Oct. 28, 2022—Bio-Rad Laboratories has launched two Exact Diagnostics molecular controls. The CT/NG Positive Run Control is intended to be used with Chlamydia trachomatis and Neisseria gonorrhoeae molecular assays. The STI Negative Run Control monitors the absence of Chlamydia trachomatis and Neisseria gonorrhoeae in various molecular assays, the company says, 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 intra- and inter-run performance.
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. The STI negative run control is a formulated synthetic matrix containing human cells. It may also be used to dilute or spike-in patient specimens or analyte-containing materials for assay validation and verification.