Chlamydia/N. gonorrhoeae and T. vaginalis RNA, Qualitative, TMA

Chlamydia/N. gonorrhoeae and T. vaginalis RNA, Qualitative, TMA

Test Code

16492
87491, 87591, 87661
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
16492
87491, 87591, 87661
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

Chlamydia/N. gonorrhoeae and T. vaginalis RNA, Qualitative, TMA - To diagnose three sexually transmitted infections associated with vaginitis.

Test Resources

Test FAQ

SureSwab® Trichomonas vaginalis RNA, Qualitative 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/Neisseria gonorrhoeae RNA, TMA, Urogenital
    Trichomonas vaginalis RNA, Qualitative, TMA

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, Urogenital Not detected
N. gonorrhoeae RNA, TMA, Urogenital Not detected
T. vaginalis RNA, QL, TMA Not detected

Alternative Name(s)

Vaginosis discharge,vaginal discharge,leukhorrea,asymptomatic cervicitis

LOINC® Codes, Performing Laboratory

Service Area must be determined
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
Trichomonas vaginalis RNA, Qualitative, TMA
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, Urogenital Not detected
N. gonorrhoeae RNA, TMA, Urogenital Not detected
T. vaginalis RNA, QL, TMA Not detected

Alternative Name(s)

Vaginosis discharge,vaginal discharge,leukhorrea,asymptomatic cervicitis
Service Area must be determined

Preferred Specimen(s)

1 vaginal swab in Aptima® Transport Tube or
1 endocervical swab in Aptima Transport Tube or
2 mL female urine in Aptima Transport Tube

Alternative Specimen(s)

Female or male Urine (no preservatives): 2 mL of urine, specimen must be transferred into the Aptima Urine Transport Medium within 24 hours of collection and before being assayed.

Minimum Volume

1 vaginal swab • 1 endocervical swab • 2 mL urine

Collection Instructions

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

Endocervical 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.

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

  • Swab in Aptima Transport
    Room temperature: 60 days
    Refrigerated: 60 days
    Frozen: 6 months

    Urine in Aptima Transport
    Room temperature: 30 days
    Refrigerated: 30 days
    Frozen: 6 months

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 • Pap vials

Setup Schedule

Service Area must be determined
1 vaginal swab in Aptima® Transport Tube or
1 endocervical swab in Aptima Transport Tube or
2 mL female urine in Aptima Transport Tube
Female or male Urine (no preservatives): 2 mL of urine, specimen must be transferred into the Aptima Urine Transport Medium within 24 hours of collection and before being assayed.
1 vaginal swab • 1 endocervical swab • 2 mL urine
Vaginal swab: Follow instructions in the Aptima Multitest Collection Kit (orange label).

Endocervical 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.
IMPORTANT: Please review the Specimen Collection instructions Specimen Collection guides for Aptima for this test
Aptima Transport Tube
Room temperature
Swab in Aptima Transport
Room temperature: 60 days
Refrigerated: 60 days
Frozen: 6 months

Urine in Aptima Transport
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 6 months
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 • Pap vials
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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