Vaginitis (VG) With Candida (Six Species), NuSwab®

CPT: 87481(x6); 87661; 87798(x3)
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Test Details

Test Includes

Bacterial vaginosis (Atopobium vaginae, BVAB 2; Megasphaera 1); Candida albicans; Candida glabrata; Candida tropicalis; Candida parapsilosis; Candida lusitaniae; Candida krusei; Trichomonas vaginalis

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 positive for BV, and samples with a score of 2 indeterminate for BV. Detect the presence of Candida albicans, Candida glabrata, Candida tropicalis, Candida parapsilosis, Candida lusitaniae, and Candida krusei 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.

Limitations

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

Room temperature

Causes for Rejection

Incorrect patient identification; unlabeled specimen; inappropriate specimen transport conditions; 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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180042 NuSwab VG, Candida 6sp 180048 Bacterial Vaginosis, NAA N/A
180042 NuSwab VG, Candida 6sp 180061 Atopobium vaginae Score 69565-0
180042 NuSwab VG, Candida 6sp 180062 BVAB 2 Score 69566-8
180042 NuSwab VG, Candida 6sp 180063 Megasphaera 1 Score 69567-6
180042 NuSwab VG, Candida 6sp 180011 Candida albicans, NAA 69562-7
180042 NuSwab VG, Candida 6sp 180012 Candida glabrata, NAA 69563-5
180042 NuSwab VG, Candida 6sp 180013 Candida tropicalis, NAA 72391-6
180042 NuSwab VG, Candida 6sp 180014 Candida parapsilosis, NAA 72495-5
180042 NuSwab VG, Candida 6sp 180015 Candida lusitaniae, NAA 72390-8
180042 NuSwab VG, Candida 6sp 180016 Candida krusei, NAA 72389-0
180042 NuSwab VG, Candida 6sp 180087 Trich vag by NAA 46154-1
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 180019 Note: 180019 Note: N/A
Reflex Table for Candida krusei, NAA
Order Code Order Name Result Code Result Name UofM Result LOINC
Reflex 1 180017 Note: 180017 Note: N/A

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