Smartphone based home-testing of Urine biomarkers in Lupus Nephritis

Lead: Rongwei Lei
Co-mentor: Dr. Willson

Project Summary:

Systemic Lupus Erythematosus (SLE) is a systemic autoimmune disease that leads to chronic inflammation in multiple organs including the kidneys. Lupus Nephritis (LN), renal involvement in SLE, has drawn our attention due to its high morbidity and mortality. In this research, we examine urine for specific biomarkers as urine closely reflects the ongoing renal pathology in LN. Based on previous research, urine CD166/ALCAM demonstrated high discriminatory power in identifying patients with LN. We believe that the status of renal disease in lupus can be tracked by monitoring the levels of ALCAM in urine. To enable patients to monitor their disease from the comfort of their home, we are generating point-of-care lateral flow strips, which work much like pregnancy test strips. We have functionalized these test strips with antibodies to ALCAM and a novel reporter agent that can be read using a smartphone. Because it is highly sensitive and quantitative, lupus patients should be able to accurately track their renal disease status, simply by assaying the levels of ALCAM  in their urine, using these novel dipsticks. Once optimized, these test strips can be used for home monitoring of the disease, or for point-of-care monitoring in outpatient clinics.

What is already known in the field?

  • Urine ALCAM levels are reflective of active disease in patients with lupus nephritis
  • Lateral flow assay dipsticks can be used to assay various urine biomarkers.
  • Early detection of renal disease or renal flares and prompt treatment improves long-term outcome in this disease.

What is new?

  • Devising test strips for home-based monitoring of ALCAM in urine
  • Use of a novel protein for normalizing urinary ALCAM concentrations
  • Use of a novel reporter that can be detected using the smartphone, as this offers substantial advantages of sensitivity and quantifiability.

Why is this important?

Currently, a diagnosis of LN is made based on a renal biopsy. Unfortunately, a renal biopsy is invasive in nature, has attendant morbidity, and cannot be serially repeated.  Thus, a non-invasive, easy to use, and affordable test is needed so that the renal status can be monitored frequently. Facilitating home-based monitoring will allow more frequent monitoring by the patient. Frequent monitoring will enable renal disease to be treated promptly, and this improves disease outcome in lupus patients.

Ongoing/future steps:

  • Optimize lyophilization steps for all reagents used in this test kit
  • Establish multiplexed detection so that 2 or more proteins can be accurately detected
  • Test patient samples using the novel LFA assay to establish the clinical utility of this approach