An Africa Lateral Flow Assay-Based Early Recognition Test for Tenofovir-Induced Acute Kidney Injury (ALERT-AKI) Development ^†

The prevalence of (TDF)-induced Acute Kidney Injury (AKI) in Africa is a concern, given the widespread use of Tenofovir disoproxil fumarate (TDF) for Human Immunodeficiency Virus (HIV) therapy. Current tests used to detect AKI are based on increased urinary creatinine levels and are often not sensitive and specific enough for early detection. There is a need for more sensitive and specific rapid tests for the early detection of AKI, particularly in resource-limited countries for early detection and timely intervention. In the present study, a multiplex lateral flow assay, named An Africa Lateral Flow Assay-Based Early Recognition Test for Acute Kidney Injury (ALERT-AKI), detecting a set of three unique biomarkers of TDF-induced AKI was developed with a limit of detection of 2 ug/mL to 50 ug/mL, indicating the suitability of developed test for determining the selected AKI biomarkers in a clinically relevant range. This study shows proof of concept for a multiplex lateral assay tested on clinical samples. The ALERT-AKI multiplex platform will be the first of its kind once further clinical studies are conducted, offering multiple advantages, including early detection, simplicity, rapidity, high sensitivity, cost-effectiveness, and timely intervention, potentially reducing the severity and prevalence of AKI. Using a multiplexed protein biomarker rather than single protein molecules will allow for a much more accurate detection of kidney damage before it becomes significant or irreversible.