SureSwab® Advanced Bacterial Vaginosis (BV), TMA

SureSwab® Advanced Bacterial Vaginosis (BV), TMA

Test Code

10016
81513
CPT Code is subject to a Medicare Limited Coverage Policy and may require a signed ABN when ordering.
10016
81513
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

SureSwab® Advanced Bacterial Vaginosis (BV), TMA - This test is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.

Test Resources

Test FAQ

SureSwab® Advanced Bacterial Vaginosis (BV), TMA

Clinical Focus

Vaginitis: Laboratory Testing for Diagnosis and Management

Test Details

Methodology

Transcription Mediated Amplification (TMA)

Reference Range(s)

Negative

Alternative Name(s)

Vaginitis,vaginal discharge,Leukorrhea,Vaginal itching,Vulvovaginitis,Fishy odor discharge

LOINC® Codes, Performing Laboratory

Service Area must be determined

Methodology

Transcription Mediated Amplification (TMA)

Reference Range(s)

Negative

Alternative Name(s)

Vaginitis,vaginal discharge,Leukorrhea,Vaginal itching,Vulvovaginitis,Fishy odor discharge
Service Area must be determined

Preferred Specimen(s)

1 vaginal swab collected in Aptima® Multitest Transport tube

Minimum Volume

1 swab

Collection Instructions

Follow instructions in the Aptima® Multitest collection kit (orange label)

Performance of the assay has not been evaluated in individuals less than 14 years of age.
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-bv-assay

Transport Container

Aptima® Multitest Transport Tube

Transport Temperature

Room temperature

Specimen Stability

  • Room temperature: 30 days
  • Refrigerated: 30 days
  • Frozen: 60 days

Reject Criteria

Transport tube with no swab • Transport tube with 2 swabs • Transport tube containing cleaning swab • Transport tube with non-Aptima swabs • Transport tube submitted with swab inverted • Swab submitted in viral transport media • Samples with excess mucus • Specimens submitted in Aptima tubes with pierced foil lids • Patients less than 14 years of age

Setup Schedule

Service Area must be determined
1 vaginal swab collected in Aptima® Multitest Transport tube
1 swab
Follow instructions in the Aptima® Multitest collection kit (orange label)

Performance of the assay has not been evaluated in individuals less than 14 years of age.
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-bv-assay
Aptima® Multitest Transport Tube
Room temperature
Room temperature: 30 days
Refrigerated: 30 days
Frozen: 60 days
Transport tube with no swab • Transport tube with 2 swabs • Transport tube containing cleaning swab • Transport tube with non-Aptima swabs • Transport tube submitted with swab inverted • Swab submitted in viral transport media • Samples with excess mucus • Specimens submitted in Aptima tubes with pierced foil lids • Patients less than 14 years of age
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.

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.

Customize the test information for your Service Area
We'd love your feedback! Take a brief survey.