Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital

Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital

Test Code

11363
87494
11363
87494
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital - C. trachomatis infections are the leading cause of sexually transmitted diseases in the United States. C. trachomatis is known to cause cervicitis, pelvic inflammatory disease (PID), epididymitis and proctitis. It is also the most frequent cause of non-gonococcal urethritis in men. Among women, the consequences of Chlamydial infections are severe if left untreated. Approximately half of Chlamydial infections are asymptomatic.
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Neisseria gonorrhoeae (gonococci) is the causative agent of gonorrhea. In men, this ...

Test Resources

Test FAQ

Chlamydia trachomatis and Neisseria gonorrhoeae RNA, TMA

Clinical Focus

Sexually Transmitted Infections Associated With Urethritis, Cervicitis, and PID

Test Guide

HIV Infection: Laboratory Testing for Diagnosis and Management

Specimen Handling - Specimen Collection Guide

Specimen Collection guides for Aptima

Test Details

Includes

  • Chlamydia trachomatis RNA, TMA, Urogenital
  • Neisseria gonorrhoeae RNA, TMA, Urogenital

Patient Preparation

Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.

Methodology

Transcription-Mediated Amplification (TMA)

Reference Range(s)

C. trachomatis RNA, TMA, UrogenitalNot detected
N. gonorrhoeae RNA, TMA, UrogenitalNot detected

Alternative Name(s)

CT/GC TMA,CT/NG TMA,CT/NG Aptima,CT/GC Aptima,Hologic

LOINC® Codes, Performing Laboratory

Service Area must be determined
Chlamydia trachomatis RNA, TMA, Urogenital
Neisseria gonorrhoeae RNA, TMA, Urogenital
Urine: Patient should not have urinated within one hour prior to collection. Female patients should not cleanse the labial area prior to providing the specimen.

Methodology

Transcription-Mediated Amplification (TMA)

Reference Range(s)

C. trachomatis RNA, TMA, UrogenitalNot detected
N. gonorrhoeae RNA, TMA, UrogenitalNot detected

Alternative Name(s)

CT/GC TMA,CT/NG TMA,CT/NG Aptima,CT/GC Aptima,Hologic
Service Area must be determined

Preferred Specimen(s)

1 vaginal swab in Aptima® Transport Tube or
1 endocervical or urethral swab in Aptima® Transport Tube or
2 mL urine in Aptima® Transport Tube or
1 mL liquid cytology ThinPrep® PreservCyt® in Aptima® Transfer Tube or
0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube

Minimum Volume

1 vaginal swab in Aptima Transport • 1 endocervical or urethral swab in Aptima Transport Tube • 2 mL urine in Aptima Transport Tube • 1 mL ThinPrep PreservCyt in Aptima Transfer Tube • 0.5 mL SurePath fluid in Aptima Transfer Tube

Collection Instructions

Vaginal swab: Follow instructions in the Aptima Multitest Collection Kit (orange label).

Endocervical or urethral swab: Follow instructions in the Aptima Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.

Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima Specimen Transport Tube within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.

Labs performing cytology: Aliquot ThinPrep® PreservCyt® solution before performance of liquid-based cytology testing.

ThinPrep PreservCyt : Transfer 1 mL ThinPrep PreservCyt solution into Aptima Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (white label).

SurePath: SurePath fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath solution into Aptima® Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).

Note: Results from the Aptima Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

The Aptima Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.

For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng

IMPORTANT: Please review the Specimen Collection instructions Specimen Collection guides for Aptima for this test

Transport Container

Aptima Transport Tube

Transport Temperature

Room temperature

Specimen Stability

  • ⁠⁠⁠⁠⁠⁠⁠Swabs in Aptima Transport Tube
    Room temperature: 60 days
    Refrigerated: 60 days
    Frozen: 1 year

    Urine in Aptima Transport Tube
    Room temperature: 30 days
    Refrigerated: 30 days
    Frozen: 1 year

    Liquid cytology ThinPrep PreservCyt
    Room temperature: 30 days
    Refrigerated: 30 days
    Frozen: 1 year

    ThinPrep PreservCyt in Aptima Transport Tube
    Room temperature: 14 days
    Refrigerated: 30 days
    Frozen: 1 year

    SurePath Preservative Fluid
    Room temperature: 14 days
    Refrigerated: 14 days
    Frozen: Unacceptable

Reject Criteria

Transport tubes with 2 swabs • Transport tubes with Non-Aptima swabs • Swab transport tubes with no swab • Specimens in broken containers • Swab submitted in viral transport media • Urine samples where the fluid level is not between the black fill lines • ThinPrep PreservCyt material previously processed for cytology • ThinPrep PreservCyt with excess mucus

Setup Schedule

Service Area must be determined
1 vaginal swab in Aptima® Transport Tube or
1 endocervical or urethral swab in Aptima® Transport Tube or
2 mL urine in Aptima® Transport Tube or
1 mL liquid cytology ThinPrep® PreservCyt® in Aptima® Transfer Tube or
0.5 mL SurePath™ Preservative Fluid in Aptima® Transfer Tube
1 vaginal swab in Aptima Transport • 1 endocervical or urethral swab in Aptima Transport Tube • 2 mL urine in Aptima Transport Tube • 1 mL ThinPrep PreservCyt in Aptima Transfer Tube • 0.5 mL SurePath fluid in Aptima Transfer Tube
Vaginal swab: Follow instructions in the Aptima Multitest Collection Kit (orange label).

Endocervical or urethral swab: Follow instructions in the Aptima Unisex Swab Specimen Collection Kit (white label). In females, to ensure collection of cells infected with N. gonorrhoeae/C. trachomatis, columnar epithelial cells lining the endocervix should be obtained. Excess mucus should be removed prior to sampling.

Urine: Direct patient to provide a first-catch urine (a maximum of 20-30 mL of the initial urine stream) into a urine collection cup free of any preservatives. 2 mL of urine specimen must be transferred into the Aptima Specimen Transport Tube within 24 hours of collection and before being assayed. Use the tube provided in the urine specimen collection kit. The fluid (urine plus transport media) level in the urine transport tube must fall within the clear pane of the tube label.

Labs performing cytology: Aliquot ThinPrep® PreservCyt® solution before performance of liquid-based cytology testing.

ThinPrep PreservCyt : Transfer 1 mL ThinPrep PreservCyt solution into Aptima Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Tube (white label).

SurePath: SurePath fluid must be transferred to Aptima® tube within 4 days of collection. Transfer 0.5 mL SurePath solution into Aptima® Specimen Transfer Tube (green label) or Aptima Multitest Collection Tube (orange label) or Unisex Swab Specimen Collection Kit (white label).

Note: Results from the Aptima Combo 2 Assay should be interpreted in conjunction with other laboratory and clinical data available to the clinician.

The Aptima Combo 2 Assay is not intended for the evaluation of suspected sexual abuse or for other medico-legal indications.

For a complete list of assay limitations we recommend that you review the manufacturers package insert, https://www.hologic.com/package-inserts/diagnostic-products/aptima-combo-2-assay-ctng
IMPORTANT: Please review the Specimen Collection instructions Specimen Collection guides for Aptima for this test
Aptima Transport Tube
Room temperature
⁠⁠⁠⁠⁠⁠⁠Swabs in Aptima Transport Tube
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year

Urine in Aptima Transport Tube
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

Liquid cytology ThinPrep PreservCyt
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

ThinPrep PreservCyt in Aptima Transport Tube
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year

SurePath Preservative Fluid
Room temperature: 14 days
Refrigerated: 14 days
Frozen: Unacceptable
Transport tubes with 2 swabs • Transport tubes with Non-Aptima swabs • Swab transport tubes with no swab • Specimens in broken containers • Swab submitted in viral transport media • Urine samples where the fluid level is not between the black fill lines • ThinPrep PreservCyt material previously processed for cytology • ThinPrep PreservCyt with excess mucus
Service Area must be determined
In-home collection may be available in your area for purchase through Quest Mobile.
Test Details

Clinical Significance

Test Resources

Reference ranges are provided as general guidance only. To interpret test results use the reference range in the laboratory report.

The CPT codes provided are based on AMA guidance and are for informational purposes only. CPT coding is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

This material contains content from LOINC® (http://loinc.org). The LOINC Table, LOINC Table Core are copyright © 1995-2019, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee and is available at no cost under the license at http://loinc.org/license.

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