GA-1171 혈당측정기와 HA-8180 헤모글로빈 A1c 측정기로 구성된 ARKRAY ADAMS 교량시스템 성능평가
Performance Evaluation of the ARKRAY ADAMS Bridge System Comprising Glucose GA-1171 and HbA1c HA-8180 Analyzers
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배경: 당뇨 환자의 치료 효과 모니터링을 위해 혈당과 헤모글로빈 A1c 검사가 함께 수행되는 경우가 많다. 이에 본 연구에서는 혈당측정기 ADAMS glucose GA-1171 analyzer (Arkray, Inc., Japan)과 헤모글로빈 A1c 측정기 ADAMS A1c HA-8180 analyzer (Arkray, Inc., Japan)로 구성된 ADAMS 교량시스템(bridge system)의 검사 성능을 평가하였다. 방법: GA-과 HA-8180에 대해 CLSI 지침에 따라 정밀도, 직선성, 상관성을 평가하였다. GA-1171에 대해서는 혈장과 전혈의 검체 간 평가도 함께 시행하였다. 또한 적혈구용적률의 영향, 검사소요시간, 검체 간 교차오염률 등을 함께 평가하였다. 결과: 정밀도 평가에서는 GA-1171의 총정밀도 변이계수가 고농도와 저농도에서 각각 1.11%, 1.21%였고, HA-8180의 총정밀도 변이계수는 고농도와 저농도에서 각각 0.86%, 1.3%였다. 직선성 평가에서 GA-1171은 혈장검체(58-532 mg/dL)와 전혈검체(74-401 mg/dL)에서 결정계수(R²)가 각각 0.9997과 0.9991로 측정되었고, HA-8180은 0.9973이었다(4.7-14.7%). GA-1171의 상관성 평가는 Synchron CX3 Delta (Beckman Coulter, Inc., USA)와 UniCel DxC 800 (Beckman Coulter, Inc., USA)에 대한 상관계수(r)가 각각 0.9989와 0.9987이었다. GA-1171의 검체 간 상관성 평가에서는 혈장에 대한 전혈 검체 검사결과의 상관계수는 0.9989였으며, HA-8180과 기존 장비인 HLC-723 G8 (Tosoh Bioscience, Inc., Japan)의 상관계수 역시 0.9980으로 우수하였다. 검체 간 교차오염률은 모두 0.5% 미만이었으며, GA-1171에서 적혈구용적률의 영향은 적혈구용적률이 증가할수록 혈당 측정치가 감소하는 경향을 보였다. 평균 검사 소요시간은 CX3 Delta와 HLC-723 G8가 각각 7분, 1.43분이었고, GA-1171과 HA-8180 장비에서 각각 2.16분, 1.54분으로 평가되었다. 결론: GA-1171과 HA-8180 장비는 혈당과 헤모글로빈 A1c측정에 있어서 적절한 검사 성능을 보였으며, 교량시스템으로 연결하였을 때 빠르고 간편하게 외래 전 혈당검사실에서 사용될 수 있을 것으로 기대된다.
Abstract
Background: In diabetic patients, both glucose and hemoglobin A1c (HbA1c) concentrations are frequently measured to monitor glycemic control. We examined the analytical performance of the recently developed, automated, ADAMS bridge system (Arkray, Inc., Japan) consisting of the ADAMS glucose GA-1171 and the ADAMS HbA1c HA-8180 analyzers, which allows the consecutive measurement of glucose and HbA1c concentrations. Methods: We evaluated precision, linearity, carry-over, effects of hematocrit, and turnaround time. Method comparison was conducted between GA-1171 and UniCel DxC 800 (Beckman Coulter, Inc., USA) and Synchron CX3 Delta (Beckman Coulter) for glucose, and between HA-8180 and HLC-723 G8 (Tosoh Bioscience, Inc., Japan) for HbA1c measurements. Results: Total precision (% CV) in measuring high and low level controls was 1.11% and 1.21% for glucose using GA-1171, and 0.86% and 1.3% for HbA1c using HA-8180, respectively. In the linearity test, R² was 0.9997, 0.9991 and 0.9973 when measuring plasma glucose (58-532 mg/dL), whole blood glucose (74-401 mg/dL), and HbA1c concentrations (4.7-14.7%), respectively. Good correlation was observed between GA-1171 and DxC 800 (r=0.9987), and between HA-8180 and HLC-723 G8 (r=0.9980). Carry-over effect was less than 0.5% for glucose and HbA1c. Turnaround time was reduced from 7 min (CX3 Delta) and 1.43 min (HLC-723 G8) to 2.16 min (GA-1171) and 1.54 min (HA-8180), respectively, when whole blood glucose and HbA1c concentrations were measured consecutively by the ADAMS bridge system. Conclusions: The ADAMS bridge system had a simple operating procedure and showed an adequate performance and a rapid turnaround time.
참고문헌 (15)
- American Diabetes Association, "Diagnosis and classification of diabetes mellitus", Diabetes Care, 3(Suppl 1), pp.S55~S60 (2008)
- Choi YJ, "Prevalence and management of diabetes in Korean adults : Korea National Health and Nutrition Examination Surveys 1998-2005", Diabetes Care, 32, pp.2016~2020 (2009)
- Clinical and Laboratory Standards Institute, "Evaluation of precision performance of quantitative measurement methods; approved guideline—second edition. CLSI document EP5-A2", Clinical and Laboratory Standards Inst, ~ (2004)
- Clinical and Laboratory Standards Institute, "Evaluation of the linearity of quantitative measurement procedures: a statistical approach; approved guideline. CLSI document EP6-A", Clinical and Laboratory Standards Institute, ~ (2003)
- Clinical and Laboratory Standards Institute, "Method comparison and bias estimation using patient samples; approved guideline. CLSI document EP9-A2", National Committee for Clinical Laboratory Standards, ~ (2002)
- American Diabetes Association, "Standards of medical care in diabetes--2012", Diabetes Care, 35(Suppl 1), pp.S11~S63 (2012)
- Action to Control Cardiovascular Risk in Diabetes Study Group, "Effects of intensive glucose lowering in type 2 diabetes", N Engl J Med, 358, pp.2545~2559 (2008)
- Sacks DB, "Guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus", Diabetes Care, 34, pp.e61~e99 (2011)
- 임진숙, "ARKRAY ADAMS HA-8180 HbA1c Analyzer의 수행능 평가", Laboratory Medicine Online, 2(3), pp.126~130 (2012), 대한진단검사의학회[DOI]
- Weykamp C, "Evaluation of the Menarini", ARKRAY ADAMS A1c HA-8180V analyser for HbA1c, 2011, pp.49, 647~651
- Choi Q, "Performance evaluation of the ADAMS A1c HA-8180 analyzer for HbA1c", J Lab Med Qual Assur, 34, pp.25~30 (2012)
- ISO, "In vitro diagnostic test system – Requirements for blood-glucose monitoring systems for self-testing in managing diabetes mellitus. ISO 15197" (2003), International Organization for Standardization
- Park HD, "Evaluation of Hemoglobin A1c on the Cobas Integra 800 Immunoassay and Tosoh HLC-723 G8 HPLC analyzer", J Lab Med Qual Assur, 31, pp.239~246 (2009)
- Weykamp C, "Effects of hemoglobin D and E on the measurement of HbA1c with the modified Menarini", ARKRAY ADAMS A1c HA-8180V analyser, 2012, pp.414, 44~45
- Sofronescu AG, "Unexpected hemoglobin A1c results", Clin Chem, 57, pp.153~156 (2011)