G/C Chlamydia by PCR, Range and Grand Itasca Only


Abbrev Code:CTNGP   
Order Code:LAB7085Order Name:G/C Chlamydia by PCR-HI, GH
Synonyms:GC; Chlamydia trachomatis; Neisseria gonorrhoeae
Methodology:Cepheid genomic real-time reverse-transcriptase PCR technology
CPT Codes: 87491 x1, 87594 x1
Turnaround Time:Performed and reported 24 hours/day.
Special Instructions:PCR testing is performed on genitourinary,urine. Refer to Chlamydia culture or Neisseria gonorrhoeae cultures for other sources.
Associated Links:

Xpert Endocervical Specimen Collection, Xpert Patient Collected Vaginal Swab Specimen Collection, Xpert Urine Specimen Collection for CT NG and TV Assays


Collection Instructions

Specimen:Female: Endocervical swab, vaginal swab or urine. Male: Urine
Female and Male (GICH only): Rectal and Throat: Use the same swab collection system as the Vaginal/Cervical
Container:GeneXpert Pink Vaginal Endocervical, GeneXpert Yellow Urine, See Collection Instructions
Alternate Containers: Plastic leakproof container, sterile
Collection Instructions:Follow manufacturer's collection instructions in the collection kit package. See Associated Links.
Causes for Rejection:
  • Leaking specimens
  • Any swab sample submitted to the lab with either no swab or any swab that was not from the Cepheid Vaginal/Endocervical Specimen Collection kit. Do not submit the cleaning swab.
  • Swabs collected on male patients. Urine specimens must be submitted for males.
  • Warning: Patient-collected vaginal swabs must be collected in a clinical setting where instructional support is available
  • Assays in which the internal sample adequacy control indicates the inability to detect human DNA are invalid, and the specimens must be recollected to yield a valid result.
  • Assay interference may be observed in the presence of blood (>1% v/v) or mucin (0.8% v/v). Adherence to the cleaning procedure for endocervical specimens is important to prevent mucin interference.
  • Specimens submitted for sources other than urine, vaginal or endocervical specimens. Specimens on alternate sources should be ordered for testing at IDDL.
 
Contraindications:Per manufacturer's package insert, the performance of the vaginal swab specimen has not been evaluated in pregnant women or teenage women less than 16 years of age.
The test is validated for pregnant patients at Fairview Range only.


Processing and Shipping

Specimen Processing:Store at room temperature.
Shipping Instructions:Ship at refrigerated temperature.
Test Performed at or Referral Lab Microbiology  (Grand Itasca, Range)


Interpretive

Reference Range:Not detected.
Limitations:The assay has not been validated in patients under 14 years of age, or over 83 years of age.
Use:This test detects the presence of Chlamydia trachomatis and Neisseria gonorrhoeae using Cepheid genomic real time reverse transcriptase PCR technology. Internal controls are able to determine if adequate human DNA is present in the specimen.


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