Bio-Rad Laboratories has expanded its molecular quality controls offering with the launch of two new Exact Diagnostics branded products.

Bio-Rad’s new offerings include the CT/NG Positive Run Control, intended to be used with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) molecular assays; and STI Negative Run Control, which monitors the absence of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in various molecular assays and can be used to detect errors in laboratory testing procedures including potential contamination events, while controlling for sample adequacy assessment. Both are external quality controls designed to be used with molecular assays to monitor their intra- and inter-run performance.  

The Exact Diagnostics 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. The product is internally value assigned using Bio-Rad Droplet Digital PCR (ddPCR).  

The Exact Diagnostics STI Negative Run Control is a formulated synthetic matrix containing human cells. The human cells simulate adequate specimen sampling, which is tested by some assays. 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. 

Both products complement the CT/NG Verification Panel and the CT/NG Verification Bundle.  They are designed to save laboratories the time and costs associated with the labor-intensive screening, qualification, manufacturing and maintenance of clinical specimens that would otherwise be used as controls.