Summary: Bio-Rad launched Exact Diagnostics GBS positive and negative run controls to enhance the accuracy and reliability of Group B Streptococcus molecular assays.


  1. The new GBS controls are designed for routine assay evaluation and operator proficiency testing, ensuring consistent performance of GBS molecular assays.
  2. These controls use whole intact heat-inactivated GBS bacteria and human cells in a Lim broth matrix to fully simulate patient specimens, monitoring the entire molecular assay workflow.
  3. Internally value assigned using Droplet Digital PCR (ddPCR), these controls offer superior lot-to-lot consistency and are manufactured separately from the existing Verification & Validation Panel.

Bio-Rad Laboratories, a provider of life science research and clinical diagnostics products, 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.

Quality Controls for GBS Assays

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.

Further reading: Group B Streptococcus: The Role of Clinically Relevant Controls

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 superior lot-to-lot consistency. They are manufactured independently from the Exact Diagnostics GBS Verification & Validation Panel.

Featured image: Exact Diagnostics GBS Positive Run Controls