Jul 23 2007, 10:30 AM EST
News source: Business Wire
The nation's first routine test for sexually transmitted infections (STIs) using DNA sequencing which eliminates the false positive test results associated with other methods, is now available to physicians and their patients, said Suri Pappu, MD, director of Milford Medical Laboratory and chairman of the department of Pathology at Milford Hospital.
A false positive diagnosis of STIs can have adverse medical, social and psychological impacts on a patient, said Sin Hang Lee, MD, who initiated and developed the DNA sequencing test based on a new LoTemp(TM) PCR amplification technology. With DNA sequencing, once a signature sequence is identified, it can only come from one specific organism, thus eliminating all false identifications. DNA sequence, confirmed by the national GenBank database, is like the "Social Security Number" of a microbe.
HPV, chlamydia and gonococcus are the causative agents for the three most common STIs in the United States. Early accurate diagnosis of STIs is important for proper health care in women. As of July 2007, the U.S. Preventive Services Task Force (USPSTF) recommends screening for chlamydial infection for all sexually active or pregnant women aged 24 and younger, and for older pregnant women who are at increased risk, so that timely treatment can be instituted. The USPSTF also cautions the physicians that in low prevalence populations a positive test is more likely to be a false positive than a true positive. This is because the DNA test kits currently on the market were originally developed for screening populations with high prevalence of STIs, all with a few percentages margin of error. In low prevalence populations, the number of false positive results generated by these test kits exceeds that of the true positives. In contrast, a DNA sequencing assay is self-validated, automatically eliminating any false positive results.
The first scientific report on routine HPV genotyping by DNA sequencing was just published in Infectious Agents and Cancer (http://www.infectagentscancer.com/content/2/1/11). The second manuscript on testing all three STIs is under peer review. Accurate HPV testing is important in following persistent HPV infections which may lead to cervical cancer. For example, HPV-66, a known carcinogenic genotype, is relatively common in New Haven County, but not targeted for detection by the commonly used Digene HC2 assay. HPV genotyping information is also useful in monitoring HPV infections before and after vaccine immunization to develop prevention strategy for the individual patients. Dr. Lee has petitioned the Food and Drug Administration (http://www.fda.gov/OHRMS/DOCKETS/DOCKETS/07p0210/07p0210.htm) to down-classify the HPV tests to class II virology device category to facilitate competitive introduction by small innovative manufacturers of their new technologies via the 510K applications in compliance with the least burdensome provisions of the FDA Modernization Act of 1997.
The molecular diagnostic procedures performed at Milford Medical Laboratory (http://www.milfordhospital.org/page9.html) are approved as high complexity tests by the State of Connecticut Department of Health and by the Centers for Medicare & Medicaid Services under the Clinical Laboratory Improvement Act of 1988, said Dr. Pappu.
More Information: http://www.milfordhospital.org/page9.html
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