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Vaginosis Screen

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

Test Codes

EPIC: LAB5532

Department

Microbiology

Instructions

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.
• Use only the swab supplied with the collection kit.
• Specimens containing glass fragments will be rejected. This may happen if the filter cap is removed from the ATTS Reagent Dropper ampule. Reagent should be dispensed THROUGH the filter cap on the ATTS Reagent Dropper ampule. Final volume is very small – do not remove the filter cap to dispense additional volume.
• 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/Draw 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).

Rejection Criteria

• Any transport system other than 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.

In-Lab Processing

Do not adhere the accession label to the transport tube (ATTS). "FLAG" accession label to ATTS transport tube.

Storage

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 

Laboratory

Dearborn Microbiology Laboratory
Taylor, Trenton and Wayne sent to Dearborn Microbiology Laboratory for testing.

Royal Oak Microbiology Laboratory
Farmington Hills, Grosse Pointe, Lenox, Livonia and Troy sent to Royal Oak Microbiology Laboratory for testing. 

Performed

Sunday – Saturday.
Results available in one business day.

Reference Range

Negative for Candida spp., Gardnerella vaginalis, Trichomonas vaginalis.

Test Methodology

Nucleic Acid Probe Hybridization (FDA Approved).

Interpretation

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.

Clinical Utility

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.

Clinical Disease

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.

Reference

AFFIRM Package Insert.

CPT Codes

87480 (Candida spp.), 87510 (Gardnerella vaginalis), 87660 (Trichomonas vaginalis).

Contacts

Last Updated

10/25/2023