Overview
Unassayed external quality control, intended to be used with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) molecular assays to monitor the performance of that given assay (6x 1.1 mL)
Safety Data Sheet
Description
Description
INTENDED USE:
The Exact Diagnostics CT/NG Positive Run Control is an independent external quality run control intended to be used with Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) molecular assays.
This product allows laboratories to evaluate their molecular assay and test for operator proficiency.
PRODUCT DESCRIPTION:
The Exact Diagnostics CT/NG Positive Run Control contains a mix of formalin-inactivated whole CT elementary bodies with heat-inactivated whole NG microorganisms and is formulated in a synthetic matrix. 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.
This product may be used for the detection of Chlamydia trachomatis DNA and RNA, and Neisseria gonorrhoeae DNA and RNA.
This product is internally value assigned using Bio-Rad Droplet Digital PCR (ddPCR).
LIMITATIONS:
For In Vitro Diagnostic Use