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Test Code CVRNA Candida Vaginitis, Nucleic Acid Amplification RNA, Vaginal


Necessary Information


 



Specimen Required


Specimen Type: Vaginal

Supplies: Aptima Multitest Swab Collection Kit (T584)

Container/Tube: Aptima Multitest Swab

Specimen Volume: Swab

Collection Instructions:

1. Specimens must be collected using the Aptima Multitest Swab Collection Kit.

2. Insert swab (pink shaft) about 5 cm past introitus and rotate gently for 30 seconds.

3. Place swab into transport tube provided in collection kit. Snap off swab at score line so swab fits into closed tube.

4. Cap tube securely, and label tube with patient's entire name and collection date and time.

5. Maintain swab container at 2 to 30° C (refrigerate temperature is preferred) and transport within 30 days of collection. If longer storage is needed, freeze at -20 to -70° C up to 60 days.


Secondary ID

620888

Useful For

Aiding in the diagnosis of Candida vaginitis

 

This test is not intended for use in medico-legal applications.

Method Name

Transcription Mediated Amplification

Specimen Type

Vaginal

Specimen Minimum Volume

See Specimen Required

Specimen Stability Information

Specimen Type Temperature Time Special Container
Vaginal Refrigerated (preferred) 30 days APTIMA VIAL
  Frozen  60 days APTIMA VIAL
  Ambient  30 days APTIMA VIAL

Reject Due To

Incorrect swab
Transport tubes containing more than one swab
Reject

Reference Values

Candida glabrata

Negative

 

Candida species group (C albicans, C tropicalis, C parapsilosis, C dubliniensis)

Negative

Interpretation

Candida species group (C albicans, C tropicalis, C parapsilosis, C dubliniensis):

Positive: Candida albicans, C tropicalis, C parapsilosis and/or C dubliniensis RNA detected. Individual organisms are not identified or reported by this assay. Results should be interpreted alongside clinical presentation. Up to 21% of asymptomatic patients may be positive by this assay.

 

Negative: No RNA detected from Candida albicans, C tropicalis, C parapsilosis or C dubliniensis. A negative result does not exclude infection.

 

Inconclusive: Repeat testing on a new sample is recommended if clinically indicated.

 

Candida glabrata:

Positive: Candida glabrata RNA detected. Results should be interpreted alongside clinical presentation. Up to 9% of asymptomatic patients may be positive for C glabrata this assay.

 

Negative: No RNA detected from Candida glabrata. A negative result does not exclude infection.

 

Inconclusive: Repeat testing on a new sample is recommended if clinically indicated.

Method Description

The Aptima CV/TV kit is used for this testing, however only the CV result is reported. This assay is an in vitro nucleic acid amplification test for the detection of RNA from microorganisms associated with vulvovaginal candidiasis and trichomoniasis. The assay utilizes real time transcription-mediated amplification (TMA) to detect and qualitatively report results for the following organisms: Candida species group (C albicans, C tropicalis, parapsilosis, C dubliniensis), Candida glabrata, and Trichomonas vaginalis (TV). The Panther system detects and discriminates between four fluorescent signals corresponding to Candida species group, C glabrata, TV, and IC amplification products. The Panther system software uses an Aptima CV/TV assay-specific algorithm that interprets the amplification signal emergence times to generate a Positive or Negative status for each target organism in the sample. Note, the TV component of this kit is not reported. (Package insert: Aptima CV/TV Assay, AW-23713-001. Hologic, Inc; Rev 001, 03/2023)

Day(s) Performed

Monday through Sunday

Report Available

1 to 4 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

87481

LOINC Code Information

Test ID Test Order Name Order LOINC Value
CVRNA Candida vaginitis, Amplified RNA 92703-8

 

Result ID Test Result Name Result LOINC Value
621517 Candida species, Amplified RNA 94422-3
621518 Candida glabrata, Amplified RNA 94421-5