An evaluation of the performance of the Point of Care Test iCHROMA™ AFP method: Precision and accuracy

Abstract

The estimation of serum alpha-fetoprotein (AFP) is useful in the diagnosis and monitoring of primary hepatocellular carcinoma, hepatoblastoma, non-seminomatous testicular germ cell tumours and other germ cell tumours. The iCHROMA™ AFP is a lateral flow chromatography, fluorescence immunoassay (FIA) for the quantitative determination of AFP in serum or plasma. In this study, the Boditech iCHROMA™ AFP assay had a very good precision of 9.8%. It showed a very good correlation with the following 12 methods: Abbott Architect (r2 = 0.9705), BioMerieux VIDAS (r2 = 0.9717), Roche Cobas 6000/8000 (r2 = 0.9738), Siemens Centaur XP/XPT/Classic (r2 = 0.9654), Siemens/DPC/Immulite 2000/2500 (r2 = 0.9673), Siemens/DPC/Immulite 1000 (r2 = 0.9670), Beckman Dxl 600/800 (r2 = 0.9676), Roche Elecsys (r2 = 0.9683), Roche Cobas 4000/e411 (r2 = 0.9688), Roche Modular E170 (r2 = 0.9692), SNIBE Maglumi (r2 = 0.9457) and Ortho Vitros 3600/5600/ECi (r2 = 0.9714). In summary, the iCHROMA™ AFP, a rapid point of care test method, has a within-run precision value of less than 10% and excellent correlations with traditional laboratory methods. There is a consistent overestimation with the iCHROMA™ method, which must be taken into consideration when setting a reference range.