Overview
The Group B Streptococcus (GBS) Verification Panel and GBS Positive and Negative Run Control have been internally value assigned using droplet digital PCR allowing robust lot-to-lot reproducibility which is an essential feature of independent quality control materials. The verification panel is used to establish points of reference (qualitative and quantitative) within a range close to typical limits of detection to aid in the assessment of assay performance. Routine use of the run controls allow laboratories to capture run-to-run, day-to-day, instrument-to-instrument, operator-to-operator and lot-to-lot variations of their molecular assays. External quality controls can also be used to train laboratory operators and evaluate proficiency.
- Whole intact, heat-inactivated GBS bacteria in adapted Lim Broth
- Calibration with digital droplet PCR
- High quality matrix to ensure lot-to-lot reproducibility
- Adapted Lim Broth matrix
- Verification Panel has 18-month shelf life from date of manufacture
Targets:
- Whole Bacterium: Group B Streptococcus (GBS or Streptococcus agalactiae)
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Panel used to verify and validate Group B Streptococcus agalactiae (GBS) molecular assay applications including the evaluation, determination of assay performance characteristics, and the testing of operator proficiency. (5 x 0.25 mL)
Bundle of panels used to verify and validate Group B Streptococcus agalactiae (GBS) molecular assay applications including the evaluation, determination of assay performance characteristics, and the testing of operator proficiency. (4 x 12020070 mL)
Unassayed external quality control, intended to be used to monitor the absence of Group B Streptococcus agalactiae (GBS) in various molecular assays (5 x 0.25 mL)
Unassayed external quality control, intended to be used with Group B Streptococcus agalactiae (GBS) molecular assays to monitor the performance of that given assay (5 x 0.25 mL)