Overview
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)
Safety Data Sheet
Description
Description
| Exact Diagnostics GBS Positive Run Control Summary | |
| Catalog Number | 12020069 |
| 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 Temperature | 2-8°C |
| Shelf Life | 18 Months from Manufacture Date |
| Open-Vial Stability | · Manual Pipetting: 5 days at 2-8°C · Swabbing: Single Use · Loading vial on instrument: Single use |
| Number of Vials Per Kit | 5 Vials |
| Fill Volume | 0.25 mL per Vial |
| Regulatory Status | In Vitro Diagnostic Use |
INTENDED USE:
The Exact Diagnostics GBS Positive Run Control is an independent external quality run control intended to be used with Group B Streptococcus (GBS or Streptococcus agalactiae) molecular assays.
This product simulates patient specimens and therefore controls the entire workflow process of molecular assays including extraction, amplification and detection.
This product also allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics GBS Positive Run Control contains whole intact heat inactivated GBS bacteria in Lim broth with preservatives, and simulates patient specimens 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.
This product is internally value assigned using Bio-Rad Droplet Digital PCR (ddPCR) to ensure lot-to-lot consistency.
This product has been manufactured to be independent of the Exact Diagnostics GBS Verification & Validation Panel.
LIMITATIONS:
- Do not use this product beyond the expiration date.
- This product is for Laboratory/Professional use only.
- This product is an unassayed control and does not have assigned values.
- 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.