Canadian society of clinical chemists (CSCC) consensus guidance for testing, selection and quality management of SARS-CoV-2 point-of-care tests

Autor: Uvaraj Uddayasankar, Nicole White-Al Habeeb, Eleonora Petryayeva, Saranya Arnoldo, Sukhbir Kaur, Michael J. Knauer, Julie L.V. Shaw, Dana Bailey, Vincent De Guire, Danijela Konforte, Susan M. Poutanen, Edward Randell, Jennifer Taher
Jazyk: angličtina
Rok vydání: 2021
Předmět:
Societies
Scientific
030213 general clinical medicine
Canada
Quality management
Consensus
EQA
external quality assessment
Computer science
Point-of-care testing
Clinical Biochemistry
POCT
point-of-care testing
NWA
nasal wash aspirate
030204 cardiovascular system & hematology
POC
point-of-care
LAMP
loop-mediated isothermal amplification
Article
TAT
turn-around time
03 medical and health sciences
Biosafety
0302 clinical medicine
RT-PCR
reverse transcription polymerase chain reaction
NAAT
Nucleic acid amplification assays
Humans
Sampling (medicine)
CSCC
Canadian Society of Clinical Chemists
Selection (genetic algorithm)
Qualitative Research
Medical education
LOD
limit of detection
SARS-CoV-2
COVID-19
NS
Nasal swab
General Medicine
Ct
Cycle threshold
Nucleic acid amplification test
Quality Improvement
NPS
Nasopharyngeal swab
Test (assessment)
QC
quality control
SOP
standard operating procedure
Quality management system
Antigen
Practice Guidelines as Topic
PPE
personal protective equipment
Qualitative research
Zdroj: Clinical Biochemistry
ISSN: 1873-2933
0009-9120
Popis: Objectives A consensus guidance is provided for testing, utility and verification of SARS-CoV-2 point-of-care test (POCT) performance and implementation of a quality management program, focusing on nucleic acid and antigen targeted technologies. Design and Methods The recommendations are based on current literature and expert opinion from the members of Canadian Society of Clinical Chemists (CSCC), and are intended for use inside or outside of healthcare settings that have varied levels of expertise and experience with POCT. Results and Conclusions Here we discuss sampling requirements, biosafety, SARS-CoV-2 point-of-care testing methodologies (with focus on Health Canada approved tests), test performance and limitations, test selection, testing utility, development and implementation of quality management systems, quality improvement, and medical and scientific oversight.
Databáze: OpenAIRE
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