Background Information

Transcription

1 Background Information r One About NAT Testing NAT testing has been widely embraced by laboratories throughout the world as a means to identify CT cases because of its high degree of accuracy and reliability in identifying infections, particularly asymptomatic infections, in genetic materials from patient samples. For example, by leveraging Nobel Prize-winning polymerase chain reaction (PCR) technology, the COBAS AMPLICOR CT/NG Test can multiply DNA from a single bacterium to millions of copies, allowing for the determination of infection even before antibodies have formed in a patient. This test is 40 percent more sensitive than cultures, percent more sensitive than DNA probe tests, and it identifies fewer false negatives and more true positives than EIA or DNA probe tests.1,2 About COBAS TaqMan The COBAS TaqMan Analyzer is Diagnostics real-time PCR instrument, designed for clinical diagnostics laboratories seeking a solution to the complexity of molecular diagnostics testing, and require a single, simple system for all of their real-time PCR needs. The instrument combines in-vitro diagnostic and research features in one instrument and automates the amplification, detection, and quantitation of DNA or RNA, creating PCR analysis that is more sensitive than traditional PCR and highly accurate. When approved, the CT test will be a menu expansion beyond the HIV, HBV, and HCV tests already available on the COBAS TaqMan 48 Analyzer.

2 The Ferrero Study Ferrero s study involved analysis of 251 patient samples (185 urine samples and 66 endocervical swab samples). Performance was evaluated on the basis of head-to-head comparison between the prototype CT test on the COBAS TaqMan 48 Analyzer, the COBAS AMPLICOR CT/NG Test, and the Becton Dickinson ProbeTec ET CT/GC Assay. Samples testing positive or negative with only one of the methods were retested with the COBAS AMPLICOR Test for confirmation testing. Ferrero observed 100% sensitivity and 100% specificity among the three assays using endocervical swabs (64 negatives, 2 positives). Urine testing demonstrated 100% sensitivity and 99% specificity among the three assays (158 negatives, 26 positives, 1 discrepant). The one discrepant sample tested negative on both the prototype CT test and the COBAS AMPLICOR CT/NG test. In performing the analysis, Ferrero s laboratory also observed a substantial improvement in the total throughput of patient samples when using the COBAS TaqMan 48 Analyzer. THE CLUB 29 STUDY: OFFERING NEW INSIGHTS ON CHLAMYDIA IN EUROPE A major study entitled Chlamydia Prevalence, Self-Sampling and Sampling Preferences in University Students from Three European Countries (informally called the Club 29 Study ) is providing important new data on this significant public health issue. Supported by Molecular Diagnostics (RMD), this European study involved two thousand women, aged 18 to 25, at multiple centers in France, Germany, and Austria. The objective of the study was to evaluate patient awareness of Chlamydia trachomatis (CT), patient attitudes toward screening preferences, the viability of self-collection of patient samples, and the performance of a leading molecular diagnostic test with self-collected patient samples. All study participants were asked to provide a urine sample as well as a self-collected vaginal swab on-site at their universities. In order to access patients ability to correctly perform the self-collected vaginal swab procedure in a non-medical environment, participants were given a sampling pack for use in their home. They were asked to return their sample at a drop-off site

3 at their universities within 48 hours. The return rate and quality of sample collected at home, compared to that obtained on-site at universities, was also assessed. Researchers announced results from this study at the 5th Meeting of the European Society for Chlamydia Research in Budapest, Hungary. The results suggest that the use of self-collected vaginal swabs may be an effective way to expand the reach of the medical profession in fighting CT as it may help to break down traditional stigma-based barriers for patients seeking diagnosis. Diagnosis with self-collected vaginal swabs was as effective as using urine samples collected at the study sites. All samples were tested for CT with the COBAS AMPLICOR CT/NG test, a polymerase chain reaction (PCR)-based molecular assay from Molecular Diagnostics. Some of the country-specific key findings: - Greater than 90% of respondents returned the home self-collected vaginal swabs to their study sites. (France, Austria, Germany) - 90% of study participants who filled out a survey questionnaire noted that they were extremely interested in their health, and yet almost half of these participants responded that they knew nothing or very little about Chlamydia and its consequences. (Germany) - 70% of study participants preferred self-collecting to a clinic visit for CT testing. (Germany) 82% of study participants in France preferred self-collecting. - 70% of participants said they would prefer a self-collected vaginal swab to providing a urine sample during a clinic visit. (Germany) - 90% of study participants who tested positive for CT did not have any symptoms. This finding is consistent with the asymptomatic nature of this infection. (Austria, Germany) - 93% of respondents said they would follow up with their physician if they tested positive with a self-collected vaginal swab. (Austria, Germany)

4 There is a notable lack of knowledge of CT in the general public, so it is very important to initiate public health efforts and broad scale studies like this, said Romain Prieur, Sr. International Marketing & Business Development Manager, Women s Health for RMD. We hope that this initiative will help identify better approaches for educating patients, and that it will ultimately encourage patients to test for the presence of this potentially serious infection. These results are very encouraging in this regard. Additionally, most of the investigators are interested in pursuing similar initiatives in order to further solidify the case for national Chlamydia screening programs in their respective countries.

5 About and Diagnostics Headquartered in Basel, Switzerland, is one of the world s leading research-intensive healthcare groups. Its core businesses are pharmaceuticals and diagnostics. As a supplier of innovative products and services for the prevention, diagnosis and treatment of disease, the Group contributes on a broad range of fronts to improving people s health and quality of life. is one of the leading companies in the global diagnostics market, the leading supplier of medicines for cancer and transplantation and a market leader in virology. In 2003, the Pharmaceuticals Division generated 19.8 billion Swiss francs in prescription drug sales, while the posted sales of 7.4 billion Swiss francs. employs roughly 65,000 people in 150 countries and has R&D agreements and strategic alliances with numerous partners, including majority ownership interests in Genentech and Chugai. s, the world leader in in-vitro diagnostics with a uniquely broad product portfolio, supplies a wide array of innovative testing products and services to researchers, physicians, patients, hospitals and laboratories world-wide. For further information, please visit our websites and For more information please contact: Horst Kramer Divisional Communications Phone Horst_k.kramer@roche.com 1. Semeniuk H. Zenter, et al, Evaluation of sequential testing strategies using non-amplified and amplified methods for detection of Chlamydia trachomatis in endocervical and urine specimens from women. Diagnostic Microbiology and Infectious Disease, 42 (2002) Bass et al. Clinical evaluation of a new polymerase chain reaction assay for detection of Chlamydia trachomatis in endocervical specimens. J Clin Microbiol. 1993:31; Please register for our convenient "NewsFlash" service in our online "Press Lounge" +++ see our Website " +++