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

Intramuscular vaccination against SARS-CoV-2 transiently induces neutralizing IgG rather than IgA in the saliva DOI Creative Commons
Stephan Winklmeier,

Heike Rübsamen,

Ceren Özdemir

et al.

Frontiers in Immunology, Journal Year: 2024, Volume and Issue: 15

Published: Feb. 5, 2024

The mucosal immunity is crucial for restricting SARS-CoV-2 at its entry site. Intramuscularly applied vaccines against stimulate high levels of neutralizing Abs in serum, but the impact these intramuscular vaccinations on features less clear. Here, we analyzed kinetic and functional properties anti-SARS-CoV-2 saliva after vaccination with BNT162b2. We a total 24 healthy donors longitudinally up to 16 months. found that specific IgG appeared second vaccination, declined thereafter reappeared third vaccination. Adjusting serum same concentration revealed strong correlation between reactivity two compartments. Reactivity VoCs correlated strongly as seen by ELISAs RBD variants live-virus assays replication-competent viruses. For further analysis, purified IgA from saliva. In vaccinated activity towards authentic virus IgG, not fraction contrast, only breakthrough infection. both fractions. Together, show mRNA transiently induces mediated thus differs Waning might be linked susceptibility

Language: Английский

Citations

3
Rapid antigen testing for COVID-19: Decreasing diagnostic reliability, potential detrimental effects and a lack of evidence to support continued public funding of community-based testing DOI Creative Commons
Tracy Beth Høeg, Vinay Prasad

Public Health in Practice, Journal Year: 2023, Volume and Issue: 6, P. 100451 - 100451

Published: Nov. 23, 2023

Rapid antigen testing continues to be broadly recommended across the world for prevention of transmission SARS-CoV-2. We explore existing recommendations in United States, evidence decreasing diagnostic reliability individual tests and potential benefits harms non-targeted testing. Recent research has found multiple commonly-used rapid now have sensitivities below 30%, with at or near 0% first 48 hours infection, using polymerase chain reaction (PCR) test positivity as gold standard. Reliance on low sensitivity could paradoxically increase risk through false assurance. Furthermore, widespread substantial direct indirect costs, while its effectiveness diminishing COVID-19 disease burden improving overall community health is unclear. Because benefit not been demonstrated high-quality evidence, we argue against 1. The continued 2. Public funding community-based

Language: Английский

Citations

8
Post-market surveillance of six COVID-19 point-of-care tests using pre-Omicron and Omicron SARS-CoV-2 variants DOI Creative Commons

Hannah M. Exner,

Branden S. J. Gregorchuk,

AC-Green Castor

et al.

Microbiology Spectrum, Journal Year: 2024, Volume and Issue: 12(7)

Published: May 17, 2024

ABSTRACT Post-market surveillance of test performance is a critical function public health agencies and clinical researchers that ensures tests maintaining diagnostic characteristics following their regulatory approval. Changes in product quality, manufacturing processes over time, or the evolution new variants may impact performance. During COVID-19 pandemic, plethora point-of-care (POCTs) was released onto Canadian market. This study evaluated several most widely distributed POCTs Canada, including four rapid antigen (Abbott Panbio, BTNX Rapid Response, SD Biosensor, Quidel QuickVue) two molecular ID NOW Lucira Check IT). All were challenged with 149 SARS-CoV-2 positives, multiple up to Omicron XBB.1.5, as well 29 negatives. Results stratified based on whether isolate pre-Omicron by reverse transcriptase quantitative PCR Ct value. The each POCT consistent manufacturers' claims showed no significant decline against any tested. These findings provide continued confidence results these they continue be used support decentralized testing. work demonstrates essential role post-market ensuring reliability tools. IMPORTANCE ensure after especially context pandemic use became widespread. Our focused IT) across assessing using many variants, subvariant XBB.1.5. Overall, we found difference variant, reinforcing use. As concerns efficacy have been raised news outlets, particularly regarding this even more timely crucial. research offers insights into but also highlights necessity for surveillance.

Language: Английский

Citations

1
Post-Market Surveillance of Six COVID-19 Point-of-Care Tests Using Pre-Omicron and Omicron SARS-CoV-2 Variants DOI Creative Commons

Hannah M. Exner,

Branden S. J. Gregorchuk,

AC-Green Castor

et al.

medRxiv (Cold Spring Harbor Laboratory), Journal Year: 2024, Volume and Issue: unknown

Published: Jan. 7, 2024

ABSTRACT Post-market surveillance of test performance is a critical function public health agencies and clinical researchers that ensures diagnostics maintain characteristics following their regulatory approval. Changes in product quality, manufacturing processes over time, or the evolution new variants may impact quality. During COVID-19 pandemic, plethora point-of-care tests (POCTs) were released onto Canadian market. This study evaluated several most widely-distributed POCTs Canada, including four rapid antigen (Abbott Panbio, BTNX Rapid Response, SD Biosensor, Quidel QuickVue) two molecular ID NOW, Lucira Check IT). All challenged with 149 SARS-CoV-2 positives, multiple up to Omicron XBB.1.5, as well 29 negatives. Results stratified based on whether isolate was pre-Omicron by RT-qPCR Ct value. The each POCT consistent manufacturers’ claims showed no significant decline against any tested. These findings provide continued confidence results these they continue be used support decentralized testing. work demonstrates essential role post-market ensuring reliability diagnostic tools.

Language: Английский

Citations

0
An Analogy between Gold Standard SARS-CoV-2 RT-qPCR with the SARS-CoV-2 Rapid Antigen Test in a Tertiary Care Setting in Central State of India DOI Creative Commons
Neha Singh, Nikita Sherwani, Jyoti Jaiswal

et al.

Journal of Pure and Applied Microbiology, Journal Year: 2024, Volume and Issue: 18(2), P. 1177 - 1182

Published: May 27, 2024

Reverse transcription-quantitative PCR (RT-qPCR)-based assays are extensively being utilized to detect coronavirus disease 2019 (COVID-19). However, due a lack of RT-qPCR testing capability, these tests cannot be carried out in community clinics. The intention our study was evaluate the specificity and sensitivity Rapid Antigen Detection (RAT) versus those using nasopharyngeal oropharyngeal specimens. Respiratory swab specimens were collected from COVID-19 patients admitted at Dr. Bhimrao Ambedkar Memorial Hospital, Raipur, CG, India, during March April 2022. RAT performed standard methods as per guidebook instructions, subjects chosen convenience sample technique. 100 swabs patients, who had earlier verified positive negative for SARS-CoV-2 via RT-qPCR, taken study. Study approved by institutional ethical committee before data collection initiation We evaluated STANDARD Q Ag test kit (SD Biosensor). On testing, an over-all recorded 74% 100%, respectively comparison kit. Further, assay’s shown 94.87%, 77.27%, 55.56%, respectively, samples with cycle thresholds (Ct) 15-25, 25-30, 30-35, >35. draw conclusion that assay has superior antigen assay. all situations where is difficult, could serve rapid simple option separating contagious non-contagious patients.

Language: Английский

Citations

0
Assessing the performance of LumiraDx™ SARS-CoV-2 Ag test in detecting Omicron lineages: 2022–2023 study DOI Creative Commons
Silvia Cocchio, Michele Nicoletti, Claudia Cozzolino

et al.

Heliyon, Journal Year: 2024, Volume and Issue: 10(12), P. e33229 - e33229

Published: June 1, 2024

BackgroundThe introduction of rapid antigen tests revolutionized the approach to SARS-CoV-2 diagnosis, offering prompt and accurate results with high sensitivity specificity. Although it is more cost- time-saving than gold standard, real-time polymerase chain reaction (RT-PCR), efficacy in general population screening both hospital- community-based settings remains unknown. Moreover, testing limited by qualitative results. This study aims evaluate diagnostic reliability LumiraDx™ test during Omicron era investigate its quantitative (analogue-to-digital converter (ADC)) comparison RT-PCR Ct values.MethodsThis prospective included all adult patients mild-to-moderate symptoms who were not hospitalised did require oxygen supplementation, consented participate, attended Infectious Tropical Diseases Unit Padua University Hospital from July 14th, 2022 January 3rd, 2023. The underwent two different simultaneously: a nasal swab assay performed on nasopharyngeal swab. Sampling was repeated several times for subset subjects.ResultsWe enrolled 266 consecutive participants collected 601 pairs samples. most prevalent variant BA.4/BA.5 (60.2 %). specificity when compared as reference standard 93.1 % 79.75 %, respectively. No significant differences found based available characteristics, age, sex, symptom status, or COVID-19 variant, except days onset. According multilevel logistic regression analysis, only independent variable significantly associated concordance value (adjusted odds ratio (OR) = 0.56, p < 0.001). Significant ADC values between false negative (FN) versus true (TN), positive (FP) (TP) tests.ConclusionsThis showed that reliable diagnosis symptoms. finding confirms monitoring vulnerable individuals current post-vaccination era. When RT-PCR, effectively quantitatively distinguishes FN TN cases, well FP TP tests, despite inaccuracies

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