Vaginitis Plus (VG+), Herpes Simplex Virus (HSV), 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 employs 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 positive for BV, and samples with a score of 2 indeterminate for BV. 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. Diagnosis of Chlamydia trachomatis, Neisseria gonorrhoeae, and Trichomonas vaginalis infections. Detect and type active HSV shedding.
Special Instructions
The test employs the Aptima® Multitest Swab or Aptima® Unisex Swab Collection Kits. Specific handling procedures include rotating the swab against the vaginal wall for 10 to 30 seconds to absorb fluid, then securing it in the transport tube immediately.
Limitations
The test aids in diagnosing active shedding of herpes simplex virus but results indicating no viral shedding are not definitive of the absence of prior infection. Negative results do not rule out the presence of infections if samples were taken later than the viral shedding phase or other conditions prevail. The performance characteristics of this test were developed by Labcorp, not cleared or approved by the FDA, but FDA clearance was determined not necessary.
Methodology
PCR-based (Nucleic acid amplification (NAA))
Biomarkers
LOINC Codes
- 69564-3
- 69565-0
- 69566-8
- 69567-6
- 11502-2
- 69562-7
- 69563-5
- 62461-9
- 21613-5
- 32705-6
- 16130-7
- 16131-5
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 vaginal fluid sample using the Aptima® swab by contacting the swab to the lower third of the vaginal wall and rotating the swab 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. Screw the cap on tightly.
Storage Instructions
Maintain specimen at room temperature or refrigerate (2° C to 30°C).
Causes for Rejection
Incorrect patient identification, unlabeled specimen, inappropriate specimen transport conditions including frozen specimens, prolonged delay over 72 hours, specimen leaked in transit, expired transport or incorrect device, multiple swabs in Aptima transport, bloody or grossly mucoid specimens, bacterial swabs, specimen in ProbeTec™ UPT transport, and inappropriate source specimens.