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Test Code UGCAPR GC Amplified Probe, Urine

Additional Information

Limitations: A Negative result does not preclude infection with C. trachomatis or N. gonorrhoeae because results are dependent on adequate specimen collection, absence of inhibitors, and sufficient rRNA to be detected. The Aptima® Combo2 assay is not intended for the evaluation of suspected sexual abuse or for other medicolegal indications such as testing patients at age younger than 13 years old.  As is true for all non-culture methods, a positive specimen obtained from a patient after therapeutic treatment cannot be interpreted as indicating the presence of viable C trachomatis or N. gonorrhoeae.
Therapeutic failure or success cannot be determined with Aptima® Combo2 assay since nucleic acid may persist following appropriate antimicrobial therapy.  A negative urine result for a patient who is clinically suspected of having a chlamydial infection does not rule out the presence of C. trachomatis or N. gonorrhoeae in the urogenital tract. Testing of an endocervical (female) or urethral (male) specimen is recommended if there is high clinical suspicion of infection.

 

Urine collection: Patient should not have urinated for at least 1 hour prior to specimen collection.  The patient should be instructed not to cleanse the area and to collect the first 20 - 30mL of voided urine, the first part of the stream rather than a midstream specimen. 2 mL of collected urine sample must be carefully transferred to an Aptima® urine transport tube within 24 hours of collection.

Collection Container

GenProbe Aptima® urine transport tube (Aptima® collection kits are available through Client Service, (413) 322-4000 option 5, ThinPrep PreservCyt® liquid Pap vial

Specimen Required

Urine: First void urine, or patient should not have urinated for at least one hour prior to specimen collection, transferred to GenProbe Aptima® urine transport tube (see “collection” for details).

 

Specimen Volume

Urine: 20 - 30 mL

 

Transport Temperature

2 - 30° C

Specimen Stability

Store urine specimens in GenProbe Aptima® tube. Urine specimen in transport tube must be tested within 30 days. Fresh urine must be transferred to Aptima® tube within 24 hours of collection. 

Reasons for Rejection

Urine specimens not transferred to Aptima® urine transport tube within 24 hours of collection; urine specimen collected as “clean catch” midstream.

Methodology

The GenProbe Aptima® Combo2 assay is a second generation nucleic acid amplification test that utilized target capture, transcription-mediated amplification, and hybridization protection asay technologies to streamline specimen processing, amplify target rRNA and detect amplicon, respectively.

Days and Times Performed

Daily; testing performed Monday - Friday

Turnaround Time

24 - 72 hours

Reference Ranges

No Chlamydia trachomatis RNA detected; no Neisseria gonorrhoeae RNA detected

CPT Code

87491 (Chlamydia amplified probe); 87591 (Gonorrhoeae amplified probe)

EMR Interface Order Code

59010