Test Overview
Test Methodology

DNA Amplification by Strand Displacement Amplification

Test Usage

Detection of Neisseria gonorrhoeae in male or female urogenital specimens.

Reference Range *

Negative

* Reference ranges may change over time. Please refer to the original patient report when evaluating results.

Test Limitations

Adequate specimen collection is important. Mucoid specimens may cause inhibition of the assay. Some feminine sprays, powders, spermicidal agents, and lubricants may interfere with the assay and should not be used prior to specimen collection. A negative result does not exclude the possibility of infection. Predictive value of test will vary depending on disease prevalence. Nucleic acids may persist for up to 4 weeks following appropriate antimicrobial therapy.

Test Details
Days Set Up
Monday - Friday
Analytic Time

1 day

Soft Order Code
GC
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection

Acceptable specimens include endocervix, vagina, and urethra. A specimen collected during menses is acceptable. A single swab from a urogenital specimen can be used for both Chlamydia trachomatis and Neisseria gonorrhoeae DNA amplification. The following specimens are unacceptable: white shaft cleaning swabs, wooden swabs, or Calgiswabs.
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ENDOCERVICAL SPECIMEN: Clean excess mucus from the cervical os and surrounding mucosa using the white shaft cleaning swab or other cleaning swab of choice. Discard cleaning swab; do not use white shaft cleaning swab to collect sample. Insert the small PINK swab from the collection kit 1 to 1.5 cm into the endocervical canal, rotate the swab clockwise for 15 to 30 seconds, and draw the swab back carefully avoiding any contact with the vaginal mucosa. Insert the swab all the way into the transport media immediately after specimen collection and bend the shaft of swab against the tube to break shaft; it is scored to break easily if the swab is inserted completely into transport. TIGHTEN LID OF TRANSPORT TUBE SECURELY TO PREVENT LOSS OF FLUID.
URETHRAL SPECIMEN: Insert the small BLUE swab from the collection kit 2 to 4 cm into the urethra, rotate clockwise for 3 to 5 seconds and withdraw. Insert the swab all the way into the transport media immediately after specimen collection and bend the shaft of swab against the tube to break shaft; it is scored to break easily if the swab is inserted completely into transport. TIGHTEN LID OF TRANSPORT TUBE SECURELY TO PREVENT LOSS OF FLUID.
VAGINAL SPECIMEN: Patient collected vaginal swab specimens are an option for screening women when a pelvic exam is not otherwise indicated; it is not for home use. Ensure the patient washes hands with soap and water. The patient should collect the sample by holding the swab with one hand and spreading skin outside the vagina. She should then insert the tip of the swab into the vaginal opening no more than 2 inches, gently rotate for 10 to 15 seconds, withdraw the swab and place the swab in the transport tube and cap securely. After collection, the patient should wash her hands and return the tube to the clinician.
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Alternate Specimen
M4-RT transport is acceptable. M4-RT kits may be stored at room temperature before use but should be refrigerated within an hour of specimen collection. However, constant refrigeration is not critical so it is okay for specimens to be placed in lock box at room temperature until pick up.
Rejection Criteria
White shaft cleaning swabs, wooden swabs, or Calgiswabs are not acceptable. BD Eswabs are not acceptable.
Contraindications
This assay should not be used for the evaluation of suspected sexual abuse or for other medico-legal investigations.
Normal Volume
1 swab
Minimum Volume
1 swab
Storage Temperature
Specimen collection kit room temperature or refrigerated for 30 days or -20C for 180 days. Dry swabs room temperature or refrigerated for 14 days or -20C for 180 days.
Additional Information

A single swab can be used for Chlamydia trachomatis, Neisseria gonorrhoeae, and/or Trichomonas vaginalis DNA Amplification. Transport tubes will be held for 1 week. Additional testing for Chlamydia trachomatis or Trichomonas vaginalis may be requested by contacting the MLabs Client Services Center.

Billing
CPT Code
87591
Fee Code
32302
LOINC
47387-6
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