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Healthcare 2000 highlights opportunities for new diagnostics
Manufacturers seeking targets for new products need only listen to what users say about the current generation of tests. At the Healthcare 2000 conference last April (Boxborough, MA), clinicians and laboratorians offered more than a handful of ideas for improving the utility of current tests.
Speaking about the field of autoimmune testing, Linda Cook, PhD, head of the immunology laboratory section at the Lahey Clinic (Burlington, MA), noted that in recent years, many autoantibodies have been identified in patients with autoimmune gastrointestinal and liver diseases. But while there are some useful tests on the market, she said, there is room for improvement. "Further education and test development is needed before the variety of useful antibodies can be routinely tested for in clinical diagnostic laboratories."
As an example, Cook noted that there are three kinds of tests for detecting the antibodies for celiac disease, each with different strengths and weaknesses. The newest is an IgA-specific EIA for antitissue transglutaminase, which came on the market in January. Early studies suggest that this test is very sensitive, said Cook, but its specificity is not yet known.
Also in need of improvement are tests to distinguish between Crohn's disease, which almost always requires surgery, and ulcerative colitis, which can usually be controlled with drug therapy. "We have work to do to determine what antigens ulcerative colitis patients are making," Cook said.
Another field open to improvement is testing for autoimmune hepatitis and primary biliary cirrhosis. According to Cook, the effectiveness of current tests for these liver diseases also varies.
The preanalytical end of coagulation testing is another area ripe for manufacturer involvement. According to Timothy Hayes, DVM, MD, chief of clinical pathology and medical director of the blood bank and coagulation laboratory at NORDX/Maine Medical Center (Portland, ME), the increasingly decentralized collection of specimens has made preanalytical variables extremely important in producing valid coagulation test results.
Ideally, Hayes noted, processing of samples should occur within an hour of collection—a goal that newer analyzers are helping laboratorians to accomplish. Point-of-care analyzers allow instant processing and may enable laboratorians to follow better preanalytical procedures, Hayes said. "Maybe we can gain control in the preanalytical area even as we lose it in the analytical."
The conference was sponsored by the Northeast region chapters of the American Association for Clinical Chemistry, the Clinical Laboratory Management Association, and the Clinical Ligand Assay Society. Next year's conference, "Management and Technology for the New Millennium," is scheduled for April 25–26, in Boxborough, MA.—Erik Swain
