Viral Controls for Molecular Diagnostic Testing
Microbiologics, Inc., a developer of biological controls and standards has entered into an agreement to source inactivated viruses from Microbix Biosystems, Inc., a global supplier of infectious disease antigens for vaccine and diagnostic manufacturers. Microbiologics will incorporate these inactivated materials into a line of full process controls under its Helix Elite™ Molecular Standards brand as well as instrument specific quality control sets.
Molecular diagnostic assays offer sensitivity and speed for the clinical lab, but are dependent on characterized and available control material to demonstrate both test performance characteristics and staff proficiency. Laboratories struggle to identify adequate biomaterials and frequently use clinical samples that may not be consistent nor well characterized. The possibility of increased regulatory oversight for LDTs and new options to satisfy CLIA regulations for nonwaived tests requires that clinical laboratories carefully consider the source, quality and format of their molecular and culture-based control materials. This partnership will combine both companies’ expertise in biomaterial development, preservation, and distribution to create highly stable viral controls for molecular testing worldwide.
Microbiologics Vice President, Molecular Products and Services, Brian Beck, Ph.D., commented, “We are pleased to use Microbix materials in Microbiologics products as they have a strong, global reputation for high quality viral preparations for the vaccine and immunodiagnostics markets.” Beck adds, “Incorporation of Microbix viral materials into our lyophilized, molecular-compatible formats complements our existing synthetic standards and extends our catalog to include extraction controls for gastrointestinal, respiratory, blood borne and sexually transmitted viral pathogens.”
Brad Goskowicz, Microbiologics’ CEO, added, “As part of our commitment to a safer, healthier world, Microbiologics continues to partner with industry leaders such as Microbix to develop advanced, yet practical controls that support the evolving field of molecular microbiology.” Goskowicz continued, “We look forward to working with molecular diagnostic manufacturers to ensure that clinical laboratories have the appropriate and highest quality control material for their instruments and assays.”
Microbiologics adheres to an industry-leading quality system including certification to ISO 13485, ISO 17025 and ISO Guide 34 standards. Additionally, Helix Elite™ Molecular standards are listed as CE Marked In-Vitro Diagnostic Medical Devices allowing their use in clinical diagnostic applications globally.
Visit the Helix Elite™ product page for a complete list of available standards.
Tags: QC Molecular Standards, Reference Materials
Date Published: April 7, 2015
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