PROJECT

Utility of MPT64 Immunocytochemistry in Diagnosing and Redefining Treatment Outcomes in Peripheral Tuberculous Lymphadenitis (UMPIRE Study)

May 2026 - May 2026

Objectives:

Primary Objective: To evaluate the utility of MPT64 immunohistochemistry for the detection of Mycobacterium tuberculosis complex in lymph node specimens from presumptive peripheral TB lymphadenitis patients. Secondary Objective: To assess the utility of MPT64 Immunohistochemistry in monitoring disease progression and to redefine treatment outcomes.

Study Overview:

This study evaluates the diagnostic and prognostic utility of MPT64 immunocytochemistry for detecting Mycobacterium tuberculosis complex in patients with presumptive TB lymphadenitis using a composite reference standard. It also explores its role in monitoring disease progression and treatment outcomes, aiming to improve diagnostic accuracy and timeliness in extrapulmonary TB.

Study Approach:

A prospective cohort clinical study enrolling adults with presumptive TB lymphadenitis from tertiary hospitals and NTEP centres, undergoing FNAC/biopsy with parallel microbiological, histopathological, and MPT64 immunocytochemistry testing. Diagnostic accuracy will be evaluated using a composite reference standard, with follow-up to assess treatment response and disease progression.

Expected Public Health Impact:

This study has the potential to enhance early and accurate diagnosis of TB lymphadenitis through MPT64 immunocytochemistry, thereby reducing diagnostic delays and improving treatment outcomes. Its findings could inform integration of improved diagnostic strategies within TB control programmes and strengthen the management of extrapulmonary TB in India.