Norudia GA 시약의 당화알부민 검사 분석능 평가 = Evaluation of the Analytical Performance of the Norudia GA Glycoalbumin Test

다국어 초록 (Multilingual Abstract)

Blood biomarkers for the diagnosis and monitoring of diabetes mellitus include fasting plasma glucose, HbA1c, glycoalbumin (GA), fructosamine, and 1,5-anhydro-D-glucitol levels. GA has a half-life of approximately three weeks, and its levels are useful for assessing short-term changes in glycemic control. Herein, we evaluated the performance of the Norudia GA assay kit (Sekisui Medical, Japan) using a Roche Modular E170 analyz er (Roche Diagnostics, Germany). We evaluated the precision and linearity of the assay in accordance with the Clinical and Laboratory Standards Institute (CLSI) EP05-A3 and EP06-A guidelines, respectively. A comparison of the Norudia GA and Lucica GA-L (Asahi Kasei Pharma Corporation, Japan) methods was performed by Passing-Bablok regression, using blood samples obtained from 121 patients, in accordance with the CLSI guideline EP09-A3. The reference interval for GA concentration was established based on 120 healthy individuals, according to CLSI guideline EP28-A3C. Repeatability (% CV) ranged from 0.9-2.5% and within-laboratory precision was 2.6-4.5% at three levels. Linearity was observed for GA concentration in the performance ranges used (21.4-713.0 μmol/L). In the equation for the correlation between Norudia GA and Lucica GA-L assay results, the slope and y-intercept were 1.014 (95% confidence interval: 1.000-1.045) and -0.017 (95% confidence interval: -0.444- 0.381), respectively. The reference interval was calculated to be 11.2-17.5%

국문 초록 (Abstract)

당뇨병의 진단과 모니터링에 사용되는 혈액 지표들은 공복 혈 당, 당화혈색소, 당화알부민, 프럭토 사민, 1,5-anhydro-D-glucitol 등이 있는데, 당화알부민은 약 3주일의 반감기를 갖기에 상대적으 로 짧은 기간의 당 조절능 을 관찰하는데 유용하다. 본 연구에서는 Roche Modular E170 (Roche Diagnostics, Germany) 장비를 이용하여 Norudia GA (Sekisui Medical, Japan) 시약의 분 석성능 을 평 가하였다. 정밀도 와 직선성은 각각 CLSI 가이드라인 EP05-A3와 EP06-A에 따라 평가했으며, 상관성 평가 를 위해 CLSI 가이드라인 EP09-A3에 따라 121명을 대상으 로 Norudia GA와 Lucica GA-L (Asahi Kasei Pharma Corporation, Japan) 시약 측정결과 에 대해 Passing-Bablok 회귀분 석을 수행하였다. 참고구간은 120명의 건강 인을 대상으 로 CLSI 가이드라인 EP28-A3C에 따라 설정하였다. 반복 정밀도 와 검사실내정밀도의 변이계수 는 각각 0.9-2.5%와 2.6-4.5% 의 분포를 보였고 , 임상적으 로 의미 있는 범위(21.44-713.01 μmol/L) 에서 직선성이 확 인되었다. 상관성 평가 에서 Norudia GA와 Lucica GA-L 두 시약 간의 동 등 성이 있음 을 확 인하였으며, 참고구간은 11.2-17.5%로 설정하였다.

참고문헌 (Reference)

1 박해일, "당화알부민의 검사수행능력 및 혈액투석 중인 당뇨병 환자에서의 임상적 유용성" 대한진단검사의학회 29 (29): 406-414, 2009

2 Furusyo N, "Utility of glycated albumin for the diagnosis of diabetes mellitus in a Japanese population study : results from the Kyushu and Okinawa Population Study(KOPS)" 54 : 3028-3036, 2011

3 Huh JH, "The relationship between BMI and glycated albumin to glycated hemoglobin(GA/A1c)ratio according to glucose tolerance status" 9 : e89478-, 2014

4 Kouzuma T, "Study of glycated amino acid elimination reaction for an improved enzymatic glycated albumin measurement method" 346 : 135-143, 2004

5 American Diabetes Association, "Standards of medical care in diabetes2019 Abridged for primary care providers" 37 : 11-34, 2019

6 Paroni R, "Performance characteristics and clinical utility of an enzymatic method for the measurement of glycated albumin in plasma" 40 : 1398-1405, 2007

7 Koga M, "Negative association of obesity and its related chronic in ammation with serum glycated albumin but not glycated hemoglobin levels" 378 : 48-52, 2007

8 Clinical and Laboratory Standards Institute, "Measurement procedure comparison and bias estimation using patient samples; Approved guideline-Third edition. CLSI document EP09-A3"

9 Kohzuma T, "Lucica GA-L glycated albumin assay kit : a new diagnostic test for diabetes mellitus" 14 : 49-51, 2010

10 Reed AH, "In uence of statistical method used on the resulting estimate of normal range" 17 : 275-284, 1971

11 Gonen B, "Haemoglobin A1 : an indicator of the metabolic control of diabetic patients" 2 : 734-737, 1977

12 Freitas PAC, "Glycated albumin : a potential biomarker in diabetes" 61 : 296-304, 2017

13 Clinical and Laboratory Standards Institute, "Evaluation of the linearity of quantitative measurement procedures; a statistical approach; Approved guideline. EP06-A"

14 Clinical and Laboratory Standards Institute, "Evaluation of precision of quantitative measurement procedures; Approved guideline-Third edition. EP05-A3"

15 Sato A, "Establishment of glycated albumin unit conversion equation from the standardized value(mmol/mol)to the routinely used value(%)" 56 : 204-209, 2019

16 Westgard QC, "Desirable Biological Variation Database speci cations"

17 Clinical and Laboratory Standards Institute, "De ning, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline-Third edition. EP28-A3C"

18 Kohzuma T, "Basic performance of an enzymatic method for glycated albumin and reference range determination" 5 : 1455-1462, 2011

19 Testa R, "Analytical performances of an enzymatic assay for the measurement of glycated albumin" 1 : 162-171, 2016

20 Danese E, "Advantages and pitfalls of fructosamine and glycated albumin in the diagnosis and treatment of diabetes" 9 : 169-176, 2015