RESUMO
BACKGROUND: External quality assessment (EQA) schemes provide objective feedback to participating laboratories about the performance of their analytical systems and information about overall regional analytical performance. The EQAs are particularly important during pandemics as they also assess the reliability of individual test results and show opportunities to improve test strategies. With the end of the COVID-19 pandemic, the testing frequency significantly decreased in Austria. Here, we analyzed whether this decrease had an effect on participation and/or performance in SARS-CoV2 virus detection EQAs, as compared to the pandemic era. MATERIAL AND METHODS: Identical samples were sent to all participating laboratories, and the EQA provider evaluated the agreement of the reported results with defined targets. The EQA was operated under two schemes with identical samples and therefore we analyzed it as a single EQA round. The performance of testing was reported as true positive ratios, comparing the post-pandemic data to previous rounds. Furthermore, subgroups of participants were analyzed stratified by laboratory type (medical or nonmedical) and the test system format (fully automated or requiring manual steps). RESULTS: While the frequency of false negative results per sample did not change during the 3 years of the pandemic (5.7%, 95% confidence interval [CI] 3.1-8.4%), an average per sample false negative ratio of 4.3% was observed in the first post-pandemic EQA (0%, 1.8%, and 11% for the 3 positive samples included in the test panel, nâ¯= 109 test results per sample). In this first post-pandemic EQA medical laboratories (average 0.4% false negative across 3 samples, nâ¯= 90) and automated test systems (average 1.2% false negative, nâ¯= 261) had lower false negative ratios than nonmedical laboratories (22.8%, nâ¯= 19) and manual test systems (16.7%, nâ¯= 22). These lower average ratios were due to a low concentration sample, where nonmedical laboratories reported 36.8% and manual test systems 54.5% true positive results. CONCLUSION: Overall ratios of true positive results were below the mean of all results during the pandemic but were similar to the first round of the pandemic. A lower post-pandemic true positive ratio was associated with specific laboratory types and assay formats, particularly for samples with low concentration. The EQAs will continue to monitor the laboratory performance to ensure the same quality of epidemiological data after the pandemic, even if vigilance has decreased.
Assuntos
COVID-19 , Pandemias , Garantia da Qualidade dos Cuidados de Saúde , SARS-CoV-2 , Áustria/epidemiologia , Humanos , COVID-19/epidemiologia , SARS-CoV-2/genética , Reprodutibilidade dos Testes , Laboratórios Clínicos , Teste de Ácido Nucleico para COVID-19/normasRESUMO
BACKGROUND: The aim of external quality assessment (EQA) schemes is to evaluate the analytical performance of laboratories and test systems in a near-to-real-life setting. This monitoring service provides feedback to participant laboratories and serves as a control measure for the epidemiological assessment of the regional incidence of a pathogen, particularly during epidemics. Using data from EQA schemes implemented as a result of the intensive effort to monitor SARS-CoV-2 infections in Austria, we aimed to identify factors that explained the variation in laboratory performance for SARS-CoV-2 detection over the course of the COVID-19 pandemic. METHODS: For this observational study, we retrospectively analysed 6308 reverse transcriptase quantitative PCR (RT-qPCR) test results reported by 191 laboratories on 71 samples during 14 rounds of three SARS-CoV-2 pathogen detection EQA schemes in Austria between May 18, 2020, and Feb 20, 2023. We calculated the overall rates of false and true-negative, false and true-positive, and inconclusive results. We then assessed laboratory performance by estimating the sensitivity by testing whether significant variation in the odds of obtaining a true-positive result could be explained by virus concentration, laboratory type, or assay format. We also assessed whether laboratory performance changed over time. FINDINGS: 4371 (93·7%) of 4663 qPCR test results were true-positive, 241 (5·2%) were false-negative, and 51 (1·1%) were inconclusive. The mean per-sample sensitivity was 99·7% in samples with high virus concentrations (1383 [99·4%] true-positive, three [0·2%] false-negative, and five [0·4%] inconclusive results for 1391 tests in which the sample cycle threshold was ≤32), whereas detection rates were lower in samples with low virus concentrations (mean per-sample sensitivity 92·5%; 2988 [91·3%] true-positive, 238 [7·3%] false-negative, and 46 [1·4%] inconclusive results for 3272 tests in which the cycle threshold was >32). Of the 1645 results expected to be negative, 1561 (94·9%) were correctly reported as negative, 10 (0·6%) were incorrectly reported as positive, and 74 (4·5%) were reported as inconclusive. Notably, the overall performance of the tests did not change significantly over time. The odds of reporting a correct result were 2·94 (95% CI 1·75-4·96) times higher for a medical laboratory than for a non-medical laboratory, and 4·60 (2·91-7·41) times greater for automated test systems than for manual test systems. Automated test systems within medical laboratories had the highest sensitivity when compared with systems requiring manual intervention in both medical and non-medical laboratories. INTERPRETATION: High rates of false-negativity in all PCR analyses evaluated in comprehensive, multiple, and repeated EQA schemes outline a clear path for improvement in the future. The performance of some laboratories (eg, non-medical laboratories or those using non-automated test systems) should receive additional scrutiny-for example, by requiring additional EQA schemes for certification or accreditation-if the aggregated data from EQA rounds suggest lower sensitivity than that recorded by others. This strategy will provide assurances that epidemiological data as a whole are reliable when testing on such a large scale. Although performance did not improve over time, we cannot exclude extenuating circumstances-such as shortages and weakened supply chains-that could have prevented laboratories from seeking alternative methods to improve performance. FUNDING: None.
Assuntos
COVID-19 , Ácidos Nucleicos , Humanos , COVID-19/diagnóstico , COVID-19/epidemiologia , SARS-CoV-2/genética , Estudos Retrospectivos , Pandemias , Áustria/epidemiologiaRESUMO
This study aims to investigate the physical and chemical characterization of six fly ash samples obtained from different municipal solid waste incinerators (MSWIs), namely grate furnaces, rotary kiln, and fluidized bed reactor, to determine their potential for CO2 and thermochemical energy storage (TCES). Representative samples were characterized via simultaneous thermal analysis (STA) in different atmospheres, i.e., N2, air, H2O, CO2, and H2O/CO2, to identify fly ash samples that can meet the minimum requirements, i.e., charging, discharging, and cycling stability, for its consideration as TCES and CO2-storage materials and to determine their energy contents. Furthermore, other techniques, such as inductively coupled plasma optical emission spectroscopy, X-ray fluorescence (XRF) spectrometry, X-ray diffraction (XRD), scanning electron microscopy, leachability tests, specific surface area measurement based on the Brunauer-Emmett-Teller method, and particle-size distribution measurement, were performed. XRF analysis showed that calcium oxide is one of the main components in fly ash, which is a potentially suitable component for TCES systems. XRD results revealed information regarding the crystal structure and phases of various elements, including that of Ca. The STA measurements showed that the samples can store thermal heat with energy contents of 50-394 kJ/kg (charging step). For one fly ash sample obtained from a grate furnace, the release of the stored thermal heat under the selected experimental conditions (discharging step) was demonstrated. The cycling stability tests were conducted thrice, and they were successful for the selected sample. One fly ash sample could store CO2 with a storage capacity of 27 kg CO2/ton based on results obtained under the selected experimental conditions in STA. Samples from rotary kiln and fluidized bed were heated up to 1150 °C in an N2 atmosphere, resulting in complete melting of samples in crucibles; however, other samples obtained from grate furnaces formed compacted powders after undergoing the same thermal treatment in STA. Samples from different grate furnaces showed similarities in their chemical and physical characterization. The leachability test according to the standard (EN 12457-4 (2002)) using water in a ratio of 10 L/S and showed that the leachate of heavy metals is below the maximum permissible values for nonhazardous materials (except for Pb), excluding the fly ash sample obtained using fluidized bed technology. The leachate contents of Cd and Mn in the fly ash samples obtained from the rotary kiln were higher than those in other samples. Characterization performed herein helped in determining the suitable fly ash samples that can be considered as potential CO2-storage and TCES materials.