Fluorescence immunochip assay for thyroid stimulating hormone in whole blood

The determination of blood level of thyroid stimulating hormone (TSH) is an important biomarker for the clinical assessment of thyroid status. Here, we presented a new fluorescence (FL) immunochip TSH assay system, which was developed with a platform of point-of-care test (POCT) for clinical applications. The assay system adopted a lateral-flow immunochromatographic technology and consisted of anti-TSH-mAb coated strip in a disposable chip, a detection buffer containing FL-labeled anti-TSH-pAb, a calibration chip, and a laser FL scanner. The analytical performance of FL immunochip TSH assay system was evaluated by linearity, interference, recovery, and imprecision tests. The comparability of the developed assay was examined with an automated reference assay. The developed assay system exhibited an excellent linearity in working range of 1-100 μIU/mL and was affected neither a large amount of various serum interference substances nor similar structure biomolecules to TSH. The analytical mean recovery of control was 97.6% in a dynamic working range and the imprecision of intra- and inter-assay of CVs was less than 10%. There was a significant correlation between the developed TSH assay and the Beckman Coulter Access 2 TSH assay (r=0.989, p<0.001). The developed FL immunochip assay is the only method that quantifies TSH concentration in whole blood and meets the criteria of POCT including affordable cost, a disposable device, and requiring minimum maintenance to perform test.