Tag Archives: Microbiologics

November 2021—Microbiologics has launched its SARS-CoV-2 Whole Virus Antigen Control, which can be used in the point-of-care setting for the detection of SARS-CoV-2 antigens and for monitoring the extraction, amplification, and detection in nucleic acid testing. In antigen-based applications, the high titer formula provides a clear positive reaction to monitor the detection of SARS-CoV-2 viral antigens. Each kit contains six individually packaged lyophilized swabs.

September 2020—Microbiologics has expanded its custom virology solutions in its renovated virology services lab to include biosafety level 3 antiviral services. With these new capabilities, the company has launched a menu of cell-based services for SARS-CoV-2 to assist assay developers, evaluate therapeutic solutions and vaccines, and provide inactivated intact virus to researchers and diagnostic companies.

August 2020—Microbiologics announced the launch of two products for COVID-19 quality control and research—a research use only protein-coated RNA process control and an IVD control with pooled gene targets.

January 2020—Microbiologics has launched rifampicin-resistant Mycobacterium tuberculosis positive and negative control panels for quality control of MTB-RIF molecular assays and test methods. Features of the controls include separate positive and negative control products, positive control representing five common mutations to the rpoB gene associated with rifampicin resistance (L511P, H526Y, S531L, D516V, S522L), room-temperature storage, and inactivated microorganism pellets for in vitro diagnostic use.

February 2019—Microbiologics launched two panels for quality control of group A Streptococcus and respiratory molecular assays and test methods. The Group A Streptococcus Control Panel and Respiratory (21 Targets) Control Panel feature multiplexed pellets and swabs that mimic patient sample processing and are stored at room temperature.

September 2018—Microbiologics has launched a series of panels for verification and routine quality control of common molecular assays.

Microbiologics has launched a Business Solutions division dedicated to partnering with diagnostic and life science technology manufacturers. Users of these instruments and assays need biological controls to meet regulatory requirements for validation, verification, and quality control.

July 2015—Microbiologics is expanding its line of Helix Elite Molecular Standards with two product formats: inactivated extraction controls and genomic DNA extracts. Used for validation, verification, proficiency testing, and quality control of molecular assays, Inactivated and Genomic Extract controls are available in multiple strains; the first genomic extracts are from low passage mycoplasma strains sourced from the National Collection of Type Cultures.

June 2015—Microbiologics has entered into an agreement to source inactivated viruses from Microbix Biosystems. 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.

August 2014—Microbiologics has partnered with Biomatrica to license Biomatrica’s DNAstable and RNAstable technology for use in its line of molecular controls for rapid diagnostic instruments and assays.

March 2014—Helix Elite is the first molecular product line from Microbiologics. It includes 13 molecular standards—intended to facilitate the development, validation, and monitoring of molecular assays—for microorganisms that are difficult to grow or cannot be cultured, such as Cryptosporidium and norovirus.