an additional urine creatinine analysis.

There was a good agreement between the HemoCue and ProSpec quantification of urine albumin, especially considering that presently there is no international calibrator for urine albumin.

In conclusion, the assay presented here is well suitable for microalbuminuria POCT in diabetic patients. The assay is easy to perform and provides results comparable to those of an existing laboratory immunoassay. This study shows a good correlation between urine albumin analyzed with the HemoCue POCT instrument, a central laboratory instrument (ProSpec), and ACR in a group of elderly men. The rapid and quantitative test results obtained directly from urine samples permit clinical decisions to be made at the time of the patient’s clinical visit.


   Footnotes
 
A table elsewhere in this issue shows conventional and Système International (SI) units and conversion factors for many substances.

Received for publication June 13, 2005. Accepted for publication October 17, 2005.


   References
TOP
 INTRODUCTION
 RESEARCH DESIGN AND METHODS
 RESULTS
 CONCLUSIONS
 References
 

  1. Ritz E, Rychlik I, Locatelli F, Halimi S: End-stage renal failure in type 2 diabetes: a medical catastrophe of worldwide dimensions. Am J Kidney Dis 34:795–808, 1999[Medline]
  2. Alberti G, Zimmet P, Shaw J, Bloomgarden Z, Kaufman F, Silink M: Type 2 diabetes in the young: the evolving epidemic: the International Diabetes Federation Consensus Workshop. Diabetes Care 27:1798–1811, 2004[Free Full Text]
  3. Mogensen CE, Keane WF, Bennett PH, Jerums G, Parving HH, Passa P, Steffes MW, Striker GE, Viberti GC: Prevention of diabetic renal disease with special reference to microalbuminuria. Lancet 346:1080–1084, 1995[Medline]
  4. American Diabetes Association: Diabetic nephropathy (Position Statement). Diabetes Care 26(Suppl. 1):S94–S98, 2003
  5. Lehmann CA: The future of home testing: implications for traditional laboratories. Clin Chim Acta 323:31–36, 2002[Medline]
  6. Price CP: Point-of-care testing: impact on medical outcomes. Clin Lab Med 21:285–303, 2001[Medline]
  7. St-Louis P: Status of point-of-care testing: promise, realities, and possibilities (Review). Clin Biochem 33:427–440, 2000[Medline]
  8. Helmersson J, Vessby B, Larsson A, Basu S: Association of type 2 diabetes with cyclooxygenase-mediated inflammation and oxidative stress in an elderly population. Circulation 109:1729–1734, 2004[Abstract/Free Full Text]
  9. American Diabetes Association: Standards of medical care in diabetes (Position Statement). Diabetes Care 28:S4–S36, 2005[Free Full Text]
  10. Pedrinelli R, Dell’Omo G, Penno G, Mariani M: Non-diabetic microalbuminuria, endothelial dysfunction and cardiovascular disease. Vasc Med 6:257–264, 2001[Abstract/Free Full Text]

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