Neisseria gonorrhoeae, TMA (Alternate Target), Urogenital

Neisseria gonorrhoeae, TMA (Alternate Target), Urogenital

Test Code

15033
87591
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
15033
87591
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
In-home collection may be available in your area for purchase through Quest Mobile.

Clinical Significance

Neisseria gonorrhoeae, TMA (Alternate Target), Urogenital - Several methods are available for the detection of N. gonorrhoeae in clinical specimens. These methods include: Observation of gram-negative intracellular diplococci in gram-stained smears of urethral discharges from men and of endocervical secretions from women; Growth of N. gonorrhoeae from the urethra (men) or endocervix on selective culture media followed by demonstration of typical colonial morphology; and/or detection of N. gonorrhoeae with non-culture laboratory tests. A definitive diagnosis of gonorrhoea requires: Isolation of N. gonorrhoeae from the sites of ...

Test Details

Methodology

Dual Kinetic Assay (DKA) • Target Capture • Transcription-Mediated Amplification (TMA)

Reference Range(s)

Not detected

Alternative Name(s)

NG APTIMA®,NG TMA,GC APTIMA®,GC TMA

LOINC® Codes, Performing Laboratory

Methodology

Dual Kinetic Assay (DKA) • Target Capture • Transcription-Mediated Amplification (TMA)

Reference Range(s)

Not detected

Alternative Name(s)

NG APTIMA®,NG TMA,GC APTIMA®,GC TMA

Preferred Specimen(s)

1 vaginal, endocervical or urethral swab collected in an APTIMA® Multitest Collection Tube, or Unisex Swab Specimen Collection Tube or
2 mL urine with no preservative transferred into an APTIMA® Urine Collection Tube or
1 mL ThinPrep® PreservCyt® transferred into APTIMA® Specimen Transfer Tube (green label) or APTIMA® Multitest Collection Tube (orange label)

Collection Instructions

Swabs: Swab must be submitted in APTIMA® Multitest collection Kit (orange label), or Unisex Swab Specimen Collection Kit (white label). Follow instructions in the APTIMA® Swab Specimen Collection Kits for Vaginal, Endocervical and Urethral Swab Specimens package insert. In females, to ensure collection of an adequate specimen, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling by using the white shaft cleaning swab which is discarded after use.
Collection Container: APTIMA® Multitest Collection Tube (orange label), or Unisex Swab Specimen Collection Tube (white label).

Urine: Urine must be submitted in APTIMA® Urine Specimen Collection Tube within 24 hours of collection. The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20-30 mL of the initial urine 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 the labial area prior to providing the specimen. Thus, a urine sample collected from a female for Chlamydia/GC TMA cannot be collected at the same voiding event as that urine which would be intended for bacterial culture. Remove the cap of the APTIMA® Urine Specimen Collection Tube and transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black lines within the clear pane on the urine specimen transport tube label.
Collection Container: APTIMA® Urine Specimen Collection Tube (white label).

ThinPrep® PreservCyt®: Transfer 1 mL of ThinPrep® PreservCyt® solution into APTIMA® Specimen Transfer Tube (green label) or APTIMA® Multitest Collection Tube (orange label).

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

  • Endocervical, urethral and vaginal swabs
    Room temperature: 60 days
    Refrigerated: 60 days
    Frozen: 1 year

    Urine in APTIMA® Urine Collection Tube
    Room temperature: 30 days
    Refrigerated: 30 days
    Frozen: 1 year

    ThinPrep® PreservCyt® solution specimen in APTIMA®
    Room temperature: 14 days
    Refrigerated: 30 days
    Frozen: 1 year

Reject Criteria

Transport tube with 2 swabs • Transport tubes with Non-Aptima® swabs • Swab transport tubes with no swab • Specimen 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

1 vaginal, endocervical or urethral swab collected in an APTIMA® Multitest Collection Tube, or Unisex Swab Specimen Collection Tube or
2 mL urine with no preservative transferred into an APTIMA® Urine Collection Tube or
1 mL ThinPrep® PreservCyt® transferred into APTIMA® Specimen Transfer Tube (green label) or APTIMA® Multitest Collection Tube (orange label)
Swabs: Swab must be submitted in APTIMA® Multitest collection Kit (orange label), or Unisex Swab Specimen Collection Kit (white label). Follow instructions in the APTIMA® Swab Specimen Collection Kits for Vaginal, Endocervical and Urethral Swab Specimens package insert. In females, to ensure collection of an adequate specimen, columnar epithelial cells lining the endocervix should be obtained. To that effect, excess mucus should be removed prior to sampling by using the white shaft cleaning swab which is discarded after use.
Collection Container: APTIMA® Multitest Collection Tube (orange label), or Unisex Swab Specimen Collection Tube (white label).

Urine: Urine must be submitted in APTIMA® Urine Specimen Collection Tube within 24 hours of collection. The patient should not have urinated for at least one hour prior to specimen collection. Direct patient to provide a first-catch urine (approximately 20-30 mL of the initial urine 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 the labial area prior to providing the specimen. Thus, a urine sample collected from a female for Chlamydia/GC TMA cannot be collected at the same voiding event as that urine which would be intended for bacterial culture. Remove the cap of the APTIMA® Urine Specimen Collection Tube and transfer 2 mL of urine into the urine specimen transport tube using the disposable pipette provided. The correct volume of urine has been added when the fluid level is between the black lines within the clear pane on the urine specimen transport tube label.
Collection Container: APTIMA® Urine Specimen Collection Tube (white label).

ThinPrep® PreservCyt®: Transfer 1 mL of ThinPrep® PreservCyt® solution into APTIMA® Specimen Transfer Tube (green label) or APTIMA® Multitest Collection Tube (orange label).
IMPORTANT: Please review the Specimen Collection instructions Specimen Collection guides for Aptima for this test
APTIMA® transport tube
Room temperature
Endocervical, urethral and vaginal swabs
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 1 year

Urine in APTIMA® Urine Collection Tube
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 1 year

ThinPrep® PreservCyt® solution specimen in APTIMA®
Room temperature: 14 days
Refrigerated: 30 days
Frozen: 1 year
Transport tube with 2 swabs • Transport tubes with Non-Aptima® swabs • Swab transport tubes with no swab • Specimen 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
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.

The tests listed by specialty and category are a select group of tests offered. For a complete list of Quest Diagnostics tests, please adjust the filter options chosen, or refer to our Directory of Services.