Do not blindly trust negative diagnostic test results! DOI Creative Commons
Christoph Buchta, Heinz Zeichhardt, Andreas Osterman

et al.

The Lancet Microbe, Journal Year: 2023, Volume and Issue: 5(2), P. e102 - e103

Published: Nov. 15, 2023

The shift to a colder season is generally accompanied by an annual increase in respiratory infections. In early September, 2023, European epidemiological surveillance systems reported the first signs of increased COVID-19 infections.1European Centre for Disease Prevention and ControlEpidemiological update: transmission EU/EEA, SARS-CoV-2 variants, public health considerations autumn 2023.https://www.ecdc.europa.eu/en/news-events/epidemiological-update-covid-19-transmission-eueea-sars-cov-2-variants-and-publicDate: Sept 7, 2023Date accessed: September 13, 2023Google Scholar Efforts testing activity have started,2USA Department Health & Human Serviceshttps://www.covid.gov/testsDate: 22, expected rise frequency calls precautionary reminder limitations diagnostic screening infectious pathogens. Every test system has unique performance characteristics, including its overall sensitivity specificity, which reflect assay design. Clinical samples with pathogen loads lower than detection limit generate negative results. sensitivities two most common methods detecting clearly differ, nucleic acid amplification tests having higher antigen tests. External quality assessments genome revealed substantial differences range representative assays, no improvement was observed over course pandemic.3Buchta C Aberle SW Allerberger F et al.Performance as external assessment schemes during three years pandemic: observational retrospective study.Lancet Microbe. 2023; 4: e1015-e1023Summary Full Text PDF Scopus (1) Google Clear sensitivity, notable deficiencies low virus loads, subjective difficulties visually recognising weakly positive reactions were rapid tests.4Vierbaum L Wojtalewicz N Grunert HP al.Results German detection.Sci Rep. 1313206Crossref PubMed Rapid continue show reduced newer sustained heterogeneity among available noteworthy.5Krenn Dächert Badell I al.Ten widely differ their ability detect omicron-BA.4 -BA.5.Med Microbiol Immunol. 212: 323-337Crossref (2) Scholar,6https://cmpt.ca/covid-19-proficiency-testing-one-year-later/Date October 26, Negative effects sampling preanalytical procedures on detectability reduce accuracy test, based analytical sensitivity.3Buchta Scholar,7Arnaout R Lee RA GR al.The matters: case benchmarking severe acute syndrome coronavirus 2 testing.Clin Infect Dis. 2021; 73: e3042-e3046Crossref (55) Ultimately, wide variety factors can lead false-negative False-negative results induce inappropriate sense safety people concerned environment, delay misdirect therapy risks, encourage further spread infection. However, are well recognised outcomes that cannot be completely prevented; only reduced. National regional strategies should aim maximise rates individuals suspected infections those symptom-free minimise proportion using high-quality medical community not support or promote use do conform highest standards. Using suitable quantified control materials, minimum limits assays evaluated, appropriate monitored error associated harm. Appropriate monitoring different entities been previously described.8Buchta Zeichhardt H al.Design definition roles providers future epidemics.Lancet e552-e562Summary An essential task raise awareness health-care professionals capable infection but ruling out infections; resolve whether absent could it. context testing, alternative conveyed more explicitly reporting detected instead negative, thereby reducing risk affected misinterpret result meaning they infected because tested negative. addition, enable readers cautiously estimate reliability Diagnostic pathogens other discussed extensively, recently. findings here apply also all We summarise our recommendations outbreaks SARS-COV-2 causes epidemics panel.PanelRecommendations strategies•National rate results.•The standards.•Health-care general aware infections.•Negative (pathogen) factual representation data obtained.•The used included when guide interpreting •National HZ declares he majority owner managing director GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin IQVD GmbH, Institut Qualitätssicherung, Berlin. LAP received from Donald B Rix Family Foundation. All authors declare competing interests.

Language: Английский

Behind the scenes of EQA – characteristics, capabilities, benefits and assets of external quality assessment (EQA) DOI
Christoph Buchta, Barbara De la Salle, Rachel Marrington

et al.

Clinical Chemistry and Laboratory Medicine (CCLM), Journal Year: 2025, Volume and Issue: unknown

Published: Jan. 3, 2025

Abstract External quality assessment (EQA) enhances patient safety through the evaluation of laboratory-based and point care testing. Regulatory agencies accreditation organizations utilize results laboratory’s response to them as part assessing fitness practice. In addition, where EQA samples are commutable assigned value has been determined using reference measurement procedures (RMPs), data contributes verification metrological traceability assays post-market surveillance in vitro diagnostic (IVD) medical devices (IVD-MDs). More broadly, scientific communities use demonstrate that laboratory examination fit for clinical purposes, evaluate common intervals, inclusion databases. Scientific groups, IVD industry, laboratories National Metrology Institutes can work with providers identify measurands, which should urgently be supported by development materials or methods. The ability health systems respond effectively fast-evolving challenges, such Coronavirus Disease-19 (COVID-19) pandemic, is reliant on confidence performance new methods testing services. uniquely positioned assess IVD-MDs addition individual sites. Although primary focus remains improvement laboratories, there many stakeholders who benefit from data.

Language: Английский

Citations

1
External quality assessments for SARS-CoV-2 genome detection in Austria DOI Creative Commons
Christoph Buchta,

Stephan W. Aberle,

Irene Görzer

et al.

Wiener klinische Wochenschrift, Journal Year: 2024, Volume and Issue: 136(15-16), P. 429 - 438

Published: April 23, 2024

External quality assessment (EQA) schemes provide objective feedback to participating laboratories about the performance of their analytical systems and information overall regional performance. The EQAs are particularly important during pandemics as they also assess reliability individual test results show opportunities improve strategies. With end COVID-19 pandemic, testing frequency significantly decreased in Austria. Here, we analyzed whether this decrease had an effect on participation and/or SARS-CoV‑2 virus detection EQAs, compared pandemic era.

Language: Английский

Citations

2
Ignoring SARS-CoV-2 testing performance during COVID-19 DOI Creative Commons
Christoph Buchta, Heinz Zeichhardt,

Andrea Griesmacher

et al.

The Lancet Microbe, Journal Year: 2023, Volume and Issue: 4(5), P. e296 - e296

Published: Feb. 3, 2023

Language: Английский

Citations

4
Performance of SARS-CoV-2 nucleic acid amplification testing in Austria as measured by external quality assessment schemes during 3 years of the COVID-19 pandemic: an observational retrospective study DOI Creative Commons
Christoph Buchta,

Stephan W. Aberle,

Franz Allerberger

et al.

The Lancet Microbe, Journal Year: 2023, Volume and Issue: 4(12), P. e1015 - e1023

Published: Nov. 16, 2023

BackgroundThe aim of external quality assessment (EQA) schemes is to evaluate the analytical performance laboratories and test systems in a near-to-real-life setting. This monitoring service provides feedback participant serves as control measure for epidemiological regional incidence pathogen, particularly during epidemics. Using data from EQA implemented result intensive effort monitor SARS-CoV-2 infections Austria, we aimed identify factors that explained variation laboratory detection over course COVID-19 pandemic.MethodsFor this observational study, retrospectively analysed 6308 reverse transcriptase quantitative PCR (RT-qPCR) results reported by 191 on 71 samples 14 rounds three pathogen Austria between May 18, 2020, Feb 20, 2023. We calculated overall rates false true-negative, true-positive, inconclusive results. then assessed estimating sensitivity testing whether significant odds obtaining true-positive could be virus concentration, type, or assay format. also changed time.Findings4371 (93·7%) 4663 qPCR were 241 (5·2%) false-negative, 51 (1·1%) inconclusive. The mean per-sample was 99·7% with high concentrations (1383 [99·4%] [0·2%] five [0·4%] 1391 tests which sample cycle threshold ≤32), whereas lower low (mean 92·5%; 2988 [91·3%] 238 [7·3%] 46 [1·4%] 3272 >32). Of 1645 expected negative, 1561 (94·9%) correctly 10 (0·6%) incorrectly positive, 74 (4·5%) Notably, did not change significantly time. reporting correct 2·94 (95% CI 1·75–4·96) times higher medical than non-medical laboratory, 4·60 (2·91–7·41) greater automated manual systems. Automated within had highest when compared requiring intervention both laboratories.InterpretationHigh false-negativity all analyses evaluated comprehensive, multiple, repeated outline clear path improvement future. some (eg, those using non-automated systems) should receive additional scrutiny—for example, certification accreditation—if aggregated suggest recorded others. strategy will provide assurances whole are reliable such large scale. Although improve time, cannot exclude extenuating circumstances—such shortages weakened supply chains—that have prevented seeking alternative methods performance.FundingNone.

Language: Английский

Citations

4
Virus sequencing performance during the SARS-CoV-2 pandemic: a retrospective analysis of data from multiple rounds of external quality assessment in Austria DOI Creative Commons
Jeremy V. Camp, Elisabeth Puchhammer‐Stöckl,

Stephan W. Aberle

et al.

Frontiers in Molecular Biosciences, Journal Year: 2024, Volume and Issue: 11

Published: Feb. 5, 2024

Introduction: A notable feature of the 2019 coronavirus disease (COVID-19) pandemic was widespread use whole genome sequencing (WGS) to monitor severe acute respiratory syndrome 2 (SARS-CoV-2) infections. Countries around world relied on and other forms variant detection perform contact tracing changes in virus genome, hopes that epidemic waves caused by variants would be detected managed earlier. As encouraged rewarded government Austria, but represented a new technicque for many laboratories, we designed an external quality assessment (EQA) scheme accuracy WGS assist laboratories validating their methods. Methods: We implemented SARS-CoV-2 EQAs Austria report results from 7 participants over 5 rounds February 2021 until June 2023. The received sample material, sequenced genomes with routine methods, provided sequences as well information about mutations lineages. Participants were evaluated completeness submitted sequence ability analyze interpret data. Results: indicate performance excellent few exceptions, these exceptions showed improvement time. extend our findings infer most publicly available are accurate within ≤1 nucleotide, somewhat randomly distributed through genome. Conclusion: continues used surveillance, will likely instrumental future outbreak scenarios. identified hurdles building next-generation capacity diagnostic laboratories. help individual maintain high output, strengthen monitoring molecular epidemiology efforts.

Language: Английский

Citations

1
Establishing quality assurance for COVID-19 antigen tests in the Indo Pacific Region: A multi-site implementation study DOI Creative Commons
Jacqueline Prestedge, Marilyn Mary Ninan, Chan Leakhena Phoeung

et al.

Diagnostic Microbiology and Infectious Disease, Journal Year: 2024, Volume and Issue: 111(3), P. 116677 - 116677

Published: Dec. 30, 2024

Quality assurance programs (QAPs) are used to evaluate the analytical quality of a diagnostic test and provide feedback improve processes in testing. Rapid tests were both laboratory non-laboratory settings diagnose COVID-19, although varied reported performance. We aimed design implement QAP for antigen rapid (Ag-RDTs) COVID-19 Cambodia, Lao PDR, Papua New Guinea. Inactivated SARS-CoV-2 material derived from cell culture Wildtype, Delta, Omicron isolates manufacture 435 control (QC) panels (consisting single positive negative sample) 36 external assessment (EQA) use across 15 sites accordance with provided training protocols. In total, 369 QC results 112 EQA submitted by electronic reporting or paper forms two countries. 19·3 % (34/176) 99·5 (192/193) samples correctly QC, 37·5 (30/80) 97·5 (39/40) EQA. This demonstrates importance operator materials, which may have contributed high rate false-negative interpretations known samples. The implementation this project, our knowledge first its kind region one only few globally, emphasised principles, including community testing sites, promote

Language: Английский

Citations

0
Do not blindly trust negative diagnostic test results! DOI Creative Commons
Christoph Buchta, Heinz Zeichhardt, Andreas Osterman

et al.

The Lancet Microbe, Journal Year: 2023, Volume and Issue: 5(2), P. e102 - e103

Published: Nov. 15, 2023

The shift to a colder season is generally accompanied by an annual increase in respiratory infections. In early September, 2023, European epidemiological surveillance systems reported the first signs of increased COVID-19 infections.1European Centre for Disease Prevention and ControlEpidemiological update: transmission EU/EEA, SARS-CoV-2 variants, public health considerations autumn 2023.https://www.ecdc.europa.eu/en/news-events/epidemiological-update-covid-19-transmission-eueea-sars-cov-2-variants-and-publicDate: Sept 7, 2023Date accessed: September 13, 2023Google Scholar Efforts testing activity have started,2USA Department Health & Human Serviceshttps://www.covid.gov/testsDate: 22, expected rise frequency calls precautionary reminder limitations diagnostic screening infectious pathogens. Every test system has unique performance characteristics, including its overall sensitivity specificity, which reflect assay design. Clinical samples with pathogen loads lower than detection limit generate negative results. sensitivities two most common methods detecting clearly differ, nucleic acid amplification tests having higher antigen tests. External quality assessments genome revealed substantial differences range representative assays, no improvement was observed over course pandemic.3Buchta C Aberle SW Allerberger F et al.Performance as external assessment schemes during three years pandemic: observational retrospective study.Lancet Microbe. 2023; 4: e1015-e1023Summary Full Text PDF Scopus (1) Google Clear sensitivity, notable deficiencies low virus loads, subjective difficulties visually recognising weakly positive reactions were rapid tests.4Vierbaum L Wojtalewicz N Grunert HP al.Results German detection.Sci Rep. 1313206Crossref PubMed Rapid continue show reduced newer sustained heterogeneity among available noteworthy.5Krenn Dächert Badell I al.Ten widely differ their ability detect omicron-BA.4 -BA.5.Med Microbiol Immunol. 212: 323-337Crossref (2) Scholar,6https://cmpt.ca/covid-19-proficiency-testing-one-year-later/Date October 26, Negative effects sampling preanalytical procedures on detectability reduce accuracy test, based analytical sensitivity.3Buchta Scholar,7Arnaout R Lee RA GR al.The matters: case benchmarking severe acute syndrome coronavirus 2 testing.Clin Infect Dis. 2021; 73: e3042-e3046Crossref (55) Ultimately, wide variety factors can lead false-negative False-negative results induce inappropriate sense safety people concerned environment, delay misdirect therapy risks, encourage further spread infection. However, are well recognised outcomes that cannot be completely prevented; only reduced. National regional strategies should aim maximise rates individuals suspected infections those symptom-free minimise proportion using high-quality medical community not support or promote use do conform highest standards. Using suitable quantified control materials, minimum limits assays evaluated, appropriate monitored error associated harm. Appropriate monitoring different entities been previously described.8Buchta Zeichhardt H al.Design definition roles providers future epidemics.Lancet e552-e562Summary An essential task raise awareness health-care professionals capable infection but ruling out infections; resolve whether absent could it. context testing, alternative conveyed more explicitly reporting detected instead negative, thereby reducing risk affected misinterpret result meaning they infected because tested negative. addition, enable readers cautiously estimate reliability Diagnostic pathogens other discussed extensively, recently. findings here apply also all We summarise our recommendations outbreaks SARS-COV-2 causes epidemics panel.PanelRecommendations strategies•National rate results.•The standards.•Health-care general aware infections.•Negative (pathogen) factual representation data obtained.•The used included when guide interpreting •National HZ declares he majority owner managing director GBD Gesellschaft für Biotechnologische Diagnostik mbH, Berlin IQVD GmbH, Institut Qualitätssicherung, Berlin. LAP received from Donald B Rix Family Foundation. All authors declare competing interests.

Language: Английский

Citations

1