Sysmex HISCL-5000으로 측정된 알파태아단백 검사의 성능평가와 임상적 유용성
Performance Evaluation and Clinical Usefulness of α-fetoprotein Test Measured on Sysmex HISCL-5000
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배경: 혈청 알파태아단백(alpha-fetoprotein, AFP) 검사는 간세포암 을 진단하거나 치료 후 재발 여부를 확인할 때 유용하다. 한국에서 는 간암 고위험군(만성 B형 간염 또는 C형 간염, 간경화)을 대상으 로 간세포암의 조기 진단을 위하여 6개월마다 AFP 검사를 시행한 다. 저자들은 HISCL-5000 (Sysmex Corporation, Japan) 장비에서 전용 시약을 이용한 AFP 검사의 분석능을 평가하고자 하였다. 방법: CLSI (Clinical and Laboratory Standards Institute) 지침을 참 고하여 정밀도, 직선성, 상관성 등을 평가하였다. 정밀도는 두 종류 의 정도관리물질과 사람 혈청 풀을 이용하여 하루에 두 번씩 20일 간 중복 측정하여 평가하였다. 직선성은 측정범위를 아우르는 검 체를 선정하여 5가지의 농도물질을 제조한 후 각각 4회씩 반복 측 정하여 평가하였다. 간세포암 환자들로부터 315검체, 양성 간질환 환자들로부터 57검체, 건강인들로부터 128검체 등 500검체에 대해 ADVIA Centaur XP (Siemens, Germany) 장비와 비교평가를 시행 하였다. 결과: 정밀도 평가에서 반복정밀도는 2.44%–9.19%, 검사실내 정 밀도는 6.47%–9.53%를 나타냈다. 직선성 평가 시 1.2–1824.3 ng/ mL의 구간에서 결정계수 0.9975로 계산되었다. HISCL-5000과 Centaur XP 사이의 상관계수는 0.9862, 일치도는 95.2%이었으며 결과값 차이의 평균은 -7.0%이었다. 건강인 검체로 추정한 참고구 간은 1.30–11.42 ng/mL로 나타났다. 결론: HISCL-5000 장비를 이용한 AFP 검사는 적절한 분석능을 보 였으며, 임상검사실에서 유용할 것으로 기대된다.
Abstract
Background: Serum α-fetoprotein (AFP) test is useful for the diagnosis of hepatocellular carcinoma (HCC) and monitoring its recurrence after treatment. In Korea, patients with a higher risk of HCC are tested every six months for AFP, as a screening process to detect HCC. We aimed to assess the analytical performance of the AFP test in the HISCL-5000 (Sysmex Corporation, Japan) instrument, which has been released recently. Methods: HISCL-5000 AFP assay was evaluated for precision, linearity, and comparison, according to the CLSI (Clinical and Laboratory Standards Institute) guidelines. For precision assessment, two control materials and one pooled human serum were measured twice a day for 20 days in duplicate. For linearity, five levels of material were produced covering the upper and lower limits of the measurable range and each of these was measured four times. Method comparison was conducted between HISCL-5000 and ADVIA Centaur XP (Siemens, Germany) with 500 samples consisting of 315 HCC, 57 benign liver disease, and 128 healthy subjects. Results: Repeatability was between 2.44% and 9.19%, and within-laboratory precision was between 6.47% and 9.53%. Coefficient of determination (R2) was 0.9975, with the range of 1.2-1824.3 ng/mL. Correlation coefficient (r) was 0.9862 between HISCL-5000 and Centaur XP. Overall percent agreement was 95.2% and difference percentage between the two instruments was 7.0%. Reference interval from healthy subjects was 1.30-11.42 ng/mL. Conclusions: The HISCL-5000 showed adequate analytical performance for AFP measurement and is expected to be useful in clinical laboratories.
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