Bio-Rad Laboratories has expanded its molecular offering of quality controls with the launch of its Exact Diagnostics GBS Positive and Negative Run Controls in complement to the previously launched Exact Diagnostics GBS Verification & Validation Panel.
These new ready-to-use independent quality controls are intended to be used with Group B Streptococcus (GBS) molecular assays for applications such as the routine evaluation of assay performance and the testing of operator proficiency.
With the positive control containing whole intact heat-inactivated GBS bacteria at a challenging concentration level to simulate a low positive clinical specimen, the negative control containing human cells to mimic adequate specimen sampling, and both controls uniquely formulated in Lim broth matrix, these Exact Diagnostics controls fully simulate patient specimens after enrichment. Therefore, they monitor the entire workflow of molecular assays including extraction, amplification and detection, while accounting for the matrix effect. Additionally, these products may also highlight issues associated with any pre-analytical workflow steps that require the dipping of swabs in Lim broth.
These controls are internally value-assigned using Bio-Rad Droplet Digital PCR (ddPCR) to ensure lot-to-lot consistency.
