New quality controls for Group B Streptococcus molecular testing
Bio-Rad Laboratories has expanded its portfolio of molecular quality controls with the introduction of Exact Diagnostics GBS Positive and Negative Run Controls. These new products complement the previously launched Exact Diagnostics GBS Verification & Validation Panel, offering clinical laboratories a comprehensive solution for Group B Streptococcus (GBS) molecular assay quality management.
Ready-to-use controls for routine performance evaluation
The newly released controls are designed for use with GBS molecular assays, providing laboratory scientists with tools for routine evaluation of assay performance and operator proficiency testing. These independent quality controls offer several key features that enhance their utility in clinical laboratory settings.
The positive control contains whole, intact heat-inactivated GBS bacteria at a challenging concentration, mimicking a low positive clinical specimen. Conversely, the negative control includes human cells to simulate adequate specimen sampling. Both controls are uniquely formulated in Lim broth matrix, closely resembling patient specimens after enrichment.
Monitoring the entire workflow
By simulating patient specimens, these controls allow for comprehensive monitoring of the entire molecular assay workflow, including extraction, amplification, and detection stages. Additionally, they account for matrix effects and may highlight issues associated with pre-analytical workflow steps involving the dipping of swabs in Lim broth.
Ensuring consistency and reliability
Bio-Rad utilises its proprietary Droplet Digital PCR (ddPCR) technology for internal value assignment of these controls, ensuring superior lot-to-lot consistency. Importantly, the new run controls are manufactured independently from the Exact Diagnostics GBS Verification & Validation Panel, providing an additional layer of quality assurance.
As clinical laboratories continue to rely on molecular methods for GBS detection, these new quality controls from Bio-Rad offer a valuable resource for maintaining high standards of accuracy and reliability in diagnostic testing.
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