Vaginitis Plus (VG+), Herpes Simplex Virus (HSV), NuSwab®

CPT: 87481(x2); 87491; 87529(x2); 87591; 87661; 87798(x3)
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Test Details

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.

Limitations

This test is intended for use as an aid in the diagnosis of herpes simplex virus (HSV) infections with active viral shedding; it also differentiates HSV-1 from HSV-2. Negative HSV NAA results indicate lack of viral shedding but do not confirm absence of previous infection.

This test was developed, and its performance characteristics determined, by LabCorp. It has not been cleared or approved by the US Food and Drug Administration (FDA). The FDA has determined that such clearance or approval is not necessary.

Methodology

Nucleic acid amplification (NAA)

Specimen Requirements

Specimen

Vaginal swab

Volume

One swab

Minimum Volume

One swab

Container

Aptima® vaginal or unisex swab

Collection

Vaginal Swab: Collect vaginal fluid sample using the Gen-Probe® 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

Specimen with incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; 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−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 For HSV: Aptima® swab transports >7 days from collection.

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180066 NuSwab VG+, HSV 180048 Bacterial Vaginosis, NAA N/A
180066 NuSwab VG+, HSV 180061 Atopobium vaginae Score 69565-0
180066 NuSwab VG+, HSV 180062 BVAB 2 Score 69566-8
180066 NuSwab VG+, HSV 180063 Megasphaera 1 Score 69567-6
180066 NuSwab VG+, HSV 180056 Candida albicans, NAA 69562-7
180066 NuSwab VG+, HSV 180057 Candida glabrata, NAA 69563-5
180066 NuSwab VG+, HSV 180087 Trich vag by NAA 46154-1
180066 NuSwab VG+, HSV 180097 Chlamydia trachomatis, NAA 43304-5
180066 NuSwab VG+, HSV 180104 Neisseria gonorrhoeae, NAA 43305-2
180066 NuSwab VG+, HSV 180031 HSV 1 NAA 16130-7
180066 NuSwab VG+, HSV 180032 HSV 2 NAA 16131-5
Reflex Table for Megasphaera 1
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 180046 Total Score, add three scores 180046 Total Score, add three scores N/A
Reflex Table for Candida glabrata, NAA
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 180054 Note: 180054 Note: N/A

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