# Development of an Anti-Immunocomplex Antibody and Non-competitive Immunoassay for the Detection of Testosterone

## TL;DR

This paper introduces a new antibody and immunoassay for accurately detecting testosterone, offering a better alternative to current methods.

## Contribution

A novel anti-immunocomplex antibody and non-competitive immunoassay for testosterone detection are developed.

## Key findings

- The anti-IC antibody was generated using phage display and used in a non-competitive immunoassay.
- The assay reliably detects testosterone in the physiological range and works with plasma samples.
- The method offers a sensitive and accessible alternative to mass spectrometry-based testosterone analysis.

## Abstract

Accurate and sensitive
quantification of testosterone using simple,
high-throughput, and low-cost methods has remained a longstanding
analytical challenge, despite the issue being highlighted by the endocrinology
community more than a decade ago. Existing competitive immunoassays
lack sensitivity and specificity, while reference methods based on
mass spectrometry are complex, costly, and unsuitable for routine
large-scale testing. Alternative approaches are needed to aid in the
diagnosis of androgen deficiency and excess in men, women, and children.
In this study, we report a novel anti-immunocomplex (anti-IC) antibody
that recognizes a monoclonal anti-testosterone antibody bound to testosterone.
The anti-IC antibody was generated using phage display, and the antibody
pair was utilized in the development of a non-competitive time-resolved
fluorescence immunoassay for the detection of testosterone. The assay
demonstrated reliable detection within the physiological range of
testosterone in men, women, and children and compatibility with plasma
as a sample matrix. These findings emphasize the potential of novel
anti-IC antibodies in the development of more sensitive immunoassays,
offering accessible alternatives to existing methods for testosterone
analysis.