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Vaginitis PCR Panel

AFFIRM Test, Vaginal, Candida, Candidiasis, Trich, Trichomonas, Trichomoniasis, Vaginosis, Vaginitis, Gardnerella

Test Codes

EPIC: LAB1231839

Department

Microbiology

Specimen Collection Criteria

Collect: a vaginal swab specimen using the BD Molecular Swab Collection Kit:

• Remove the sterile swab from its sheath, taking care not to contaminate the tip or shaft. If the swab tip is touched or if the swab is laid down, discard it and use a new collection kit. Check for presence of the swab tip. If the swab has no tip, discard it and request a new BD Molecular Collection Swab.
• Holding the swab by the cap, insert it into the vagina no more than 2 inches and rotate for 10–15 seconds.
• Withdraw the swab carefully, avoiding contact with the skin.
• The swab must be broken into the BD Molecular Swab Sample Buffer Tube immediately after specimen collection.
• Unscrew the cap of the BD Molecular Swab Sample Buffer Tube, taking care not to contaminate the contents or the outside of the tube.
• Immediately after collection, insert the BD Molecular Collection Swab into the tube so that the score mark indicated by the black line is at the lip of the tube. Carefully break the swab shaft at the score mark and allow the swab to drop into the tube. Use caution to avoid splashing of the tube contents.
• Tighten the cap securely on the BD Molecular Swab Sample Buffer Tube.
• Label the BD Molecular Swab Sample Buffer Tube with patient information and date/time collected.
• NOTE: Do not obscure the barcodes on the tube. Obscuring the barcode may result in instrument errors and inability to test the sample.
• Transport to the testing laboratory following the storage and stability requirements above.

Additional instructions:

• Do not pre-wet the swab with the BD Molecular Swab Sample Buffer prior to collection.
• Do not use expired reagents and/or materials.
• Do not use swabs if the sheaths are open or broken.
• The BD Molecular Swab Collection Kit is for single use only. Reuse may cause a risk of infection and/or inaccurate results.

Physician Office/Draw Specimen Preparation

Maintain the BD Molecular Swab Sample Buffer Tube at room temperature or refrigerated (2-30°C or 36-86°F) prior to transport.

Preparation for Courier Transport

Transport the BD Molecular Swab Sample Buffer Tube at room temperature or refrigerated (2-30°C or 36-86°F).

Rejection Criteria

• Specimens not received in the BD Molecular Swab Sample Buffer Tube.
• Specimens received without a swab in the buffer tube
• Specimen greater than 20 days old.
• Frozen specimens.

In-Lab Processing

Do not obscure the barcodes on the tube. Obscuring the barcode may result in instrument errors and inability to test the sample.

Storage

Specimen Stability for Testing:

Room Temperature (20-26°C or 68-78.8°F): 21 days
Refrigerated (2-8°C or 36-46°F): 21 days
Frozen (-20°C/-4°F or below): Unacceptable

Specimen Storage in Department Prior to Disposal:

Room Temperature (20-26°C or 68-78.8°F): 1 day

Laboratory

Royal Oak Microbiology Laboratory

Performed

Sunday – Saturday.
Results available in 48 hours.

Reference Range

• Bacterial vaginosis markers not detected.
• Candida species not detected.
• Candida glabrata not detected.
• Candida krusei not detected.
• Trichomonas vaginalis not detected.

Test Methodology

Qualitative Real-Time Polymerase Chain Reaction (FDA Approved).

Interpretation

A result of “Bacterial vaginosis markers detected” indicates a shift in vaginal flora associated with Bacterial Vaginosis. Results should be correlated with clinical presentation. Up to 34% of asymptomatic women may be positive for Bacterial Vaginosis markers.

A result of “Candida species detected” indicates the presence of DNA of C. albicans, C. tropicalis, C. parapsilosis, and/or C. dubliniensis. One or more of these organisms may be present. The test does not identify which of these organisms is present. Results should be correlated with clinical presentation. Up to 21% of asymptomatic women may have detectable levels of Candida spp. DNA.

A result of “Candida glabrata detected” indicates the presence of C. glabrata DNA. Results should be correlated with clinical presentation. Up to 6% of asymptomatic women may have detectable levels of Candida glabrata DNA.

A result of “Candida krusei detected” indicates the presence of C. krusei DNA. Results should be correlated with clinical presentation. <2% of asymptomatic women may have detectable levels of Candida krusei DNA.

A result of “Trichomonas vaginalis detected” indicates the presence of T. vaginalis DNA and is strongly suggestive of infection with T. vaginalis. Although up to 11% of asymptomatic women may have detectable levels of T. vaginalis DNA, T. vaginalis is not part of normal vaginal flora.

A result of “Not detected” for any analyte does not rule out the associated disease.

An invalid result suggests the presence of interfering substances in the sample. Collect a new specimen if clinically indicated.

Clinical Utility

The BD MAX™ Vaginal Panel is intended to aid in the diagnosis of vaginal infections in women with a clinical presentation consistent with bacterial vaginosis, vulvovaginal candidiasis and trichomoniasis.

Clinical Disease

Vaginitis, one of the most common gynecological problems in clinical medicine, accounts for millions of office visits each year. The three main infectious causes of vaginitis are bacterial vaginosis (BV), yeast vaginitis (candidiasis) and T. vaginalis vaginitis (trichomoniasis). Bacterial vaginosis is the most common infectious vaginal complaint, and accounts for 40 to 50 percent of cases in women of childbearing age. Hydrogen-peroxide producing Lactobacillus species are important members of the normal vaginal flora and are generally known to decrease in patients suffering from vaginosis. The decrease of these bacteria rather than their colonization of the vagina is a recognized marker of vaginosis. In opposition to this decrease in Lactobacillus species; there is an increase in well-known species of anaerobes such as Atopobium vaginae and Gardnerella vaginalis. Colonization also occurs with non-cultivable anaerobe organisms such as BVAB-2 and Megasphaera-1. Additional microorganisms including Prevotella, Lachnospira, Sneathia, Mobiluncus, Mycoplasma hominis, and Ureaplasma spp. have also been found in women with bacterial vaginosis. However, these organisms are less associated with BV due to their relatively low prevalence, sensitivity and/or specificity. Bacterial vaginosis is associated with a high incidence of endometritis and pelvic inflammatory disease following abortion and gynecologic procedures in the general population. Bacterial vaginosis has been also associated with late-term miscarriages, premature rupture of membranes, and preterm birth, and has been strongly linked with an increased risk of human immunodeficiency virus (HIV) and other sexually transmitted diseases. Although it is known that asymptomatic women may have microbial flora consistent with bacterial vaginosis, treatment is generally not indicated by current guidelines for these patients.

Seventeen (17) to 39 percent of women symptomatic for vaginitis are diagnosed with vulvovaginal candidiasis. Multiple epidemiologic studies have indicated that Candida albicans is responsible for 65% to 90% of vulvovaginal candidiasis cases and that non-Candida albicans species may be responsible for up to 30% of vulvovaginal candidiasis episodes. Among these species, the most frequently reported in literature are C. glabrata, C. parapsilosis, and C. tropicalis. C. glabrata and C. krusei are the main Candida species resistant to fluconazole-based antifungal therapy. Vulvovaginal candidiasis is usually associated with high Candida loads but symptoms may be associated with lower loads in women predisposed by factors altering the vaginal milieu.

Complications of vulvovaginal candidiasis are rare. Chorioamnionitis in pregnancy and vulvar vestibulitis syndrome have been reported. Women may also be colonized with Candida spp. and be asymptomatic.

Trichomoniasis, caused by Trichomonas vaginalis, is one of the most common sexually transmitted infections worldwide with over 170 million cases per year. Four (4) to 35 percent of women symptomatic for vaginitis are diagnosed with trichomoniasis. This disease is associated with several adverse health outcomes, such as preterm birth, delivery of a low-birth weight infant, and facilitation of sexual transmission of Human Immunodeficiency Virus (HIV).

Reference

BD MAX Vaginal Panel Instructions for Use, P0258(04), 2024-01.
BD Molecular Swab Collection Kit Instructions for Use, P0246(04), 2023-03.

CPT Codes

81514

Contacts

Last Updated

11/21/2024