Home
HelpTest Code RMCVAGPNL Vaginitis Panel NAAT*
Performing Laboratory
Rutland Regional Medical Center Laboratory
Specimen Requirements
Call Rutland Regional Medical Center Laboratory Customer Service at 802-747-1771 to obtain Multitest Swabs.
Specimen Type: Vaginal 
Container/Tube: Aptima Multitest Swab (Orange Tube)
Specimen Volume: Entire specimen
Collection Instructions: Follow instructions on Aptima Multitest Vaginal Collection Guide
Stability: Ambient 30 days
Specimen Transport Temperature
Multitest Swab: Ambient 30 days
Reference Values
Negative
Day(s) Performed
Monday to Friday
Analytical Time:
1-3 days
Methodology
The Hologic Panther Aptima BV, CV/TV assays combine the technologies of target capture, TMA, and DKA.
The Aptima® BV assay is an in vitro nucleic acid amplification test that utilizes real time transcription-mediated amplification (TMA) for detection and quantitation of ribosomal RNA from bacteria associated with bacterial vaginosis (BV), including Lactobacillus (L. gasseri, L. crispatus, and L. jensenii), Gardnerella vaginalis, and Atopobium vaginae.
The assay reports a qualitative result for BV and does not report results for individual organisms. The assay is intended to aid in the diagnosis of BV on the automated Panther® system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis and/or vaginosis.
The Aptima® CV/TV 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, C. parapsilosis, C. dubliniensis)
• Candida glabrata
• Trichomonas vaginalis
The assay differentiates between Candida glabrata and the Candida species group (C spp) by targeting the RNA component of RNAse P ribonucleoprotein; the assay does not differentiate among C spp. For Trichomonas vaginalis, the assay targets ribosomal RNA (rRNA) and differentiates the result from results for Candida glabrata and C spp. The assay is intended to aid in the diagnosis of vulvovaginal candidiasis and trichomoniasis on the automated Panther® system using clinician-collected and patient-collected vaginal swab specimens from females with a clinical presentation consistent with vaginitis or vulvovaginitis.
Test Classification and CPT Coding
|
RRMC Order Code |
RRMC Result Name |
RRMC Test ID Code |
CPT Codes |
LOINC Codes |
|
RMCVAGPNL |
Candida species group |
RMCL802771 |
87481 |
94422-3 |
|
Candida glabrata |
RMCL802772 |
87481 |
94421-5 |
|
|
Bacterial Vaginosis |
RMCL802773 |
81513 |
94420-7 |
|
|
Trichomonas vaginalis |
RMCL802774 |
87661 |
70165-6 |
Interpretation
Performance Data:
Test results are automatically determined by the assay software. The table below shows the possible results reported in a valid run and result interpretations. There can be concomitant positive results within a panel.
Samples with invalid test results are retested once, and if the second result is invalid, it will be reported as invalid in the panel result.
* Bacterial Vaginosis Assay: The Panther system detects and discriminates between four fluorescent signals corresponding to Lactobacillus group, Atopobium vaginae, Gardnerella vaginalis, and IC amplification products. The Panther system software compares signal emergence times for each target organism to calibration information to determine the BV Positive or Negative status of each sample.
+ Candida Species group tests for: C. albicans, C. parapsilosis, C. dubliniensis, and/or C. tropicalis
Test Limitations
-
Test Limitations: Aptima BV Assay and Aptima CV/TV Assay
§ Use of this assay is limited to personnel who have been trained in the procedure. Failure to follow the instructions given in this package insert may result in erroneous results.
§ The effects of other potential variables such as vaginal discharge, use of tampons, and specimen collection variables have not been determined.
§ Performance with specimen types other than vaginal swab specimens has not been evaluated.
§ Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Failure to observe proper procedures in any one of these steps can lead to incorrect results. Because the transport system used for this assay does not permit microscopic assessment of specimen adequacy, training of clinicians in proper specimen collection techniques is necessary. See Specimen Collection and Storage for instructions. For detailed information, refer to the appropriate instructions for use.
§ Therapeutic failure or success cannot be determined with the Aptima BV and Aptima CV/TV 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.
§ Results from the Aptima CV/TV assay should be interpreted in conjunction with other clinical data available to the clinician.
§ A negative result does not preclude a possible infection. Test results may be affected by improper specimen collection, technical error, specimen mix-up, or target levels below the assay limit of detection (LoD)..
§ The Aptima BV assay and Aptima CV/TV assay provides qualitative results. Therefore, a correlation cannot be drawn between the magnitude of a positive assay signal and the number of organisms in a specimen.
§ Performance of the assay has not been evaluated in individuals less than 14 years of age.
§ Customers must independently validate an LIS transfer process.
§ The Aptima BV assay and Aptima CV/TV has not been evaluated for use with specimens collected by patients at home.
§ Collection and testing of patient-collected vaginal swab specimens with the Aptima BV assay and Aptima CV/TV assay is not intended to replace clinical examination. Vaginal infections may result from other causes or concurrent infections may occur.
§ A Candida species group positive result can be due to one or multiple Candida species.
§ Public health recommendations should be consulted regarding testing for additional sexually transmitted infections (STI) for patients with a positive result with the Aptima BV assay. Negative Negative for BV Invalid Invalid test Table 1: Result Interpretation BV Result Interpretation Aptima BV Assay 16 AW-23712-001 Rev. 001 Aptima® For Regulatory Submission Use Only
§ Additional microorganisms not detected by the Aptima BV assay such as Prevotella species and 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 (17).
§ 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).
§ Interference with the Aptima CV/TV 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). Aptima CV/TV Assay 17 AW-23713-001 Rev. 001 Limitations Aptima®
§ Cross-reactivity was observed with the Aptima BV assay in the presence of Lactobacillus acidophilus (1x104 CFU/mL).
§ 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).
§ A positive test result does not necessarily indicate the presence of viable organisms. A positive result is indicative of the presence of target RNA.