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Different combinations of monoclonal antibodies and polyclonal antibodies in the design of neonatal hypothyroidism diagnostic kit

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A Correction to this article was published on 20 August 2022

A Correction to this article was published on 14 July 2022

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Abstract

Neonatal hypothyroidism is a deficiency of thyroid hormones at birth that can cause lifelong mental and physical disorders in humans. Lack of timely detection could lead to irreversible damage by neonatal hypothyroidism. However, it could be managed quickly and efficiently via timely diagnosis. The screening programs rely on immunoassays to diagnose neonatal hypothyroidism in most countries. This method is time-consuming, needs laboratory equipment, and should be performed by trained and skilled technicians. Given these circumstances, the ELISA method is not a preferable method for the diagnosing of neonatal hypothyroidism. However, it can be used as a confirmatory method in infants with suspected and unknown neonatal hypothyroidism. In the present study, the homemade SR95-1, SR95-2, and SR95-3 anti-β-TSH polyclonal and the commercially available monoclonal antibodies were used to detect β-TSH in a rapid assay kit design hypothyroidism screening. To design the kit, the different combinations of the antibodies were used to establish a sandwich immune-chromatography method. The designed rapid neonatal hypothyroidism tests were used to measure neonatal β-TSH in 100 dry blood samples. This study showed that the best antibody pair in terms of sensitivity is the SR95-1 antibody as capture antibody and the SR95-2 as a conjugated antibody. Using 100 clinical samples, the designed assay was shown to have 94% sensitivity, 83% specificity, and 94% accuracy. The results showed that polyclonal antibodies (SR95-1 as capture) and SR95-2 (as detector) antibodies can detect the reference range of β-TSH in dried blood samples and can be used in the screening of neonatal hypothyroidism.

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The authors confirm that the data supporting the findings of this study are available within the article.

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Acknowledgements

The authors wish to thank Payame Noor University and Dezful University of Medical Sciences for supporting the conduct of this research. We also thank the Dezful University of Medical Sciences Research Center for its cooperation and provision of the necessary facilities for this research.

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Authors and Affiliations

  1. Department of Biology, Payame Noor University, Tehran, Iran

    Neda Shakerian & Sima Nasri

  2. Department of Clinical Biochemistry, Faculty of Medical Sciences, Dezful University of Medical Sciences, Dezful, Iran

    Maysam Mard-Soltani

  3. Department of Medical Biotechnology, Faculty of Medical Sciences, Tarbiat Modares University, Tehran, Iran

    Mohammad Javad Rasaee

  4. Department of Biology Sciences, Shahid Rajaee Teacher Training University, Tehran, Iran

    Saeed Khalili

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  1. Neda Shakerian
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  5. Saeed Khalili
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Contributions

All authors contributed to the study’s conception and design. Material preparation, data collection, and analysis were performed by [Maysam Mard-Soltani], [Neda Shakarian], and [Saeed Khalili]. The first draft of the manuscript was written by [Neda Shakarian], and all authors commented on previous versions of the manuscript. All authors read and approved the final manuscript.

Corresponding author

Correspondence to Maysam Mard-Soltani.

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Participation of the authors

Dr. Maysam Mard-Soltani designed the study, expressed and purified the recombinant protein and prepared the conjugated antibody. Dr. Sima Nasri analyzed the data and corrected the manuscript. Ms. Neda Shakarian did the laboratory work of the project and analyzed the data and wrote the manuscript. All the authors helped to analyze and discuss the results.

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Informed consent was obtained from all individual participants included in the study.

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not applicable

Informed consent

Parents of all study participants received a full explanation of the study and were obtained a written informed consent prior to their inclusion in the study.

Research involving human participants and/or animals

All procedures were performed according to the ethical guidelines of the review board of Payame Noor University of East Tehran (ID: IR.PNU.REC.1399.045).

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The authors report no conflict of interest.

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Shakerian, N., Mard-Soltani, M., Nasri, S. et al. Different combinations of monoclonal antibodies and polyclonal antibodies in the design of neonatal hypothyroidism diagnostic kit. Appl Biochem Biotechnol 194, 3167–3181 (2022). https://doi.org/10.1007/s12010-022-03888-7

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  • DOI: https://doi.org/10.1007/s12010-022-03888-7

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