Progress in Applied Research on the Laboratory Diagnosis of Sexually Transmitted Diseases and the Role of the STD Journal

Julius Schachter's 3-part review on chlamydia infections in the New England Journal of Medicine in 1978 had a profound influence on my research career. I had spent 8 years building a new diagnostic Virology Laboratory at McMaster University in Hamilton, Canada, pursuing new rapid methods, which led me to become a co-founder with Ken McIntosh (Harvard) and Stanley Plotkin (Wistar Institute) in 1977, of the Pan American Group for Rapid Diagnosis, which evolved into a professional Society. Schachter's articles convinced me to add chlamydia to the testing menu. Julie and I met in 1983 as co-speakers at a symposium in California organized by Luis de la Maza. We soon began a research collaboration that lasted a lifetime. Our successful research programs can be attributed to our willingness to listen carefully to each other and the impeccable laboratory skills of our long-time research assistants, Dan Jang and Jeanne Moncada. A Sexually Transmitted Diseases Diagnostics Initiative was established by an international group in 1990, and Julie was invited to chair a chlamydia working group. In 1993, I was invited to chair an international advisory group for the Initiative, which included representation from the World Health Organization acting as the secretariat.1 With funding from the National Institutes of Health, industry, and private foundations, we refereed 75 proposals and funded 8 from 1994 to 2000. Most of the projects yielded new technologies for rapid diagnostics, but none fulfilled the point-of-care criteria to win the Rockefeller Prize of 1 million US dollars, and none achieved rigorous field evaluation on appropriate patients. Because of our interactions with many of the vendors of diagnostic tests, Julie and I conducted many clinical trials with new diagnostic products. Data from these studies and from other investigators were used to gain Food and Drug Administration (FDA) clearance and European Conformity (CE)mark. Most of the earlier studies were published in the Journal of Clinical Microbiology. Julie was appointed editor-in-chief of the STD journal in 1989, and in 1990 invited me and several others interested in diagnostics to join the journal review board. Researchers performing studies with the new antigen and nucleic acid amplification assays were encouraged to publish in the STD journal to enable easy access for clinician and public health readers. Julie had the idea of more formal collaboration with other interested investigators. Thus, many of our test performance studies were designed, performed and coauthored with Walt Stamm, Bill McCormack, Tom Quinn, Dave Martin, Stephanie Taylor, Ned Hook, and more recently Barbara Van der Pol, Charlotte Gaydos, Harold Wiessenfeld, Kenneth Mayer, and Matthew Golden. As each company developed a new assay, they were provided with a team of experts willing to evaluate their tests against FDA-cleared assays in appropriate patient populations. Many clinical trials provided my laboratory the opportunity to focus on variables of the preclinical phase of laboratory testing. We showed the frequency of false positives and negatives of commercial antigen detection assays and the increased accuracy provided by nucleic acid amplification tests. The ligase chain reaction from Abbott provided a sufficient increase in sensitivity and specificity2 to be used on first void urine. Other commercial polymerase chain reaction assays followed and provided similar results with urines, and cervical and vaginal swabs. We discovered that some specimens contained inhibitors of amplification, which needed to be removed to optimize testing. We and others demonstrated the value of pooling of specimens on cost and efficiency of laboratory testing.3,4 The impact of order of collection of urine samples was determined.5 Urine and vaginal swabs were compared, and preference for vaginal swabbing was documented.6 Comparing collection devices showed that flocked nylon swabs collected and released more analyte for testing than traditional wrapped rayon swabs.7 We focused on comparing many self-sampling devices for Chlamydia trachomatis (CT) and Neisseria gonorrhoeae (NG), which has led to their use for many human papillomavirus studies. We validated the testing of liquid-based Papanicolaou test (Pap) samples for the detection of human papillomavirus, CT, and NG using commercially available SurePath, PreservCyt, and new collection kits.8,9 We determined that a self-collected swab of the urinary meatus detected more cases of CT, NG, and Mycoplasma genitalium than urines or urethral swabs.10 With the development of automated laboratory testing, we compared most of the commercial assays for accuracy, workflow, and maintenance costs.11 With the discovery of oral and anal sampling for CT and NG, companies were presented with the dilemma that none of the FDA-approved assays were cleared for these sample types. The complexity and costs for any one of the companies to gain clearances were a challenge. Schachter proposed that a head-to-head comparison of all the currently cleared specimen types and oral and anal specimens on the same men or women could achieve the need for these data. He formed a team of investigators and company representatives of cleared assays to work together to design the FDA-approved study. After 4 years, the data were published, and specimen clearance was achieved. I think that this new approach to specimen clearance provides an alternative model to the traditional FDA approaches that commercial assays have required. Data on tests with traditional turnaround times, some more rapid assays and automated instruments, were evaluated, and most of these studies were published in the STD journal during Schachter's 25-year tenure and beyond. In retrospect, CT and NG were the perfect STDs for this expansion of applied research. They cause serious treatable diseases in adults and children, but a proportion of infected adults are without symptoms, rendering syndromic treatment a poor option. Thus, more convenient and acceptable specimens were explored from asymptomatic patients. This has enabled the implementation of screening programs, with treatment of positive patients and their contacts in the effort of keeping these infections controlled. During 34 years of research collaborations, publishing and reviewing papers for the journal, I have interacted with many outstanding individuals in academia and public health. I have also collaborated with many brilliant company-employed scientists such as Helen Lee, Jean-Pierre Allain, Damon Getman, Janel Dockter, and Attila Lorinz, to name a few. Some have crossed over into or from university positions. Although the underlying reason for industry participation in STD science is commercially driven, their participation has enabled our amazing progress. In celebration of the 50th anniversary of the STD journal, it is gratifying to have participated in its growth and to have helped to shape its scientific presence by reviewing 98 submissions and contributing 30 peer-reviewed papers since 1988.

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