AFFIRM Test, Vaginitis, Vaginal, Candida, Candidiasis, Trich, Trichomonas, Trichomoniasis, Bacterial Vaginosis, Bacterial Vaginitis, Gardnerella, Antrim #42347, EPIC: LAB5532, SOFT: AFFRM
Prepare the patient as follows:
- Place the patient in position for a pelvic examination.
- Insert an UNLUBRICATED speculum (WITHOUT JELLY) into the vagina to permit visualization of the posterior vaginal fornix.
Specimen Collection Criteria
Collect: Vaginal specimen using the AFFIRM VP-III Ambient Temperature Transport System (ATTS) Test Kit.
- For more information, please see the Specimen Collection Manual.
- The patient's name and collection date must be written on the AFFIRM label which accompanies the ATTS. Attach the AFFIRM label around the top of the transport tube, directly under the cap.
Physician Office/Drawsite Specimen Preparation
Maintain the AFFIRM ATTS at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F) prior to transport.
Preparation for Courier Transport
Transport: AFFIRM ATTS at room temperature (20-26°C or 68-78.8°F) or refrigerated (2-8°C or 36-46°F).
- Any transport system other the AFFIRM VP-III Ambient Temperature Transport System (ATTS).
- Specimens not received in the AFFIRM VP-III Ambient Temperature Transport System (ATTS).
- Specimen older than 72 hours old.
- Frozen specimens.
- Any specimen containing broken glass.
Specimen Stability for Testing:
Room Temperature (20-26°C or 68-78.8°F): 72 hours
Refrigerated (2-8°C or 36-46°F): 72 hours
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): 48 hours
Grosse Pointe sent to Royal Oak Microbiology Laboratory for testing.
Royal Oak Microbiology Laboratory.
Troy sent to Royal Oak Microbiology Laboratory for testing.
Farmington Hills sent to Royal Oak Microbiology Laboratory for testing.
Sunday - Saturday.
Results available in one business day.
Negative for Candida spp., Gardnerella vaginalis, Trichomonas vaginalis.
Nucleic Acid Probe Hybridization (FDA Approved).
A positive result for Candida, Gardnerella, and/or Trichomonas means nucleic acid for Candida species (C. albicans, C. glabrata, C. kefyr, C. krusei, C. parapsilosis, C. tropicalis), G. vaginalis and/or T. vaginalis, respectively, is present in the sample at clinically significant levels indicating that the patient has candidiasis, bacterial vaginosis, and/or trichomoniasis when consistent with clinical signs and symptoms. Simultaneous infections by more than one organism are common.
The Affirm VP-III Microbial Identification Test is a DNA probe test intended for use in 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.
Vaginitis, one of the most common problems in clinical medicine, accounts for more than 10 million office visits each year. The three main categories of vaginitis are bacterial vaginosis (BV), yeast vaginitis (candidiasis) and T. vaginalis vaginitis (trichomoniasis). BV is the most common vaginal infection, and accounts for 15 to 50% of vaginitis/vaginosis depending upon the patient population. While G. vaginalis is no longer thought to be the etiologic agent of BV, it is an indicator of the disease and is still considered to be one of the major bacteria contributing to the infection which involves an increase in anaerobic bacteria and reduction in the normal Lactobacillus flora. The complications of BV can be especially significant in pregnant women, resulting in increased risk of adverse pregnancy outcome, including pre-term labor and birth. Trichomoniasis, a non-reportable sexually transmitted disease, has been estimated to affect 180 million annually worldwide. In the United States, an estimated 3 million women contract trichomoniasis each year. Pregnant women positive for T. vaginalis are more likely to have pre-term rupture of membranes, as well as pre-term labor and birth.
AFFIRM Package Insert.
87480 (Candida spp.), 87510 (Gardnerella vaginalis), 87660 (Trichomonas vaginalis).
Antrim #42347, EPIC: LAB5532, SOFT: AFFRM