Improved Alere Determine Lipoarabinomannan Antigen Detection Test for the Diagnosis of Human and Bovine Tuberculosis by Manipulating Urine and Milk

Juan Ignacio Garcia 1,2,13, Holden V. Kelley3,13, Johanna Meléndez4, Rosa Alejandra Alvarez de León5, Alejandra Castillo6, Sabeen Sidiki7, Kizil A. Yusoof3, Elizabete Nunes8, Cesar López Téllez6, Carlos Rodolfo Mejía-Villatoro4,14, Janet Ikeda9, Alberto L. Garcia-Basteiro2,10,11, Shu-Hua Wang12 & Jordi B. Torrelles2*

Tuberculosis (TB) disease still kills 1-person every 21-seconds. Few TB diagnostic tests are considered truly appropriate for point of care settings. The WHO-endorsed immunodiagnostic Alere Determine Lipoarabinomannan Ag-test (LAM-test) detects Mycobacterium tuberculosis complex LAM in urine, and its use is recommended for TB diagnosis among HIV co-infected individuals with low CD4 T-cell counts.  Here we found that a simple 15-minute enzymatic treatment at room temperature of LAM-spiked urine with α-mannosidase (for human TB), and LAM-spiked milk with combined lactase and caseinase (for bovine TB), enhanced 10-fold the detection levels of the LAM-test and thus, improved the detection of LAM by the LAM-test in urine and milk that otherwise could be missed in the field. Future separate clinical research studies specifically designed to address the potential of these findings are required.

Scientific Reports,