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IFCC interim guidelines on rapid point-of-care antigen testing for SARS-CoV-2 detection in asymptomatic and symptomatic individuals.
Bohn, Mary Kathryn; Lippi, Giuseppe; Horvath, Andrea R; Erasmus, Rajiv; Grimmler, Matthias; Gramegna, Maurizio; Mancini, Nicasio; Mueller, Robert; Rawlinson, William D; Menezes, María Elizabeth; Patru, Maria-Magdalena; Rota, Fabio; Sethi, Sunil; Singh, Krishna; Yuen, Kwok-Yung; Wang, Cheng-Bin; Adeli, Khosrow.
  • Bohn MK; Department of Paediatric Laboratory Medicine, CALIPER Program, The Hospital for Sick Children, Toronto, ON, Canada.
  • Lippi G; Department of Laboratory Medicine and Pathobiology, University of Toronto, Toronto, ON, Canada.
  • Horvath AR; University Hospital of Verona, Verona, Italy.
  • Erasmus R; Department of Clinical Chemistry, NSW Health Pathology, Prince of Wales Hospital, Sydney, NSW, Australia.
  • Grimmler M; Stellenbosch University, Cape Town, Western Cape, Republic of South Africa.
  • Gramegna M; DiaSys Diagnostic Systems, Holzheim, Germany.
  • Mancini N; Sentinel CH. SpA, Milan, Italy.
  • Mueller R; Vita-Salute San Raffaele University, Milan, Italy.
  • Rawlinson WD; Abbott Laboratories, Abbott Park, IL, USA.
  • Menezes ME; Department of Virology, NSW Health Pathology, Prince of Wales Hospital, Sydney, NSW, Australia.
  • Patru MM; Secretaria de Saúde do Estado de Santa Catarina, Florianópolis, Brazil.
  • Rota F; Ortho Clinical Diagnostics, Raritan, NJ, USA.
  • Sethi S; Sentinel Diagnostics, Milan, Italy.
  • Singh K; National University Hospital, Singapore, Singapore.
  • Yuen KY; Siemens Healthcare USA, Malvern, PA, USA.
  • Wang CB; University of Hong Kong, Hong Kong, P. R. China.
  • Adeli K; Chinese PLA General Hospital, Beijing, P. R. China.
Clin Chem Lab Med ; 59(9): 1507-1515, 2021 08 26.
Article in English | MEDLINE | ID: covidwho-1206212
Semantic information from SemMedBD (by NLM)
1. Point-of-Care Testing DIAGNOSES 2019 novel coronavirus
Subject
Point-of-Care Testing
Predicate
DIAGNOSES
Object
2019 novel coronavirus
2. Infected PROCESS_OF Persons
Subject
Infected
Predicate
PROCESS_OF
Object
Persons
3. Laboratory LOCATION_OF Immunoassay method
Subject
Laboratory
Predicate
LOCATION_OF
Object
Immunoassay method
4. Rapid immunoassay USES Chromatography
Subject
Rapid immunoassay
Predicate
USES
Object
Chromatography
5. Antigen test USES Detection
Subject
Antigen test
Predicate
USES
Object
Detection
6. Point-of-Care Testing DIAGNOSES 2019 novel coronavirus
Subject
Point-of-Care Testing
Predicate
DIAGNOSES
Object
2019 novel coronavirus
7. Infected PROCESS_OF Persons
Subject
Infected
Predicate
PROCESS_OF
Object
Persons
8. Laboratory LOCATION_OF Immunoassay method
Subject
Laboratory
Predicate
LOCATION_OF
Object
Immunoassay method
9. Rapid immunoassay USES Chromatography
Subject
Rapid immunoassay
Predicate
USES
Object
Chromatography
10. Antigen test USES Detection
Subject
Antigen test
Predicate
USES
Object
Detection
ABSTRACT
With an almost unremittent progression of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) infections all around the world, there is a compelling need to introduce rapid, reliable, and high-throughput testing to allow appropriate clinical management and/or timely isolation of infected individuals. Although nucleic acid amplification testing (NAAT) remains the gold standard for detecting and theoretically quantifying SARS-CoV-2 mRNA in various specimen types, antigen assays may be considered a suitable alternative, under specific circumstances. Rapid antigen tests are meant to detect viral antigen proteins in biological specimens (e.g. nasal, nasopharyngeal, saliva), to indicate current SARS-CoV-2 infection. The available assay methodology includes rapid chromatographic immunoassays, used at the point-of-care, which carries some advantages and drawbacks compared to more conventional, instrumentation-based, laboratory immunoassays. Therefore, this document by the International Federation for Clinical Chemistry and Laboratory Medicine (IFCC) Taskforce on COVID-19 aims to summarize available data on the performance of currently available SARS-CoV-2 antigen rapid detection tests (Ag-RDTs), providing interim guidance on clinical indications and target populations, assay selection, and evaluation, test interpretation and limitations, as well as on pre-analytical considerations. This document is hence mainly aimed to assist laboratory and regulated health professionals in selecting, validating, and implementing regulatory approved Ag-RDTs.
Subject(s)
Keywords

Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / Practice Guidelines as Topic / Point-of-Care Testing / SARS-CoV-2 / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2021 Document Type: Article Affiliation country: Cclm-2021-0455

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Full text: Available Collection: International databases Database: MEDLINE Main subject: Immunoassay / Practice Guidelines as Topic / Point-of-Care Testing / SARS-CoV-2 / COVID-19 / Antigens, Viral Type of study: Diagnostic study / Experimental Studies / Prognostic study Limits: Humans Language: English Journal: Clin Chem Lab Med Journal subject: Chemistry, Clinical / Laboratory Techniques and procedures Year: 2021 Document Type: Article Affiliation country: Cclm-2021-0455