Evaluation an immunofluorescence-based antigen test for hospital point-of-care diagnosis of SARS-CoV-2 infection
Year: 2021
Type: article
Study design: Observational Study
Abstract: Introduction: Since the emergence of the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), real-time reverse-transcription polymerase chain reaction (RT-PCR)-based testing remains the gold standard for its laboratory diagnosis.Due to the increasing diagnosis demand, resources for RT-PCR testing are limited in many countries, especially in Africa.Here, we evaluated the LumiraDx SARS-CoV-2 antigen test for alternative diagnosis of SARS-CoV-2 in hospital setting. Materials and methods:This prospective validation study was conducted among 184 subjected presented at the hospital for COVID-19 testing.Nasal swap samples have been collected into 0.7 mL of the extraction buffer for LumiraDx antigen test.In parallel, oropharyngeal and nasopharyngeal sap samples were collected into viral transport media for RT-PCR testing.Results: Compared to the RT-PCR, the sensitivity and specificity of the LumiraDx antigen SARS-CoV-2 test were 81.6% [95%CI 66.8-91.3]and 100% [95%CI 96.4-100] respectively.Given to the threshold cycle (Ct)the sensitivity and specificity were 94.4% [95%CI 79.9-99.0]and 100% [95%CI 96.4-100], respectively when the Ct value was below or equal 33 cycles, and 27.2% [95%CI 7.3-60.6]and 100% [95%CI 96.4-100] when it was above 33.The kappa coefficient showed was 0.86 when considering all the patients and 0.96 for Ct values below 30 cycles.The agreement with RT-PCR ranged from was 88.2 to 100% in patients within 12 days of the onset of symptoms.Conclusions: Our data have shown that the LumiraDx antigen SARS-Co-2 test elicits high sensitivity and good agreement when compared to the RT-PCR and can significantly improve the SARS-CoV-2 diagnosis in clinic-based settings. Mbow M (2021) Evaluation an immunofluorescence-based antigen test for hospital point-of-care diagnosis of SARS-CoV-2 infection
Authors: Moustapha Mbow, Papa Alioune Badara Dieye, Ndeye Khady Ba, Marouba Cisse, Gora Lo, Moctar Gningue, Ibrahima Diallo, Nafissatou Leye, Mamadou Diouf, Yacine Amet Dia, Oumar Diop, Agbogbenkou Tevi Dela-del Lawson, Abdou Padane, Aminata Mboup, Djibril wade, Josephine Khady Badiane, Doudou George Massar Niang, Aminata Dia, Ambroise Ahouidi, Babacar Mbengue, Maguette Deme Sylla Niang, Sylvie Diop, Papa Alassane Diaw, Tandakha Ndiaye Dieye, Badara Cisse, El Hadj Mamadou Mbaye, Souleymane Mboup, Alioune Dieye
Language: English
Subfield: Infectious Diseases
Field: Medicine
Domain: Health Sciences
Open Access status: diamond
OpenAlex ID: W4235721376