Bio-Rad D-100의 헤모글로빈 A1c 분석능 평가
Analytical Performance of Bio-Rad D-100 on a Hemoglobin A1c Assay
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배경: 헤모글로빈 A1c (HbA1c)는 당뇨의 진단과 치료, 추적 관찰에 유용한 지표로서 표준화된 검사법에 의한 정확한 검사 결과를 제공하는 것이 중요하다. 본 연구에서는 고성능 액체크로마토그래피법(HPLC)을 이용하여 HbA1c를 측정하는 장비인 D-100 (Bio-Rad Laboratories, USA)의 분석 성능을 평가하고자 하였다. 방법: Clinical and Laboratory Standards Institute (CLSI)의 지침에따라 D-100의 정밀도와 직선성, 검체 간 교차오염률을 평가하였다. 그리고 D-100과 기존 운용장비인 Integra 800 (Roche Diagnostics, Germany), Capillarys 3 (Sebia, France)와의 상관성 및 일치도를 조사하였다. 마지막으로 세 검사법의 검사 소요 시간을 비교 분석하였다. 결과: D-100을 사용한 HbA1c 측정의 검사차례 내 정밀도와 총 정밀도는 저농도와 고농도 모두에서 1% 미만의 변이계수를 보였다. 직선성은 HbA1c 3.51-18.7%에서 우수하였고 검체 간 교차오염률은 관찰되지 않았다. D-100의 Integra 800과 Capillarys 3에 대한 상관성 평가(n=144)에서 상관계수는 각각 0.993, 0.996으로 높은 상관성을 보였으며 세 가지의 임상적 의사결정 농도(5.7%, 6.5%, 10.0%) 모두에서 바이어스(%bias)는 허용범위 이내에 존재하였다. 검사 소요시간은 세 장비의 특성에 따라 차이가 있었다. D-100은 Integra 800에 비해 최초 검체를 더 빨리 처리하였으나(2.4분 vs. 11.1분) 연속 검체 처리시간은 더 길었다(0.8분 vs. 0.3분). 결론: D-100은 우수한 정밀도와 직선성 및 기존의 장비와의 비교에서 높은 상관성과 빠른 검체 처리속도를 보여주었다. 임상적으로 당뇨병의 진단과 치료, 당뇨 합병증의 예방을 위한 추적 관찰에 유용하게 사용할 수 있을 것으로 예상된다.
Abstract
Background: Hemoglobin A1c (HbA1c) is considered a marker useful for the follow-up and diagnosis of diabetes and implies the importance of reliable assay methods that are traceable to a reference method. We evaluated analytical performance of a new high-performance liquid chromatography system for the HbA1c assay: D-100 from Bio-Rad Laboratories (USA). Methods: We evaluated precision, linearity, and carry-over of D-100, according to the Clinical and Laboratory Standards Institute’s guidelines. Comparative analysis of D-100 with Integra 800 (Roche Diagnostics, Germany) and Capillarys 3 (Sebia, France) was conducted. Additionally, we evaluated the throughput of the three instruments. Results: Precision of low- and high-concentration controls in D-100 showed a CV of less than 1%. The linearity was excellent (R2=0.999) in the range of 3.51-18.7%, and carry-over was not observed. HbA1c results of D-100 (n=144) showed good correlation with those of Integra 800 (r=0.993) and Capillarys 3 (r=0.996). The % bias between D-100 and Integra 800 or Capillarys 3 was within the allowable range at all 3 medical decision levels (5.7%, 6.5%, and 10.0%). Elapsed time in the analysis of the first sample by D-100 was shorter than that of Integra 800 (2.4 vs. 11.1 minutes), but subsequent samples took more time (0.8 vs. 0.3 minutes per sample). Conclusions: D-100 showed reliable analytical performance with good precision and linearity, minimal carry-over, and acceptable comparative characteristics relative to other instruments. D-100 is expected to be useful for clinical measurements of HbA1c for diabetes diagnosis and theranostics.
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