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SureSwab® Advanced Vaginitis, TMA
Test Code10119
CPT Codes
81513, 87481 (x2), 87661
Includes
SureSwab® Advanced Bacterial Vaginosis (BV), TMA
SureSwab® Advanced Candida Vaginitis (CV), TMA
Trichomonas vaginalis (TV), TMA
SureSwab® Advanced Candida Vaginitis (CV), TMA
Trichomonas vaginalis (TV), TMA
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)
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
SureSwab® Adv Bacterial Vaginosis (BV), TMA | Negative |
Candida species | Not detected |
Candida glabrata | Not detected |
Trichomonas vaginalis (TV), TMA | Not detected |
Clinical Significance
The assay is intended to aid in the diagnosis of vaginitis using clinician-collected and patient-collected vaginal swab specimens from individuals with a clinical presentation consistent with vaginitis. Testing for bacterial vaginosis (BV), vulvovaginal candidiasis and trichomoniasis are included.
The BV 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, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms.
For vulvovaginal candidiasis and trichomoniasis, a real time transcription-mediated amplification (TMA) assay is used to detect and qualitatively report results for Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), C. glabrata, and Trichomonas vaginalis.
The BV 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, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae. The assay reports a qualitative result for BV and does not report results for individual organisms.
For vulvovaginal candidiasis and trichomoniasis, a real time transcription-mediated amplification (TMA) assay is used to detect and qualitatively report results for Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis), C. glabrata, and Trichomonas vaginalis.