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SureSwab® Advanced Bacterial Vaginosis (BV), TMA
Test Code10016
CPT Codes
81513
Preferred Specimen
1 vaginal swab collected in Aptima® Multitest Transport tube
Minimum Volume
1 swab
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
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
Refrigerated: 30 days
Frozen: 60 days
Reject Criteria (Eg, hemolysis? Lipemia? Thaw/Other?)
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
Methodology
Transcription Mediated Amplification (TMA)
Setup Schedule
Set up: Daily; Report available: Next day
Reference Range
Negative
Clinical Significance
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.
