Evaluation of Enzymatic Method using an Automated Chemistry Analyzers for Homocysteine Measurement

In clinical practice, homocysteine has gained popularity because its elevated values are strongly associated with an increased risk of cardiovascular disease. More recently, a new enzymatic colorimetric assay for homocysteine in biological sample, suitable for automated clinical analyzers, has been proposed. To evaluate one of these enzymatic methods and compare the results obtained with this method with those of an immunoenzymatic method, thirty-two samples were analyzed for total homocysteine by HiSens$^{(R)}$ homocysteine reagent on the automated chemistry analyzers TBA 200FR and compared to the widely used immunoenzymatic method ADVIA Centaur. In TBA 200FR, the within-run CVs of two control materials were 3.23% and 0.92%, respectively; the between run CVs were 4.58% and 2.55%, respectively. And in ADVIA 1650, the within-run CVs were 6.81% and 0.99%, respectively; the between run CVs were 9.0% and 3.9%, respectively. The recovery for homocysteine was 100% ($60.8{\mu}mol/L$), 99.1% ($48.64{\mu}mol/L$), 96.3% ($36.48{\mu}mol/L$), 96.1% ($24.32{\mu}mol/L$), and 92.1% ($12.16{\mu}mol/L$). The regression equation of TBA 200FR vs. ADVIA Centaur was y=0.9095x-2.5086 (r=0.9632). And the regression equation for the ADVIA 1650 chemistry vs. Immulite 2000 was y=0.8418x + 0.3207 (r=0.9625). In conclusion, this enzymatic method using automated chemistry analyzer for homocysteine assay shows acceptable analytical performance. I suggest that this assay will be suitable for routine analysis.

호모시스테인은 관상동맥질환, 뇌혈관 질환의 위험인자로 알려지고 있다. 초기의 호모시스테인 측정은 HPLC를 이용하여 일반적인 검사실에서 이용하기에는 어려움이 많았으며 현재 여러 가지 면역분석기가 도입되어 시행되고 있다. 하지만 최근 자동화학분석기를 이용한 새로운 효소법의 시약이 개발되어 이 시약의 유용성 평가를 하기위해 본 연구에서는 기존의 면역분석기와 비교분석하였다. 그 결과 정밀도 평가에서 변이계수는 0.98 - 3.23%, 2.55~4.58%를 나타내었고, 자동화학분석기(TBA 200FR와 Advia 1650)를 이용한 새로운 효소법(HBI)과 기존의 면역분석기(Advia Centaur와 Immulite 2000)간의 상관관계 평가에서 상관계수는 0.9632와 0.9625로 우수한 상관관계를 보였다. 이 결과를 토대로 호모시스테인 측정에 있어 새로운 효소법의 자동화학분석기를 이용한 방법이 제시되어 보다 간편하고 쉬운 routine analysis에 적합하리라 사료된다.