# An Antigen-Detection Blood Test for Pulmonary Tuberculosis

> **NIH NIH R01** · UNIVERSITY OF CALIFORNIA, SAN DIEGO · 2020 · $694,190

## Abstract

Project Summary
The objective of our proposed study is to continue to improve the accuracy and usability of our prototype
NanoDisk-MS assay for the detection of tuberculosis (TB) in blood samples.
In Aim 1 we will add previously identified Mycobacterium tuberculosis (Mtb)-specific tryptic peptides of
Ag85B to our prototype assay to improve sensitivity and explore the optimal number of peptides for antigens
CFP-10, ESAT-6 and Ag85B required to maximize specificity of the test using previously-collected blood
samples from 1,500 patients with and without TB (samples from the NIH-funded Clinical Suspicion of
Tuberculosis study (CSTB) R01AI053731). In Aim 2 we will validate the performance of the optimized assay
using previously collected blood samples from 250 patients and compare its performance on a standard
MALDI-TOF MS to the Mini-12 instrument (samples from the NIH funded Global Consortium for Drug-
resistant TB Diagnostics [GCDD U01AI082229]). In Aim 3 we will evaluate final assay performance using
blood samples from 3,000 prospectively enrolled patients at risk for TB in clinics in Moldova, Mexico and the
US to determine how well the assay distinguishes patients with active TB disease from those with latent TB,
non-TB pulmonary diseases, and healthy controls. Our goal is to improve the sensitivity and specificity of our
prototype assay in order to meet World Health Organization (WHO) performance criteria for TB screening
(sensitivity:95%, specificity:90% ) and diagnosis (sensitivity:98%, specificity:98% ).

## Key facts

- **NIH application ID:** 9971457
- **Project number:** 5R01AI141500-02
- **Recipient organization:** UNIVERSITY OF CALIFORNIA, SAN DIEGO
- **Principal Investigator:** ANTONINO CATANZARO
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2020
- **Award amount:** $694,190
- **Award type:** 5
- **Project period:** 2019-07-03 → 2024-06-30

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/9971457

## Citation

> US National Institutes of Health, RePORTER application 9971457, An Antigen-Detection Blood Test for Pulmonary Tuberculosis (5R01AI141500-02). Retrieved via AI Analytics 2026-05-23 from https://api.ai-analytics.org/grant/nih/9971457. Licensed CC0.

---

*[NIH grants dataset](/datasets/nih-grants) · CC0 1.0*