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

Authors

  • John Bolodeoku JB Consulting (MDP) Limited, Cherwell Innovation Centre, Oxfordshire, UK
  • Olu Coker JB Consulting (MDP) Limited, Cherwell Innovation Centre, Oxfordshire, UK
  • Suman Bains JB Consulting (MDP) Limited, Cherwell Innovation Centre, Oxfordshire, UK
  • Chidi Anyaeche Pathaway Services Limited, Headlands House, Berkhamsted, UK
  • Tae Kyum Kim Boditech Med Inc., Chuncheon-si, Gangwon-do 24398, Korea

DOI:

https://doi.org/10.51496/jogm.v1.7

Keywords:

iCHROMA, AFP, RIQAS, comparison, 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.

References

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Published

28-12-2021

How to Cite

Bolodeoku, J., Coker, O. ., Bains, S. ., Anyaeche, C. ., & Kim, T. K. . (2021). An evaluation of the performance of the Point of Care Test iCHROMA™ AFP method: Precision and accuracy. Journal of Global Medicine, 1(2), e7. https://doi.org/10.51496/jogm.v1.7

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