Xpert CT/NG Assay, kit/120

General description:
The Xpert CT/NG Assay is a qualitative, in vitro real-time PCR test for the
detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG), from genital swabs and urine samples, to aid in the diagnosis of chlamydial and gonorrheal urogenital disease, performed on the GeneXpert Instrument Systems.

Technical Specifications:
Sensitivity: CT: 96.0 – 99.5%
NG: 94.4 – 100%

Specificity: CT: 99.1 – 99.8%
NG: 94.4 – > 99.9%

Materials included:
Xpert CT/NG Assay kit (GXCT/NG-CE-120) contains:
·Sufficient reagent to process 120 quality control samples
·120 x Xpert CT/NG Assay Cartridges with Integrated Reaction Tubes
·125 x Disposable Transfer Pipettes
·1 x CD

Materials required but not provided:
·Xpert CT/NG Vaginal/Endocervical Specimen Collection kit (CT/NGSWAB-50) or Xpert Vaginal/Endocervical Specimen Collection Kit (SWAB/A-50)
·Xpert CT/NG Urine Specimen Collection kit (CT/NGURINE-50) or Xpert Urine Specimen Collection Kit (URINE/A-50)
·GeneXpert Instrument System (catalog number varies by configuration): 6-color GeneXpert instrument, computer with proprietary GeneXpert Software Version 4.3 or higher, barcode scanner, and appropriate GeneXpert Instrument System operator manual
·Printer

Product Code:
GXCT/NG-CE-120

Storage and temperature instructions:
·2 - 28°C
·Do not open a cartridge lid until you are ready to perform testing.

IFU: Included

Material safety data sheet information (MSDS):
It is available at www.cepheid.com