June 11, 2024—Bio-Rad Laboratories has launched its Exact Diagnostics GBS positive and negative run controls. The independent quality controls are intended to be used with Group B streptococcus molecular assays for the routine evaluation of assay performance and testing of operator proficiency. The positive control contains whole, intact heat-inactivated GBS bacteria at a challenging concentration level to simulate a low positive clinical specimen, and the negative control contains human cells to mimic adequate specimen sampling. Both controls are formulated in Lim broth matrix, simulate patient specimens after enrichment, and monitor the entire workflow of molecular assays including extraction, amplification, and detection. The products may also highlight issues associated with preanalytical workflow steps that require the dipping of swabs in Lim broth.
The controls are internally value assigned using Bio-Rad Droplet Digital PCR (ddPCR) to ensure superior lot-to-lot consistency and are manufactured independently from the Exact Diagnostics GBS Verification and Validation panel.