Journal of Diabetes and Metabolic Disorders 2011. 10( ):22-.

Comparison study of semiquantitative test strips for detecting human serum albumin (HSA) in urine specimens
Darziani Azizi M, Mansouri M, Omidfar K, Larijani B


Background: Microalbuminuria (MAU) is a powerful predictive marker of early diabetic nephropathy, progressive cardiovascular disease in diabetic and hypertensive patients as well as in the general population.
Methods: This study was designed to compare the diagnostic performance of the two semi-quantitative immunostrip tests for rapid detection of urinary albumin based on monoclonal antibody (mAb) conjugated with colloidal gold particles (AuNPs) (test A) and MCM-41 mesoporous nanoparticles conjugated with HSA (test B). The measurements of the analyte were compared with the values obtained by immunoturbidimetry (IT) assay (test C).
Results: 30 randomly chose urine samples were analyzed by tests A, B and C. Resemble to the gold standard, 10 patients were normoalbuminuric, 18 were microalbuminuric and 2 were macroal-buminuric by test B. By comparison with IT, the immunostrip tests had a sensitivity of 90% and 100% for test A and B, respectively. False-negative results were yielded in 6.6% of specimens in the normoalbuminuric group, by using test A. No false-negative results occurred in the group of macroalbuminuric and microalbuminuric patients by this test. The agreement degree of the test A and B was 86% which were classified as substantial with regard to Kappa index (κ=0.857).
Conclusion: Our findings suggest that the immunostrip test with MCM-41 is a very reliable method for detecting urine albumin in the range of 0 to >200mg/L. This test with sensitivity of 100% is easy to perform, low-cost and rapid as compared to other sophisticated tests which are time-consuming and expensive to perform.


Semiquantitative test strips, Albuminuria, Comparison study,

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