Test Code LAB1376C GC/Chlamydia, PCR
Intended Use
The Xpert® CT/NG Assay, performed on the GeneXpert® Instrument Systems, is a qualitative in vitro real-time PCR test for the automated detection and differentiation of genomic DNA from Chlamydia trachomatis (CT) and/or Neisseria gonorrhoeae (NG) to aid in the diagnosis of chlamydial and gonorrheal disease in the urogenital tract and extragenital sites (pharynx and rectum). The assay may be used to test the following specimens from asymptomatic and symptomatic individuals: urine, vaginal/endocervical swabs, pharyngeal and rectal swabs.
Methodology
Real-Time Polymerase Chain Reaction (RT-PCR)
Performing Laboratory
RCH
Specimen Requirements
Xpert Swab Specimen Kit (Pink Cap):
-Use this kit for throat, rectal, Vaginal, or Cervical sources.
-For rectal swab collection, highly soiled fecal swabs should not be used as they may result in errors.
First Catch Urine (Male or Female):
Must be dirty void/catch. Volume: 20 mL.
Specimen Stability
Urine Collection (Unpreserved):
Female:
Ambient: 24 hours
Refrigerated: 8 Days
Male:
Ambient: 3 days
Refrigerated: 8 days
Urine Collection (Preserved):
Ambient: 8 days
Refrigerated: 45 days
Vaginal/Endocervical, Rectal, and Pharyngeal Collection in Preservative:
Ambient: 60 days
Refrigerated: 60 days
Day(s) Test Set Up
Monday through Sunday
Test Classification and CPT Coding
87491, 87591