Test Catalog

Test Id : CVRNA

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Candida Vaginitis, Nucleic Acid Amplification RNA, Vaginal

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Overview

Test Catalog

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of Candida vaginitis

 

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

Method Name
A short description of the method used to perform the test

Transcription Mediated Amplification

NY State Available
Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test

Candida vaginitis, Amplified RNA

Aliases
Lists additional common names for a test, as an aid in searching

Candidal vaginosis

Vaginitis

Amsel's Criteria

Specimen Type
Describes the specimen type validated for testing

Vaginal

Specimen Required
Defines the optimal specimen required to perform the test and the preferred volume to complete testing

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

Specimen Minimum Volume
Defines the amount of sample necessary to provide a clinically relevant result as determined by the testing laboratory. The minimum volume is sufficient for one attempt at testing.

See Specimen Required

Reject Due To
Identifies specimen types and conditions that may cause the specimen to be rejected

Incorrect swab
Transport tubes containing more than one swab 		Reject

Specimen Stability Information
Provides a description of the temperatures required to transport a specimen to the performing laboratory, alternate acceptable temperatures are also included

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

Useful For
Suggests clinical disorders or settings where the test may be helpful

Aiding in the diagnosis of Candida vaginitis

 

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

Clinical Information
Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

This test is intended to aid in the diagnosis of vulvovaginal candidiasis from vaginal samples collected from symptomatic individuals. Vaginitis is characterized by a spectrum of signs and symptoms, including vaginal/vulvar irritation, odor, discharge, and pruritus. Vaginitis may develop as a result of mechanical and/or chemical irritants (eg, feminine hygiene products, contraceptive materials), or due to a dysbiosis of the microbiota in the vaginal tract. Up to 90% of vaginitis cases are infectious due to Bacterial vaginosis (BV), vulvovaginal candidiasis (Candida vaginitis, CV) and/or trichomoniasis (Trichomonas vaginalis, TV). BV, CV and TV individually account for 22% to 50%, 17% to 39%, and 4% to 35% of vaginitis cases, respectively.

 

CV, commonly known as a yeast infection, is the second most frequent cause of vaginitis. CV is characterized by an overgrowth of Candida species in the vaginal tract and is associated with development of inflammation, abnormal vaginal discharge, vaginal soreness, pruritus, dyspareunia, and external dysuria. Up to 89% of CV cases are caused by C albicans, while non-albicans species may be responsible for 11%. C glabrata, which is responsible for the majority of non-albicans CV in the U.S., has decreased susceptibility to standard antifungal regiments for CV as compared to C albicans, which is why C glabrata is specifically reported by this assay.

Reference Values
Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Candida glabrata

Negative

 

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

Negative

Interpretation
Provides information to assist in interpretation of the test results

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.

Cautions
Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

The effects of tampon use, douching, and specimen collection variables have not been evaluated for their impact on assay performance.

 

This report is intended for clinical monitoring or management of patients; it is not intended for use in medico-legal applications.

 

Appropriate specimen collection and handling is necessary for optimal assay performance.

 

Therapeutic failure or success cannot be determined with this assay since nucleic acid may persist following appropriate antimicrobial therapy.

 

A negative result does not preclude a possible infection because results are dependent on adequate specimen collection. Test results may be affected by improper specimen collection, technical error, specimen mix-up, or low numbers of organisms in the specimen (target levels below the assay limit of detection).

 

Therapeutic failure or success cannot be determined since nucleic acid may persist following appropriate antimicrobial therapy.

 

Performance of the assay has not been evaluated in women younger than 14 years.

 

Collection and testing of patient-collected vaginal swab specimens with the assay is not intended to replace clinical examination. Vaginal infections may result from other causes or concurrent infections may occur.

 

Interference with the assay was observed in the presence of the following substances: Tioconazole 6.5% Ointment (3% W/V, all analytes), Vaginal Moisturizing Gel (1% W/V, C spp; 5% W/V, C glabrata; 3% W/V, TV), and Glacial Acetic Acid (5% V/V, C spp only).

 

The following organism was observed to cross-react above the stated concentrations:

Candida famata at concentrations higher than 5x105 CFU/mL.

 

Competitive interference was observed in co-infected samples for the combination of low

C glabrata (3X LoD) and high T vaginalis (1x105 or 1x104 cells/mL).

Clinical Reference
Recommendations for in-depth reading of a clinical nature

1. Workowski KA, Bachmann LH, Chan PA, et al. Sexually transmitted infections treatment guidelines, 2021. MMWR Recomm Rep. 2021;70(4):1-187. doi:10.15585/mmwr.rr7004a1

2. Huang SH, Hsu HC, Lee TF, et al. Prevalence, Associated Factors, and Appropriateness of Empirical Treatment of Trichomoniasis, Bacterial Vaginosis, and Vulvovaginal Candidiasis among Women with Vaginitis, 2023. American Society for Microbiology. 2023;11(3):e00161-23.doi:10.1128/spectrum.00161-23

3. Farr, A., Effendy, I., Frey Tirri, B., Hof, H., et al. Guideline: Vulvovaginal candidosis (AWMF 015/072, level S2k), 2021. Mycoses. 2021;64(6) 583-602. doi.org/10.1111/myc.13248

Method Description
Describes how the test is performed and provides a method-specific reference

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)

PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information

No

Day(s) Performed
Outlines the days the test is performed. This field reflects the day that the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time before the test is performed. Some tests are listed as continuously performed, which means that assays are performed multiple times during the day.

Monday through Sunday

Report Available
The interval of time (receipt of sample at Mayo Clinic Laboratories to results available) taking into account standard setup days and weekends. The first day is the time that it typically takes for a result to be available. The last day is the time it might take, accounting for any necessary repeated testing.

1 to 4 days

Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location
Indicates the location of the laboratory that performs the test

Rochester

Fees
Several factors determine the fee charged to perform a test. Contact your U.S. or International Regional Manager for information about establishing a fee schedule or to learn more about resources to optimize test selection.

  • Authorized users can sign in to Test Prices for detailed fee information.
  • Clients without access to Test Prices can contact Customer Service 24 hours a day, seven days a week.
  • Prospective clients should contact their account representative. For assistance, contact Customer Service.

Test Classification
Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR) product.

This test has been cleared, approved, or is exempt by the US Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information
Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Clinic Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

CPT codes are provided by the performing laboratory.

87481

LOINC® Information
Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the order and results codes of this test. LOINC values are provided by the performing laboratory.

Test Id Test Order Name Order LOINC Value
CVRNA Candida vaginitis, Amplified RNA 92703-8
Result Id Test Result Name Result LOINC Value
Applies only to results expressed in units of measure originally reported by the performing laboratory. These values do not apply to results that are converted to other units of measure.
621517 Candida species, Amplified RNA 94422-3
621518 Candida glabrata, Amplified RNA 94421-5

Test Setup Resources

Setup Files
Test setup information contains test file definition details to support order and result interfacing between Mayo Clinic Laboratories and your Laboratory Information System.

Excel | Pdf

Sample Reports
Normal and Abnormal sample reports are provided as references for report appearance.

Normal Reports | Abnormal Reports

SI Sample Reports
International System (SI) of Unit reports are provided for a limited number of tests. These reports are intended for international account use and are only available through MayoLINK accounts that have been defined to receive them.

SI Normal Reports | SI Abnormal Reports

Test Update Resources

Change Type Effective Date
New Test 2024-08-20