Test Id : BVRNA
Bacterial Vaginosis, Nucleic Acid Amplification, Vaginal
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aid for diagnosis of bacterial vaginosis
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.
Reporting Name
Lists a shorter or abbreviated version of the Published Name for a test
Aliases
Lists additional common names for a test, as an aid in searching
Bacterial Vaginosis
Vaginitis
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. Specimen 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 between 2 and 30 degrees C (refrigerate temperature is preferred) and transport within 30 days of collection. If longer storage is needed, store frozen between -20 and -70 degrees C for 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 tube 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 |
| Ambient | 30 days | APTIMA VIAL | |
| Frozen | 60 days | APTIMA VIAL |
Useful For
Suggests clinical disorders or settings where the test may be helpful
Aid for diagnosis of bacterial vaginosis
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
The Aptima BV (bacterial vaginosis) assay is intended to aid in the diagnosis of BV in individuals with clinical presentation consistent with vaginitis and/or vaginosis. 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 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 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. BV has been associated with pelvic inflammatory disease, cervicitis, elevated risk of acquisition of sexually transmitted infections (such as chlamydia, gonorrhea, herpes simplex virus, and HIV), spontaneous abortion, and preterm birth.
Bacterial vaginosis is characterized by a change in the vaginal microbiota dominated by Lactobacillus species to a polymicrobial anaerobe-dominated microbiota that includes Gardnerella vaginalis, Atopobium vaginae, Prevotella, Bacteroides, Peptostreptococcus, Mobiluncus, Sneathia (Leptotrichia), Mycoplasma, and BV-associated bacteria. A change in the normal vaginal microbiota is associated with the development of multiple signs and symptoms (eg, discharge, vaginal discomfort, and discharge). Diagnosis of BV can alternatively be established based on clinical criteria alone, referred to as Amsel's criteria, which include measuring vaginal pH, assessment for the presence of clue cells (eg, epithelial cells layered with bacterial cells), discharge, and malodor.
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.
Negative
Interpretation
Provides information to assist in interpretation of the test results
Positive: Results should be interpreted alongside clinical presentation. Up to 40% of asymptomatic patients may test positive by this assay. Assay result is based on relative amounts of Lactobacillus (Lactobacillus gasseri, Lactobacillus crispatus, Lactobacillus jensenii), Gardnerella vaginalis, and Atopobium vaginae. Individual organisms are not reported.
Negative: A negative result does not exclude infection. Assay result is based on relative amounts of Lactobacillus (L gasseri, L crispatus, L jensenii), G vaginalis, and A vaginae.
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
Therapeutic failure or success cannot be determined with the Aptima bacterial vaginosis (BV) assay since nucleic acid may persist following appropriate antimicrobial therapy.
Bacterial species targeted by the Aptima BV assay may comprise part of the normal microbiome for a significant number of women; a BV positive result should be interpreted in conjunction with other clinical data available to the clinician.
A negative result does not preclude a possible infection. Reliable results are dependent on adequate specimen collection, transport, storage, and processing.
Performance of the assay has not been evaluated in individuals younger than 14 years.
Additional microorganisms not detected by the Aptima BV assay such as Prevotella species, Mobiluncus species, Ureaplasma, Mycoplasma, and numerous fastidious or uncultivated anaerobes have also been found in women with BV but are less associated with BV due to their relatively low prevalence, sensitivity, and/or specificity.
Interference with the Aptima BV assay was observed in the presence of the following substances: mucus (1.5% V/V), vaginal moisturizing gel (0.5% W/V) and tioconazole (5% W/V).
Cross-reactivity was observed with the Aptima BV assay in the presence of Lactobacillus acidophilus (1x10(4) CFU/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
2. Muzny CA, Cerca N, Elnaggar JH, Taylor CM, Sobel JD, Van Der Pol B. State of the art for diagnosis of bacterial vaginosis. J Clin Microbiol. 2023;61(8):e0083722. doi:10.1128/jcm.00837-22
Method Description
Describes how the test is performed and provides a method-specific reference
The Aptima BV (bacterial vaginosis) assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification for detection and quantitation of ribosomal RNA from bacteria associated with BV, including Lactobacillus (Lactobacillus gasseri, Lactobacillus crispatus, Lactobacillus jensenii), Gardnerella vaginalis, and Atopobium vaginae. The Panther system detects and discriminates between four fluorescent signals corresponding to Lactobacillus group, Atopobium vaginae, Gardnerella vaginalis, and IC amplification products. Signal emergence times for each target organism are compared to calibration information to determine the BV Positive or Negative status of each sample.(Package Insert: Aptima BV Assay. Hologic, Inc; 9/2020)
PDF Report
Indicates whether the report includes an additional document with charts, images or other enriched information
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.
Specimen Retention Time
Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded
Performing Laboratory Location
Indicates the location of the laboratory that performs the test
Fees :
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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.
CPT codes are provided by the performing laboratory.
81513
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 |
|---|---|---|
| BVRNA | Bacterial Vaginosis, Amplified RNA | 103590-6 |
| 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.
|
|---|---|---|
| 620738 | Bacterial Vaginosis, Amplified RNA | 103590-6 |