Urine is a useful biospecimen that can be easily collected in large quantities with noninvasive procedures. Urine is routinely used at the point-of-care and in laboratory settings to detect pregnancies, diagnose diseases and screen potential health problems. Molecules in urine originate from glomerular filtration of plasma and excretion from and shedding of epithelial cells, representing a biomarker repertoire that can be exploited for diagnosis and monitoring of renal and systemic diseases. Urine is composed of mostly water and solutes like urea, small ions, creatinine, albumin, bilirubin, and low concentrations of other small proteins. Concentrations of these solutes as well as the presence of other uncommon molecules are reflective of physiological conditions and can be assayed for disease diagnosis.
Current lateral flow assays (LFA) for diagnosing active tuberculosis (TB) disease detects the lipoarabinomannan (LAM) antigen that is released by active or degenerating Mycobacterium tuberculosis in the patient urine samples. The TB-LAM LFA is more rapid, less expensive and uses a safer sample than other common TB diagnostic methods. However, the LFA has low sensitivity due to the low concentration of LAM in urine. To address this challenge, the urine sample processor is designed to increase LAM concentration in urine and simultaneously remove molecules in the sample that may interfere with the test. The low-cost, portable, and power-free device with rapid processing time will complement existing TB-LAM LFAs and enable TB testing at the point-of-care.