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The EarlyCDT-Lung test is a blood-based autoantibody assay intended to identify high-risk individuals for low-dose computed tomography lung cancer screening. However, there is a paucity of evidence on the performance of the EarlyCDT-Lung test in ever-smokers. We conducted a nested case-control study within two prospective cohorts to evaluate the risk-discriminatory performance of the EarlyCDT-Lung test using prediagnostic blood samples from 154 future lung cancer cases and 154 matched controls. Cases were selected from those who had ever smoked and had a prediagnostic blood sample The EarlyCDT-Lung test is a blood-based autoantibody assay intended to identify high-risk individuals for low-dose computed tomography lung cancer screening. However, there is a paucity of evidence on the performance of the EarlyCDT-Lung test in ever-smokers. We conducted a nested case-control study within two prospective cohorts to evaluate the risk-discriminatory performance of the EarlyCDT-Lung test using prediagnostic blood samples from 154 future lung cancer cases and 154 matched controls. Cases were selected from those who had ever smoked and had a prediagnostic blood sample

Summary Introduction Quantitation of ADAMTS13 activity, functional inhibitors, and autoantibodies is crucial in diagnosis and management of thrombotic thrombocytopenic purpura. We compared and optimized commercial assay kits and validated a testing panel. Methods Citrated plasma specimens from healthy volunteers and residual samples submitted for clinical testing were used in the study. Commercially available ADAMTS13 activity assays including ACTIFLUOR™ ADAMTS13 (Sekisui Diagnostics, Stamford, CT, USA), LIFECODES ATS-13 (Gen-Probe Inc., San Diego, CA, USA), and TECHNOZYM® ADAMTS-13 (Technoclone, Vienna, Austria) were evaluated. Functional inhibitor assays were performed using internally developed mixing protocols. Two autoantibody assays were also evaluated: IMUBIND® (Sekisui Diagnostics) and TECHNOZYM® ADAMTS-13 INH ELISA kits (Technoclone). Results A laboratory-developed assay using ACTIFLUOR™ reagents showed best agreement with the reference method, and full validation showed a reportable range of 5% (LLOQ) to 114% with a reference interval of ≥68%. Both intra- and interassay coefficients of variation were

Immunology laboratories perform diagnostic tests to identify the autoantibody markers needed to classify disorders which are complex, often rare, and hard to define. The recent introduction of new markers and the use of increasingly complicated assay procedures can cause difficulty in interpreting test results. Moreover, during the performance of some tests, some autoantibodies which were not requested, and consequently not expected, may be identified by chance. It is advisable for these positive results to be reported only when they have a high predictive value and suggest the possible presence of an autoimmune disease. An interpretative comment on autoantibody test results is crucial in a number of cases: when autoantibodies with a significant clinical correlation (high specificity) are found; when two or more methods are used to determine the same autoantibody and the results disagree; when unexpected autoantibody positivity is found and in case of results generated by further diagnostic tests conducted by the laboratory on its own initiative. The interpretative comment should be based on the patient's personal characteristics (sex, age) and the other laboratory parameters available; it should specify the diagnostic accuracy of the assay methods used, the clinical and diagnostic correlations of the antibodies which tested positive, and any further tests needed to complete the diagnostic process.

During the 12th International Workshop on Autoantibodies and Autoimmunity (IWAA) held in Sao Paulo, Brazil, on August 28, 2014, a full day session was devoted to establishing a consensus on the nomenclature of staining patterns observed in the antinuclear antibody (ANA) indirect immunofluorescence test on HEp-2 cells. The current report summarizes the collective agreements with input from the host Brazilian and international communities that represented research, clinical, and diagnostic service laboratories. Patterns are categorized in three major groups (nuclear, cytoplasmic, and mitotic patterns) and each pattern has been defined and described in detail. The consensus nomenclature and representative patterns are made available online at the International Consensus on Antinuclear antibody Pattern (ICAP) website (www.ANApatterns.org). To facilitate continuous improvement and input, specific comments on ICAP are encouraged and these will be discussed in subsequent ICAP meetings. The ultimate goal with the establishment of the ICAP is to promote harmonization and understanding of autoantibody test nomenclature, as well as interpretation guidelines for ANA testing, thereby optimizing usage in patient care.

Four weeks ago (31 July, p 273) we presented the case of Mrs Prior, a 40 year old woman with cystitis, itching, and rash. When her biochemical results showed raised liver enzyme concentrations, her general practitioner was advised to refer her for ultrasonography and an autoantibody test (7 August, p 342). The scan suggested the possibility of hepatic infiltration but the autoantibody screen gave negative …