Deploying a rapid point-of-care polymerase chain reaction test for SARS-CoV-2 in a clinical research unit to ensure healthy volunteer safety

The entire world was severely affected by the outbreak of the SARS-CoV-2 virus. Early phase clinical research was no exception and clinical healthy volunteer trials were halted across the globe. To enable continuation of development of new drugs, we developed a testing strategy for nonsymptomatic tr...

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Bibliographic Details
Published inBioanalysis Vol. 13; no. 24; pp. 1799 - 1804
Main Authors Trigt, Radboud van, Neat, Jason, Brouwer, Jan Leendert, Hays, Amanda, Westerhof, Hans
Format Journal Article
LanguageEnglish
Published England Newlands Press Ltd 01.12.2021
Subjects
COVID-19
COVID-19 - diagnosis
COVID-19 - virology
CRU
Healthy Volunteers
Humans
Phase I clinical trials
point-of-care PCR
Point-of-Care Systems - organization & administration
Polymerase Chain Reaction - methods
SARS-CoV-2 - isolation & purification
SARS-CoV-2 testing
Special Report
COVID-19
point-of-care PCR
Phase I clinical trials
SARS-CoV-2 testing
CRU
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Summary:The entire world was severely affected by the outbreak of the SARS-CoV-2 virus. Early phase clinical research was no exception and clinical healthy volunteer trials were halted across the globe. To enable continuation of development of new drugs, we developed a testing strategy for nonsymptomatic trial participants in an early stage of the outbreak. A point-of-care polymerase chain reaction test combined with a gold standard polymerase chain reaction test and strict social distancing and hygiene measures limited the number of infected subjects entering our clinical research units and reduced further spread for the duration of the clinical trial. Thus, proving efficacy of this strategy to allow safe and effective continuation of early phase clinical trials during the COVID-19 pandemic.
ISSN:1757-6180
1757-6199
DOI:10.4155/bio-2021-0079