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Electrochemiluminescence Assays for Human Islet Autoantibodies
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Immunoglobulin E Detection Method Based on Cascade Enzymatic Reaction Utilizing Portable Personal Glucose Meter.

Hyogu Han1,2, Junhyun Park1,3, Jun Ki Ahn1

  • 1Material & Component Convergence R&D Department, Korea Institute of Industrial Technology (KITECH), Ansan 15588, Korea.

Sensors (Basel, Switzerland)
|October 13, 2021
PubMed
Summary

A novel cascade enzymatic reaction (CER) method uses a personal glucose meter (PGM) for sensitive IgE detection. This approach offers a portable, cost-effective alternative to ELISA for allergy diagnostics.

Keywords:
alkaline phosphatasebiosensorcascade enzymatic reactionimmunoglobulin Epersonal glucose meter

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Area of Science:

  • Biochemistry and Analytical Chemistry
  • Immunodiagnostics
  • Point-of-Care Testing

Background:

  • Accurate and accessible detection of Immunoglobulin E (IgE) is crucial for diagnosing allergic diseases.
  • Current methods like ELISA are effective but require specialized equipment and trained personnel, limiting point-of-care applications.
  • There is a need for simplified, portable, and cost-effective IgE detection systems.

Purpose of the Study:

  • To develop a novel cascade enzymatic reaction (CER)-based assay for IgE detection.
  • To utilize a personal glucose meter (PGM) for quantifying IgE levels, enabling point-of-care use.
  • To evaluate the sensitivity, specificity, and diagnostic capability of the developed method.

Main Methods:

  • A sandwich assay format was employed to capture target IgE, incorporating alkaline phosphatase (ALP) activity.
  • ALP activity regulated adenosine triphosphate (ATP) levels, which served as a substrate for the CER.
  • Changes in glucose levels, catalyzed by CER, were measured using a standard personal glucose meter (PGM).

Main Results:

  • The method achieved a limit of detection (LOD) as low as approximately 29.6 ng/mL for IgE.
  • High specificity was demonstrated against various proteins, confirming assay accuracy.
  • The PGM-based approach showed comparable LOD to commercial ELISA kits but without complex equipment or washing steps.

Conclusions:

  • The developed CER-based IgE detection method using a PGM is sensitive, specific, and portable.
  • This assay offers a cost-effective and simplified alternative to traditional ELISA for IgE quantification.
  • The method's diagnostic capability was validated in real human serum samples with excellent recovery (100 ± 6%).