Nucleic acid amplification tests (NAATs) have demonstrated high sensitivity and specificity for detection of CT and NG. The need to test different at risk populations calls for the use of diverse specimen types from urogenital and other anatomical localizations. While screening guidelines are promoting the use of vaginal swabs in females and urine in males, other specimen types may be advisable. 

Studies have shown that the cobas® CT/NG Test is an effective avenue to facilitate screening and diagnosis of infection with CT and NG. The Test offers flexibility in population type and specimen choice without compromising accuracy, and is validated with clinician-collected vaginal swab specimens, clinician-instructed self-collected vaginal swab specimens, male and female urine, endocervical swab specimens, and in cervical specimens for liquid based cytology.

According to the WHO, more than 85 million cases of Chlamydia and over 62 million cases of Gonorrhea occur worldwide annually.

Abbott’s RealTime CT/NG assay is an in vitro polymerase chain reaction (PCR) assay for the direct, qualitative detection of the plasmid DNA of Chlamydia trachomatis and the genomic DNA of Neisseria gonorrhoeae in female endocervical or vaginal swab specimens, male urethral specimens, or in male or female urine specimens. The assay is designed for use on Abbott’s automated molecular diagnostics system, the m2000, which utilizes real-time PCR technology for detecting and monitoring infectious diseases. Outside of the U.S, Abbott offers a separate CT  and CT/NG assay available on the m2000 and the m24 systems.

HPV infections are among the most common STIs. Persistent HPV infection may result in progression to cervical cancer. Approximately 70% of invasive cervical cancer cases worldwide are caused by HPV 16 and HPV 18. The Abbott RealTime HR HPV assay is a qualitative in vitro test that amplifies and detects HR HPV DNA in cervical cells collected in liquid media. The detection of fourteen HR HPV genotypes (HPV 16, 18, 31, 33, 35, 39, 45, 51, 52, 56, 58, 59, 66, and 68) is achieved through a primer mix targeting a conserved region of HPV genomes and single stranded DNA probes. Specimens can be collected in PreservCyt Solution (Cytyc Corporation), SurePath Preservative Fluid (TriPath Imaging, Inc.), and the Abbott Cervi-Collect Specimen Collection Kit. The Abbott RealTime HR HPV assay is available outside of the U.S on the m2000 and the m24.

Trichomonas vaginalis (TV) is a sexually transmitted parasite that can cause vaginitis, urethritis, and premature membrane rupture in pregnancy; and can increase susceptibility to infection with HIV-1. The majority of Trichomonas testing currently centers on the diagnosis of symptomatic infections; however, it has been estimated that as many as 50% of infections in women are asymptomatic.  Increases in screening of asymptomatic patients could provide a significant impact on overall health care costs by reducing the negative consequences of untreated infections and the spread of disease. Screening is enabled with the use of nucleic acid amplification tests (NAATs), which offer increased sensitivity for detection of Trichomonas and improved laboratory workflow.

This symposium will present data from recent clinical evaluations using the new APTIMA® Trichomonas vaginalis Assay that demonstrates TV prevalence nearly double that observed by conventional methods and highlights the need for increased screening for TV in at-risk populations.

Attendees of this symposium will learn about the latest developments in laboratory testing for Trichomonas.

For years laboratories have attempted to overcome the time it takes culture to produce an HSV result, the lack of sensitivity of culture and the ability to effectively type.  Laboratories have developed laboratory developed tests and have used ASRs to provide faster results directed towards CSF samples.  These molecular tests are not approved or cleared by any regulatory agency and are manual and labor intensive.  The clinical value outweighed the process issues, yet has kept these tests from being widely adopted for HSV 1 and HSV 2 lesion samples.  With the availability of antiviral therapy and the fact of varying recurrence between HSV 1 and HSV 2, different treatment modalities are recommended based on the specific type of HSV, the need for more sensitive and cost effective testing has grown.  With the prevalence of HSV 2 in the genital area increasing the need to type HSV becomes more critical because of the different counseling and treatments for HSV 2 vs. more aggressive therapy for HSV 1 to reduce symptomatic episodes.  BD has made available the first fully automated and cleared HSV 1 and HSV 2 assay. This assay delivers the automation and process efficiency to enable fast and highly sensitive results.  This symposium will inform on the need for a more aggressive diagnosis of HSV in lesion samples and the new BD assay now available to meet this clinical demand.

CT/GC NAAT assays that employ nucleic acid isolation prior to amplification have consistently been shown to be the most sensitive. Since NAAT assays are very similar in sensitivity and specificity, there are other features that should be considered as important factors in selecting the best CT/GC NAAT assay and automated system.

From an operational perspective, the VERSANT CT/GC assay’s workflow and time-to-result of 5.5 to 6 hours allows for the processing of large numbers of specimens in a relatively short period of time. Kinetic PCR (kPCR) DNA technology combined with Siemens’ proprietary bead technology for the isolation of nucleic acids from clinical specimens and workflow performance provides a reliable and efficient CT/GC assay on the VERSANT kPCR Molecular System.