Performance Evaluation and Clinical Usefulness of α-fetoprotein Test Measured on Sysmex HISCL-5000

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.