title: Point of care testing system via enzymatic method for the rapid, efficient assay of glycated albumin.
abstract: The ratio of glycated albumin to albumin concentration in serum is termed the glycated albumin (GA) value. The GA value provides a time-averaged index of the state of glycemic control for the previous 2 weeks. In this study, a dry chemistry system (GA monitor) via an enzymatic method was proposed in order to provide a GA value measurement for point of care testing (POCT). The GA monitor was made from three devices a set of test-tapes, a test-strip and an optical analyzer. A GA test-tape, a ketoamine test-tape and an albumin test-tape were enclosed in the fabricated test-strip. Time-course changes of the optical characteristics were evaluated using the test-strip. It was found that the three test tapes must be enclosed in the test-strip to create a dry chemistry system for small sample volumes (20 microl). A temperature control unit, which could hold the temperature of the GA test-tape at 45 degrees C and at 25 degrees C for the other two types of test-tape was incorporated into the optical analyzer. With the GA test-tape held separately and controlled at 45 degrees C, the analytical time decreased to one-third of the time taken for the three tapes at 25 degrees C. The analytical accuracy of the three types of test-tape showed favorable results, with R2 values of 0.96-0.98 and coefficients of variation (CV) of 2.4-6.8%. Compared with a commercially available liquid chemistry system, the analytical accuracy of the GA monitor exhibited a relatively favorable linearity of R=0.82. According to these results, a new GA value analytical system was realized, in which the GA value could be assayed within five minutes using only 20 microl of blood sample with a disposable test-strip. This system could potentially be used for clinical purposes as test equipment for rapid and efficient POCT.
authors.affiliation: Department of Material Systems Engineering and Life Science, Faculty of Engineering, Toyama University, 3190 Gofuku, Toyama 930-8555, Japan.
authors.forename: Masaki
authors.initials: M
authors.lastname: Yamaguchi
authors.forename: Shigenori
authors.initials: S
authors.lastname: Kambe
authors.forename: Takashi
authors.initials: T
authors.lastname: Eto
authors.forename: Masaru
authors.initials: M
authors.lastname: Yamakoshi
authors.forename: Takuji
authors.initials: T
authors.lastname: Kouzuma
authors.forename: Nobuyuki
authors.initials: N
authors.lastname: Suzuki
mesh_terms: D015415:Biomarkers / Q000032:analysis; D015374:Biosensing Techniques / Q000295:instrumentation* / Q000379:methods; D003920:Diabetes Mellitus / Q000097:blood* / Q000175:diagnosis*; D004797:Enzyme-Linked Immunosorbent Assay / Q000295:instrumentation* / Q000379:methods; D004867:Equipment Design; D019544:Equipment Failure Analysis; D017127:Glycation End Products, Advanced; D006801:Humans; D019095:Point-of-Care Systems; D011933:Reagent Kits, Diagnostic; D015203:Reproducibility of Results; D012680:Sensitivity and Specificity; D012709:Serum Albumin / Q000032:analysis*; D000093423:Glycated Serum Albumin
chemical_list: D015415:Biomarkers; D017127:Glycation End Products, Advanced; D011933:Reagent Kits, Diagnostic; D012709:Serum Albumin; D000093423:Glycated Serum Albumin