Sign in →

Test Code M14 Chlamydia/GC PCR, Urine

Important Note

Assay interference may be observed in the presence of blood, mucin, bilirubin, or Vagisil feminine powder with urine specimens.

The Xpert CT/NG Assay provides qualitative results. No correlation can be drawn between the magnitude of the Ct value and the number of cells in an infected sample.

Xpert CT/NG Assay performance has not been evaluated in patients less than 14 years of age.

Xpert CT/NG Assay performance has not been evaluated in pregnant women, or in patients with a history of hysterectomy.

The Xpert CT/NG Assay has not been evaluated with patients who are currently being treated with antimicrobial agents active against CT or NG.

A negative test result does not exclude the possibility of infection because test results may be affected by improper specimen collection, technical error, specimen mix-up, concurrent antibiotic therapy, or the number of organisms in the specimen which may be below the sensitivity of the tests.

The Xpert CT/NG Assay should not be used for the evaluation of suspected sexual abuse or for other medico-legal indications. Additional testing is recommended in any circumstance when false positive or false negative results could lead to adverse medical, social, or psychological consequences.

Additional Codes

ALAB: CTGCU

PowerChart: Chlamydia/GC PCR Urine

MA Cerner: Chlamydia/GC rPCR-Urine

Test Method

Polymerase Chain Reaction (PCR); Cepheid, GeneXpert

Specimen Requirement

Urine collected from a female or male subject using Xpert Urine Specimen Collection Kit (Cepheid #URINE/A-50) is required.

Additional Specimen Collection Information

Urine Specimens

 

Collection Instructions:

  1. The patient should not have urinated for at least 1 hour prior to specimen collection.
  2. Female patients should not cleanse the labial area prior to specimen collection.
  3. Male patients should not cleanse the tip of the penis prior to specimen collection.
  4. Direct patient to provide first-catch urine into a urine collection cup free of any preservatives.
  5. Ensure that urine is well mixed in the urine cup before transferring sample to the Xpert Urine Transport Reagent tube.
  6. Obtain an Xpert CT/NG Urine Specimen Collection Kit.
  7. Insert the provided disposable transfer pipette into the urine cup so that the tip is near the bottom of the cup. Transfer approximately 7 ml of urine into the Urine Transport Reagent tube (yellow cap). The correct volume has been added when the liquid level reaches the black dashed line on the label.
  8. Recap the transport tube and tighten securely. Invert the tube 3-4 times to ensure proper mixing.
  9. Label the plastic transport tube with the patient name, patient identification number, date & time of collection and the initials of the nurse who collected the specimen.

Interfering Substances: 
Interference may be observed in the presence of blood, mucin, bilirubin, or Vagisil feminine powder with urine specimens.

 

Storage:

  1. Female urine not in transport tubes: 24 hours at room temperature, 8 days refrigerated.
  2. Male urine not in transport tubes: 3 days at room temperature, 8 days refrigerated.
  3. Female urine in Xpert Transport tubes: 3 days at room temperature, 45 days refrigerated.
  4. Male urine in Xpert Transport tubes: 45 days at room temperature or refrigerated.

Performance

Testing is performed Monday through Sunday.

Typically completed the same day the specimen arrives at the testing site.

Reference Values

Chlamydia trachomatis PCR: Negative

Neisseria gonorrhoeae PCR: Negative

 

All positive results are reported to the Iowa Department of Public Health.

CPT Code Information

87491 Detection Infectious Agents by Probe Techniques; Chlaydia trachomatis, amplified probe technique

87591 Detection Infectious Agents by Probe Techniques; Neisseria gonorrhoeae, amplified probe technique

Useful For

Detection of Chlamydia trachomatis or Neisseria gonorrhoeae.

LOINC Code Information

72828-7 Chlamydia trachomatis and Neisseria gonorrhoeae DNA panel - Unspecified specimen

Related Tests