Clinical evaluation of SARS-CoV-2 point-of-care tests
Autor: | Dominic E. Dwyer, Roselle S. Robosa, Indy Sandaradura, Matthew V. N. O'Sullivan |
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Jazyk: | angličtina |
Rok vydání: | 2020 |
Předmět: |
0301 basic medicine
Adult Male medicine.medical_specialty Adolescent Point-of-care testing Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) serology Immunofluorescence Tertiary referral hospital Antibodies Viral Sensitivity and Specificity Pathology and Forensic Medicine COVID-19 Serological Testing 03 medical and health sciences Young Adult 0302 clinical medicine Internal medicine medicine Humans Child skin and connective tissue diseases Point of care Aged Retrospective Studies Aged 80 and over medicine.diagnostic_test biology business.industry SARS-CoV-2 fungi virus diseases COVID-19 Retrospective cohort study Middle Aged body regions Coronavirus 030104 developmental biology Point-of-Care Testing 030220 oncology & carcinogenesis Child Preschool biology.protein Original Article Female Antibody business Clinical evaluation |
Zdroj: | Pathology |
Popis: | The aim of this study was to assess the analytic and clinical performance of four rapid lateral flow point-of-care tests (POCTs) for identifying SARS-CoV-2-specific antibodies. A retrospective study was conducted between 22 January and 30 March 2020 on 132 serum samples for SARS-CoV-2-specific antibody detection referred to a tertiary referral hospital laboratory in New South Wales. Multiple sera were tested from 20 confirmed or suspected COVID-19 patients with SARS-CoV-2-specific antibodies detected by immunofluorescence (IFA) or neutralisation, and 71 SARS-CoV-2 uninfected individuals. We measured the sensitivity and specificity for detection of SARS-CoV-2 IgM and IgG antibodies for each POCT in comparison to positive SARS-CoV-2-specific IFA and viral neutralisation, our current laboratory benchmark tests. All POCTs were found to have a low analytic sensitivity for SARS-CoV-2 antibodies, ranging from 27.3% to 58.2%, with a specificity between 88.3% and 100%, and a low clinical sensitivity from 45% to 65%, with a clinical specificity between 87.3% and 100%. All POCTs had an increased sensitivity when specimens were collected more than 14 days from onset of symptoms. The detection using point-of-care testing of SARS-CoV-2-specific antibodies after disease onset lagged behind IFA by a range of 0-9 days. POCTs promise the benefit of providing quick easy testing for SARS-CoV-2-specific antibodies. However, their poor sensitivity and delayed antibody detection make them unsuitable as a diagnostic or screening tool alone. |
Databáze: | OpenAIRE |
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