ARKRAY ADAMS A1c HA-8190V 장비의 HbA1c 분석능 평가
Analytical Performance Evaluation of the ARKRAY ADAMS A1c HA-8190V Analyzer
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초록
배경: 당화혈색소는 한국에서 점점 더 중요해지는 건강문제인 당뇨병의 진단 및 치료 반응 모니터링에 유의미하게 쓰이는 지표이다. 본 연구에서는 고성능 액체크로마토그래피(HPLC)를 이용하여 HbA1c를 측정하는 ADAMS A1c HA-8190V (ARKRAY Inc., Japan) 장비의 분석능을 평가하였다. 방법: HA-8190V의 정밀도, 직선성, 검체 간 교차오염률을 평가하였다. 120개의 잔여 검체를 사용하여 HA-8190V와 HLC-723 G11 (Tosoh Corporation, Japan) 간의 상관성 분석을 시행하였다. IFCC 표준검사법으로 당화혈색소 수치를 측정한 26개의 교환가능성 물질을 사용하여 장비의 정확도를 평가하였다. 21개의 헤모글로빈 변이형 샘플을 이용하여 헤모글로빈 변이형의 장비에 대한 간섭효과를 평가하였다. 결과: 저농도와 고농도 정도관리물질의 반복정밀도의 변이계수는 각각 0.5%와 0.4%였으며 검사실내정밀도의 변이계수는 각각 1.0%와 0.9%였다. 직선성 평가에서 선형성허용편차 5% 기준을 만족하면서 결정계수(R2)는 0.9988로 3.0%에서 20.2%의 농도 범위 내에서 우수한 직선성을 보였다. 유의미한 검체 간 교차오염률은 관찰되지 않았다. HA-8190V로 측정한 HbA1c값은 G11로 측정한 값과 비교하였을 때, 우수한 상관성을 보였다(r=0.997). 의학적 결정 농도(5.7%와 6.5%)에서 % 바이어스가 모두 허용범위 미만이었다. 헤모글로빈 변이형으로 인한 간섭효과를 평가하였을 때 HA-8190V는 비교적 적은 간섭효과를 보였다. 결론: HA-8190V는 우수한 정밀도, 직선성 및 적은 교차오염률을 보였다. G11과 높은 상관성이 있었으며 다른 HbA1c 측정장비들과 비교하였을 때 헤모글로빈 변이형으로 인한 간섭효과 또한 적은 편이었다. HA-8190V는 HbA1c값을 정확하게 측정하여 당뇨병을 진단, 치료 및 추적하는데 임상 검사실에서 유용하게 사용될 수 있을 것으로 판단된다.
Abstract
Background: Hemoglobin A1c is an important marker used in the diagnosis and treatment monitoring of diabetes mellitus, which is an increasingly significant health problem in South Korea. We evaluated the analytical performance of the HPLC-based ADAMS HA-8190V (ARKRAY, Japan) HbA1c analyzer. Methods: The precision, linearity, and carryover of the HA-8190V device were evaluated. Using 120 residual samples, comparative analysis between the HA-8190V and HLC-723 G11 (Tosoh, Japan) devices was conducted. Accuracy was evaluated using commutable samples with known HbA1c concentrations measured using an International Federation of Clinical Chemistry reference measurement procedure. Interference by common Korean Hb variants was evaluated with 21 known Hb variant samples. Results: The repeatability (%CV) for the low- and high-level controls was 0.5% and 0.4%, respectively, while the within-laboratory precision was 1.0% and 0.9%, respectively. For linearity, the coefficient of determination was 0.9988, with excellent linearity in a range of 3.0–20.2%. No significant carryover was observed. HbA1c concentrations measured by HA-8190V showed good correlation (r=0.997) with the G11. Percentage biases at medical decision levels (5.7% and 6.5%) were within the allowable range. The HA-8190V showed the least interference from Hb variants compared to other instruments in standard mode. Conclusions: HA-8190V showed reliable analytical performance with good precision, linearity, and minimal carryover. Furthermore, HA-8190V showed good correlation with the G11 and was least affected by Hb variants compared to other commercial analyzers. Hence, HA-8190V can be utilized in clinical laboratories to accurately measure HbA1c for the diagnosis and treatment monitoring of diabetes mellitus.
참고문헌 (21)
- Saeedi P, "Global and regional diabetes prevalence estimates for 2019 and projections for 2030 and 2045 : results from the International Diabetes Federation Diabetes Atlas, 9th edition", Diabetes Res Clin Pract, 157, pp.107843~ (2019)
- "Diabetes fact sheet in Korea 2022" (2023)[URL]
- Bonora E, "The pros and cons of diagnosing diabetes with A1C", Diabetes Care, 34(S2), pp.S184~S190 (2011)
- Little RR, "Glycated hemoglobin standardization-National glycohemoglobin Standardization Program(NGSP)perspective. 2003", Clin Chem Lab Med, 41, pp.1191~1198 (2003)
- Higgins TN, "Analytical evaluation of the Bio-Rad variant II automated HbA1c analyzer", Clin Biochem, 34, pp.361~365 (2001)
- Holmes EW, "Analytic bias among certified methods for the measurement of hemoglobin A1c : a cause for concern?", Am J Clin Pathol, 129, pp.540~547 (2008)
- Hoelzel W, "IFCC reference system for measurement of hemoglobin A1c in human blood and the national standardization schemes in the United States, Japan, and Sweden : a method-comparison study", Clin Chem, 50, pp.166~174 (2004)
- Clinical and Laboratory Standards Institute, "Evaluation of precision of quantitative measurement procedures; Approved guideline-" (2014), Clinical and Laboratory Standards Institute
- Clinical and Laboratory Standards Institute, "Evaluation of linearity of quantitative measurement procedures" (2020), Clinical and Laboratory Standards Institute
- Clinical and Laboratory Standards Institute, "Measurement procedure comparison and bias estimation using patient samples" (2018), Clinical and Laboratory Standards Institute
- American Diabetes Association Professional Practice Committee, "8. Obesity and weight management for the prevention and treatment of type 2 diabetes: standards of medical care in diabetes-2022", Diabetes Care, 45, pp.S113~S124 (2022)
- Ko SH, "2021 Clinical practice guidelines for diabetes mellitus in Korea", J Korean Diabetes, 22, pp.244~249 (2021)
- Lee ST, "Incidence of variant hemoglobin(Hb)and increased fetal Hb concentrations and their effect on Hb A1c measurement in a Korean population", Clinical chemistry, 52, pp.1445~1446 (2006)
- Yun YM, "Hb variants in Korea : effect on HbA1c using five routine methods", Clin Chem Lab Med, 55, pp.1234~1242 (2017)
- Sacks DB, "Executive summary : guidelines and recommendations for laboratory analysis in the diagnosis and management of diabetes mellitus", Clin Chem, 57, pp.793~798 (2011)
- Choi Q, "Performance evaluation of the ADAMS A1c HA-8180 analyzer for HbA1c", J Lab Med Qual Assur, 34, pp.25~30
- 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)
- Liu C, "Analytical performance of Bio-Rad D-100 on a hemoglobin A1c assay", Lab Med Online, 7, pp.59~65 (2017)
- Park MS, "Accurate and rapid measurement of glycated hemoglobin using HLC-723 G11 variant mode", Ann Lab Med, 39, pp.237~244 (2019)
- Lee ST, "Effects of 7 hemoglobin variants on the measurement of glycohemoglobin by 14 analytical methods", Clin Chem, 53, pp.2202~2205 (2007)
- van der Hagen EAE, "Evaluation of the ARKRAY HA-8190V instrument for HbA1c", Clin Chem Lab Med, 59, pp.965~970 (2021)