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#Gastroenterology #Hepatology #Multispeciality
Liver disease poses significant economic health burden in both high-income and low-income countries. It causes over 2 million global deaths, annually. However, liver disease are the most common neglected health issues despite of the significant mortality burden. These diseases are not prioritized due to a lack of correct incidence and prevalence statistics, as well as national and international programmes targeting these diseases. Evidences suggest that maximum number of deaths are caused due to liver diseases, which cannot be treated, cured or prevented, if prompt diagnosis is not made. Therefore, it is mandatory to fund the development of prompt, efficient diagnostics for liver function, particularly in low-income and middle-income countries (LMICs) where the landscape for this testing is scarce.
The standard of care in high-income settings comprises of evaluating of ALT through a venipuncture blood draw, followed by centrifugation to separate serum or plasma, and then examining of the serum or plasma through an absorbance-based assay on a large, automated platform in a centralised laboratory. However, this evaluation is almost unachievable due to a lack of trained phlebotomists, equipment and reagent shortages in LMICs. In addition, supply chain concerns causes major delays in clinical decision-making and a considerable loss for patient follow-up.
Therefore, in order to overcome these challenges and bring ALT testing (from the centralised facility) to the point-of-care (POC), two FDA-approved devices have been developed in the market such as Roche Reflotron Plus and Alere Cholestech LDX. Nonetheless, both of these devices are costly and need technical capacity that may not be locally available and hence, are not feasible for LMICs. Therefore, WHO has generated a benchmark for technology development in LMICs, depicting the ideal design targets into the ASSURED criteria, which stands for affordable, specific, sensitivity, user-friendly, rapid/robust, equipment free and delivered/accessible.