ABSTRACT
Introduction: external Quality Assessment (EQA) is a valuable tool to monitor and improve the analytical performances of clinical laboratories. To guarantee suitable results also during the COVID-19 pandemic, EQA scheme providers have implemented specific schemes assessing different SARS-CoV-2 diagnostic systems. This study aims to describe the results collected in an experimental EQA scheme for molecular diagnostic of SARS-CoV-2 managed by INSTAND eV with the collaboration of the Centre of Biomedical Research for Quality in Laboratory Medicine for Veneto Region Laboratories. Methods: the qualitative EQA results collected in three surveys (two in 2020 and one in 2021) for 18 samples total, have been summarized to identify the percentage of laboratory results per sample. Control samples were provided by NationalesKonsiliarlaboratorium fur Coronaviren of Berlin. Results: even though the average of the participating laboratories strongly decreased between surveys, a good agreement was found among results (95% to 99.8%). A totally of 0.2% - 4% of incorrect results and 0% - 1.1% of indeterminate results were reported. In addition, the sequencing analysis and the point mutations analysis, included in the last analyzed survey, revealed a good agreement between participating laboratories with an overall score from 74.8% to 89.6% for the sequencing and from 90.65% to 95.33% for the point mutations, respectively. Conclusions: the EQA programs are a fundamental quality assurance tool to evaluate the laboratory performance and to appreciate the State-of-the-Art of the different diagnostic systems used by participating laboratories. The need for an EQA scheme for every test performed in the laboratory is mandatory to guarantee patient safety.
ABSTRACT
Background: External Quality Assessment (EQA) is a valuable tool to monitor and improve the analytical performances of clinical laboratories. During the COVID-19 pandemic, the number of kits to detect the infection and the number of tested samples intensified to satisfy the test request. To guarantee suitable results, EQA scheme providers have implemented specific schemes assessing different SARS-CoV-2 diagnostic systems. This study aims to describe the results collected in an experimental EQA scheme for molecular diagnostic of SARS-CoV-2 managed by INSTAND e.V with the collaboration of the Centre of Biomedical Research for Quality in Laboratory Medicine for Veneto Region Laboratories. Methods: The qualitative EQA results collected, two surveys in 2020 and one in 2021, for 18 samples total, have been summarized to identify the percentage of laboratory results per sample. Control samples included SARS-CoV-2 or other seasonal coronaviruses (MERSCoV, HCoV 229E, HCoV OC43) provided by Nationales Konsiliarlaboratorium fur Coronaviren of Berlin. SARSCoV-2 Variants of Concern (VOCs) were included only in the 2021 survey. Results: The average of the participating laboratories strongly decreased between the first survey of 2020 (927) and the last analysed survey, March 2021 (594). The main analytical procedures used, in the first, second and third survey respectively were CEPHAID kits (11.6%, 12% and 11.7%), in-house produced assays (10.4, 6.2 and 5%), SEEGENE kits (8.5%, 8.1% and 7.9%), ROCHE Diagnostics (8.3%, 8.5% and 6.9%) and ALTONA Diagnostics kits (6.1, 6.2 and 4.5%). A good agreement was found among laboratories results, with an overall range from 95% to 99.8%. Furthermore, generally from 0.2% to 2.9% of incorrect results and 0% to 1.1% of indeterminate results were reported. Conclusions: The EQA programs are a fundamental quality assurance tool to evaluate the laboratory performance and know the State-of-the-Art diagnostic systems used by participating laboratories. The need for an EQA scheme for every test performed in the laboratory is mandatory to guarantee patient safety.
ABSTRACT
Introduction: D-Dimer assessment represents a cornerstone in the diagnostic approach to several thrombotic disorders. Recent literature has highlighted the role of D-Dimer also in the diagnostic pathway of coronavirus infection (COVID-19) and the importance of harmonized reporting [D-dimer unit (DDU) or fibrinogen equivalent unit (FEU);unit of measure;cut-off] in order to guarantee the correct interpretation of the results. Methods: D-Dimer data from 100 EQA participants and the inter-laboratory variability (CV%) of the last 7 years for the most used analytical systems: Werfen, HemosIL HS;Werfen, HemosIL HS-500;Auto D-D, Sclavo;Innovance, Siemens;VIDAS, bioMérieux and STA Liatest, Stago have been evaluated. Results: Concerning the results expression in DDU or FEU, we observed a prevalence of FEU (55.1%) over DDU (44.9%);the value was confirmed in the last 7 years (average FEU = 55.6%), differently from data obtained in the survey conducted in 2014 at a national level. The units used are: ng/mL (67.8%), μg/L (29.0%) and mg/L (3.2%) for D-Dimer DDU;ng/mL (57.9%), μg/mL (21.0%), μg/L (15.8%) and mg/L (5.3%) for D-Dimer FEU. Inter-laboratory variability (mean CV%) calculated on a total of 72 controls is lower for all diagnostic systems at pathological levels than the one observed for concentrations below the cut-off. Discussion: This study demonstrates that the reporting of D-Dimer results does not comply with the 2014 SIBioC consensus document which recommended the use of μg/L FEU, and highlights 8 different types of information. Data reported in this study call for the harmonization of D-Dimer reporting in order to guarantee the correct interpretation of the information, both in the case of COVID-19 and in all the diseases already known where this analyte has a clinical relevance.
ABSTRACT
The recent pandemic outbreak caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) and associated with the pathology called COVID-19 (coronavirus disease 2019), has now become one of the most strenuous health care challenges since the emergence of the three pandemics caused by influenza viruses during the past century. Throughout the clinical decision-making of COVID-19, laboratory tests are essential for supporting the screening, diagnosis, prognostication and therapeutic monitoring of this severe infectious disease. Serological testing, that reflects the humoral immune response developing after interaction between the host and the virus (or its components), enables to garner a vast array of clinical information which can be especially used in seroprevalence or seroconversion studies. To this end, the Task Force on COVID-19 of the Italian Society of Clinical Biochemistry and Clinical Molecular Biology (SIBioC) has endorsed a series of technical, practical and clinical ad interim recommendations, aimed at facilitating and optimizing the introduction, clinical usage and governance of SARS-CoV-2 serological immunoassays in routine practice.
ABSTRACT
With the ongoing coronavirus disease 2019 (COVID-19) pandemic outbreak spreading all around the world, an extensive vaccination against severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is now universally regarded as one of the most effective strategies for counteracting the unremittent spread of this novel coronavirus. Nonetheless, the reasonable need to identify segments of the population in which vaccination shall be prioritized for avoiding a possible shortage of vaccines seems to collide with indications provided by many national and international healthcare organizations, that endorse widespread vaccination irrespective of a positive history of prior symptomatic or asymptomatic SARS-CoV-2 infection. To this end, this document provides an ad interim guidance aimed at prioritizing SARS-CoV-2 vaccination in people who are more likely to be infected, re-infected and/or to develop more aggressive COVID-19 illness, essentially based on routine assessment and monitoring of anti-SARS-CoV-2 immune response.
ABSTRACT
Introduction: D-Dimer assessment represents a cornerstone in the diagnostic approach of several thrombotic disorders. Recent literature has highlighted the role of D-Dimer also in the diagnostic pathway of COVID-19 and the importance of a harmonized reporting [D-dimer unit (DDU) or fibrinogen equivalent unit (FEU);unit of measure;cut-off] in order to guarantee the correct interpretation of the results1. Purpose and Methods: Evaluation of D-Dimer data from 100 EQA participants and the inter-laboratory variability (CV%) of the last 7 years for the most used analytical systems: HemosIL HS, IL-HS (n=37}4), HemosIL HS-500, IL-HS500 (n=8}1), Sclavo Auto, SCLA (n=12}5), Siemens Innovance, INN (n=14}3), bioMerieux VIDAS, VID (n=10}3), Stago STA Liatest, STA (n=10}3). Results: Concerning the results expression in DDU or FEU, there is a prevalence of FEU (55.1%) over DDU (44.9%), value confirmed in the last 7 years (average FEU = 55.6%), differently from data obtained in the survey conducted in 2014 at national level2.The units used are: Ng/mL (67.7%), μg/L (29.0%) and mg/L (3.2%) for D-Dimer DDU;ng/mL (57.9%), μg/mL (21.1%), μg/L (15.8%) and mg/L (5.3%) for D-Dimer FEU. Inter-laboratory variability (mean CV%}SD) calculated on a total of 68 control samples (range, μg/L):-D-Dimer, DDU = SCLA: 8.8}3.3 (82-170);5.4}2.7% (402-1482);IL-HS: 12.8}6.1 (122-166);6.4}2.7% (480-1705).-D-Dimer, FEU = IL-HS: 13.9}2.0 (192-340);5.2}2.3 (1016-3158);IL-HS500: 5.1}2.6 (1430-3442);INN: 11.3}5.6 (191-330);6.3}2.3% (1439-4521);VID: 6.9}3.5 (158-378);5.4}2.3 (673-2018);STA: 7.1}6.6% (220-385);5.1}2.0% (860-2600). Discussion: This study demonstrates that the reporting of D-Dimer results does not comply with the 2014 SIBioC consensus document which recommended the use of μg/L FEU3, and highlights 8 different types of information. The CV% is lower for all diagnostic systems at pathological levels than the ones at concentrations near to the cut-off. Conclusion: Data reported in this study call for the harmonization of D-Dimer reporting in order to guarantee the correct interpretation of information, both of COVID-19 and all diseases already.