Chlamydia trachomatis/Neisseria gonorrhoeae PCR

LAB5907 48

GENEXPERT
GC CHLAMYDIA
CTNG
CTGC
CHLAMYDIA
NEISSERIA
GC
CT
PCR

NEISSERIA GONORRHOEAE DNA PROBE (PRESENCE) IN UNSP SPEC
CHLAMYDIA TRACHOMATIS DNA PROBE (PRESENCE) IN UNSP SPEC
FCHD NEISSERIA GONORRHOEAE RNA PROBE (PRESENCE) IN UNSP
FCHD CHLAMYDIA TRACHOMATIS RNA PROBE (PRESENCE) IN UNSP
NEISSERIA GONORRHOEAE PCR POPLAR
CHLAMYDIA TRACHOMATIS PCR POPLAR

Urine

Males:  First morning unpreserved urine.  Minimum 10 mL collected in a sterile container.  Catheterized and urethral swab specimens are unacceptable.
 
Females:  First morning unpreserved urine.  Minimum 10 mL collected in a sterile container.  Catheterized specimens are unacceptable. Vaginal and Endocervical collection using the Xpert CT/NG Vaginal/Endocervical specimen collection kit.
 
Urine – (all genders) Preferred specimen is first void, but any void urine is acceptable.
 
Vaginal, Endocervical, Throat, Mouth, Anal sources using ONLY approved Xpert CT/NG swab collection kit.
 
Unacceptable specimens: Catheterized urine, swabs submitted in collection devices other than the Xpert CT/NG swab collection kit.
 
Unacceptable Source: Catheterized urine of any type.  Source other than listed above.
Unacceptable collection: 
  Urine submitted in a preservative. 
  Urine in non-sterile container.
  Less than 10mL urine.
  Catheter or non-void urine collection.
  Leaked specimen.
  Swab other than Xpert swab.  
  Expired collection device.
  Sample received for testing with improper identification (no patient name, MR# or DOB, or without patient label)
  Xpert swab received without buffer.
  Xpert swab without swab. 
  Xpert swab with the LARGE swab in vial.  
  Anal swab = heavily soiled with feces.
  Specimen received unlabeled.
 
Acceptable Specimen Collection: Urine – color lid may vary


Acceptable Specimen Collection: Swab 
Vaginal, Endocervical, Throat, Rectal/Anal Swab – Xpert Swab/G-50

Collection Instructions - 
Urine Void/First catch – Minimum amount = 10mL

Vaginal Collection Instructions.  
Discard Large swab

Throat Collection Instructions.  
Discard Large swab

Rectal Collection Instructions.  
Discard Large swab

 

URINE

Refrigerated

First catch female unpreserved urine specimens must be transferred to the Xpert CT/NG Urine Transport Reagent tube within 24 hours of primary collection if shipped and/or stored at room temperature. Transfer to the transport medium is performed by Microbiology staff.

First catch male unpreserved urine specimens must be transferred to the Xpert CT/NG Urine Transport Reagent tube within 3 days of primary collection if shipped and/or stored at room temperature. Transfer to the transport medium is performed by Microbiology staff.

Storage: Urine (unpreserved) at room temperature = 24 hours.
Urine (unpreserved) stored at 2-6°C = 8 days.
Urine must be transferred to Xpert Urine Container upon receipt into lab.
Xpert Swab collections - Transport to lab at 2-30°C up to 60 days.
Transport : 2-28°C
Requires Source/Type match for add-on: Yes
Can this be shared: Vag only can be shared with MVP assay.

Unacceptable specimens: Catheterized urine, swabs submitted in collection devices other than the Xpert CT/NG swab collection kit.
 
Unacceptable Source: Catheterized urine of any type.  Source other than listed above.
Unacceptable collection: 
Urine submitted in a preservative. 
Urine in non-sterile container.
Less than 10mL urine.
Catheter or non-void urine collection.
Leaked specimen.
Swab other than Xpert swab.  
Expired collection device.
Sample received for testing with improper identification (no patient name, MR# or DOB, or without patient label)
Xpert swab received without buffer.
Xpert swab without swab. 
Xpert swab with the LARGE swab in vial.  
Anal swab = heavily soiled with feces.
Specimen received unlabeled.

Neisseria gonorrhea DNA- Not Detected

Chlamydia trachomatis DNA- Not Detected

FCHD Neisseria gonorrhea RNA- Negative

FCHD Chlamydia trachomatis RNA- Negative

The Xpert CT/NG Assay is an automated in-vitro diagnostic test for qualitative detection and differentiation of DNA from Chlamydia trachomatis and Neisseria gonorrhoeae (CT/NG). The Cepheid GeneXpert Instrument System automates and integrates sample purification, nucleic acid amplification, and detection of the target sequences in simple or complex samples using real-time PCR and RT-PCR assays.

The Xpert CT/NG Assay is designed for use with the following specimens collected from symptomatic and asymptomatic individuals: first-catch urine – any gender, vaginal swab specimens, as well as orifice swabs specimens such as throat and anal.