# Highly sensitive immunoassay for determination of biomarkers for neurodegenerative diseases

> **NIH NIH R43** · ALLIED INNOVATIVE SYSTEMS, LLC · 2021 · $422,885

## Abstract

Abstract
 The long-term objective of this proposal is to further develop a photochemical signal amplification method
(PSAM) for increasing the sensitivity of conventional enzyme-linked immunosorbent assays (ELISA) for
determination of biomarkers for various neurodegenerative diseases, such as Alzheimer’s Disease (AD).
Immunoenzymatic methods such as ELISA are widely used in biology and medicine for drug screening, for
detecting viruses (including coronaviruses), bacteria, and biomarkers, particularly cytokines and interleukins for
cancer and immunological disorders, and biomarkers for neurodegenerative diseases. They are routinely used
in manual, semi-automated, and automated systems where high volumes of tests are performed. However, in
many cases the sensitivity of ELISA is inadequate.
 Some of the key biomarkers for early diagnosis of AD include three cerebrospinal fluid (CSF) biomarkers:
amyloid ß-42 (Aß-42), which causes formation of oligomeric plaques, total tau (t-tau), and phosphorylated tau
(p-tau) (which increases intracellular neurofibrillary tangles (NFTs). To date, there is no sensitive and cost-
effective method for the quantification of these three proteins, hindering the diagnosis and progression
monitoring of AD.
 Existing highly sensitive methods are cumbersome and expensive. Therefore, there is an increased
necessity for a common ELISA platform to detect low levels of Aß-42, t-tau, p-tau and other biomarkers for
various neurodegenerative diseases that is both inexpensive and simple enough to not require specialized
laboratory equipment. In our Phase I project, we propose to further develop a very sensitive and inexpensive
immunoassay platform for detection of biomarkers for various neurodegenerative diseases. The proposed
technology, ELISA + PSAM, consists of two steps: (1) a conventional horseradish peroxidase (HRP)-mediated
assay (ELISA) in which a common chromogenic HRP substrate, is used and (2) a substrate solution containing
the product of the enzymatic reaction is irradiated by visible light. Illumination of the sample leads to a DAP-
catalyzed drastic increase in DAP concentration (autocatalytic photochemical reaction).
 The Specific aims of Phase I are:
 1. To explore all variables affecting the performance of ELISA + PSAM assays for detection of Aß-42, t-tau
and p-tau and optimize the performance of the assays. To develop a universal approach for transitioning from
ELISA to ELISA + PSAM assays.
 2. To validate the universal approach for optimization of ELISA + PSAM assays by using up to 3
commercially available ELISA kits from different manufacturers for each analyte. This will include determination
of sensitivity and reproducibility/precision of the assays.

## Key facts

- **NIH application ID:** 10255799
- **Project number:** 1R43AG073141-01
- **Recipient organization:** ALLIED INNOVATIVE SYSTEMS, LLC
- **Principal Investigator:** Simon Bystryak
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $422,885
- **Award type:** 1
- **Project period:** 2021-09-01 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10255799

## Citation

> US National Institutes of Health, RePORTER application 10255799, Highly sensitive immunoassay for determination of biomarkers for neurodegenerative diseases (1R43AG073141-01). Retrieved via AI Analytics 2026-05-26 from https://api.ai-analytics.org/grant/nih/10255799. Licensed CC0.

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