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SureSwab® Advanced Vaginitis Plus, TMA : 10120
Test CodeCGBCT or 10120
CPT Codes
81513, 87481x2, 87661, 87491, 87591
Includes
Bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L.crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.
and
1. Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) 2. Candida glabrata 3. Trichomonas vaginalis
and
Chlamydia trachomatis and Neisseria gonorrhoeae
and
1. Candida species group (C. albicans, C. tropicalis, C. parapsilosis, C. dubliniensis) 2. Candida glabrata 3. Trichomonas vaginalis
and
Chlamydia trachomatis and Neisseria gonorrhoeae
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).
Age restrictions may apply.
See individual tests for further information.
Age restrictions may apply.
See individual tests for further information.
Transport Temperature
Room temperature.
Specimen Stability
Swabs in Aptima® Transport:
Room temperature: 30 days; Refrigerated: 30 days; Frozen: 60 days
Room temperature: 30 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; Specimens in broken containers; Specimens in leaking containers
Please note that ONLY Chlamydia trachomatis and Neisseria gonorrhoeae will be reported.
Note: 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 inserts: https://www.hologic.com/package-inserts/diagnostic-products/aptima-bv-assay https://www.hologic.com/package-inserts/diagnostic-products/aptima-trichomonas-vaginalis-assay https://www.hologic.com/package-inserts/diagnostic-products/aptima-cvtv-assay
Please note that ONLY Chlamydia trachomatis and Neisseria gonorrhoeae will be reported.
Note: 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 inserts: https://www.hologic.com/package-inserts/diagnostic-products/aptima-bv-assay https://www.hologic.com/package-inserts/diagnostic-products/aptima-trichomonas-vaginalis-assay https://www.hologic.com/package-inserts/diagnostic-products/aptima-cvtv-assay
Methodology
Transcription-Mediated Amplification (TMA)
Setup Schedule
Monday - Saturday
Report Available
1-3 days
Reference Range
NOT DETECTED
Bacterial Vaginoisis: NEGATIVE
Bacterial Vaginoisis: NEGATIVE
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.
Performing Laboratory
med fusion
