Test Overview
Test Methodology

DNA Amplification by Strand Displacement Amplification

Test Usage

Detection of Neisseria gonorrhoeae in male or female rectal specimens.

Reference Range *

Negative

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
GCR
Laboratory
Microbiology
Section
Microbiology
Specimen Requirements
Collection

A single swab from a rectal specimen can be used for both Chlamydia trachomatis and Neisseria gonorrhoeae DNA amplification. Swab rectal site. 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. The following specimens are unacceptable: white shaft cleaning swabs, wooden swabs, or Calgiswabs.

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 both Chlamydia trachomatis and Neisseria gonorrhoeae DNA Amplification if both tests are requested. Transport tubes will be held for 1 week. Additional testing for Chlamydia trachomatis may be requested by contacting the MLabs Client Services Center.

Billing
CPT Code
87591
Fee Code
32302
NY State Approved
No