Search

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]

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]

Effective management of clinical laboratories participating in external quality assessment schemes (EQAS) is of fundamental importance in ensuring reliable analytical results. The International Standard ISO 15189:2012 requires participation in interlaboratory comparison [e.g. external quality assessment (EQA)] for all tests provided by an individual laboratory. If EQAS is not commercially available, alternative approaches should be identified, although clinical laboratories may find it challenging to choose the EQAS that comply with the international standards and approved guidelines. Great competence is therefore required, as well as knowledge of the characteristics and key elements affecting the reliability of an EQAS, and the analytical quality specifications stated in approved documents. Another skill of fundamental importance is the ability to identify an alternative approach when the available EQAS are inadequate or missing. Yet the choice of the right EQA program alone does not guarantee its effectiveness. In fact, the fundamental steps of analysis of the information provided in EQA reports and the ability to identify improvement actions to be undertaken call for the involvement of all laboratory staff playing a role in the specific activity. The aim of this paper was to describe the critical aspects that EQA providers and laboratory professionals should control in order to guarantee effective EQAS management and compliance with ISO 15189 accreditation requirements. [ABSTRACT FROM AUTHOR]

The article presents a study which discusses analytical performance of general chemistry analytes across countries and across manufacturers in the INPUtS project of external quality assessment (EQA) organizers. Topics include reference measurement procedures (RMPs), evaluation of general chemistry analytes according to performance specifications derived from biological variation (BV), and minimum performance specification for cholesterol and high-density density (HDL) cholesterol.

Background: Manual microscopy still represents the gold standard for urinary sediment (US) examination. We report the results obtained in the period 2012-2015 by the EQA Italian program on US, which today involves about 260 laboratories. Methods: The program includes four surveys per year. In two surveys, participants are asked to supply identification and clinical association of US particles. In two other surveys, they are asked to supply the diagnosis of clinical cases, presented with images, some key laboratory findings and a short clinical history. Sixty-six images of US particles (21 cells, 2 lipids, 21 casts, 10 crystals, 3 microorganisms, 15 contaminants) and seven clinical cases were presented. Results: The correct identification rate for each category of particles, in decreasing order, was: micro-organisms (mean±SD: 92.4%±4.5%), lipids (92.0%±1.8%), casts (82.8%±8.8%), crystals (79.4%±29.8%), cells (77.3%±13.5%), and contaminants (70.9%±22.2%). For 13 particles, a correct clinical association was indicated by 91.5%±11.7% of participants, while it was 52.7% for particles associated with urinary tract infection. For clinical cases, due to a high rate of particles misidentification, only 44.3%±10.1% of participants achieved access to clinical diagnosis, which was then correctly indicated by 92.5%±5.3% of them. Conclusions: The results of the EQA program confirm that, while some US particles are well known in terms of identification, clinical association and clinical meaning, others particles still are not, and this represents an important reason to encourage EQA programs on US. [ABSTRACT FROM AUTHOR]

The article comments on the paper "The Empower project--A new way of assessing and monitoring test comparability and stability" by L. M. Thienpont and colleagues. Topics discussed include the call for the harmonization and standardization of clinical laboratory testing, a project which creates collaboration between manufacturers and laboratories to monitor the stability and test comparability of laboratory results and the four pillars of the Empower project.