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Please use this identifier to cite or link to this item: http://hdl.handle.net/1942/13830

Title: A sensitive quantitative test strip based point-of-care albuminuria screening assay
Authors: Decavele, An-Sofie C.
Fiers, Tom
Penders, Joris
Delanghe, Joris R.
Issue Date: 2012
Abstract: Background: Chronic kidney disease is a major health problem and the global guidelines require screening of albuminuria. Therefore, affordable and sensitive albuminuria screening tests are needed. We explored the potential of urine strips, generally reported in the ordinal scale, measured on an automatic strip reader for reporting quantitative and sensitive albumin results. Methods: We compared reflectance data of Combur-Test (R) strips obtained from the Cobas U411 reader (Roche) with albuminuria data from a nephelometer BNII (Siemens) and with protein concentrations from the pyrogallol red method (Modular P, Roche) for 389/328 non-pathologic and pathologic urine samples, respectively. Results: Imprecision of the reflectance signal of the Cobas U411 was measured with commercial control material (Bio-Rad). Inter-run coefficients of variations (CVs) for reflectance for levels 1 and 2 were 1.7%/4.9%, respectively, and intra-run CVs were 1.8%/4.2%, respectively. Good agreement was obtained between the albumin concentration of the BNII and the protein strip reflectance data (n=389): Y (10000/protein reflectance, 1/%)=160+0.132.X (albuminuria BNII, mg/L)-0.0000111.X-2 (albuminuria BNII, mg/L); r(2)=0.921. Lower agreement was found between the protein assay (n=328) and the reflectance (r(2)=0.831). A calibration curve was made between 11.5 mg/L and 121.5 mg/L. The limit of blank (LOB) was 44.7 mg/L. Conclusions: The present study demonstrates that reflectance data generated by a test strip reader allows for quantitative analysis of albumin. Although the lower limit of the microalbumin range (30 mg/L) cannot be achieved with the dye-binding method, the results are satisfactory for screening purposes.
Notes: [Decavele, An-Sofie C.; Fiers, Tom; Penders, Joris; Delanghe, Joris R.] Ghent Univ Hosp, Dept Clin Chem, B-9000 Ghent, Belgium. [Penders, Joris] Hasselt Univ, Biomed Res Inst, Diepenbeek, Belgium. [Penders, Joris] ZOL, Dept Biol Clin, Genk, Belgium.
URI: http://hdl.handle.net/1942/13830
DOI: 10.1515/cclm-2011-0849
ISI #: 000304337100012
ISSN: 1434-6621
Category: A1
Type: Journal Contribution
Validation: ecoom, 2013
Appears in Collections: Research publications

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