At AACC booth 5038, Microbiologics Inc, St. Cloud, Minn, will showcase its newly expanded line of Helix Elite molecular standards, which include inactivated extraction controls, synthetic nucleic acids, and genomic extracts. The fully intact process controls are used for validation, verification, proficiency testing, and quality control of molecular assays. FDA-cleared and CE-marked in vitro diagnostic medical devices for use in clinical laboratories, the inactivated extraction controls are non-viable viral and bacterial targets produced in the form of lyophilized pellets, which are shipped and stored at room temperature. The quick-dissolving pellets may be reconstituted in relevant buffers or transport media and then processed using the same protocols as the patient sample. The synthetic molecular standards contain consensus sequences of diagnostic regions from a target’s genome, and represent the known genetic diversity of the microorganism. The genomic extract molecular standards are dried, stabilized, and quantitated nucleic acid extracted from target pathogens. Used as positive controls for the amplification and detection steps in molecular assays, each preparation is assessed for purity and integrity, and provided with a gene copy number for quantitation. For more information, visit Microbiologics.
November 11, 2022
November 19, 2019