Vaginitis Plus (VG+), NuSwab®
Use
This test is intended to be used as an aid to the diagnosis of bacterial vaginosis (BV) in women with a clinical presentation consistent with this disorder. The BV test utilizes semiquantitative PCR analysis of the three most predictive marker organisms (Atopobium vaginae, BVAB-2, and Megasphaera-1) to generate a total score that correlates directly with the presence or absence of BV. In this test system, samples with a total score of 0 to 1 are considered negative for BV, samples with a score of 3 to 6 are positive for BV, and samples with a score of 2 are indeterminate for BV. 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. Also used in the diagnosis of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections.
Special Instructions
Ensure proper sample collection by using the Aptima® swabs, which involve contacting the lower third of the vaginal wall and properly rotating the swab to absorb fluid. Once collected, the swab must be placed in the transport tube and secured by breaking the shaft against the tube's side. Immediate storage at room temperature or refrigeration is required to maintain specimen stability.
Limitations
This test was developed by Labcorp and its performance characteristics have not been cleared or approved by the FDA. The FDA has determined that clearance or approval is not necessary. The test must be performed within the stability period specified for room temperature or refrigerated conditions. Specimen rejection may occur due to improper identification, transport, or if specific collection instructions are not followed.
Methodology
PCR-based (NAA)
Biomarkers
LOINC Codes
- 92703-8
- 69565-0
- 69566-8
- 69567-6
- 11502-2
- 69562-7
- 69563-5
- 62461-9
- 21613-5
- 32705-6
Result Turnaround Time
3-4 days
Related Documents
For more information, please review the documents below
Specimen
Vaginal Swab
Volume
One swab
Minimum Volume
One swab
Container
Aptima® Multitest Swab Specimen Collection Kit or Aptima® Unisex Swab Specimen Collection Kit
Collection Instructions
Collect using Aptima® swab by contacting the lower third of the vaginal wall and rotating for 10 to 30 seconds. Place swab in transport tube and break swab shaft against tube side. Secure cap tightly.
Storage Instructions
Maintain specimen at room temperature or refrigerate (2°C to 30°C).
Causes for Rejection
Improper patient identification; unlabeled specimen; inappropriate transport conditions including specimens frozen; delayed specimens over 72 hours; leaking, bloody, or grossly mucoid specimens; expired or incorrect transport device; non-Aptima® swabs submitted.
Stability Requirements
| Temperature | Period |
|---|---|
| Room Temperature | 30 days |
| Refrigerated | 30 days |
| Frozen | Not acceptable |