Vaginitis Plus (VG+), NuSwab®

Clinical Use

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

Not provided.

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.

Test Details

Methodology

PCR-based (NAA)

Biomarkers

3 components

Bacterial Vaginosis Detection • NAACandida Detection • NAASTI Detection • NAA

LOINC Codes

Order Codes

92703-8 - Vag pathogens pnl Vag NAA+probe

Result 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
11502-2 - Laboratory report
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
21613-5 - C trach DNA Spec Ql NAA+probe
32705-6 - N gonorrhoea DNA Vag Ql NAA+probe

Result Turnaround Time

3-4 days

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.