Candidiasis and Bacterial Vaginosis (BV) involve overgrowth of organisms normally present in flora.

Trichomonas, Candida, and BV by nucleic acid amplification (NAA)  is the preferred diagnostic test for the common causes of vaginal symptoms, including bacterial vaginosis, Candida, and Trichomonas.

• Reliable results are dependent on adequate specimen collection, transport, storage, and processing. Because the transport system used for this assay does not permit microscopic assessment of specimen adequacy, proper specimen collection techniques are necessary.
• Performance of the assay has not been evaluated in women less than 14 years of age
• 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)
  • Glacial Acetic Acid (5% V/V, C spp only)
  • Excessive vaginal mucus
• Low levels of C. glabrata may be masked by high level of Trichomonas
• Not all organisms detected are viable; positive results can be caused by trace organisma RNA
• Assay results cannot be used to indicate successful antimicrobial therapy
• The organisms tested may be present in a healthy microbiome; results should not be used by themselves and should correlate to the other clinical data
• Negative results should not be considsered as definitively negative as pre-analytical errors may influence results
• Other organisms associated with bacterial vaginosis and similar conditions such as Prevotella, Mobilunus, Mycoplasma and Ureaplasma are not examined by these assays.

Aptima Multitest swab specimen collection kit 

1. Partially peel open the Multitest swab package. Remove the swab. Do not touch the soft tip or lay the swab down. If the soft tip is touched, the swab is laid down, or the swab is dropped, use a new Aptima Multitest Swab Specimen Collection Kit.
2. Hold the swab, placing your thumb and forefinger in the middle of the swab shaft covering the score line. Do not hold the swab shaft below the score line.
3. Carefully insert the swab into the vagina about 2 inches (5 cm) past the introitus and gently rotate the swab for 10 to 30 seconds. Make sure the swab touches the walls of the vagina so that moisture is absorbed by the swab and then withdraw the swab without touching the skin.
4. While holding the swab in the same hand, unscrew the cap from the tube. Do not spill the contents of the tube. If the contents of the tube are spilled, use a new Aptima Multitest Swab Specimen collection kit.
5. Immediately place the swab into the transport tube so that the score line is at the top of the tube.
6. Carefully break the swab shaft at the score line against the side of the tube.
7. Discard the top portion of the swab shaft
8. Tightly screw the cap onto the tube.

Note: A single vaginal collection container can be shared for testing of vaginal specimens submitted for Chalmydia trachomatis and Neisseria gonorrhea.

Aptima Multitest swab specimen collection kit

Ambient - 30 days

Refrigerated - 30 days

• Improper label (unlabeled or mislabeled)
• Time delay between time of collection and receipt of specimen
• Improper transport container
  • Specimen not submitted in Aptima-Multitest collection vial
• Collection vials submitted without swabs
• Improper transport temperature
• Inappropriate specimen type
  • Sources other than vaginal
• Leaking container

Nucleic acid amplification test (NAAT)

Negative

• Invalid results can and do occur due to interfering substances. (See list of interferences under limitations)
  • Recollection is recommended if signs and symptoms warrant testing.
  • Invalid rates of 0.7%-1.7% are expected with this test.
• Candida famata can produce cross reactivity with the CT/TV assay
• Lactobacillus acidophilus can produce cross reactivity with the BV assay
• Interference with the BV assay was observed with mucus, vaginal moisturizing gel, and Tioconazole. Hologic has not  exhaustively researched the effect of all medication and topical agents.