Improving Sensitivity of Flow-Based Diagnostics

A team at IV Lab is working to improve the sensitivity of LFA devices platform-wide by improving analyte availability, sample preparation and concentration, flow materials, signaling and signal enhancement, and detection while retaining the cost and ease of use needed in low-resource settings.

In low-resource settings lateral flow assays (LFAs) are one of the primary methods for initial diagnosis for a range of infectious diseases, such as malaria and dengue. The relative simplicity, low cost, and chemistry stability make LFAs an ideal diagnostic test in point-of-care settings, especially in areas with unreliable electricity and where health providers have limited training.

Many possible applications of LFA technology to assay targets of importance in low-resource settings are limited by their sensitivity. The limit of detection and sensitivity of the test is restricted by needing a sufficient concentration of analyte to create a visible test line for a positive result. For example, current malaria LFAs are only able to detect P. falciparum malaria in symptomatic patients, they are not sensitive enough to detect asymptomatic P. falciparum infections or the P. vivax malaria parasite, which are needed for malaria elimination from a population. By improving the sensitivity of the LFA test, health care providers would be able to identify and treat latent malaria more effectively than ever before.

A team at IV Lab is working to improve the sensitivity of LFA devices platform-wide by improving analyte availability, sample preparation and concentration, flow materials, signaling and signal enhancement, and detection while retaining the cost and ease of use needed in low-resource settings. Their initial focus areas are malaria (P. falciparum) elimination, malaria (P. vivax) case management, Loa Loa, and a TB test that will not require collection of sputum.

Since the underlying technology of the LFA format could be used for detection and management of a wide variety of diseases, a more sensitive LFA platform could be adapted to target other diseases including Shistosomiasis and Onchocerciasis, cervical cancer, HIV, preeclampsia, and many other global health assays.