Description
INTENDED USE:
The Exact Diagnostics GBS Negative Run Control is an independent external quality run control intended to monitor the absence of Group B Streptococcus (GBS or Streptococcus agalactiae) when running molecular assays and can be used to detect errors in laboratory testing procedures including potential contamination events.
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.
This product may be utilized for dilution or spike-in purposes.
PRODUCT DESCRIPTION:
The Exact Diagnostics GBS Negative Run Control is formulated Lim broth with preservatives containing human Jurkat cells. It simulates patient specimens devoid of GBS after the Lim broth enrichment step, and is therefore non-reactive for Streptococcus agalactiae DNA and RNA.
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. The presence of human Jurkat cells simulates adequate specimen sampling, which is tested by some assays.
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.
