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Test Code GCAPR GC Amplified Probe

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.

 

Female endocervical swab collection: Remove excess mucus from the cervical os and surrounding mucosa using the cleaning swab (white shaft).  Discard this swab.  Insert the specimen collection swab (blue shaft) into the endocervical canal.  Gently rotate the swab clockwise for 10 - 30 seconds to ensure adequate sampling. Withdraw swab; avoid contact with vaginal mucosa.  Remove cap from specimen transport tube and immediately place BLUE specimen collection swab in the transport tube.  Break swab shaft at the scoreline and recap the swab specimen transport tube tightly.  Use of the BLUE unisex specimen collection swab included in the GenProbe Aptima® swab collection kit is required.

 

Male urethral swab collection: Patient should refrain from urinating for at least 1 hour prior to sample collection. Insert the specimen collection swab (blue shaft) 2-4 cm into the urethra.  Gently rotate swab clockwise for 2 - 3 seconds to ensure adequate sampling.  Withdraw swab. Remove cap from specimen transport tube and immediately place BLUE specimen collection swab into the transport tube.  Break swab shaft at the scoreline and recap the swab specimen transport tube tightly.

 

Rectal/Pharyngeal swab collection: Insert the specimen collection swab (blue shaft) into anal canal or pharynx.  Gently rotate swab clockwise for 2-3 seconds to ensure adequate sampling.  Withdraw swab.  Remove cap from specimen transport tube and immediately place blue specimen collection swab into transport tube.  Break swab shaft at the scoreline and recap the swap specimen transport tube tightly.

Collection Container

GenProbe Aptima® swab (Aptima® collection kits are available through Client Service, (413) 322-4000 option 5

Specimen Required

Urogenital swab: Male urethral or female cervical/endocervical or vaginal swab in appropriate Unisex GenProbe Aptima® swab transport tube.

Rectal/Pharyngeal swab: Male or female rectal or pharyngeal swab placed in Unisex GenProbe Aptima® swab transport tube.

Specimen Volume

Swab: GenProbe Aptima® swab for each source

Transport Temperature

2 - 30° C

Specimen Stability

Store swab in GenProbe Aptima® tube. Swab specimens must be tested within 60 days of collection.  

Reasons for Rejection

Swab specimens collected into the Aptima® transport tubes received without a swab other than urine; Aptima® transport tube received containing the white “cleaning” swab instead of the collection swab.

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

59035