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30th September 2019 Content supplied by: Microbiologics, Inc.
Microbiologics Adds Rifampicin-Resistant Mycobacterium tuberculosis To Its Molecular QC Offering
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 Centers for Disease Control and Prevention (CDC). Multidrug-resistant TB (MDR-TB) is on the rise due to mismanaged treatment and person-to-person transmission. World Health Organization (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.
“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,” said Brad Goskowicz, Chief Executive Officer. “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.”
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
Visit microbiologics.com to view all molecular controls for respiratory pathogen testing. Additionally, a full list of the Microbiologics verification and quality control panels for common diagnostic systems including the BD MAX™ and Cepheid GeneXpert®, and syndromic assays including Blood Culture Identification (BCID), Women’s Health/STI and Healthcare-Associated Infections (HAIs), can be found at microbiologics.com.
Date Published: 30th September 2019
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