Microbix Biosystems Inc. (TSX: MBX, OTCQX: MBXBF, Microbix®), a life sciences innovator, manufacturer, and exporter, and Aurevia Oy via its Labquality EQAS affiliate (Aurevia), announce a pilot external quality assessment (“EQA”) program to help clinical laboratories establish their proficiency at using molecular diagnostic methods (e.g., PCR tests) to diagnose bacterial vaginosis (“BV”).
BV is a common vaginal condition that will affect a large percentage of women during adulthood. BV is caused by an imbalance in the bacterial flora of the vagina, with non-beneficial species becoming dominant. BV has historically been diagnosed by changes in vaginal acidity, odor, or by microbiology – methods which are sometimes not definitive. In contrast, molecular diagnostic (“MDx”) tests can distinguish each of the organisms that should be present in vaginal flora and detect whether their proportions are normal. Accordingly, MDx tests for BV can provide definitive diagnoses and help determine a treatment plan.
The EQA program being introduced by Aurevia is number 5305, titled “Bacterial vaginosis and vaginitis multiplex nucleic acid detection.” The current pilot study is intended for clinical labs diagnosing BV, as well as other vaginal infections, such as vulvovaginal candidiasis and trichomoniasis. The program will be run with simulated samples made by Microbix (“QAPs™”). After completion of the pilot study and analysis of its results, it is anticipated that an ongoing program for BV will be added to the Aurevia Labquality EQAS portfolio of EQA schemes to which clinical laboratories testing for BV can subscribe.
Microbix QAPs are designed to fully emulate clinical specimens from patients while being safe and stable. For this BV pilot program, Microbix has created three QAPs samples formatted onto Copan® FLOQSwabs® – to correctly emulate the workflow of MDx tests for BV from collection of patient specimens through to the reporting of test results. Each of the three QAPs is non-infectious and, as for Microbix’s full portfolio of PROCEEDx®FLOQ® and REDx®FLOQ® QAPs, is stable at room temperature for at least two years.
Heidi Berghäll, EQA Solutions Manager, R&D of Aurevia, commented, “It is important that emerging MDx tests for the diagnosis of BV are properly validated. With a proper EQA scheme to monitor labs’ ongoing performance, such tests should improve access to care, ensure timely and accurate diagnosis, and help determine curative treatment. Aurevia is proud to be addressing these important clinical needs.”
Cameron Groome, CEO & President of Microbix, also commented, “It is a pleasure to work with global leaders like Aurevia to validate complex next-generation diagnostic tests, such as MDx tests for BV. Our objective is to be the leading partner for PT/EQA providers, test-makers, and clinical labs for providing QAPs to help ensure that their testing attains and sustains the highest possible levels of accuracy and quality assurance.”
Enquiries about Microbix QAPs can be e-mailed to customer.service@microbix.com.
Enquiries about Aurevia, or the BV EQA Scheme can be emailed to info@aurevia.com
