Microbix Biosystems Inc. announces that it is presenting results of a Quality Assessment Product (?QAPTM?) for supporting the clinical use and accuracy of molecular (?MDx?) tests for infection with Helicobacter pylori (?H. pylori?), the bacterial cause of stomach ulcers, at Labquality Days, a lab diagnostics conference taking place in Helsinki, Finland from February 8 to 10, 2024. H. pylori infection was discovered to be the cause of stomach (gastric) ulcers in the 1980's, in what became a Nobel Prize winning health discovery. The bacteria impact about half of the world's population and, due to untreated infections and the emergence of antibiotic-resistant strains, poses serious health risks.

It is difficult to culture this pathogen, leading to the use of MDx methods for rapid diagnosis. However, it has been a challenge to ensure accuracy and reliability of MDx testing for H. pylori infection, as existing liquid matrix test-controls have been found unstable and therefore especially unsuited to point-of- care tests. At Labquality Days, Microbix will present a poster titled ?A New External Quality Assessment Program for Laboratories that Detect H. pylori and Antimicrobial Resistance Markers Using Nucleic Acid Amplification Test Methods.?

The poster details the results of a collaboration with Labquality, within which Microbix developed highly-stable QAPs for H. pylori and Labquality created a pilot external quality assessment (?EQA?) program, each to support labs running MDx tests for the pathogen. Microbix developed its H. pylori QAP to resemble patient specimens, support the whole testing process, and contain all possible MDx test targets - stabilized and dessicated onto a Copan® FLOQSwab® to ensure stability at room temperature. The pilot EQA program confirmed the performance of these QAPs within 13 laboratories running seven different assays/platforms. These H. pylori QAPs are now being made available on a research-use-only (RUO) basis from Microbix as part of its PROCEEDx FLOQ catalogue of products.