Lab Med Online.  2016 Apr;6(2):64-69. 10.3343/lmo.2016.6.2.64.

Analytical Evaluation of the DiaSys Albumin in Urine/CSF FS Kit for Urine Albumin Measurement Using a JEOL BioMajesty JCA-BM6010/C Analyzer

• Kim HJ
• Ji M
• Moon HW
• Hur M
• Yun YM

• KMID: 2160086
• DOI: http://doi.org/10.3343/lmo.2016.6.2.64

Abstract

BACKGROUND
High albuminuria is defined as albumin excretion of >30 mg/24 hr or an albumin-to-creatinine ratio of 30 mg/g in a random urine sample. We assessed the analytical performance of the Albumin in Urine/CSF FS kit (DiaSys Inc., UK) using a BioMajesty JCA-6010/C analyzer (JEOL Inc., Japan).
METHODS
Urine albumin concentrations were measured by the Albumin in Urine/CSF FS kit using a BioMajesty JCA-BM6010/C analyzer. Imprecision, linearity, and carry-over were measured according to the Clinical Laboratory and Standards Institute documents EP10 and EP9. The assay was compared with the ALB-T TQ Gen.2 (Roche, Germany) assay on a Cobas8000 C702 (Roche, Germany), the Tina-Quant Albumin (Roche, Switzerland) assay on a Hitachi7600-210 (Hitachi, Japan), and an Abbott urine albumin assay (Abbott Laboratories, USA) on a TBA 200FR (Toshiba, Japan) using 50 random urine samples.
RESULTS
Within-run and total imprecision were 0.551-1.023% and 0.551-1.214%, respectively. Linearity ranged from 6.31 to 30.60 mg/dL, and functional sensitivity was 0.5 mg/dL. Results from the Albumin in Urine/CSF FS kit showed good correlation with the ALB-T TQ Gen.2 (r=0.987) and the Tina-Quant Albumin assays (r=0.991). However, the four assays categorized 18 of 50 urine samples into different albuminuria groups.
CONCLUSIONS
Albumin in Urine/CSF FS testing on a BioMajesty JCA-BM6010/C analyzer showed good linearity, functional sensitivity, precision, and correlation with the ALB-T TQ Gen.2 and Tina-Quant Albumin assays. However, because some samples were categorized into different albuminuria groups by the different assays, further studies on the standardization of albuminuria assays are needed.

Keyword

High albuminuria; Albumin-to-creatinine ratio; Performance

MeSH Terms

Albuminuria

Figure

• 

  Fig. 1 Regression plots of results from Albumin in Urine/CSF FS testing on a BioMajesty JCA-BM6010/C analyzer. (A) Correlation of results from Albumin in Urine/CSF FS (DiaSys) testing on a JCA-BM6010/C analyzer and ALB-T TQ Gen.2 (Roche) testing on a Cobas8000 C702 showed a slope of 0.8628 and an intercept of 2.344 (N=44). (B) Correlation of results from Albumin in Urine/CSF FS (DiaSys) testing on a JCA-BM6010/C analyzer and Tina-Quant Albumin (Roche) testing on a Hitachi 7600-210 showed a slope of 1.056 and an intercept of 4.808 (N=44). (C) Correlation of results from Albumin in Urine/CSF FS (DiaSys) testing on a JCA-BM6010/C analyzer and Microalbumin (Abbott) testing on a TBA-200FR showed a slope of 7.134 and an intercept of -87.43.

• 

  Fig. 2 Bland-Altman plots of albumin concentrations from Albumin in Urine/CSF FS (DiASys) testing on a BioMajesty JCA-BM6010/C analyzer. (A) Comparison of ALB-T TQ Gen.2 (Roche) testing on a Cobas8000 C702 and Albumin in Urine/CSF FS (DiaSys) testing on a JCA-BM6010/C. (B) Comparison of Tina-Quant Albumin (Roche) testing on a Hitachi 7600-210 and Albumin in Urine/CSF FS (DiaSys) testing on a JCA-BM6010/C. (C) Comparison of Microalbumin (Abbott) testing on a TBA-200FR and Albumin in Urine/CSF FS (DiaSys) testing on a JCA-BM6010/C. Thick solid lines show the means of the paired differences, and thin solid lines represent lines of identity. Dashed lines show the upper and lower 95% limits of agreement (LoA).

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