Cutting edge diagnostics in rheumatology: The role of patients, clinicians, and laboratory scientists in optimizing the use of autoimmune serology

Introduction Autoimmune serology has become a potentially powerful tool for experienced clinicians. However, it currently is not being used optimally due to lack of widely used standardized assays, local working conditions, traditions, different technology, cost constraints by medical insurers, and ability on the part of clinicians to correctly interpret the results of certain assays. New serologic technologies and assays are developed by laboratory scientists and the commercial industry at a very fast pace and may eventually lead to better reproducibility in confirming a diagnosis and estimating prognosis, ultimately improving the quality of clinical care. To achieve this goal, the accuracy of such testing must be demonstrated in studies involving sufficiently large patient populations before a new assay can be accepted for clinical use. In the past, there have been very few studies with a prospective, unbiased, multicenter design. Thus, the clinical accuracy of certain laboratory diagnostic studies is still unknown. To be useful in a clinical day-to-day diagnostics setting, the differential diagnostic potential and performance characteristics of a test must be known so that clinical misinterpretation, false diagnoses, and potentially harmful treatment can be avoided. The degree to which an assay will give false-positive or false-negative results is important. To aid in developing a followup and therapeutic strategy in a given patient, the prognostic significance of identifying a certain autoantibody in a patient with clinical findings of an autoimmune disease should be known. Presence of autoantibodies indicating a poor prognosis in the clinical setting of early signs of disease should lead to appropriate followup and monitoring of risk manifestations. Such findings should also evoke early awareness of the potential need for effective treatment, before irreversible organ damage takes place. Factual knowledge about these matters necessitates close collaboration between patients, experienced and motivated clinicians, and laboratory scientists, as well as cooperation with the diagnostics industry. Once a diagnostic assay has been developed, standardized postmarketing surveillance and quality assurance by manufacturers and laboratories alike should be mandatory (1).