Finally, in contemporary clinical environments, it is highly recommended that each patient be asked to sign a consent form that will permit their serum and plasma to be used for research and development

Finally, in contemporary clinical environments, it is highly recommended that each patient be asked to sign a consent form that will permit their serum and plasma to be used for research and development. Regulatory and quality assurance companies Both the industry and diagnostic laboratories have access to and utilize a set of standardized sera provided by the International Union of Immunology Societies/Arthritis Foundation/World Health Organization/Center for Diseases Control Serology Committee and made available through the Center for Diseases Control in Atlanta [40]. improving the quality of patient care through the use of autoantibody screening and analysis. strong class=”kwd-title” Keywords: Theophylline-7-acetic acid autoantibodies, autoimmunity, diagnosis, diagnostic kits, quality assurance, standardization Introduction Over the past five decades, the detection of autoantibodies in human sera has become an increasingly important approach to the diagnosis and management of patients with a variety of autoimmune conditions. The need for materials and reagents to perform these assays has become a major entry point for manufacturers and commercial vendors to develop and market a wide variety of diagnostic packages. Although some diagnostic laboratories still use assays that are developed in house, commercial packages have gained a significant foothold in many areas of autoimmune serology. The reasons that the use of commercial packages has become so widespread are that they are cost-effective, are easy to use and can satisfy criteria for accreditation. Kits usually provide all the necessary reagents and a cookbook approach to overall performance of the assay. Commercial autoantibody assay packages employ a variety of technologies that include indirect immunofluorescence (IIF), immunodiffusion, immunoblotting, ELISA and, more recently, addressable laser beads and antigen arrays. One of the more popular technology platforms is based on the ELISA because it offers sensitivity, high throughput and relatively low cost on the background of only modest equipment needed to perform the assay. Regrettably, little has been carried out to standardize these packages [1], and postmarketing surveillance and quality assurance is largely left to the manufacturers. A number of studies have evaluated the overall performance characteristics of antinuclear antibody (ANA) [2-13] and antineutrophil cytoplasmic antibody (ANCA) [14] packages. Studies that compared enzyme immunoassay (EIA) packages from different manufacturers with standard assays such as IIF and immunodiffusion concluded that there was significant discordance between standard assays and EIAs [3,5] and significant discordance between packages from different manufacturers [4]. In one study EIAs were found to be more sensitive than immunodiffusion [2], and another study that used a cross-section of serum referred to a rheumatology laboratory found moderate to good agreement between ANA-IIF and anti-DNA results with two commercial EIA packages [6]. Analysis of the design of some studies suggests that the lack of agreement between EIA and standard assays may depend on the diagnosis and/or the selection bias of the patients under Rabbit polyclonal to ABCA6 study [2-4,6]. A study by Tan and colleagues [15] focused on the EIA packages themselves, and in particular highlighted deficiencies in intrinsic properties of the packages (sensitivities and specificities). A more recent study focused on the clinical laboratories themselves and, although one might expect academic laboratories to be rather proficient in the implementation of the EIA packages, that was not the case [12]. As in other studies [1], it was suggested that quality control procedures for daily overall performance of assessments in Theophylline-7-acetic acid the clinical laboratory setting should not be ignored, and that a minimal overall performance target of coefficients of variance in EIA assays should be established [12]. If the conclusions of these studies can be briefly summarized, it could be said that there are significant concerns with the accuracy (sensitivity, specificity), reliability, and quality of many commercial packages. In many cases the manufacturer has been assumed the root cause for these shortcomings; however, the use of commercial packages and their appropriate application in a clinical setting involves a rather complex chain of constituencies and events. The factors that have disconnected the highly regulated and good laboratory practices of the manufacturer and the assumptions of the client clinician are numerous. The goal of the present evaluate is to identify the principal links Theophylline-7-acetic acid in this chain, to identify the factors that weaken the chain and to propose a plan of resolution. It is suggested that a higher level of commitment and partnership between all of the participants is required to achieve the goal of improving the quality Theophylline-7-acetic acid of patient care through the use of autoantibody screening and analysis. The matrix of developing and application of autoantibody diagnostic packages (Fig. ?(Fig.11) Open in a separate window Physique 1 The chain of production, use and application of autoantibody test packages. The delivery of health care in.