# Antibody isotyping for discrimination of disease stage and diagnosis of early Lyme disease.

> **NIH NIH R43** · IMMUNO TECHNOLOGIES, INC. · 2020 · $298,123

## Abstract

ABSTRACT
More than 3 million tests are performed each year to support the laboratory diagnosis of human Lyme
disease (LD). While the CDC conventional standard two-tier (CSTT) approach for serodiagnosis of
LD has worked relatively well when used as recommended, there is plenty of room for improvement.
Of a number of weaknesses associated with the supplemental immunoblot of the CSTT the most
significant is low reproducibility due to the subjective visual interpretation of results. To overcome
these weaknesses the CDC recently updated its recommendations based on a modified STT (MSTT)
in that a second EIA can replace the immunoblot. The major goal of this project is to develop an
objective, quantitative, multiplex EIA that can detect four antibody isotypes (IgM/D/G/A) and all four
IgG subclasses (IgG1/2/3/4) to leverage acquisition of simultaneous antibody profile information on
multiple B. burgdorferi antigens to build an assay that can discriminate Lyme disease stage with
increased overall sensitivity without incurring in loss of specificity. The novelty of this study relies on:
1) evaluation of B. burgdorferi antigen-specific antibody isotypes and IgG subclasses that can be
correlated with Lyme disease stage; and 2) development of new diagnostic tools using machine
learning techniques to train and integrate all data and produce an objective result to discriminate early
Lyme from early disseminated/late Lyme disease. We expect this Phase I SBIR to allow us to develop
a new EIA for serodiagnosis of Lyme disease (isoEIAplex-Ld) and to further an ongoing collaboration
with DCN diagnostics for the adaptation of our biomarkers to a new rapid Lateral Flow Assay (see
Letter of Support) for a follow up Phase II SBIR .

## Key facts

- **NIH application ID:** 10080461
- **Project number:** 1R43AI155211-01
- **Recipient organization:** IMMUNO TECHNOLOGIES, INC.
- **Principal Investigator:** Maria Gomes-Solecki
- **Activity code:** R43 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $298,123
- **Award type:** 1
- **Project period:** 2020-07-01 → 2022-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10080461

## Citation

> US National Institutes of Health, RePORTER application 10080461, Antibody isotyping for discrimination of disease stage and diagnosis of early Lyme disease. (1R43AI155211-01). Retrieved via AI Analytics 2026-05-22 from https://api.ai-analytics.org/grant/nih/10080461. Licensed CC0.

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