Microbiologics, Saint Cloud, Minn, has introduced positive and negative controls for clinical laboratory quality control of rifampicin-resistant Mycobacterium tuberculosis (MTB-RIF) molecular assays and test methods.
The new MTB-RIF positive control panel and MTB-RIF negative control panel were designed to make QC 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 (D516V, H526Y, L511P, S522L, S531L).
- Room-temperature storage allowing laboratories to store the controls next to the diagnostic system, save freezer and refrigerator space, and reduce shipping costs.
- For in vitro diagnostic use, inactivated microorganism pellets that closely mimic the patient sample testing process, helping laboratories to meet regulatory requirements.
One fourth of the world’s population is infected with tuberculosis (TB), and 10 million people became ill with the disease in 2017, according to the US Centers for Disease Control and Prevention.1 Multidrug-resistant TB (MDR-TB) is on the rise because of mismanaged treatment and person-to-person transmission. The World Health Organization estimates that 600,000 people worldwide developed MDR-TB in 2016, including 110,000 cases caused by MTB-RIF.2
Brad Goskowicz, Microbiologics.
“Clinical laboratory professionals are some of the world’s greatest unsung heroes. They are tasked with delivering uncompromising precision while maintaining rapid turnaround times day-in and day-out,” says Brad Goskowicz, CEO at Microbiologics. “We share their mission of protecting the health and safety of people around the world. We’re focused on providing the highest quality biological controls that laboratories can rely on to ensure the accuracy and consistency of their diagnostic assays. The new MTB-RIF controls are the latest addition to our growing line of controls for molecular diagnostics.”
The new offerings from Microbiologics add to the company’s line of inactivated and live culture controls for clinical laboratories performing respiratory testing. The line includes rifampicin-resistant Mycobacterium tuberculosis positive control and negative control panels in an inactivated pellet format.
For more information visit Microbiologics.
Reference
- Tuberculosis (TB) [online]. Atlanta: Centers for Disease Control and Prevention, 2019. Available at: www.cdc.gov/globalhealth/newsroom/topics/tb/index.html. Accessed November 11, 2019.
- Tuberculosis (TB) [online]. Geneva: World Health Organization, 2019. Available at: https://www.who.int/tb/areas-of-work/drug-resistant-tb/en. Accessed November 11, 2019.
