A negative result may be obtained if the specimen collection is inadequate or if antigen concentration is below the sensitivity of the test.

This test does not differentiate between viable and non-viable organisms.

Patients with vaginitis/vaginosis symptoms may have mixed infections.  Therefore, a test indicating the presence of T. vaginalis does not rule out the presence of candidiasis or bacterial vaginosis.

Routine screening for T. vaginalis infection is not advised for asymptomatic persons without HIV infection who do not have risk factors.

Self-collection of vaginal swabs is permissible.  The swab and specific specimen collection information must be provided to the patient by the care provider; the care provider must ensure the patient clearly understands self-collection information before proceeding with collection.  It is not appropriate for patients to present to a laboratory and request a swab for self-collection; such requests will be refused by the laboratory.  Self-collection applies ONLY to patients being assessed for Trichomonas (one Copan M40 swab) and bacterial vaginosis/yeast (a second Copan M40 swab is acceptable for self-collected vaginal swabs for bacterial vaginosis/yeast; the preferred sample collection device for provider collected specimens is the Copan ESwab Collection, Transport and Preservation System).  Cervical sample self-collection is not possible; self-collected cervical samples for Neisseria gonorrhoeae culture will be rejected.

Patient Preparation Instructions: Not applicable.