An Evaluation of the Boditech i-CHROMA™ Thyroid-Stimulating Hormone (TSH) Method: Precision and Accuracy

The objective of this study was to evaluate the precision and accuracy of the Boditech i-CHROMA^™ TSH method. In this study, the inter and intra assay precision was < 10% and there was very good correlation (r2>0.97) between the Boditech i-CHROMA™ TSH method and the following methods: Abbott Architect, BioMerieux Vidas TSH, BioMerieux Vidas TSH3 Ultrasensitive, Roche COBAS® 6000/8000, Siemens Centaur XP/XPT/Classic, Siemens Centaur XP/XPT/Classic 3rd generation, Siemens Centaur XP/XPT/Classic TSH3 Ultra, Siemens Dimension, Siemens Immulite, Siemens Immulite 1000, Beckman DXI 600/800 Fast TSH, Beckman DXI 600/800 Hyper TSH, Roche Elecsys, DiaSorin Liaison, Monobind Inc ELISA/CLIA, Roche COBAS® 4000/e411, Roche Modular E-170, Beckman Access/ LXi725 hyper TSH 3rd generation, Tosoh, Ortho Vitros 3600/5600/ECi. The Boditech i-CHROMA™ TSH method was negatively biased compared to the other methods, with a range between -0.6 uIU/mL and -3.25 uIU/mL with an average of -1.93 uIU/mL. In addition, the Boditech i- CHROMA™ method identified 18/18 (100%) all the samples grouped as TSH <0.4 uIU/mL and 0.4 – 4.0 uIU/mL. However, the Boditech i-CHROMA™ method was only able to identify 15/18 (83%) of the samples with >4 uIU/mL. In conclusion, the Boditech i-CHROMA™ TSH method which is a quantitative method showed very good precision and reasonable accuracy with the other laboratory methods and therefore useful for the diagnosis and management of primary hypothyroidism.