EPIC Code

LAB4739
CTNGAMP

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

  • Urine
  • Genital
  • Rectal
  • Throat
  • Eye swab: ARUP

Genital, Rectal, Throat, or Eye: HOLOGIC Aptima® Unisex Swab Specimen Collection Kit or Aptima® Multitest Swab Collection Kit.

Urine: HOLOGIC Aptima® Urine Specimen Collection Kit.
Acceptable: >2 mL of urine in a Clear Top (no additive, sterile container) received in lab within 24 hours of collection.


Do NOT dip swabs in urine.


Patient Preparation

For urine collections, first-catch (“dirty”) urine is preferred.

Specimen Preparation

Genital, Rectal, Throat, or Eye: Follow collection instructions on package insert. Make sure to place the blue collection swab in the Aptima® Swab Specimen Transfer Tube (not the white cleaning swab). Or for the Aptima® Multitest Swab Transport Media (STM), the pink swab.

Urine: Follow instructions on package and use the disposable pipette provided to transfer 2 mL of urine into the HOLOGIC Aptima® Urine Specimen Transport Tube within 24 hours of collection. Correct volume of urine is added when fluid level is between the black fill lines on the Urine Specimen Transport Tube.
Acceptable: >2 mL of urine in a Clear Top (no additive, sterile container) received in lab within 24 hours of collection.

Unacceptable Conditions

General:
  • Sources other than urine, genital, throat, rectal, or eye.
  • Punctured or damaged foil caps.
  • Specimens in any transport media other than those indicated above.
  • Sample not properly identified, incorrect container, insufficient volume, or past stability.
Genital, Rectal, Throat, or Eye (Aptima® Swabs):
  • ESwabs®.
  • Aptima® Unisex Swab Specimen Transfer Tube submitted without the blue collection swab.
Urine:
  • Aptima® Swab Collection Kits filled with urine or swab dipped in urine.
  • Urine not transferred to Aptima® Urine Specimen Transport Tube within 24 hours of collection.
  • Aptima® Urine Tubes with fluid level not between the black fill lines on the Aptima® Urine Tube.
  • Lab Note: Samples processed in lab using non-sterile technique—including samples previously tested with a “common needle” on an instrument (e.g., Sysmex)—are unacceptable.

Storage/Transport Temperature

Ambient

Performed

Daily

Stability (from collection to initiation)

Room Temp: ≥30 days
Refrigerated: ≥30 days
Frozen: Not preferred
Note: Urine must be transferred to an Aptima® Urine Specimen Transport Tube within 24 hours of collection.

Remarks

​​​​​​Specimen source must be identified on order or requisition.

This test detects Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in urine, genital, rectal, throat, and eye (ARUP Labs) samples.

Performed

Daily

Methodology

Qualitative Transcription-Mediated Amplification (TMA) using HOLOGIC Panther® system

Reported

1–2 days

Synonyms

  • CTNGAMP
  • Chlamydia/Gonorrhea Amplification
  • CTNG Amplification
  • Chlamydia/GC Gen Probe
  • Chlamydia/GC Panel
  • Chlamydia trachomatis Amplification
  • Neisseria gonorrhoeae Amplification
  • C. trachomatis and N. gonorrhoeae by TMA
  • 0060241 Chlamydia trachomatis and Neisseria gonorrhoeae by Transcription-Mediated Amplification (TMA)
  • CT/NG TMA
  • Chlamydia/GC

Ordering Recommendations

Order will route to in-house or reference lab (eye swab to ARUP) test based upon the Specimen Type/Source selected.

For LGV (L1-L3) testing in patients with positive Chlamydia trachomatis see LAB2041 CHLAMYDIA TRACHOMATIS LGV (SEROVARS L1-L3) PCR.

EPIC Code

LAB4739
CTNGAMP

Reference Interval

C TRACHOMATIS AMPLIFICATION Not Detected
N GONORRHOEAE AMPLIFICATION Not Detected

Interpretive Data

Interpretation:
Not detected (C. Trachomatis or N. gonorrhoeae) = Negative, organisms not detected

Detected (C. Trachomatis or N. gonorrhoeae) = Positive, organisms detected

Methodology:
This assay utilizes target capture, transcription-mediated amplification, and dual kinetic assay.   A positive result should be coupled with clinical indicators for diagnosis.  A "Not detected" result for this assay does not exclude C. trachomatis or N. gonorrhoeae involvement in a disease process.  This test has been approved by the U.S. Food and Drug Administration for testing the following sample types: endocervical, vaginal, male urethral, male urine, and patient collected vaginal swabs.  Other sample types are not FDA-approved but were validated by the UCH Molecular Diagnostics Laboratory. This test is used for clinical purposes.  It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.

The APTIMA Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For those patients for whom a false positive result may have adverse psycho-social impact, the CDC recommends retesting.

CPT Codes

87491; 87591

Collection

EPIC Code

LAB4739
CTNGAMP

Performing Lab

UCHealth University of Colorado Hospital Clinical Laboratory - Molecular Diagnostics

Collect

  • Urine
  • Genital
  • Rectal
  • Throat
  • Eye swab: ARUP

Genital, Rectal, Throat, or Eye: HOLOGIC Aptima® Unisex Swab Specimen Collection Kit or Aptima® Multitest Swab Collection Kit.

Urine: HOLOGIC Aptima® Urine Specimen Collection Kit.
Acceptable: >2 mL of urine in a Clear Top (no additive, sterile container) received in lab within 24 hours of collection.


Do NOT dip swabs in urine.


Patient Preparation

For urine collections, first-catch (“dirty”) urine is preferred.

Specimen Preparation

Genital, Rectal, Throat, or Eye: Follow collection instructions on package insert. Make sure to place the blue collection swab in the Aptima® Swab Specimen Transfer Tube (not the white cleaning swab). Or for the Aptima® Multitest Swab Transport Media (STM), the pink swab.

Urine: Follow instructions on package and use the disposable pipette provided to transfer 2 mL of urine into the HOLOGIC Aptima® Urine Specimen Transport Tube within 24 hours of collection. Correct volume of urine is added when fluid level is between the black fill lines on the Urine Specimen Transport Tube.
Acceptable: >2 mL of urine in a Clear Top (no additive, sterile container) received in lab within 24 hours of collection.

Unacceptable Conditions

General:
  • Sources other than urine, genital, throat, rectal, or eye.
  • Punctured or damaged foil caps.
  • Specimens in any transport media other than those indicated above.
  • Sample not properly identified, incorrect container, insufficient volume, or past stability.
Genital, Rectal, Throat, or Eye (Aptima® Swabs):
  • ESwabs®.
  • Aptima® Unisex Swab Specimen Transfer Tube submitted without the blue collection swab.
Urine:
  • Aptima® Swab Collection Kits filled with urine or swab dipped in urine.
  • Urine not transferred to Aptima® Urine Specimen Transport Tube within 24 hours of collection.
  • Aptima® Urine Tubes with fluid level not between the black fill lines on the Aptima® Urine Tube.
  • Lab Note: Samples processed in lab using non-sterile technique—including samples previously tested with a “common needle” on an instrument (e.g., Sysmex)—are unacceptable.

Storage/Transport Temperature

Ambient

Performed

Daily

Stability (from collection to initiation)

Room Temp: ≥30 days
Refrigerated: ≥30 days
Frozen: Not preferred
Note: Urine must be transferred to an Aptima® Urine Specimen Transport Tube within 24 hours of collection.

Remarks

​​​​​​Specimen source must be identified on order or requisition.

This test detects Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG) in urine, genital, rectal, throat, and eye (ARUP Labs) samples.
Ordering

Performed

Daily

Methodology

Qualitative Transcription-Mediated Amplification (TMA) using HOLOGIC Panther® system

Reported

1–2 days

Synonyms

  • CTNGAMP
  • Chlamydia/Gonorrhea Amplification
  • CTNG Amplification
  • Chlamydia/GC Gen Probe
  • Chlamydia/GC Panel
  • Chlamydia trachomatis Amplification
  • Neisseria gonorrhoeae Amplification
  • C. trachomatis and N. gonorrhoeae by TMA
  • 0060241 Chlamydia trachomatis and Neisseria gonorrhoeae by Transcription-Mediated Amplification (TMA)
  • CT/NG TMA
  • Chlamydia/GC

Ordering Recommendations

Order will route to in-house or reference lab (eye swab to ARUP) test based upon the Specimen Type/Source selected.

For LGV (L1-L3) testing in patients with positive Chlamydia trachomatis see LAB2041 CHLAMYDIA TRACHOMATIS LGV (SEROVARS L1-L3) PCR.

EPIC Code

LAB4739
CTNGAMP

Result Interpretation

Reference Interval

C TRACHOMATIS AMPLIFICATION Not Detected
N GONORRHOEAE AMPLIFICATION Not Detected

Interpretive Data

Interpretation:
Not detected (C. Trachomatis or N. gonorrhoeae) = Negative, organisms not detected

Detected (C. Trachomatis or N. gonorrhoeae) = Positive, organisms detected

Methodology:
This assay utilizes target capture, transcription-mediated amplification, and dual kinetic assay.   A positive result should be coupled with clinical indicators for diagnosis.  A "Not detected" result for this assay does not exclude C. trachomatis or N. gonorrhoeae involvement in a disease process.  This test has been approved by the U.S. Food and Drug Administration for testing the following sample types: endocervical, vaginal, male urethral, male urine, and patient collected vaginal swabs.  Other sample types are not FDA-approved but were validated by the UCH Molecular Diagnostics Laboratory. This test is used for clinical purposes.  It should not be regarded as investigational or for research. This laboratory is certified under the Clinical Laboratory Improvement Amendment of 1988 ("CLIA") as qualified to perform high complexity clinical testing.

The APTIMA Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications. For those patients for whom a false positive result may have adverse psycho-social impact, the CDC recommends retesting.
Administrative

CPT Codes

87491; 87591

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