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Development of a novel parallel determination platform: a feasibility study tested on a chemiluminescence device

Abstract

The potential of obtaining incremental diagnostic information using a parallel assay is attractive. In this paper, a novel parallel determination platform was developed for the simultaneous determination of hormones including Human growth hormone (GH), prolactin (PRL), Thyroid stimulating hormone (TSH), Follicle stimulating hormone (FSH) and luteinizing hormone (LH). Polystyrene was used as support material and the device was comprised of an antibody capture area, connecting channel, and an isolating bar. After immobilizing antibodies in antibody capture area, 50μL antigens and 1.5 mL of HRP-labelled antibodies were mixed and bound to the capture antibodies by flowing in the connecting channel continually. After adding chemiluminescence substrates, isolating bar made the connecting channel into the detection site in a 1:1 ratio. Fluorescein isothiocyanate labelled bovine serum albumin (FITC-BSA) was used as an internal standard. The developed method was validated in terms of limits of detection (LOD), linearity, recovery and precision. The LOD were 0.01 mIU/L, 0.01 IU/L, 0.03 mIU/L, 0.05 mIU/L, and 0.01 IU/L for GH, FSH, TSH, PRL, and LH, respectively. The assay was linear up to 230 mIU/L for GH (r2=0.995), 300 IU/L for FSH (r2=0.991), 100 mIU/L for TSH (r2=0.997), 8,000 mIU/L for PRL (r2=0.994), and 260 IU/L for LH (r2=0.992). The mean recoveries were calculated at two concentration levels and the values were found between 90.5% and 108.3%. The intra and inter-assay coefficients of variation were <10% and <11%, respectively. The method was successfully applied to determine serum sample (n=120) and results were strongly correlated with the Siemens and Abbott immunoassay, showing a bias offset of 1.7 mIU/L, 2.4 IU/L, 0.1 mIU/L, 7.6 mIU/L and 1.5 IU/L for GH, FSH, TSH, PRL, and LH. This sensitive and cost-efficient platform is expected to be a powerful tool to measure combinations of various biomarkers.

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Publication details

The article was received on 11 Oct 2017, accepted on 11 Nov 2017 and first published on 13 Nov 2017


Article type: Paper
DOI: 10.1039/C7AY02394D
Citation: Anal. Methods, 2017, Accepted Manuscript
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    Development of a novel parallel determination platform: a feasibility study tested on a chemiluminescence device

    C. Yang, Z. Sun, G. Zhang, L. Wang, J. Zhang and X. Zhang, Anal. Methods, 2017, Accepted Manuscript , DOI: 10.1039/C7AY02394D

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