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Catalog ID PCR CT+NG Chlamydia trachomatis and Neisseria gonorrhoeae DNA Amplification

CPOE Test Name

PCR Amplified Chlamydia and Gonorrhea

Synonyms

CTNGAMP; Chlamydia/Gonorrhea Amplification; CT/NG

Specimen Type

Endocervical swab; urine (male or female)

Specimen Requirements

Correct specimen collection is crucial. Specimen collection kits are available in the Microbiology Lab, 1-2807. Both Chlamydia and gonorrhea testing are performed on the same specimen.

 

Submit only 1 of the following specimens:

 

Specimen Type: Urine, random

Container/Tube: sterile urine cup

Volume: 20-50mL

Collection Instructions: This assay should be performed on 20-50mL of the initial urine stream. Collection of larger volumes of urine or midstream collection may result in specimen dilution that may cause false-negative results. Submit within 1 hour to the Microbiology lab.

 

Specimen Type: Endocervical swab

Container/Tube: Xpert Vaginal/Endocervical Swab Collection Kit (pink top)

Volume: 1 swab

Collection Instructions:

  1. Collection kit contains Individual Collection Kit and Cleaning Swab.
  2. Remove excess mucus from the cervix and surrounding area using the large individually wrapped cleaning swab. Discard the swab.
  3. Open package that contains the pin-capped Xpert Swab Transport Reagent tube and individually wrapped swab. Open the collection swab wrapper by peeling open the top of the wrapper.
  4. Hold the swab in your hand, placing your thumb and forefinger in the middle of the swab shaft.
  5. Insert the collection swab into the endocervical canal. Rotate the swab clockwise for 10-30 seconds in the endocervical canal. Withdraw the swab carefully.
  6. Unscrew the cap from the transport tube. Immediately place the specimen collection swab into the transport reagent tube.
  7. Identifying the scoreline, break the swab shaft against the side of the tube. Discard the top portion of the swab shaft.
  8. Re-cap the swab transport reagent tube and tighten the cap securely.
  9. Label the transport tube with sample ID, including date and time of collection.
  10. Transport to lab.

Storage and Transport

Swabs should be transported at ambient temperature. Sterile cups of urine should be immediately placed on wet ice or refrigerated.

Causes for Rejection

Improper collection kit used; improper swab used for collection; improper labeling; delay in transit; specimens other than those listed.

Reference Range

No Chlamydia trachomatis or Neisseria gonorrhoeae DNA detected.

Interpretation

A positive result indicates the presumptive presence of Chlamydia trachomatis and/or Neisseria gonorrhoeae in the specimen.

 

This nucleic acid amplification test (NAAT) detects genomic DNA from Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) using qualitative real-time PCR. This test is approved by the USA Food and Drug Administration for endocervical swab specimens and male and female urine specimens. The performance characteristics for these specimen types have been verified by the AU Medical Center Microbiology Laboratory. The performance characteristics of this test have not been evaluated in pregnant women or individuals less than 14 years of age. This assay should not be used for the evaluation of suspected sexual abuse or for other medico-legal indications. This test detects both viable and non-viable organisms and should not be used for test of cure.

Test Consists

Extraction, amplification, and detection of both Neisseria gonorrheae and Chlamydia trachomatis DNA. Testing performed using the Cepheid Xpert CT/NG molecular assay. 

Turn Around Time

Test is performed Monday-Sunday, turnaround time < 24 hours

 

Performing Lab

Microbiology BA-1672

721-2807

Methodology

PCR

CPT / HCPCS Code

N. gonorrhoeae detection 87591; C. trachomatis detection 87491; Concentration 87015

Special Instructions

Positive results are reported to the county and state health departments. Results called to the physician or unit upon request.