The detection and identification of Candida species, Gardnerella vaginalis and Trichomonas vaginalis nucleic acid in vaginal fluid specimens from patients with symptoms of vaginitis/vaginosis.

• Specimen collection is a critical step. Personnel collecting the vaginal specimen should be well-trained to minimize the possibility of inadequate specimens.
• The Affirm VPIII Microbial Identification Test is for use with vaginal specimens from patients with symptoms of vaginitis/vaginosis. Performance with other specimens or other patient populations has not been established.
• Patient specimen must be collected immediately after the ATTS reagent has been dispensed into the Sample Collection tube.
• The assay is intended to be used with the Affirm VPIII Ambient Temperature Transport System Set. Other methods of collection have not been evaluated.
• Specimen collection is a critical step. Personnel collecting the vaginal specimen should be well-trained to minimize the possibility of inadequate specimens.
• Blood and water-based lubricants do NOT interfere with the test.
• Detection is dependent on the quantity of organisms present in the specimen. This is influenced by patient factors, stage of infection, organism strain, and adequate specimen collection.
• A negative test result does not exclude the possibility of vaginitis/vaginosis.
• The presence of G. vaginalis, although suggestive, is not diagnostic for bacterial vaginosis. As in many clinical situations, diagnosis should not be based on the results of a single laboratory test. Results should be interpreted in conjunction with other clinical and laboratory data.
• Mixed infections may occur. Therefore, a test indicating the presence of Candida species, G. vaginalis, and/or T. vaginalis, does not rule out the presence of other organisms, including Mobiluncus mulieris, Mycoplasma hominis, and/or Prevotella bivia.
• The presence or absence of Candida species, G.vaginalis, or T.vaginalis cannot be used as a test for therapeutic success or failure. DNA may persist for 4-6 weeks after treatment.

BD Affirm VPIII ambient temperature transport system

1. Place the patient in position for a pelvic examination. Insert speculum into the vagina to permit visualization of the posterior vaginal fornix.
2. Using the sterile swab from the BD Affirm VPIII kit, obtain a sample from the posterior vaginal fornix. Twist or roll the swab against the vaginal walls two or three times, ensuring the entire circumference of the swab has touched the vaginal wall. Swab the lateral vaginal wall while removing the swab.
3. Open the foil pouch and remove the ATTS (Ambient Temperature Transport System) Reagent Dropper
4. Break ampule in ATTS Reagent Dropper by firmly squeezing the dropper close to its center with finger and thumb, ONE TIME ONLY.
5. Dispense entire ATTS Reagent into Sample Collection Tube by continuing to squeeze the dropper.                                                                                                                                  Note: The patient specimen must be collected immediately after the ATTS reagent has been dispensed. Do NOT pre-dispense the ATTS reagent into the Specimen Transport Tube.
6. Peel wrapper to expose patient swab. Remove swab, discard wrapper.
7. Collect patient specimen:
1. Place the patient in position for a pelvic examination. Insert speculum into the vagina to permit visualization of the posterior vaginal fornix.
2. Using the sterile swab, obtain a sample from the posterior vaginal fornix. Twist or roll the swab against the vaginal walls two or three times, ensuring the entire circumference of the swab has touched the vaginal wall. Swab the lateral vaginal wall while removing the swab.
8. Immediately place the patient swab in the Sample Collection Tube containing the ATTS Reagent.
9. With the swab touching the bottom of the collection tube, grasp the pre-scored handle of the swab just above the top of the tube and bend until the swab breaks.   Discard the remaining shaft into an infectious waste container.
10. Place the Sample Collection Cap over the exposed end of the swab and firmly press the cap onto the Sample Collection Tube. The cap will 'snap' onto the tube when it is properly seated.
11. Label the Sample Collection Tube with patient identification information. Include date and time that the sample was collected.

Place the sample collection tube  in "small" bag before transport

BD Affirm VPIII Ambient Transport System

Ambient  (15 - 30 °C) - 72 hours

Refrigerated (2 - 8°C) - 72 hours

• No swab in BD Affirm VPIII Ambient Temperature Transport System
• Swab not from BD Affirm collection kit
• Frozen
• Sources from other than vaginal site
• Specimen exceeding 72 hours after collection
• Self-collected vaginal specimen.
  • Speculum is inserted into the vagina to permit visualization of the posterior vaginal fornix. See Limitations.
• BD Affirm Transport Reagent not added to swab (swab is dry)

Non-amplified DNA probe

Negative