Candida albicans and Candida glabrata, NAA

CPT: 87481(x2)
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Test Details

Use

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

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. Tightly screw on the cap.

Storage Instructions

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

Stability Requirements

Temperature

Period

Room temperature

30 days

Refrigerated

30 days

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

LOINC® Map

Order Code Order Code Name Order Loinc Result Code Result Code Name UofM Result LOINC
180055 C albicans + C glabrata, NAA 180056 Candida albicans, NAA 69562-7
180055 C albicans + C glabrata, NAA 180057 Candida glabrata, NAA 69563-5
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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CPT Statement/Profile Statement

The LOINC® codes are copyright © 1994-2017, Regenstrief Institute, Inc. and the Logical Observation Identifiers Names and Codes (LOINC) Committee. Permission is granted in perpetuity, without payment of license fees or royalties, to use, copy, or distribute the LOINC® codes for any commercial or non-commercial purpose, subject to the terms under the license agreement found at https://loinc.org/license/. Additional information regarding LOINC® codes can be found at LOINC.org, including the LOINC Manual, which can be downloaded at LOINC.org/downloads/files/LOINCManual.pdf