Published: February 2014
At the end of the Hot Topic presentation, submit your questions on the survey screen that is shown. This is an opportunity for viewers to submit questions to the Hot Topic presenter.
The opportunity to submit questions for this topic is now closed.
The following questions were submitted by viewers and answered by the presenter, Bobbi Pritt, MD,
Director of the Clinical Parasitology Laboratory at Mayo Clinic, Rochester, Minnesota at Mayo Clinic in Rochester, Minnesota.
Questions are presented as submitted (unedited).
- Where does it start? Is it not true that people who are not sexually active can be infected with this organism if the patient lives in an unclean environment without bathing facilities?
Although there may be rare instances where Trichomonas vaginalis is spread through fomites (eg, shared damp towels), this organism is transmitted almost exclusively through direct sexual/genital-to-genital contact. The organism itself is very fragile and cannot survive in the environment for very long.
- Where did the initial Trichomonas originate? What geographic areas are affected most?
It is not known where trichomoniasis originated, but it likely has been infecting humans for a very long time (centuries). Trichomoniasis is found worldwide in both temperature and tropical/subtropical climates. It is thought to be the most common curable sexually transmitted infection in the United States AND in the world.
- I'd like to see how Trichomonas looks in culture media.
The video in the Hot Topic shows a T vaginalis from culture. It is grown most commonly in liquid media and must be viewed microscopically, since it cannot be seen with the naked eye.
- What documentation must be done for the MTRNA/TV test to be validated to be used for male testing?
When commercial tests are performed on specimens that are not FDA-approved/cleared, then an evaluation must be done to determine if the test performs just as well on the non-FDA approved specimens as it does on the FDA-approved specimens. According to regulations by the Centers for Medicare and Medicaid (through the Clinical Laboratory Improvement Act), this testing must include an assessment of accuracy, precision, reportable range, analytical sensitivity, analytical specificity and reference range. The Clinical Laboratory Standards Institute has published suggestions for how to perform each of these experiments that can help guide the laboratory in performing these studies.
It’s important to note that all testing must be performed and documented before the test is used on clinical specimens.
- Do you submit your data to FDA for approval?
No, this data must be submitted by the company who makes the APTIMA TV test (Gen Probe). We hope that they decided to submit data to the FDA in the future since the infection is common in males and can be passed to their sexual partners.
- How do you go about validating the methodology for male specimens?
Please see the answer to question 4 above.