Overview
Unassayed external control used to monitor the absence of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) (6 x 1.1 mL)
Safety Data Sheet
Description
Description
INTENDED USE:
The Exact Diagnostics STI Negative Run Control is an independent external quality run control intended to monitor the absence of Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in various molecular assays and can be used to detect errors in laboratory testing procedures including potential contamination events.
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 STI Negative Run Control is a formulated synthetic matrix containing human cells. This product is dispensed in barcoded vials and is intended to simulate patient specimens, testing the entire process of a molecular assay including extraction, amplification and detection. The human cells simulate adequate specimen sampling, which is tested by some assays.
This product is non-reactive for Chlamydia trachomatis DNA and RNA, and Neisseria gonorrhoeae DNA and RNA.
LIMITATIONS:
For In Vitro Diagnostic Use.