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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