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Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: a cross-sectional study

Standard

Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: a cross-sectional study. / Olearo, Flaminia; Nörz, Dominik; Hoffman, Armin; Grunwald, Moritz; Gatzemeyer, Kimani; Christner, Martin; Both, Anna; Campos, Cristina Elena Belmar; Braun, Platon; Andersen, Gabriele; Pfefferle, Susanne; Zapf, Antonia; Aepfelbacher, Martin; Knobloch, Johannes K M; Lütgehetmann, Marc.

in: J INFECTION, Jahrgang 83, Nr. 5, 11.2021, S. 589-593.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Olearo, F, Nörz, D, Hoffman, A, Grunwald, M, Gatzemeyer, K, Christner, M, Both, A, Campos, CEB, Braun, P, Andersen, G, Pfefferle, S, Zapf, A, Aepfelbacher, M, Knobloch, JKM & Lütgehetmann, M 2021, 'Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: a cross-sectional study', J INFECTION, Jg. 83, Nr. 5, S. 589-593. https://doi.org/10.1016/j.jinf.2021.08.047

APA

Olearo, F., Nörz, D., Hoffman, A., Grunwald, M., Gatzemeyer, K., Christner, M., Both, A., Campos, C. E. B., Braun, P., Andersen, G., Pfefferle, S., Zapf, A., Aepfelbacher, M., Knobloch, J. K. M., & Lütgehetmann, M. (2021). Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: a cross-sectional study. J INFECTION, 83(5), 589-593. https://doi.org/10.1016/j.jinf.2021.08.047

Vancouver

Olearo F, Nörz D, Hoffman A, Grunwald M, Gatzemeyer K, Christner M et al. Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: a cross-sectional study. J INFECTION. 2021 Nov;83(5):589-593. https://doi.org/10.1016/j.jinf.2021.08.047

Bibtex

@article{1fec9304ef784ed1827e6c603bb2383d,
title = "Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: a cross-sectional study",
abstract = "INTRODUCTION: The large number of asymptomatic SARS-CoV-2 infections necessitates general screening of employees. We evaluate the performance of a SARS-CoV-2 screening program in asymptomatic healthcare-workers (HCW), utilizing self-sampled gargling-solution and sample pooling for RT-qPCR.METHODS: We conducted a cross-sectional retrospective study to collect real-life data on the performance of a screening-workflow based on automated-pooling and high-throughput qPCR testing over a 3-month-period at the University Hospital Hamburg.RESULTS: Matrix validation reveals that lower limit of detection for SARS-CoV-2 RNA in gargling-solution was 180 copies/mL (5-sample-pool). A total of 55,122 self-collected gargle samples (=7,513 HCWs) was analyzed. The median time to result was 8.5 hours (IQR 7.2-10.8). Of 11,192 pools analyzed, 11,041 (98.7%) were negative, 69 (0.6%) were positive and 82 (0.7%) were invalid. Individual testing of pool participants revealed 57 SARS-CoV-2 previously unrecognized infections. All 57 HCWs were either pre-symptomatic or asymptomatic (prevalence 0.76%,CI95%0.58-0.98%). Accuracy based on HCWs with gargle-solution and NP-swab available within 3-day-interval (N=521) was 99.5% (CI95%98.3-99.9%), sensitivity 88.9% (CI95%65.3-98.6%) while specificity 99.8% (CI95%98.9-99.9).CONCLUSION: This workflow was highly effective in identifying SARS-CoV-2 positive HCWs, thereby lowering the potential of inter-HCW and HCW-patient transmissions. Automated-sample-pooling helped to conserve qPCR reagents and represents a promising alternative strategy to antigen testing in mass-screening programs.",
author = "Flaminia Olearo and Dominik N{\"o}rz and Armin Hoffman and Moritz Grunwald and Kimani Gatzemeyer and Martin Christner and Anna Both and Campos, {Cristina Elena Belmar} and Platon Braun and Gabriele Andersen and Susanne Pfefferle and Antonia Zapf and Martin Aepfelbacher and Knobloch, {Johannes K M} and Marc L{\"u}tgehetmann",
note = "Copyright {\textcopyright} 2021. Published by Elsevier Ltd.",
year = "2021",
month = nov,
doi = "10.1016/j.jinf.2021.08.047",
language = "English",
volume = "83",
pages = "589--593",
journal = "J INFECTION",
issn = "0163-4453",
publisher = "W.B. Saunders Ltd",
number = "5",

}

RIS

TY - JOUR

T1 - Clinical performance and accuracy of a qPCR-based SARS-CoV-2 mass-screening workflow for healthcare-worker surveillance using pooled self-sampled gargling solutions: a cross-sectional study

AU - Olearo, Flaminia

AU - Nörz, Dominik

AU - Hoffman, Armin

AU - Grunwald, Moritz

AU - Gatzemeyer, Kimani

AU - Christner, Martin

AU - Both, Anna

AU - Campos, Cristina Elena Belmar

AU - Braun, Platon

AU - Andersen, Gabriele

AU - Pfefferle, Susanne

AU - Zapf, Antonia

AU - Aepfelbacher, Martin

AU - Knobloch, Johannes K M

AU - Lütgehetmann, Marc

N1 - Copyright © 2021. Published by Elsevier Ltd.

PY - 2021/11

Y1 - 2021/11

N2 - INTRODUCTION: The large number of asymptomatic SARS-CoV-2 infections necessitates general screening of employees. We evaluate the performance of a SARS-CoV-2 screening program in asymptomatic healthcare-workers (HCW), utilizing self-sampled gargling-solution and sample pooling for RT-qPCR.METHODS: We conducted a cross-sectional retrospective study to collect real-life data on the performance of a screening-workflow based on automated-pooling and high-throughput qPCR testing over a 3-month-period at the University Hospital Hamburg.RESULTS: Matrix validation reveals that lower limit of detection for SARS-CoV-2 RNA in gargling-solution was 180 copies/mL (5-sample-pool). A total of 55,122 self-collected gargle samples (=7,513 HCWs) was analyzed. The median time to result was 8.5 hours (IQR 7.2-10.8). Of 11,192 pools analyzed, 11,041 (98.7%) were negative, 69 (0.6%) were positive and 82 (0.7%) were invalid. Individual testing of pool participants revealed 57 SARS-CoV-2 previously unrecognized infections. All 57 HCWs were either pre-symptomatic or asymptomatic (prevalence 0.76%,CI95%0.58-0.98%). Accuracy based on HCWs with gargle-solution and NP-swab available within 3-day-interval (N=521) was 99.5% (CI95%98.3-99.9%), sensitivity 88.9% (CI95%65.3-98.6%) while specificity 99.8% (CI95%98.9-99.9).CONCLUSION: This workflow was highly effective in identifying SARS-CoV-2 positive HCWs, thereby lowering the potential of inter-HCW and HCW-patient transmissions. Automated-sample-pooling helped to conserve qPCR reagents and represents a promising alternative strategy to antigen testing in mass-screening programs.

AB - INTRODUCTION: The large number of asymptomatic SARS-CoV-2 infections necessitates general screening of employees. We evaluate the performance of a SARS-CoV-2 screening program in asymptomatic healthcare-workers (HCW), utilizing self-sampled gargling-solution and sample pooling for RT-qPCR.METHODS: We conducted a cross-sectional retrospective study to collect real-life data on the performance of a screening-workflow based on automated-pooling and high-throughput qPCR testing over a 3-month-period at the University Hospital Hamburg.RESULTS: Matrix validation reveals that lower limit of detection for SARS-CoV-2 RNA in gargling-solution was 180 copies/mL (5-sample-pool). A total of 55,122 self-collected gargle samples (=7,513 HCWs) was analyzed. The median time to result was 8.5 hours (IQR 7.2-10.8). Of 11,192 pools analyzed, 11,041 (98.7%) were negative, 69 (0.6%) were positive and 82 (0.7%) were invalid. Individual testing of pool participants revealed 57 SARS-CoV-2 previously unrecognized infections. All 57 HCWs were either pre-symptomatic or asymptomatic (prevalence 0.76%,CI95%0.58-0.98%). Accuracy based on HCWs with gargle-solution and NP-swab available within 3-day-interval (N=521) was 99.5% (CI95%98.3-99.9%), sensitivity 88.9% (CI95%65.3-98.6%) while specificity 99.8% (CI95%98.9-99.9).CONCLUSION: This workflow was highly effective in identifying SARS-CoV-2 positive HCWs, thereby lowering the potential of inter-HCW and HCW-patient transmissions. Automated-sample-pooling helped to conserve qPCR reagents and represents a promising alternative strategy to antigen testing in mass-screening programs.

U2 - 10.1016/j.jinf.2021.08.047

DO - 10.1016/j.jinf.2021.08.047

M3 - SCORING: Journal article

C2 - 34499947

VL - 83

SP - 589

EP - 593

JO - J INFECTION

JF - J INFECTION

SN - 0163-4453

IS - 5

ER -