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SureSwab® Advanced Vaginitis Plus, TMA
Test Code10120
CPT Codes
81513, 87481 (x2), 87661, 87491, 87591
Includes
SureSwab® Advanced Bacterial Vaginosis (BV), TMA
SureSwab® Advanced Candida Vaginitis (CV), TMA
Trichomonas vaginalis (TV), TMA
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
SureSwab® Advanced Candida Vaginitis (CV), TMA
Trichomonas vaginalis (TV), TMA
Chlamydia/Neisseria gonorrhoeae RNA, TMA, Urogenital
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 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 • Samples with excess mucus • Specimens submitted in Aptima® tubes w/pierced foil lids • Specimen in broken containers • Specimens in leaking containers • Swab submitted in viral transport media
Methodology
Transcription Mediated Amplification (TMA)
Setup Schedule
Sets up 7 days a week.
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, as well as Chlamydia trachomatis and Neisseria gonorrhoeae is 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.
For Chlamydia trachomatis and Neisseria gonorrhoeae, A target capture assay for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae is utilized.
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.
For Chlamydia trachomatis and Neisseria gonorrhoeae, A target capture assay for the in vitro qualitative detection and differentiation of ribosomal RNA (rRNA) from Chlamydia trachomatis and/or Neisseria gonorrhoeae is utilized.
