Vaginitis (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 Trichomonas vaginalis infections.

Special Instructions

Not provided.

Limitations

This test's performance characteristics have been determined by Labcorp. It has not received clearance or approval from the FDA, although the FDA has determined that such clearance or approval is not necessary.

Test Details

Methodology

PCR-based (qPCR)

Biomarkers

3 components

Bacterial Vaginosis Evaluation • qPCRCandida Detection • qPCRTrichomonas Detection • qPCR

LOINC Codes

Order Codes

62461-9 - T vaginalis DNA Vag Ql NAA+probe
69562-7 - C albicans DNA Vag Ql NAA+probe
69563-5 - C glabrata DNA Vag Ql NAA+probe
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

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
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

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 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. Tightly screw on the cap.

Storage Instructions

Maintain specimen at room temperature or refrigerate (2°C to 30°C).

Causes for Rejection

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions, including specimens received frozen; specimens received after prolonged delay (usually >72 hours); specimen leaked in transit; 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-Aptima® 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