요 알부민 측정에서 DiaSys Albumin in Urine/CSF FS 시약의 JEOL BioMajesty JCA-BM6010/C 기기에서 분석능 평가
Analytical Evaluation of the DiaSys Albumin in Urine/CSF FS Kit for Urine Albumin Measurement Using a JEOL BioMajesty JCA-BM6010/C Analyzer
1
조회
0
다운로드
0
인용
0
참고문헌
키워드
초록
배경: 고알부민뇨증은 24시간 요에서 알부민의 배설이 30 mg 이상 또는 임의뇨에서 크레아티닌에 대한 알부민의 농도가 30 mg/g 이상인 경우로 정의된다. 저자들은 Albumin in Urine/CSF FS (DiaSys Inc., UK) 시약의 BioMajesty JCA-6010/C analyzer (JEOL Inc., Japan) 장비에서의 분석능을 평가하였다. 방법: 요 알부민 농도는 BioMajesty JCA-BM6010/C 장비에서 Albumin in Urine/CSF FS 시약으로 측정되었다. 평가는 정도관리물질을 사용하여 CLSI EP10과 EP9에 따라 비정밀도, 직선성, 잔효를 포함하였다. 이 검사방법은 50개의 임의뇨 검체를 이용하여 Cobas8000 C702 (Roche, Germany) 장비에서 ALB-T TQ Gen.2(Roche, Germany) 시약, Hitachi7600-210 (Hitachi, Japan) 장비에서 Tina-Quant Albumin (Roche, Switzerland) 시약, 그리고 TBA 200FR (Toshiba, Japan) 장비에서 Abbott urine albumin assay (Abbott Laboratories, USA) 시약을 이용한 검사방법과 비교하였다. 결과: 3개의 정도관리물질을 이용한 검사차례 내 그리고 총 비정밀도는 각각 0.551-1.023%와 0.551-1.214%였다. 직선성은 6.31부터 30.60 mg/dL까지 관찰되었고, 기능적 민감도는 0.5 mg/dL였다. BioMajesty JCA-BM6010/C에서 Albumin in Urine/CSF FS 시약의 검사방법은 Cobas8000 C702에서 ALB-T TQ Gen.2 시약의 검사법 및 Hitachi7600-210에서 Tina-Quant Albumin 시약의 검사법과 우수한 상관관계를 보였다. 그러나 네 개 검사법은 50개의 요검체 중 18검체를 서로 다른 알부민뇨 그룹으로 분류하였다. 결론: BioMajesty JCA-BM6010/C 장비에서 Albumin in Urine/CSF FS 시약의 검사방법은 우수한 직선성, 기능적 민감도, 비정밀도를 보였고, Cobas8000 C702에서 ALB-T TQ Gen.2를 사용하는 경우와 Hitachi 7600-210에서 Tina-Quant Albumin을 사용하는 검사법과 우수한 상관관계를 보여주었다. 그러나, 각각의 검사방법에 의해 50개의 검체 중 상당수가 다른 알부민뇨 그룹으로 분류되었기 때문에, 알부민뇨에 대한 앞으로의 연구와 검사 제품 간의 표준화에 대한 연구가 더 필요할 것으로 생각하였다.
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.
참고문헌 (15)
- Levey AS, "Proteinuria as a surrogate outcome in CKD: report of a scientific workshop sponsored by the National Kidney Foundation and the US Food and Drug Administration", Am J Kidney Dis, 54, pp.205~226 (2009)
- The Korean Society for Laboratory Medicine, "Laboratory Medicine", pp.15~ (2014), Beommun Education
- Hillege HL, "Urinary albumin excretion predicts cardiovascular and noncardiovascular mortality in general population", Circulation, 106, pp.1777~1782 (2002)
- Kidney Disease Outcomes Quality Initiative, "National kidney practice guidelines for chronic kidney disease: evaluation, classification, and stratification", Ann Intern Med, 139, pp.137~147 (2003)
- Clinical and Laboratory Standards Institute, "Preliminary evaluation of quantitative clinical measurement procedures; approved guideline. 3rd ed. CLSI document EP10-A3", Clinical and Laboratory Standards Institute, ~ (2014)
- Clinical and Laboratory Standards Institute, "Method comparison and bias estimation using patient samples; approved guideline. 2nd ed. CLSI document EP9-A2", Clinical and Laboratory Standards Institute, ~ (2002)
- DiaSys Diagnostics Systems GmbH, "Reagent information of Albumin in Urine", CSF FS, 2011
- 조진희, "Lumipulse G1200의 종양표지자 분석능 평가", Laboratory Medicine Online, 2(3), pp.131~138 (2012), 대한진단검사의학회[DOI]
- "Desirable specifications for total error, imprecision, and bias, derived from intra- and inter-individual biologic variation" (2014)[URL]
- Fraser CG, "Generation and application of data on biological variation in clinical chemistry", Crit Rev Clin Lab Sci, 27, pp.409~437 (1989)
- Ricós C, "Current databases on biological variation: pros, cons and progress", Scand J Clin Lab Invest, 59, pp.491~500 (1999)
- National Kidney Foundation: K, "DOQI", Clinical practice guidelines for chronic kidney disease: evaluation, classification, and stratification, 2002, pp.39, S1~S266
- Warram JH, "Effect of duration of type I diabetes on the prevalence of stages of diabetic nephropathy defined by urinary albumin", creatinine ratio, 1996, pp.7, 930~937
- Jensen JS, "Arterial hypertension, microalbuminuria, and risk of ischemic heart disease", Hypertension, 35, pp.898~903 (2000)
- Architect, "Reagent information of Microalbumin", ~ (2004)