Nucleic Acid Test Approved for Sexually Transmitted Parasite

A molecular based assay that detects the protozoan parasite, Trichomonas vaginalis, has received official approval for use in clinical laboratories.

The assay is an in vitro qualitative nucleic acid amplification test (NAAT) that utilizes target capture, chemiluminescent probe hybridization that detect ribosomal ribonucleic acid (rRNA) from T. vaginalis.


The assay is designed to test the following specimens from symptomatic or asymptomatic individuals: clinician-collected endocervical swabs and vaginal swabs, female urine specimens, and specimens collected in specific transport solution. The assay utilizes Target Capture, Transcription-Mediated Amplification (TMA), and Hybridization Protection Assay (HPA) technologies

When the APTIMA Trichomonas vaginalis Assay (Gen-Probe Incorporated, San Diego, CA, USA), is performed, the target rRNA is isolated from the specimen by use of capture oligomers via target capture that utilizes magnetic microparticles. The capture oligomers contain sequences complementary to specific regions of the T. vaginalis rRNA target molecules as well as a string of deoxyadenosine residues. During the hybridization step, the sequence-specific regions of the capture oligomers bind to specific regions of the T. vaginalis rRNA target molecule. The capture oligomer: target complex is then captured out of solution by decreasing the temperature of the reaction to room temperature. The assay is used on the fully automated TIGRIS system, which is also manufactured by Gen-Probe.

Carl W. Hull, MBA, Gen-Probe's president and CEO, said, "Our assay will provide a convenient tool for physicians and laboratories because it employs the same technology as our market-leading tests for Chlamydia and gonorrhea, can be used with the same female samples, and runs on our unique, fully automated TIGRIS system." The APTIMA Trichomonas assay has been cleared for marketing by the US Food and Drug Administration, (FDA, Silver Springs, MD, USA).

T. vaginalis is a sexually transmitted parasite that causes vaginitis, urethritis and cervicitis in women. If left untreated, complications can include premature labor, low-birth-weight offspring, and premature membrane rupture in pregnancy. The US Centers for Disease Control and Prevention (CDC; Atlanta, GA, USA) estimate that 7.4 million American men and women are infected with this parasite annually.

Related Links:
Gen-Probe Incorporated
US Food and Drug Administration
US Centers for Disease Control and Prevention