Isabelle Goupil-Sormany1,2, Jean Longtin3,4, Jeannot Dumar4,5, Marieve Jacob-Wagner3, Frédéric Bouchard6, Liliana Romero7, Julie Harvey8, Julie Bestman-Smith3,4, Mathieu Provençal9, Stéphanie Beauchemin9, Valérie Richard2, Annie-Claude Labbé9,10,11. 1. Direction de la vigie sanitaire, Ministère de la Santé et des Services sociaux du Québec, QC. 2. Département de médecine sociale et préventive, Faculté de Médecine, Université Laval, Québec, QC. 3. Département de microbiologie et d'infectiologie du centre hospitalier universitaire (CHU) de Québec - Université Laval, Québec, QC. 4. Département de microbiologie-infectiologie et d'immunologie, Faculté de Médecine, Université Laval, Québec, QC. 5. Département de microbiologie et d'infectiologie, CISSS de Chaudière-Appalaches, Lévis, QC. 6. Laboratoire de biochimie médicale, CISSS de Chaudière-Appalaches, Lévis, QC. 7. Direction de la Santé publique, CISSS de Chaudière-Appalaches, Lévis, QC. 8. Direction de la Santé publique, CIUSSS de la Capitale-Nationale, Québec, QC. 9. Département des laboratoires de biologie médicale, Grappe Optilab-CHUM, Centre hospitalier de l'Université de Montréal, Montréal, QC. 10. Département de microbiologie, infectiologie et immunologie, Université de Montréal, Montréal, QC. 11. Service de maladies infectieuses, Hôpital Maisonneuve-Rosemont, CIUSSS de l'Est-de-l'Île-de-Montréal, Montréal, QC.
Abstract
BACKGROUND: This PRONTO study investigated the clinical performance of the Abbott ID NOWTM (IDN) COVID-19 diagnostic assay used at point of care and its impact on turnaround time for divulgation of test results. METHODS: Prospective study conducted from December 2020 to February 2021 in acute symptomatic participants presenting in three walk-in centres in the province of Québec. RESULTS: Valid paired samples were obtained from 2,372 participants. A positive result on either the IDN or the standard-of-care nucleic acid amplification test (SOC-NAAT) was obtained in 423 participants (prevalence of 17.8%). Overall sensitivity of IDN and SOC-NAAT were 96.4% (95% CI: 94.2-98.0%) and 99.1% (95% CI: 97.6-99.8), respectively; negative predictive values were 99.2% (95% CI: 98.7-99.6%) and 99.8% (95% CI: 99.5-100%), respectively. Turnaround time for positive results was significantly faster on IDN. CONCLUSION: In our experience, IDN use in symptomatic individuals in walk-in centres is a reliable sensitive alternative to SOC-NAAT without the need for subsequent confirmation of negative results. Such deployment can accelerate contact tracing, reduce the burden on laboratories and increase access to testing.
BACKGROUND: This PRONTO study investigated the clinical performance of the Abbott ID NOWTM (IDN) COVID-19 diagnostic assay used at point of care and its impact on turnaround time for divulgation of test results. METHODS: Prospective study conducted from December 2020 to February 2021 in acute symptomatic participants presenting in three walk-in centres in the province of Québec. RESULTS: Valid paired samples were obtained from 2,372 participants. A positive result on either the IDN or the standard-of-care nucleic acid amplification test (SOC-NAAT) was obtained in 423 participants (prevalence of 17.8%). Overall sensitivity of IDN and SOC-NAAT were 96.4% (95% CI: 94.2-98.0%) and 99.1% (95% CI: 97.6-99.8), respectively; negative predictive values were 99.2% (95% CI: 98.7-99.6%) and 99.8% (95% CI: 99.5-100%), respectively. Turnaround time for positive results was significantly faster on IDN. CONCLUSION: In our experience, IDN use in symptomatic individuals in walk-in centres is a reliable sensitive alternative to SOC-NAAT without the need for subsequent confirmation of negative results. Such deployment can accelerate contact tracing, reduce the burden on laboratories and increase access to testing.
Authors: Victor M Corman; Olfert Landt; Marco Kaiser; Richard Molenkamp; Adam Meijer; Daniel Kw Chu; Tobias Bleicker; Sebastian Brünink; Julia Schneider; Marie Luisa Schmidt; Daphne Gjc Mulders; Bart L Haagmans; Bas van der Veer; Sharon van den Brink; Lisa Wijsman; Gabriel Goderski; Jean-Louis Romette; Joanna Ellis; Maria Zambon; Malik Peiris; Herman Goossens; Chantal Reusken; Marion Pg Koopmans; Christian Drosten Journal: Euro Surveill Date: 2020-01
Authors: Jorge L Sepulveda; Rami Abdulbaki; Zachary Sands; Maria Codoy; Salome Mendoza; Nancy Isaacson; Olga Kochar; John Keiser; Tenagne Haile-Mariam; Andrew C Meltzer; Christopher N Mores; Antonia R Sepulveda Journal: J Clin Virol Date: 2021-04-24 Impact factor: 3.168