ARKRAY ADAMS A1c HA-8180의 분석능 평가
Performance Evaluation of the ARKRAY ADAMS A1c HA-8180
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초록
당화혈색소 Hb A1c는 당뇨병의 진단기준과 혈당 조절의 모니터링 지표로 널리 이용되고 있다. 본 연구에서는 Hb A1c 측정 자동화 장비인 ARKRAY ADAMS A1c HA-8180 (ARKRAY KDK, Japan)의 성능을 평가하였다. ARKRAY ADAMS A1c HA-8180의 직선성, 정밀도 및 기존 검사실 장비인 HLC-723 G7 (Tosoh Corporation, Japan)과의 상관성을 CLSI 지침에 따라 평가하였고, 분석속도를 측정하였다. 저농도와 고농도의 Hb A1c 정도관리물질의 검사 내 변이계수는 각각 0.6%와 0.3%였으며, 총 변이계수는 0.8%와 0.6%였다. 직선성은 3.0-18.5% 범위에서 R2=0.9975였다. Tosoh HLC-723 G7과의 상관성 평가에서도 4.8-14.6% 범위에서 r=0.9955의 상관성을 보였고, 분석 속도는 검체 당 57초였다. ARKRAY ADAMS A1c HA-8180는 임상검사실에서 우수한 분석성능으로 대량 검체를 신속하게 검사할 수 있을 것으로 생각된다.
Abstract
The hemoglobin A1c (Hb A1c) test is widely used to diagnose diabetes mellitus and monitor glycemic control in patients with diabetes. We evaluated the performance of the ARKRAY ADAMS A1c HA-8180 (ARKRAY KDK, Japan), an automated, HPLC-based Hb A1c analyzer. The ARKRAY ADAMS A1c HA-8180 was evaluated for its linearity and precision and compared to the HLC-723 G7 (Tosoh Corporation, Japan), according to the Clinical and Laboratory Standards Institute’s guidelines. The coefficients of variation (CVs) for within-run precision at low and high levels were 0.6% and 0.3%, respectively, and the total CVs at low and high levels were 0.8% and 0.6%, respectively. The coefficient of determination (R2) was 0.9975, with linearity in the range of 3.0-18.5%. A comparison between the ARKRAY ADAMS A1c HA-8180 and HLC-723 G7 revealed a good correlation (r=0.9955) in the range of 4.8-14.6%. The runtime was 57 s per sample. The ARKRAY ADAMS A1c HA-8180 showed good analytical performance and high throughput. Therefore, it is suitable for routine use for clinical measurements of Hb A1c.
참고문헌 (20)
- 김신곤, "특집", 우리나라 당뇨병의 현황, 2008, pp.51(9), 791~798[DOI]
- "National Health Insurance Statistical Yearbook" (2011)[URL]
- American Diabetes Association, "Executive summary: Standards of medical care in diabetes--2010", Diabetes Care, 33(S1), pp.S4~S10 (2010)
- Song J, "Annual report on external quality assessment in metabolic disorders in Korea", J Lab Med Qual Assur, 31, pp.143~159 (2009)
- 고승현, "2011 Clinical Practice Guidelines for Type 2 Diabetes in Korea", Diabetes and Metabolism Journal, 35(5), pp.431~436 (2011), 대한당뇨병학회
- Clinical and Laboratory Standards Institute, "Evaluation of precision performance of quantitative measurement methods; Approved guideline -Second edition. EP5-A2", Clinical and Laboratory Standards Institute, ~ (2004)
- Clinical and Laboratory Standards Institute, "Evaluation of the linearity of quantitative measurement procedures; A statistical approach; Approved guideline. EP6-A", Clinical and Laboratory Standards Institute, ~ (2003)
- Clinical and Laboratory Standards Institute, "Method comparison and bias estimation using patient samples; Approved guideline-Second edition. EP9-A2", Clinical and Laboratory Standards Institute, ~ (2002)
- Clinical and Laboratory Standards Institute, "Defining, establishing, and verifying reference intervals in the clinical laboratory; Approved guideline-Thrid edition. C28-A3", Clinical and Laboratory Standards Institute, ~ (2008)
- Marshall SM, "Standardization of HbA1c measurements: a consensus statement", Ann Clin Biochem, 37, pp.45~46 (2000)
- Goodall I, "Desirable performance standards for HbA(1c) analysis - precision, accuracy and standardisation: consensus statement of the Australasian Association of Clinical Biochemists (AACB), the Australian Diabetes Society (ADS), the Royal College of Pathologists of Australasia (RCPA), Endocrine Society of Australia (ESA), and the Australian Diabetes Educators Association (ADEA)", Clin Chem Lab Med, 45, pp.1083~1097 (2007)
- "Minimum specifications from biological variation database" (2014)[URL]
- 임진숙, "ARKRAY ADAMS HA-8180 HbA1c Analyzer의 수행능 평가", Laboratory Medicine Online, 2(3), pp.126~130 (2012), 대한진단검사의학회
- Choi Q, "Performance evaluation of the ADAMS A1c HA-8180 Analyzer for Hb A1c", J Lab Med Qual Assur, 34, pp.25~30 (2012)
- Nakanishi K, "Basic Investigation of ADAMS A1c HA-8180, a new Hb A1c measuring instrument using high performance liquid chromatography (HPLC)", JJCLA, 35, pp.243~249 (2010)
- "The Korean Association of Quality Assurance for Clinical Laboratory" (2013)[URL]
- Clinical and Laboratory Standards Institute, "Verification of comparability of patient results within one health care system; Proposed guideline. C54-P", Clinical and Laboratory Standards Institute, ~ (2007)
- 이수연, "Tosoh HLC-723 G7 Hemoglobin Alc 분석기 평가", Annals of Laboratory Medicine, 23(3), pp.180~185 (2003), 대한진단검사의학회
- Jeong GY, "Performance evaluation of TOSOH automated glycohemoglobin analyzer HLC-723GHb V A1c 2.2TM", Korean J Clin Pathol, 19, pp.36~39 (1999)
- Bry L, "Effects of hemoglobin variants and chemically modified derivatives on assays for glycohemoglobin", Clin Chem, 47, pp.153~163 (2001)