Clinical evaluation of SARS-CoV-2 point-of-care tests

Autor: Dominic E. Dwyer, Roselle S. Robosa, Indy Sandaradura, Matthew V. N. O'Sullivan
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