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Background: TSH receptor antibodies (TRAb) are the diagnostic hallmark of Graves' disease (GD) and immunoassays for their detection have been available for more than 30 years over three generations of laboratory methods. Despite a growing body of data produced by clinical and laboratory research which demonstrates its elevated sensitivity and specificity, TRAb testing is poorly used for diagnosing GD. The aim of our systematic review and meta-analysis is to verify the diagnostic performance of TRAb detected with 2nd and 3rd generation immunoassay methods., Methods: We searched for English articles using MEDLINE with the search terms "TSH receptor antibody assay", "TSH Receptor antibody tests" and "Graves' disease". We analyzed studies reporting on TSH receptor antibody tests performed by quantitative immunoassays, on untreated patients with GD as the index disease (sensitivity) and on a control group of either healthy subjects or patients affected by other thyroid diseases (specificity). A total of 681 titles were initially identified with the search strategy described. 560 publications were excluded based on abstract and title. Full-text review was undertaken as the next step on 111 publications providing data on TRAb testing; 58 articles were subsequently excluded because they did not include untreated GD patients, or used either bioassays or 1st generation immunoassays. 32 were also excluded because they included data only on sensitivity or only on specificity of the assay, or were duplicates. Finally, 21 articles were selected for meta-analysis. Extraction of data from selected articles was performed by two authors independently, using predefined criteria: the number of patients with GD and the number of healthy or diseased controls; specification of the analytical method used to detect TRAb; sensitivity and specificity of the assay., Results: The meta-analysis showed that the overall pooled sensitivity and specificity of the 2nd and 3rd generation TRAb assays are 97.1% and 97.4%, and 98.3% and 99.2%, respectively, with little difference between the types of immunoassay methods employed (human or porcine receptor, manual or automated procedure). The likelihood of a TRAb-positive individual to have GD is 1367- to 3420-fold greater (depending upon the type of assay) compared to a TRAb-negative person., Conclusions: Data from the meta-analysis showed that TRAb measured with 2nd and 3rd generation immunoassay methods have very high sensitivity and specificity in the diagnosis of GD. The difference between 2nd and 3rd generation methods is small and is equally useful. In contrast with recommendations made by clinical endocrinologists who are not familiar with the state of the art in diagnostic technologies of autoimmunology laboratories, we propose a wide application of these tests in clinical practice to screen all hyperthyroid patients., (Copyright © 2012 Elsevier B.V. All rights reserved.)

Detection of anti-phospholipid (aPL) antibodies for state-of-the art diagnosis of antiphospholipid syndrome(APS) still remains a laboratory challenge due to the great diversity of aPL antibodies and their relevance with regard to the diagnostic criteria. According to the recently revised classification criteria for APS, several enzyme-linked immunosorbent assays (ELISAs) should be performed simultaneously in routine laboratories for the detection of aPL antibodies. Therefore, new approaches to aPL profiling have been proposed recently to provide information regarding diagnosis and eventually outcome in APS patients. Multiplex analysis could meet the increasing demand for cost-efficient detection and profiling of aPL antibodies. Multi-line immunodot assays or bead-based multiplex techniques candidate as alternatives to assess several aPL antibodies simultaneously employing different solid-phases for bound/free separation of reactants. Particularly, multi-line immunodot assays present an alternative to ELISA for aPL antibody detection and profiling in APS patients. The use of hydrophobic membranes as solid-surface by this technique appears to offer a distinct solid-phase reaction environment for the assessment of aPL antibodies. This article reviews novel developments in the field of laboratory diagnostics of APS with special emphasis on multiplex assays., (Copyright © 2012. Published by Elsevier B.V.)

Background: This review aims to make laboratory professionals and clinicians more familiar with the basic concepts that deal with the clinical performance characteristics of a laboratory test., Content: Basic measures of the clinical performance characteristics of a laboratory test, such as sensitivity, specificity, likelihoods, likelihood ratio, post-test probability, odds, Bayes theorem, and receiver-operator characteristic curve are explained. The concepts are illustrated with examples (anti-CCP antibodies) that are worked out in a spreadsheet., Summary: This review seeks to provide laboratory professionals and clinicians with a better understanding of the clinical performance characteristics of a laboratory test and of evidence-based laboratory medicine. The manuscript emphasizes a strong link between clinical statistics and evidence-based laboratory medicine.

The investigation of autoimmunity provides an interest challenge in "omics" research and, particularly, proteome research, as autoimmune diseases are common disorders of unsolved etiology that occur in a wide range of manifestations, in all of which tissues and organs are attacked by the body's own immune system. Autoantibodies are a hallmark of many autoimmune diseases and the presence of autoantibodies is a distinctive and key characteristic of autoimmune diseases. Conventionally, the study of autoimmune response has always been conducted by analysing the presence and/or concentration of individual antibodies in biological fluids. New proteomic techniques allow the simultaneous identification/measurement of different autoantibodies in sera of patients suffering from autoimmune diseases. The possibility of simultaneously measuring a number of correlated analytes appears to be very interesting for analytical reasons (reduced volumes of biological samples, reagents and low costs), logistical/managerial reasons, and pathophysiological reasons (combination of markers in disease-oriented or organ-oriented profiling). In particular, we describe data collected by using high-throughput techniques such as antigen microarrays and mass spectrometry for antibody profiling. While recently collected data demonstrate satisfactory analytical sensitivity and reproducibility, some issues such as standardization and data interpretation have to be solved before the introduction of these new and promising techniques into clinical practice.