Exact Diagnostics Group B Streptococcus

Exact Diagnostics Group B Streptococcus

Overview

A family of unassayed external controls, verification panels to support monitoring the presence and determining the accuracy and sensitivity of assays for the presence of Group B Streptococcus (GBS).

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Description

Description

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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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EDX GBS Verification and Validation Panel
12020070

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)

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QC EDX GBS Bundle
17009668

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)

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12020068 GBS Negative
12020068

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)

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12020069_GBS_Positive
12020069

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)

Documents

Documents

Number Description Options
Q-1673
Exact Diagnostics products catalog