Vaginitis (VG), NuSwab
Use
This test is used to detect the presence of Candida albicans and Candida glabrata DNA in vaginal samples as an aid to the diagnosis of vulvovaginal candidiasis in symptomatic women. It is also used in the diagnosis of Trichomonas vaginalis infections. Additionally, it aids in the diagnosis of bacterial vaginosis (BV) by utilizing semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score correlating with the presence or absence of BV.
Special Instructions
Not provided.
Limitations
The test is intended for use as an aid in the diagnosis of BV in women with symptoms consistent with BV. Samples with a score of 0 to 1 are negative, 3 to 6 are positive, and a score of 2 is indeterminate for BV. The test has not been cleared or approved by the FDA, but approval is not deemed necessary by the FDA. The performance characteristics of the test have been determined by LabCorp.
New York Approved
Methodology
PCR-based (Nucleic acid amplification (NAA))
Biomarkers
LOINC Codes
- 69565-0 - A vaginae DNA Vag Ql NAA+probe
- 69566-8 - BVAB2 DNA Vag Ql NAA+probe
- 69567-6 - Mega1 DNA Vag Ql NAA+probe
- 69562-7 - C albicans DNA Vag Ql NAA+probe
- 69563-5 - C glabrata DNA Vag Ql NAA+probe
- 62461-9 - T vaginalis DNA Vag Ql NAA+probe
Result Turnaround Time
5-8 days
Related Documents
For more information, please review the documents below
Specimen
Vaginal Swab
Volume
One swab
Minimum Volume
One swab
Container
APTIMA Multitest, vaginal, or unisex swab
Collection Instructions
Collect vaginal fluid sample using the Gen-Probe Aptima swab by contacting the swab to the lower third of the vaginal wall and rotating for 10 to 30 seconds to absorb fluid. Immediately place the swab into the transport tube and carefully break the swab shaft against the side of the tube. Tightly screw on the cap. Submit one vaginal swab in APTIMA Multitest, vaginal, or unisex swab. Ship refrigerate.
Causes for Rejection
Grossly contaminated specimens, leaking or broken tube, inappropriate specimen transport conditions, and specimens received frozen or after a prolonged delay (usually >72 hours); specimen in expired transport or incorrect transport device; specimens with inappropriate source for test requested; specimen with fixative or additives; Aptima urine transport; Aptima swab transport >30 days from collection; Aptima swab specimen without a swab; cleaning swab (white-shaft swab) in Aptima swab transport; any non-Gen-Probe swab submitted in Aptima transport device; transport device with multiple swabs; bloody or grossly mucoid specimens; bacterial swabs; specimen in ProbeTec UPT transport; ProbeTec Q-swabs
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |