# Validation of urine/serum LAM in HIV/nonHIV TB suspects and POC Test Development

> **NIH NIH R01** · COLORADO STATE UNIVERSITY · 2021 · $558,656

## Abstract

Despite the emergence of multiple and extensively drug resistant strains, tuberculosis (TB) is largely a curable
disease if treated appropriately. However, in some tuberculosis-endemic areas, fewer than 40% of TB cases
are diagnosed due to the lack of accurate and easy-to-use diagnostic assays, and these continue to drive the
epidemic. Currently, diagnosis relies on demonstration of the bacteria, Mycobacterium tuberculosis, in clinical
specimens by sputum smear microscopy and repeat culture. Limitations of culture often include slow growth
(up to 8 weeks), low sensitivity as a result of required decontamination procedures, difficulty in obtaining serial
samples in children and non-sputum producers, and the high cost of the assay. A non-sputum, non-growth
based biomarker assay could replace microbiologic intermediate endpoints, could transform the pace and
scope of TB drug development and of global TB control. It may additionally have utility for reaching a
population of paucibacillary disease as is often seen in children, extrapulmonary TB, and HIV/TB.
This proposed research will establish our goal towards developing a highly sensitive approach to the
quantitative detection of lipoarabinomannan (LAM), a cell envelope lipoglycan in serum and urine with clinical
diagnostic accuracy. The project aims are 1) to optimize the urine and serum pretreatment protocol by testing
proteases and chaotropic agents, thus making maximal amount of the LAM available for detection; 2) to
generate highly specific and unique monoclonal antibodies directed against “in vivo” forms of LAM; and 3) to
take forward non-sputum based LAM detection via a capture ELISA with further validation in well-characterized
adult cohorts with suspected TB in countries which have high burdens of TB and HIV (South Africa, Thailand,
Kenya) and (Peru) with low HIV exposure. Given the recognized imperfection of culture as a gold standard, in
a separate exploratory analysis we will determine ELISA sensitivity and specificity using LAM detection by Gas
Chromatography/Mass Spectrometry (GC/MS) as the reference standard. Our capture ELISA accuracy targets
are ≥85% sensitivity and ≥95% specificity. In addition, we will determine, the changes in urine and serum LAM
concentrations during TB treatment; this will use a separate set of existing specimens and is intended to
establish whether LAM in urine might be useful as a biomarker of treatment response. Our ultimate goal is to
develop an accurate, simple Point-of-Care test based on quantitative engineering of capture chemistry and
conditions for LAM detection in non-sputum specimens. The test should reach all TB cases irrespective of their
HIV status. The chosen demonstration will not be a final device but will demonstrate a proof-of-principle that is
aligned with the design goals.

## Key facts

- **NIH application ID:** 10179309
- **Project number:** 5R01AI132680-04
- **Recipient organization:** COLORADO STATE UNIVERSITY
- **Principal Investigator:** DELPHI CHATTERJEE
- **Activity code:** R01 (R01, R21, SBIR, etc.)
- **Funding institute:** NIH
- **Fiscal year:** 2021
- **Award amount:** $558,656
- **Award type:** 5
- **Project period:** 2018-06-08 → 2023-05-31

## Primary source

NIH RePORTER: https://reporter.nih.gov/project-details/10179309

## Citation

> US National Institutes of Health, RePORTER application 10179309, Validation of urine/serum LAM in HIV/nonHIV TB suspects and POC Test Development (5R01AI132680-04). Retrieved via AI Analytics 2026-05-24 from https://api.ai-analytics.org/grant/nih/10179309. Licensed CC0.

---

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