Bio-Rad Laboratories launches two Exact Diagnostics branded products: The CT/NG Positive Run Control is intended to be used with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) molecular assays, while the STI Negative Run Control can be used to detect errors in laboratory testing procedures, including potential contamination events. This product may also be used to dilute or spike-in patient specimens or analyte-containing materials for purposes such as assay validation and verification. The CT/NG Positive Run Control contains a mix of formalin-inactivated whole CT elementary bodies with heat-inactivated whole NG microorganisms and is formulated in a synthetic matrix, and the STI Negative Run Control contains a formulated synthetic matrix containing human cells.
Both controls are external quality controls designed to monitor their intra- and inter-run performance and are manufactured with the goal of saving laboratories the time and costs associated with the labor-intensive screening, qualification, manufacturing, and maintenance of clinical specimens as alternative controls.