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GC/Chlamydia by PCR
Test CodeLAB6483
Alias/See Also
Gonorrhea and Chlamyida by PCR Probe
GC and Chlamydia by PCR Probe
GC and Chlamydia by PCR Probe
Preferred Specimen
First catch Urine (dirty urine) in sterile container is optimal, can also collect in Xpert urine collection tube (yellow top).
Endocervical, Pharyngeal, or Rectal swab in Xpert transport tube (pink top).
Endocervical, Pharyngeal, or Rectal swab in Xpert transport tube (pink top).
Minimum Volume
Minimum Volume
1 vaginal swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
1 endocervical or urethral swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
7 mL urine in Xpert CT/NG Urine Transport Reagent tube
1 Throat Swab/ Pharyngeal in Xpert CT/NG Swab/G-50 transport tube (pink top).
1 vaginal swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
1 endocervical or urethral swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
7 mL urine in Xpert CT/NG Urine Transport Reagent tube
1 Throat Swab/ Pharyngeal in Xpert CT/NG Swab/G-50 transport tube (pink top).
Other Acceptable Specimens
Minimum Volume
1 vaginal swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
1 endocervical or urethral swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
7 mL urine in Xpert CT/NG Urine Transport Reagent tube
1 Throat Swab/ Pharyngeal in Xpert CT/NG Swab/G-50 transport tube (pink top).
1 vaginal swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
1 endocervical or urethral swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
7 mL urine in Xpert CT/NG Urine Transport Reagent tube
1 Throat Swab/ Pharyngeal in Xpert CT/NG Swab/G-50 transport tube (pink top).
Instructions
• Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Xpert CT/NG Urine Transport Reagent tube within 24 hours of primary collection. First catch male urine specimen 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. Minimun vol=7ml.
• Endocervical or urethral swab: Follow instructions in the Xpert CT/NG Swab/G-50 transport kit. In females, to ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.
• Throat swab: Follow instructions in the Xpert CT/NG Swab/G-50 transport tube (pink top)
• Rectal swab: Follow instructions in the Xpert CT/NG Swab/G-50 transport tube (pink top)
• Endocervical or urethral swab: Follow instructions in the Xpert CT/NG Swab/G-50 transport kit. In females, to ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.
• Throat swab: Follow instructions in the Xpert CT/NG Swab/G-50 transport tube (pink top)
• Rectal swab: Follow instructions in the Xpert CT/NG Swab/G-50 transport tube (pink top)
Transport Container
1 vaginal swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
1 endocervical or urethral swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
7 mL urine in Xpert CT/NG Urine Transport Reagent tube
1 Throat Swab in Xpert CT/NG Swab/G-50 transport tube (pink top).
1 Rectal Swab in Xpert CT/NG Swab/G-50 transport tube (pink top).
1 endocervical or urethral swab in Xpert CT/NG Swab/G-50 transport tube (pink top)
7 mL urine in Xpert CT/NG Urine Transport Reagent tube
1 Throat Swab in Xpert CT/NG Swab/G-50 transport tube (pink top).
1 Rectal Swab in Xpert CT/NG Swab/G-50 transport tube (pink top).
Transport Temperature
Refrigerated
Specimen Stability
Specimen Stability
Endocervical, Urethral, Vaginal, Throat, Rectal swab in Xpert CT/NG Swab/G-50 transport tube (pink top).
Room temperature: 60 days
Refrigerated: 60 days
Frozen: unacceptable
• First catch urine specimens must be transferred to the Xpert Urine Transport Reagent or Xpert CT/NG Urine
Transport Reagent tubewithin 24 hours of primary collection if shipped and/or stored at room temperature.
• First catch male and female urine specimen NOT transferred to the Xpert Urine Transport Reagent or Xpert CT/NG Urine
TransportReagent tube (unpreserved urine specimen) can be shipped and/or stored for up to 8 days at 4 °C ± 2°C.
• First catch urine specimens that are transferred to the Xpert Urine Transport Reagent or Xpert CT/NGUrine Transport
Reagent tube (preserved urine specimen) can be shipped and/or stored up to 45 days at 2 °C to 15 °C, or up to 3 days
at 2 °C to 30 °C before testing with the Xpert CT/NG test.
samples stored in Xpert Swab Transport Reagent or Xpert CT/NG Swab Transport Reagent tubes should be
transported to the laboratory at 2 °C to 30 °C.
• Swab samples in Xpert Swab Transport Reagent or Xpert CT/NG Swab Transport Reagent tubes are stable up to 60 days at
2 °C to 30 °C before testing with the Xpert CT/NG test.
Endocervical, Urethral, Vaginal, Throat, Rectal swab in Xpert CT/NG Swab/G-50 transport tube (pink top).
Room temperature: 60 days
Refrigerated: 60 days
Frozen: unacceptable
• First catch urine specimens must be transferred to the Xpert Urine Transport Reagent or Xpert CT/NG Urine
Transport Reagent tubewithin 24 hours of primary collection if shipped and/or stored at room temperature.
• First catch male and female urine specimen NOT transferred to the Xpert Urine Transport Reagent or Xpert CT/NG Urine
TransportReagent tube (unpreserved urine specimen) can be shipped and/or stored for up to 8 days at 4 °C ± 2°C.
• First catch urine specimens that are transferred to the Xpert Urine Transport Reagent or Xpert CT/NGUrine Transport
Reagent tube (preserved urine specimen) can be shipped and/or stored up to 45 days at 2 °C to 15 °C, or up to 3 days
at 2 °C to 30 °C before testing with the Xpert CT/NG test.
samples stored in Xpert Swab Transport Reagent or Xpert CT/NG Swab Transport Reagent tubes should be
transported to the laboratory at 2 °C to 30 °C.
• Swab samples in Xpert Swab Transport Reagent or Xpert CT/NG Swab Transport Reagent tubes are stable up to 60 days at
2 °C to 30 °C before testing with the Xpert CT/NG test.
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
Sources other than urine, endocervical, pharyngeal or rectal; collection devices other than sterile container (urine) or Xpert collection kit (endocervical, pharyngeal or rectal)
Specimens exceeding stability limits.
Transport tubes with 2 swabs ∙ Specimens in broken containers ∙ Swab submitted in viral transport media ∙ Swab transport tubes with no swab ∙ Urine samples where the fluid level is not between the black fill lines
Specimens exceeding stability limits.
Transport tubes with 2 swabs ∙ Specimens in broken containers ∙ Swab submitted in viral transport media ∙ Swab transport tubes with no swab ∙ Urine samples where the fluid level is not between the black fill lines
Methodology
Cepheid Xpert CT/NG molecular assay for DNA by PCR
Setup Schedule
Every day 7am to 9pm
Limitations
The test has not been validated in patients less than 14 years of age, in pregnant women or in patients with a history of hysterectomy.
Endocervical - interference may be caused by:
Endocervical - interference may be caused by:
- blood at a concentration greater than 1% v/v
- Mucin at a concentration greater than 0.8% w/v
- Blood at a concentration greater than 0.3% v/v
- Mucin at a concentration greater than 0.2%w/v
- Bilirubin at a concentration greater than 0.2 mg/ml
- Vagisil feminine powder at a concentration greater than 0.2% w/v
Reference Range
Negative
