Amplified Nucleic Acid CT/GC

CERNER / EPIC MNEMONIC: PRB CHL/GC
POE DESCRIPTION:

Amplified Probe Chlm and GC

CPT CODE:

87491, 87591

CDM NUMBER:

3421089

TEST INFORMATION:

The Aptima Combo 2 Assay is a target amplification nucleic acid probe test for the detection of rRNA from Chlamydia trachomatis and/or Neisseria gonorrhoeae.

DAYS PERFORMED:

Monday-Friday

TURNAROUND TIME: 24-72 hours
SPECIAL INSTRUCTIONS:

The specific anatomic site of the specimen MUST be specified on the order or requisition.

Additional Collection Information:
Urine: Collection for male and female  Patient should not have urinated for 1 hour prior to specimen collection. Direct patient to provide approximately 20 - 30 ml of initial stream into a urine collection cup free of any preservatives. Collection of larger volumes of urine may result in specimen dilution that may reduce test sensitivity. Female patients should NOT cleanse labial area prior to providing specimen. Remove cap from Aptima urine transport tube and transfer 2 ml of urine into urine specimen transport tube using disposable pipette provided. The correct volume of urine has been added when fluid level is between black fill lines on urine specimen transport tube label. Re-cap urine specimen transport tube tightly.   Alternatively, urine specimens still in the primary collection container may be submitted to the laboratory within 24 hours of collection.

CONTAINER TYPE:

1 unisex swab (for endocervical or urethral) in Gen-Probe Aptima  transport medium; preservative free urine in  cup or 2ml of urine added to Aptima  urine transport medium

COLLECTION:

Endocervical: Remove excess mucus from the cervical os and surrounding mucosa using cleaning swab (white shaft swab).  Discard the swab. Insert the specimen collection (blue shaft) swab into the endocervical canal. Rotate the swab for 10 -30 seconds to ensure adequate sampling. Withdraw the swab carefully to avoid any contact with the vaginal mucosa. Insert the swab into the Aptima transport medium. Break off the swab shaft to fit the tube, then cap the tube, tightly.

Urethra: Patients should not have urinated for 1 hour prior to sample collection. Collect the urethral exudate or insert the swab from the collection kit 2- 4 cm into the urethra. Rotate the swab gently using sufficient pressure to ensure the swab comes in to contact with all urethral surfaces. Allow the swab to remain inserted for 2-3 seconds. Withdraw swab and insert into Aptima transport medium. Break off the swab shaft to fit the tube, then cap the tube.

See SPECIAL INSTRUCTIONS and ADDITIONAL INFORMATION for urine.

SPECIMEN REQUIREMENTS:

Endocervical, or urethral swab; urine

REJECTION CRITERIA: Improper collection and/or transport of specimen (ie. Gen-Probe Aptima collection kit and/or transport medium not used); more than one swab submitted in transport container; specimens from sites other than endocervix, urethra, or urine; insufficent quantity of specimen;  Gen-Probe Aptima urine tube over or underfilled.
MINIMUM VOLUME:

One (blue) swab in Aptima Gen-Probe transport medium
20 -30 mL urine in sterile urine cup
2 ml urine added to Aptima urine transport tube

HANDLING INSTRUCTIONS: Specimen should be transported as soon as possible. When transportation is delayed, leave at room temperature.
REFERENCE RANGE:

No Neisseria gonorrhoeae or Chlamydia trachomatis detected.

LIMITATIONS OF TEST:  A  negative urine result for Neisseria gonorrhoeae from a female patient  has a lower sensitivity than does an endocervical or vaginal swab result (91.3 % for urine, versus 99.3 % for endocervical swabs) (Gaydos CA et al. Journal  Clinical Microbiology, 2003; 41:304-9).       Results obtained by nucleic acid amplification probe testing should not be used for medicolegal purposes.  Neisseria gonorrhoeae or Chlamydia trachomatis cultures must be performed in such cases.
METHODOLOGY: Transcription Mediated  Amplification and non isotopic nucleic acid probe testing
ADDITIONAL INFORMATION:

Patients in whom Neisseria gonorrhoeae or Chlamydia trachomatis is detected  are reported to the City of Chicago Board of Health.  This is mandated by law.

LAST UPDATED:

7-3-2013

TEST SYNONYM(S):PCR, TMA or Amplification for Chlamydia trachomatis or Neisseria gonorrhoeae; Gen-Probe for Neisseria gonorrhoeae or Chlamydia trachomatis; DNA Probe for Neisseria gonorrhoeae or Chlamydia trachomatis; Gonorrhoeae by DNA Probe; Chlamydia by DNA Probe