Exact Diagnostics GBS Verification & Validation Panel #12020070

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EDX GBS Verification and Validation Panel

Overview

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)

Safety Data Sheet

Safety Data Sheet

Description

Description

Exact Diagnostics GBS Verification & Validation Panel Summary
Catalog Number 12020070
Target Analyte Group B Streptococcus (GBS or Streptococcus agalactiae)
Source Material Whole Bacterium
Inactivation Method Heat
Matrix Adapted Lim Broth
Internal Value Assignment Method Bio-Rad’s Droplet Digital PCR (ddPCR)
Storage 2-8°C
Shelf Life 18 Months from Manufacture Date
Usability Single Use
Number of Vials Per Kit 5 Vials
Fill Volume 0.25 mL per Vial
Regulatory Status For Research Use Only (Not for use in diagnostic procedures)
Target GBS Concentration 1,000 copies/mL

 

INTENDED USE:
The Exact Diagnostics GBS Verification & Validation Panel is an independent reference material intended to be used with Group B Streptococcus (GBS or Streptococcus agalactiae) molecular assays for Research Use Only (RUO) applications such as the evaluation or determination of assay performance characteristics, training of laboratory operators, and operator proficiency evaluation.

SUMMARY AND PRINCIPLE:
Reference materials may be used to assist with the verification of In Vitro Diagnostics (IVD) assays and the validation of laboratory developed tests.

PRODUCT DESCRIPTION:
The Exact Diagnostics GBS Verification & Validation Panel contains whole intact heat inactivated GBS bacteria in Lim broth with preservatives, and is similar in nature to the materials obtained by laboratories after GBS enrichment in Lim broth.

This product may be used to monitor pre-analytical workflow steps that require dipping swabs in Lim broth, and to test the entire molecular assay process including extraction, amplification and detection.

Exact Diagnostics GBS Verification & Validation Panel is internally value assigned using Bio-Rad’s Droplet Digital PCR (ddPCR) to ensure lot-to-lot consistency.

This product has been manufactured to be independent of the Exact Diagnostics run controls.

LIMITATIONS:

  1. For Research Use Only. Not for use in diagnostic procedures.
  2. Do not use this product beyond the expiration date.
  3. Reference material dilution in an appropriate matrix requires validation by the laboratory.
  4. It is the responsibility of each laboratory to implement its own quality assurance program to determine the suitability of this product for its particular use.