Microbix Biosystems Inc. announces that Labquality Ltd., a collaborator and customer, is presenting results of its use of Microbix Quality Assessment Products (QAPsTM) for accreditation of clinical labs for conducting molecular (MDx) tests for antimicrobial- resistant (AMR) strains of M. genitalium (Mgen), a common sexually-transmitted infection (STI). Mgen is a common STI in both men and women who have been sexually-active. Left untreated, Mgen is known to cause chronic health problems in women, such as chronic pain, ectopic pregnancy, infertility, and pelvic inflammatory disease, and non-gonococcal urethritis in men.

As many as 50% of Mgen infections can be resistant to first-line antibiotic treatments. Tests for Mgen were not commonly conducted until the past several years, in part due to the unavailability of controls (e.g., QAPs) to assess and validate the accuracy of tests for antibiotic-susceptible and AMR strains of this bacteria. As testing for Mgen and AMR Mgen infections becomes more widespread, external quality assessment (EQA) programs are needed to evaluate the proficiency of clinical labs and provide them accreditation to test patient-samples.

The poster presents results of a Labquality program evaluating the proficiency of 38 clinical labs in their use of 16 different MDx assays (12 commercial & 4 lab-developed). Each clinical lab was evaluated for its ability to detect (i) Mgen, and (ii) an Mgen-related marker of resistance to macrolide antibiotics. It was found that (i) the Microbix Mgen QAPs (positives & negatives) were well-suited for this usage, (ii) the performance of labs and assays was excellent, (iii) specific reporting guidelines are needed to avoid errors, and (iv) there is a need for such an EQA program to support Mgen testing.

Microbix developed its Mgen QAPs to resemble patient specimens, support the whole testing process, and contain all possible MDx test targets - buffered and desiccated onto a Copan® FLOQSwab® to ensure multi- year product stability at room temperature. The pilot EQA program confirmed the performance of these QAPs across all clinical labs, instrument platforms, and assays. These Mgen QAPs are now available from Microbix as part of its PROCEEDx®FLOQ® (RUO) or REDxTMFLOQ® (IVD) catalogue of products.