Sensitivity, Specificity, and Acceptability of a Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning: Prospective Observational and Randomized Studies

What this Trial Is About

Methanol poisoning is a serious health problem, especially in low- and middle-income countries, where outbreaks can cause severe harm to communities. Diagnosing methanol poisoning is difficult because its symptoms resemble other conditions, and traditional tests require costly laboratory equipment. This research aims to evaluate a new bedside test that uses a single drop of blood to detect formate, a substance only present in methanol poisoning, to improve diagnosis speed and accuracy. The research includes two parts: first, an observational study comparing the new point-of-care formate test to standard laboratory tests to check its accuracy. If the new test shows good sensitivity, a second study will follow, which is a feasibility trial where hospitals are randomly assigned to different diagnostic approaches. This trial will investigate whether using the bedside test can lead to faster diagnosis and treatment, reduce unnecessary treatments, and evaluate clinical and cost outcomes. Participants suspected of methanol poisoning or unexplained metabolic acidosis at large hospitals in Bangladesh and India will be involved. During the studies, timing from patient arrival to diagnosis and treatment will be measured, along with clinical outcomes such as death rates and treatment needs. The research will also assess how well hospitals can be recruited for this type of trial and aims to raise awareness about methanol poisoning and improve care practices over the study period ending in 2028.

A Study on Bedside Formate Assay as a Diagnostic Tool in Methanol Poisoning