Microbiologics, Inc. has launched positive and negative controls for quality control of Rifampicin-Resistant Mycobacterium tuberculosis (MTB-RIF) molecular assays and test methods to help clinical laboratories deliver fast and accurate results.
One fourth of the world’s population is infected with tuberculosis (TB) and 10.0 million people became ill with TB disease in 2017 according to the CDC. Multidrug-resistant TB (MDR-TB) is on the rise due to mismanaged treatment and person-to-person transmission. WHO estimated 600,000 people worldwide developed MDR-TB in 2016 with 110,000 cases caused by MTB-RIF.
The new Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel and Rifampicin-Resistant Mycobacterium tuberculosis Negative Control were designed to make quality control testing of molecular assays simple, reliable, and affordable. Features of the controls include:
• Separate positive and negative control products that enable laboratories to minimize waste by only purchasing the volume of controls needed.
• Positive control representing five common mutations to the rpoB gene associated with rifampicin-resistance (L511P, H526Y, S531L, D516V, S522L).
• Room temperature storage allowing laboratories to store the controls next to the diagnostic system, save freezer and refrigerator space, and reduce shipping costs.
• Inactivated microorganism pellets that are for in vitro diagnostic use (IVD) and closely mimic the patient sample testing process to help laboratories meet regulatory requirements.
Microbiologics now offers a full spectrum of inactivated and live culture controls for clinical laboratories performing respiratory testing including:
• Rifampicin-Resistant Mycobacterium tuberculosis Positive Control Panel (Catalog #8206) – Inactivated pellet format
• Rifampicin-Resistant Mycobacterium tuberculosis Negative Control (Catalog #8238) – Inactivated pellet format
