Neisseria gonorrhoeae RNA, TMA, Throat

Neisseria gonorrhoeae RNA, TMA, Throat

Test Code

70049
87591
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
70049
87591
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
In-home collection is not available in your area through Quest Mobile.

Clinical Significance

Neisseria gonorrhoeae RNA, TMA, Throat - Neisseria gonorrhoeae may infect the oral/pharyngeal cavity of sexually active individuals. Detection of this organism may be important for determining the risk for disease progression or transmission.

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

Methodology

Transcription-Mediated Amplification (TMA)

Assay Category

The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

Not detected

Alternative Name(s)

NG APTIMA®,NG TMA,GC APTIMA®,GC TMA

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Transcription-Mediated Amplification (TMA)
The analytical performance characteristics of this assay have been determined by Quest Diagnostics. The modifications have not been cleared or approved by the FDA. This assay has been validated pursuant to the CLIA regulations and is used for clinical purposes.

Reference Range(s)

Not detected

Alternative Name(s)

NG APTIMA®,NG TMA,GC APTIMA®,GC TMA
Service Area must be determined

Preferred Specimen(s)

1 throat swab submitted in Aptima® Multitest transport tube

Alternative Specimen(s)

Aptima Unisex Swab Specimen Collection Kit (white label)

Minimum Volume

1 throat swab submitted in Aptima Multitest transport tube

Collection Instructions

Use the Aptima Multitest transport tube (orange label). Using a tongue depressor, insert the swab and vigorously rub the tonsils and the posterior pharynx. Carefully remove the swab without touching any area of the mouth. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. Carefully break the swab shaft at the score line. Re-cap the swab specimen transport tube tightly, label and ship to the lab.

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 Multitest transport tube (orange label)

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 30 days
    Refrigerated: 30 days
    Frozen: 30 days

Reject Criteria

Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Specimens in broken containers • Swab submitted in M4 transport media • Swabs submitted in Viral Culture Media (VCM)

Setup Schedule

Service Area must be determined
1 throat swab submitted in Aptima® Multitest transport tube
Aptima Unisex Swab Specimen Collection Kit (white label)
1 throat swab submitted in Aptima Multitest transport tube
Use the Aptima Multitest transport tube (orange label). Using a tongue depressor, insert the swab and vigorously rub the tonsils and the posterior pharynx. Carefully remove the swab without touching any area of the mouth. Remove the cap from the swab specimen transport tube and immediately place the swab into the transport tube. Carefully break the swab shaft at the score line. Re-cap the swab specimen transport tube tightly, label and ship to the lab.

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 Multitest transport tube (orange label)
Room temperature
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 30 days
Transport tubes with 2 swabs • Transport tubes with non-Aptima® swabs • Specimens in broken containers • Swab submitted in M4 transport media • Swabs submitted in Viral Culture Media (VCM)
Service Area must be determined
In-home collection is not available in your area 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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