IDEAS home Printed from https://ideas.repec.org/a/gam/jijerp/v19y2022i7p3826-d777946.html
   My bibliography  Save this article

Rapid Antigen Test LumiraDx TM vs. Real Time Polymerase Chain Reaction for the Diagnosis of SARS-CoV-2 Infection: A Retrospective Cohort Study

Author

Listed:
  • Anna Maria Cattelan

    (Infectious and Tropical Diseases Unit, Azienda Ospedale Università di Padova, 35128 Padova, Italy)

  • Lolita Sasset

    (Infectious and Tropical Diseases Unit, Azienda Ospedale Università di Padova, 35128 Padova, Italy)

  • Federico Zabeo

    (Department of Cardiac Thoracic and Vascular Sciences and Public Health, University of Padova, 35127 Padova, Italy)

  • Anna Ferrari

    (Infectious and Tropical Diseases Unit, Azienda Ospedale Università di Padova, 35128 Padova, Italy)

  • Lucia Rossi

    (Microbiology Department, Azienda Ospedale Università di Padova, 35128 Padova, Italy)

  • Maria Mazzitelli

    (Infectious and Tropical Diseases Unit, Azienda Ospedale Università di Padova, 35128 Padova, Italy)

  • Silvia Cocchio

    (Department of Cardiac Thoracic and Vascular Sciences and Public Health, University of Padova, 35127 Padova, Italy)

  • Vincenzo Baldo

    (Department of Cardiac Thoracic and Vascular Sciences and Public Health, University of Padova, 35127 Padova, Italy)

Abstract

Background: Real time reverse transcription polymerase chain reaction (real time RT-PCR) testing is the gold standard for the diagnosis of SARS-CoV-2 infections. However, to expand the testing capacity, new SARS-CoV-2 rapid antigen tests (Ag-RDTs) have been implemented. Ag-RDTs are more rapid, but less reliable in terms of sensitivity, and real-life data on their performance in comparison with the real time RT-PCR test are lacking. Methods: We aimed at assessing the diagnostic performance of the third-generation antigenic swab LumiraDx™ compared with real time RT-PCR in a retrospective cohort study at the Infectious Diseases Unit of Padua. All of the patients who were consecutively tested for SARS-CoV-2 in our centre (by both real time RT-PCR and Ag-RTD LumiraDx TM ) from 19 January to 30 May 2021, were included. Cycle-threshold (Ct) values of positive real time RT-PCR were recorded as well as the number of days from symptoms’ onset to testing. Results: Among the 282 patients included, 80.9% (N = 228) tested positive to real time RT-PCR, and among these, 174 tested positive also to LumiraDx™. Compared with real time RT-PCR, which is considered as the gold standard for the assessment of the presence/absence of SARS-CoV-2 infection, LumiraDx™ showed an overall sensitivity of 76.3% and specificity of 94.4%. Sensitivity increased to 91% when testing was performed <10 days from symptoms’ onset, and to 95% when considering Ct < 25. Multivariable binomial logistic regression showed that false negative LumiraDx™ results were significantly associated with high Ct values, and with further testing from symptoms’ onset. Conclusions: The results of our study suggested that the LumiraDx™ SARS-CoV-2 antigen assay may be appropriate for the detection of SARS-CoV-2 infection, especially in its early phase when the test largely meets the performance requirements of the European Centre for Disease Prevention and Control (ECDC).

Suggested Citation

  • Anna Maria Cattelan & Lolita Sasset & Federico Zabeo & Anna Ferrari & Lucia Rossi & Maria Mazzitelli & Silvia Cocchio & Vincenzo Baldo, 2022. "Rapid Antigen Test LumiraDx TM vs. Real Time Polymerase Chain Reaction for the Diagnosis of SARS-CoV-2 Infection: A Retrospective Cohort Study," IJERPH, MDPI, vol. 19(7), pages 1-12, March.
    • Handle: RePEc:gam:jijerp:v:19:y:2022:i:7:p:3826-:d:777946
    as

    Download full text from publisher

    File URL: https://www.mdpi.com/1660-4601/19/7/3826/pdf
    Download Restriction: no
    File URL: https://www.mdpi.com/1660-4601/19/7/3826/
    Download Restriction: no
    ---><---

    References listed on IDEAS

    as
    1. Roman Wölfel & Victor M. Corman & Wolfgang Guggemos & Michael Seilmaier & Sabine Zange & Marcel A. Müller & Daniela Niemeyer & Terry C. Jones & Patrick Vollmar & Camilla Rothe & Michael Hoelscher & To, 2020. "Author Correction: Virological assessment of hospitalized patients with COVID-2019," Nature, Nature, vol. 588(7839), pages 35-35, December.
    2. Lukas E Brümmer & Stephan Katzenschlager & Mary Gaeddert & Christian Erdmann & Stephani Schmitz & Marc Bota & Maurizio Grilli & Jan Larmann & Markus A Weigand & Nira R Pollock & Aurélien Macé & Sergio, 2021. "Accuracy of novel antigen rapid diagnostics for SARS-CoV-2: A living systematic review and meta-analysis," PLOS Medicine, Public Library of Science, vol. 18(8), pages 1-41, August.
    3. Stephen M Kissler & Joseph R Fauver & Christina Mack & Scott W Olesen & Caroline Tai & Kristin Y Shiue & Chaney C Kalinich & Sarah Jednak & Isabel M Ott & Chantal B F Vogels & Jay Wohlgemuth & James W, 2021. "Viral dynamics of acute SARS-CoV-2 infection and applications to diagnostic and public health strategies," PLOS Biology, Public Library of Science, vol. 19(7), pages 1-17, July.
    4. Roman Wölfel & Victor M. Corman & Wolfgang Guggemos & Michael Seilmaier & Sabine Zange & Marcel A. Müller & Daniela Niemeyer & Terry C. Jones & Patrick Vollmar & Camilla Rothe & Michael Hoelscher & To, 2020. "Virological assessment of hospitalized patients with COVID-2019," Nature, Nature, vol. 581(7809), pages 465-469, May.
    5. Sin Fun Sia & Li-Meng Yan & Alex W. H. Chin & Kevin Fung & Ka-Tim Choy & Alvina Y. L. Wong & Prathanporn Kaewpreedee & Ranawaka A. P. M. Perera & Leo L. M. Poon & John M. Nicholls & Malik Peiris & Hui, 2020. "Pathogenesis and transmission of SARS-CoV-2 in golden hamsters," Nature, Nature, vol. 583(7818), pages 834-838, July.
    Full references (including those not matched with items on IDEAS)

    Citations

    Citations are extracted by the CitEc Project, subscribe to its RSS feed for this item.
    as


    Cited by:

    1. Jing Qi & Jia Neng Tan & Soh Heng Hui & Neoh Choo Lim & Titus Lau & Sabrina Haroon, 2022. "The Implementation and Role of Antigen Rapid Test for COVID-19 in Hemodialysis Units," IJERPH, MDPI, vol. 19(22), pages 1-10, November.

    Most related items

    These are the items that most often cite the same works as this one and are cited by the same works as this one.
    1. Juan Liu & Fengfeng Mao & Jianhe Chen & Shuaiyao Lu & Yonghe Qi & Yinyan Sun & Linqiang Fang & Man Lung Yeung & Chunmei Liu & Guimei Yu & Guangyu Li & Ximing Liu & Yuansheng Yao & Panpan Huang & Dongx, 2023. "An IgM-like inhalable ACE2 fusion protein broadly neutralizes SARS-CoV-2 variants," Nature Communications, Nature, vol. 14(1), pages 1-18, December.
    2. Hanyu Li & Kazuki Kuga & Kazuhide Ito, 2022. "SARS-CoV-2 Dynamics in the Mucus Layer of the Human Upper Respiratory Tract Based on Host–Cell Dynamics," Sustainability, MDPI, vol. 14(7), pages 1-18, March.
    3. Julia M. Adler & Ricardo Martin Vidal & Christine Langner & Daria Vladimirova & Azza Abdelgawad & Daniela Kunecova & Xiaoyuan Lin & Geraldine Nouailles & Anne Voss & Sandra Kunder & Achim D. Gruber & , 2024. "An intranasal live-attenuated SARS-CoV-2 vaccine limits virus transmission," Nature Communications, Nature, vol. 15(1), pages 1-16, December.
    4. Shanlin Ke & Scott T. Weiss & Yang-Yu Liu, 2022. "Dissecting the role of the human microbiome in COVID-19 via metagenome-assembled genomes," Nature Communications, Nature, vol. 13(1), pages 1-15, December.
    5. Tobias Schlager & Ashley V. Whillans, 2022. "People underestimate the probability of contracting the coronavirus from friends," Palgrave Communications, Palgrave Macmillan, vol. 9(1), pages 1-11, December.
    6. Joseph Pateras & Preetam Ghosh, 2022. "A Computational Framework for Exploring SARS-CoV-2 Pharmacodynamic Dose and Timing Regimes," Mathematics, MDPI, vol. 10(20), pages 1-12, October.
    7. Marta Baselga & Juan J. Alba & Alberto J. Schuhmacher, 2022. "The Control of Metabolic CO 2 in Public Transport as a Strategy to Reduce the Transmission of Respiratory Infectious Diseases," IJERPH, MDPI, vol. 19(11), pages 1-19, May.
    8. Lisa Cariani & Beatrice Silvia Orena & Federico Ambrogi & Simone Gambazza & Anna Maraschini & Antonella Dodaro & Massimo Oggioni & Annarosa Orlandi & Alessia Pirrone & Sara Uceda Renteria & Mara Berna, 2020. "Time Length of Negativization and Cycle Threshold Values in 182 Healthcare Workers with Covid-19 in Milan, Italy: An Observational Cohort Study," IJERPH, MDPI, vol. 17(15), pages 1-10, July.
    9. Dapeng Li & David R. Martinez & Alexandra Schäfer & Haiyan Chen & Maggie Barr & Laura L. Sutherland & Esther Lee & Robert Parks & Dieter Mielke & Whitney Edwards & Amanda Newman & Kevin W. Bock & Mahn, 2022. "Breadth of SARS-CoV-2 neutralization and protection induced by a nanoparticle vaccine," Nature Communications, Nature, vol. 13(1), pages 1-15, December.
    10. Lorenz Schubert & Robert Strassl & Heinz Burgmann & Gabriella Dvorak & Matthias Karer & Michael Kundi & Manuel Kussmann & Heimo Lagler & Felix Lötsch & Christopher Milacek & Markus Obermueller & Zoe O, 2021. "A Longitudinal Seroprevalence Study Evaluating Infection Control and Prevention Strategies at a Large Tertiary Care Center with Low COVID-19 Incidence," IJERPH, MDPI, vol. 18(8), pages 1-10, April.
    11. Susanna Esposito & Federico Marchetti & Marcello Lanari & Fabio Caramelli & Alessandro De Fanti & Gianluca Vergine & Lorenzo Iughetti & Martina Fornaro & Agnese Suppiej & Stefano Zona & Andrea Pession, 2021. "COVID-19 Management in the Pediatric Age: Consensus Document of the COVID-19 Working Group in Paediatrics of the Emilia-Romagna Region (RE-CO-Ped), Italy," IJERPH, MDPI, vol. 18(8), pages 1-29, April.
    12. Ramon Roozendaal & Laura Solforosi & Daniel J. Stieh & Jan Serroyen & Roel Straetemans & Anna Dari & Muriel Boulton & Frank Wegmann & Sietske K. Rosendahl Huber & Joan E. M. van der Lubbe & Jenny Hend, 2021. "SARS-CoV-2 binding and neutralizing antibody levels after Ad26.COV2.S vaccination predict durable protection in rhesus macaques," Nature Communications, Nature, vol. 12(1), pages 1-10, December.
    13. Shengwei Zhu & Tong Lin & John D. Spengler & Jose Guillermo Cedeño Laurent & Jelena Srebric, 2022. "The Influence of Plastic Barriers on Aerosol Infection Risk during Airport Security Checks," Sustainability, MDPI, vol. 14(18), pages 1-14, September.
    14. Sasha Harris-Lovett & Kara L. Nelson & Paloma Beamer & Heather N. Bischel & Aaron Bivins & Andrea Bruder & Caitlyn Butler & Todd D. Camenisch & Susan K. De Long & Smruthi Karthikeyan & David A. Larsen, 2021. "Wastewater Surveillance for SARS-CoV-2 on College Campuses: Initial Efforts, Lessons Learned, and Research Needs," IJERPH, MDPI, vol. 18(9), pages 1-20, April.
    15. Maria de Lourdes Aguiar-Oliveira & Aline Campos & Aline R. Matos & Caroline Rigotto & Adriana Sotero-Martins & Paulo F. P. Teixeira & Marilda M. Siqueira, 2020. "Wastewater-Based Epidemiology (WBE) and Viral Detection in Polluted Surface Water: A Valuable Tool for COVID-19 Surveillance—A Brief Review," IJERPH, MDPI, vol. 17(24), pages 1-19, December.
    16. Kumawat, Nitesh & Rashid, Mubasher & Srivastava, Akriti & Tripathi, Jai Prakash, 2023. "Hysteresis and Hopf bifurcation: Deciphering the dynamics of an in-host model of SARS-CoV-2 with logistic target cell growth and sigmoidal immune response," Chaos, Solitons & Fractals, Elsevier, vol. 176(C).
    17. Nagel, Kai & Rakow, Christian & Müller, Sebastian A., 2021. "Realistic agent-based simulation of infection dynamics and percolation," Physica A: Statistical Mechanics and its Applications, Elsevier, vol. 584(C).
    18. Rabih Ghostine & Mohamad Gharamti & Sally Hassrouny & Ibrahim Hoteit, 2021. "Mathematical Modeling of Immune Responses against SARS-CoV-2 Using an Ensemble Kalman Filter," Mathematics, MDPI, vol. 9(19), pages 1-13, September.
    19. Patrick T. Acer & Lauren M. Kelly & Andrew A. Lover & Caitlyn S. Butler, 2022. "Quantifying the Relationship between SARS-CoV-2 Wastewater Concentrations and Building-Level COVID-19 Prevalence at an Isolation Residence: A Passive Sampling Approach," IJERPH, MDPI, vol. 19(18), pages 1-15, September.
    20. Afnan Al Agha & Safiya Alshehaiween & Ahmed Elaiw & Matuka Alshaikh, 2021. "A Global Analysis of Delayed SARS-CoV-2/Cancer Model with Immune Response," Mathematics, MDPI, vol. 9(11), pages 1-27, June.

    Corrections

    All material on this site has been provided by the respective publishers and authors. You can help correct errors and omissions. When requesting a correction, please mention this item's handle: RePEc:gam:jijerp:v:19:y:2022:i:7:p:3826-:d:777946. See general information about how to correct material in RePEc.

    If you have authored this item and are not yet registered with RePEc, we encourage you to do it here. This allows to link your profile to this item. It also allows you to accept potential citations to this item that we are uncertain about.

    If CitEc recognized a bibliographic reference but did not link an item in RePEc to it, you can help with this form .

    If you know of missing items citing this one, you can help us creating those links by adding the relevant references in the same way as above, for each refering item. If you are a registered author of this item, you may also want to check the "citations" tab in your RePEc Author Service profile, as there may be some citations waiting for confirmation.

    For technical questions regarding this item, or to correct its authors, title, abstract, bibliographic or download information, contact: MDPI Indexing Manager (email available below). General contact details of provider: https://www.mdpi.com .

    Please note that corrections may take a couple of weeks to filter through the various RePEc services.

    IDEAS is a RePEc service. RePEc uses bibliographic data supplied by the respective publishers.