This order is for Jay (ED and inpatients), North, Fishers, and West, for all other locations; please order the Multiplex Vaginitis Panel by PCR.
Collect
Specimen Type: Vaginal
Collection Method/Container: Affirm Transport Media (Affirm Ambient Temperature Transport System)
Preferred Draw Volume
1 swab
Minimum Draw Volume
1 swab
Unacceptable Conditions
Specimens >72 hours old
Self collection
Any specimens other than vaginal
Any collection device other than the Affirm transport.
Tubes with glass in them
Frozen specimens
Swabs that are not provided by the Affirm VP III Ambient Temperature Transport system; (wooden shaft swabs)
Collection Comments
Link to BD Affirm Ambient Temperature Collection System Instruction for providers: Collection System Instructions
Note for providers: please ensure no broken glass from the ampule is included in the Affirm Transport Media.
Trichomonas Prep is approved ONLY for vaginal specimens sent in the Affirm transport media. The Affirm Ambient Temperature Transport System allows specimens to be stored at room temperature or refrigerated for up to 72 hours, if necessary. Urine samples are not acceptable for TrichPrep - please see Trichomonas vaginalis PCR for specimen collection, container, and ordering information.
Storage/Transport Temperature
Room Temperature or Refrigerated
Stability (from collection to initiation)
Room temperature: 3 days
Refrigerated: 3 days
Ordering Recommendations
A Trichomonas Prep for a vaginal specimen includes a DNA probe for the presence of the sexually transmitted protozoan parasite Trichomonas vaginalis. A physician may order this test if the patient has symptoms of a T. vaginalis infection such as difficulty, pain and/or discomfort during urination or a foul-smelling vaginal discharge.
Performed
Monday - Sunday; Days, Evenings, Nights
Methodology
DNA Probe
Reported
24 hours
Performing Lab
Molecular
Other Performing Labs
Arnett, Bedford, Bloomington, CAH Southside, CAH Westside, Frankfort, Jay County, Morgan, North, Paoli, Fishers, West, and White Laboratories
Synonyms
3109
Affirm
Vaginosis
Reference Interval
Not Detected
Assay Limitation(s)
Optimal test results require appropriate specimen collection. Test results may be affected by improper specimen collection, handling and/or storage conditions. A negative test result does not exclude the possibility of vaginitis/vaginosis.
Adulteration of reagents or failure to follow instructions exactly as set forth in the directions for use may adversely affect performance as described in the labeling.
Specimens held longer than 72hrs at ambient or refrigerated conditions may cause false results.
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 available to the clinician such as pH, amine odor, clue cells and vaginal discharge characteristics.
The performance of this test on patient specimens collected during or immediately after antimicrobial therapy is unknown. The presence or absence of Candida species, G. vaginalis or T. vaginalis cannot be used as a test for therapeutic success or failure.
Clinical Interpretation
The Trichomonas Prep (submitted in the Affirm 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. The sensitivity and specificity of the Affirm test for the identification of Candida, G. vaginalis, and T. vaginalis are significantly greater than other methods such as wet prep and Gram stain. Likewise, the specificity and sensitivity of the Affirm test is greater than that of culture for G. vaginalis. Additional information on sensitivity and specificity supplied on request.
CPT Codes
87480, 87510, 87660
Test Code (Outreach Synonym)
3109
Catalog Code
828041216
Collection
Test Information
This order is for Jay (ED and inpatients), North, Fishers, and West, for all other locations; please order the Multiplex Vaginitis Panel by PCR.
Collect
Specimen Type: Vaginal
Collection Method/Container: Affirm Transport Media (Affirm Ambient Temperature Transport System)
Preferred Draw Volume
1 swab
Minimum Draw Volume
1 swab
Unacceptable Conditions
Specimens >72 hours old
Self collection
Any specimens other than vaginal
Any collection device other than the Affirm transport.
Tubes with glass in them
Frozen specimens
Swabs that are not provided by the Affirm VP III Ambient Temperature Transport system; (wooden shaft swabs)
Collection Comments
Link to BD Affirm Ambient Temperature Collection System Instruction for providers: Collection System Instructions
Note for providers: please ensure no broken glass from the ampule is included in the Affirm Transport Media.
Trichomonas Prep is approved ONLY for vaginal specimens sent in the Affirm transport media. The Affirm Ambient Temperature Transport System allows specimens to be stored at room temperature or refrigerated for up to 72 hours, if necessary. Urine samples are not acceptable for TrichPrep - please see Trichomonas vaginalis PCR for specimen collection, container, and ordering information.
Storage/Transport Temperature
Room Temperature or Refrigerated
Stability (from collection to initiation)
Room temperature: 3 days
Refrigerated: 3 days
Ordering
Ordering Recommendations
A Trichomonas Prep for a vaginal specimen includes a DNA probe for the presence of the sexually transmitted protozoan parasite Trichomonas vaginalis. A physician may order this test if the patient has symptoms of a T. vaginalis infection such as difficulty, pain and/or discomfort during urination or a foul-smelling vaginal discharge.
Performed
Monday - Sunday; Days, Evenings, Nights
Methodology
DNA Probe
Reported
24 hours
Performing Lab
Molecular
Other Performing Labs
Arnett, Bedford, Bloomington, CAH Southside, CAH Westside, Frankfort, Jay County, Morgan, North, Paoli, Fishers, West, and White Laboratories
Synonyms
3109
Affirm
Vaginosis
Result Interpretation
Reference Interval
Not Detected
Assay Limitation(s)
Optimal test results require appropriate specimen collection. Test results may be affected by improper specimen collection, handling and/or storage conditions. A negative test result does not exclude the possibility of vaginitis/vaginosis.
Adulteration of reagents or failure to follow instructions exactly as set forth in the directions for use may adversely affect performance as described in the labeling.
Specimens held longer than 72hrs at ambient or refrigerated conditions may cause false results.
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 available to the clinician such as pH, amine odor, clue cells and vaginal discharge characteristics.
The performance of this test on patient specimens collected during or immediately after antimicrobial therapy is unknown. The presence or absence of Candida species, G. vaginalis or T. vaginalis cannot be used as a test for therapeutic success or failure.
Clinical Interpretation
The Trichomonas Prep (submitted in the Affirm 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. The sensitivity and specificity of the Affirm test for the identification of Candida, G. vaginalis, and T. vaginalis are significantly greater than other methods such as wet prep and Gram stain. Likewise, the specificity and sensitivity of the Affirm test is greater than that of culture for G. vaginalis. Additional information on sensitivity and specificity supplied on request.
