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Urine albumin is a well-known biomarker of proven clinical utility for relevant pathological conditions and a risk factor for cardiovascular mortality. This paper is aimed to illustrate the state-of-art of albuminuria measurement and the adherence to the official recommendations in scientific writing. In spite of the urine albumin clinical importance, the standardisation of the analyte is not completed yet, but the adoption of decisional values (established in 2013) would require standardized methods to allow the correct classification of patients. The Italian EQA scheme for albuminuria shows variable bias to the consensus value, depending on the analytical system: a typical situation originating from the lack of international standardisation. The harmonisation of the measure is more advanced: the EQA data show that 74% of participants use the albumin/creatinine ratio to report the urine albumin excretion. A recent systematic review examined how the albuminuria data are reported in clinical studies. A sub-optimal situation is illustrated: the laboratory information is often lacking or incorrectly reported. The obsolete term "microalbuminuria" is used in >40% of the studies, only 20% of the studies uses the correct sample (first morning void). The data about the post-analytical are more encouraging: the measurement units and the decisional values are correctly reported in the majority of the studies. The correction of this situation, that makes it difficult to transfer the results from clinical studies to the daily practice, requires a stringent collaboration between laboratory professionals and clinicians: working together in multidisciplinary groups to understand the respective needs is to be promoted. [ABSTRACT FROM AUTHOR]

Introduction: in spite of the introduction of automated systems for urine sediment analysis, microscopy examination remains the gold standard. External Quality Assessment (EQA) programs on urine sediment are rare. This paper provides an analysis of results from 2012 to date of the EQA Italian program (Centro di Ricerca Biomedica, Regione Veneto) which involves today 255 laboratories. Methods: the EQA program includes four surveys/year. Participants are asked to identify and provide the clinical association of the presence of specific particles (2 surveys) and formulate the diagnosis of clinical cases presented (2 surveys). In 11 years, 202 images were proposed: 64 cells (9 types), 10 lipids (4 types), 59 casts (16 types), 36 crystals (13 types), 14 microorganisms (5 types), 19 contaminants (8 types) and 22 clinical cases were presented. Results: the correct identification rate (median; interquartiles) was very high for micro organisms (96.4; 91.9-99.9); high for crystals (92.2; 80.2-96.3) and lipids (91.1; 90.5-93.6); followed by casts (87.7; 80.1-91.8); contaminants (87.3; 77.2-96.0) and cells (82.8; 74.4-91.3). For clinical associations, the rate of correct answers was 96.5 (range 48.7- 100%). For clinical cases, due to the overall rate of particle misidentification throughout surveys, only 58.6% (44.9- 68.8%) of participants achieved access to clinical diagnosis. Of these, 92,0% (78.1-95.5%) were able to indicate the correct diagnosis. Conclusions: the program can be used as a tool to improve the identification of urine particles and the knowledge of their clinical significance and to encourage specialists of laboratory medicine to correlate urine findings with other laboratory data and the clinical history of the patient, an aspect that improves the value of the day by day work. [ABSTRACT FROM AUTHOR]

Numerous analytical systems, rapidly made available on the market throughout the SARS-CoV-2 pandemic, aim to detect COVID-19, and to continuously update and improve the same systems. Medical laboratory professionals have also developed in-house analytical procedures in order to satisfy the enormous volume of requests for tests. These developments have highlighted the need control the analytical procedures used in order to guarantee patient safety. The External Quality Assessment (EQA) Scheme, an important quality assurance tool, aims to guarantee high standard performance for laboratory and analytical procedures. The aim of the present study was to report on the results collected in an experimental EQA scheme for the serological diagnosis of SARS-CoV-2. All qualitative results collected in the different EQA surveys were summarized in order to identify the percentage of laboratory results in relation to typology of antibodies, results and samples. A total of 4,867 data sets were collected. The analysis of EQA data made, demonstrates a better agreement among laboratories results for total Ig than single immunoglobulins (IgG, IgM, IgA) in the case samples positive for SARS-CoV-2, and a wide divergence between IgM results for positive samples (only 34.9% were correct). Results for negative controls and specificity controls demonstrated a better overall agreement than results for positive samples. Working in collaboration with the IVD manufacturers, laboratory professionals must strive to achieve harmonization of results, and to develop well-defined protocols complying with the ISO 15189 requirements. [ABSTRACT FROM AUTHOR]