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|Title:||A sensitive quantitative test strip based point-of-care albuminuria screening assay||Authors:||Decavele, An-Sofie C.
Delanghe, Joris R.
|Issue Date:||2012||Publisher:||WALTER DE GRUYTER & CO||Source:||CLINICAL CHEMISTRY AND LABORATORY MEDICINE, 50 (4), p. 673-678||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.||Keywords:||Medical Laboratory Technology; aluminuria; chronic kidney disease; COBAS U411; proteinuria; reflectance data;albuminuria; chronic kidney disease; Cobas U411; proteinuria; reflectance data; urine strips||Document URI:||http://hdl.handle.net/1942/13830||ISSN:||1434-6621||e-ISSN:||1437-4331||DOI:||10.1515/cclm-2011-0849||ISI #:||000304337100012||Category:||A1||Type:||Journal Contribution||Validations:||ecoom 2013|
|Appears in Collections:||Research publications|
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