Test Directory

527 Vaginitis, Microbial Identification, Affirm

Specimen Type
Specimen Stability
Reference Range
BD Affirm Ambient Temperature Transport System or
YourSwab™ (BD ESwab)
BD Affirm-72hrs, Room Temp YourSwab™ (BD ESwab) -48hrs Room Temp
Negative

Specimen Requirements

Preferred amount: 1 Swab in Sample Collection Tube
Minimum amount: 1 Swab in Sample Collection Tube

Method

DNA Probe.The AFFIRM microbial vaginitis test identifies the three most common causes of infectious vaginitis (Candida species, Gardnerella vaginalis, and Trichomonas vaginalis) utilizing the FDA approved nucleic acid probe technology by Becton Dickinson. Test performance characteristics of the assay are as follows per the Becton Dickinson kit insert: Sensitivity: Relative to Microscopy: Gardnerella vaginalis - Trichomonas vaginalis - 95% 93% Relative to Culture: Specificity: Candida species - 82% Gardnerella vaginalis - Trichomonas vaginalis - 98% 90% Relative to Microscopy: Gardnerella vaginalis - Trichomonas vaginalis - 100% 99.9% Relative to Culture: Candida species - 98.4% Gardnerella vaginalis - Trichomonas vaginalis - 100% 99.9% Although highly sensitive and specific, if test results aren't consistent with clinical presentation, additional testing by other methods may be warranted. YourSwab™ (BD ESwab) was validated by Pathology, Inc. as an acceptable alternate collection device.

Schedule

Mon-Fri

Turn-Around Time

24-48hrs

Instructions/Notes

See Appendix, Vaginal Specimen Collection

Clinical Utility

Detect bacterial infection, which can cause pre-term labor, bacterial vaginosis and vaginitis

CPT Codes

87480, 87510, 87660

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