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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]

In spite of the introduction of automated systems for urinary sediment analysis, microscopy examination remains the gold standard, and it is more than ever important to perform it with a good and reliable quality. External Quality Assessment (EQA) programs on urinary sediment are rare. The present paper provides an analysis of results from 2001 to date of the EQA Italian program which involves today 230 laboratories. The program includes four surveys per year. Participants are asked the identification and clinical associations of urinary sediment particles, shown as phase contrast microscopy images in the website of the Center of Biomedical Research (CRB) (2 surveys), and the diagnosis of clinical cases presented by both images and a short clinical history (2 surveys). The results of each survey are then scored and commented. In 20 years, 298 images were presented: 90 cells (9 types), 23 lipids (5 types), 87 casts (21 types), 53 crystals (14 types), 22 microorganisms (5 types), and 23 contaminants (9 types). Moreover, 27 clinical cases, covering a wide spectrum of conditions with different degrees of complexity, were presented to participants. Identification: among urinary particle categories, the correct identification rate (obtained for each particle from the sum of correct + partially correct answers) was very high for micro-organisms (mean ± SD: 96.2 ± 3.5%), high for lipids (88.0 ± 11.8%) and crystals (87.0 ± 16.5%) followed, in decreasing order, by cells (82.1 ± 15.9%), casts (81.8 ± 14.8%), and contaminants (76.7 ± 22.1%). Clinical associations (n=67): the rate of correct answers was 93.5 ± 5.7% ranging from 75.0 to 100% for all but one clinical association (i.e., acute glomerulonephritis: 55.4%). Clinical cases: throughout surveys, due to the overall rate of particle misidentification, only 59.8 ± 17.1%, (range 32.5–88.7%) of participants achieved access to clinical diagnosis. Of these, 88.7 ± 10.6% (range 59.9–99.3%) were able to indicate the correct diagnosis. Our program can be used as a tool to improve the identification of urine particles and the knowledge of their clinical meaning and to encourage specialists of laboratory medicine to correlate urinary findings with other laboratory data and the clinical history, an aspect that improves the value of the day by day work. [ABSTRACT FROM AUTHOR]

Background: The need to harmonize laboratory information is particularly intense in the field of plasma proteins, considering their clinical impact and relevance in monitoring diseases. Methods: We evaluated units and reference intervals (RIs) utilized by participants of the External Quality Assessment Scheme (EQAS) for plasma proteins of the Centre of Biomedical Research. Moreover, we evaluated inter-laboratory analytical variability from 2001 to 2017. Results: The census of participants' units employed in 2017 showed that for albumin (ALB), ~66% of laboratories still used dL instead of L, and for most other proteins, ~70% still expressed the results in mg/dL. Laboratories primarily used the RIs reported in the packaging inserts of their analytical systems, but for each protein, there was a wide variability of RIs, also among laboratories using the same analytical method. Mean CVs% of the 13 certified proteins in the last five EQA cycles ranged from 3.8% of haptoglobin (HPT) to 12.4% of α1-antitrypsin (AAT) and decreased from 2001 to 2017 for most of them, in particular for C3, ALB, α2-macroglobulin (A2M), HPT and transferrin (TRF). Conclusions: In the face of a reduction in inter-laboratory variability for a lot of proteins, there has not been a substantial change in the units and in the RIs used by the participants. To change old habits is difficult and requires coordination and collaboration. The EQAS plays an important role in the assessment and monitoring of all elements that contribute to the formulation of laboratory information and may be useful to contribute to their harmonization. [ABSTRACT FROM AUTHOR]

Introduction Reliable serum creatinine measurements are of vital importance for the correct classification of chronic kidney disease and early identification of kidney injury. The National Kidney Disease Education Programme working group and other groups have defined clinically acceptable analytical limits for creatinine methods. The aim of this study was to re-evaluate the performance of routine creatinine methods in the light of these defined limits so as to assess their suitability for clinical practice. Method In collaboration with the Dutch External Quality Assurance scheme, six frozen commutable samples, with a creatinine concentration ranging from 80 to 239  μmol/L and traceable to isotope dilution mass spectrometry, were circulated to 91 laboratories in four European countries for creatinine measurement and estimated glomerular filtration rate calculation. Two out of the six samples were spiked with glucose to give high and low final concentrations of glucose. Results Results from 89 laboratories were analysed for bias, imprecision (%CV) for each creatinine assay and total error for estimated glomerular filtration rate. The participating laboratories used analytical instruments from four manufacturers; Abbott, Beckman, Roche and Siemens. All enzymatic methods in this study complied with the National Kidney Disease Education Programme working group recommended limits of bias of 5% above a creatinine concentration of 100  μmol/L. They also did not show any evidence of interference from glucose. In addition, they also showed compliance with the clinically recommended %CV of ≤4% across the analytical range. In contrast, the Jaffe methods showed variable performance with regard to the interference of glucose and unsatisfactory bias and precision. Conclusion Jaffe-based creatinine methods still exhibit considerable analytical variability in terms of bias, imprecision and lack of specificity, and this variability brings into question their clinical utility. We believe that clinical laboratories and manufacturers should work together to phase out the use of relatively non-specific Jaffe methods and replace them with more specific methods that are enzyme based. [ABSTRACT FROM AUTHOR]

With these recommendations the Interdisciplinary Urinalysis Group (GIAU) aims to stimulate the following aspects : improvement and standardization of the post analytical approach to physical, chemical and morphological urine examination (ECMU); emphasize the value added to ECMU by selection of clinically significant parameters, indication of analytical methods, of units of measurement, of reference values; improvement of interpretation of dip stick urinalysis with particular regard to the reconsideration of the diagnostic significance of the evaluated parameters together with an increasing awareness of the limits of sensitivity and specificity of this analytical method. Accompanied by the skills to propose and carry out in-depth investigations with analytical methods that are more sensitive and specific;increase the awareness of the importance of professional skills in the field of urinary morphology and their relationships with the clinicians. through the introduction, in the report, of descriptive and interpretative comments depending on the type of request, the complexity of the laboratory, the competence of the pathologist;implement a policy of evaluation of the analytical quality by using, in addition to traditional internal and external controls, a program for the evaluation of morphological competence. The hope is to revalue the enormous potential diagnostic of ECMU, implementing a urinalysis on personalized diagnostic needs that each patient brings with it., (Copyright by Società Italiana di Nefrologia SIN, Rome, Italy.)