TY - JOUR
T1 - Rapid implementation and validation of a cold-chain free SARS-CoV-2 diagnostic testing workflow to support surge capacity
AU - Bosworth, Andrew
AU - Whalley, Celina
AU - Poxon, Charlie
AU - Wanigasooriya, Kasun
AU - Pickles, Oliver
AU - Aldera, Erin L
AU - Papakonstantinou, Danai
AU - Morley, Gabriella L
AU - Walker, Eloise M
AU - Zielinska, Agnieszka E
AU - McLoughlin, Dee
AU - Webster, Craig
AU - Plant, Tim
AU - Ellis, Andrew
AU - Richter, Alex
AU - Kidd, I Michael
AU - Beggs, Andrew D
PY - 2020/7
Y1 - 2020/7
N2 - BACKGROUND: In January 2020 reports of unidentified severe respiratory illness were described in Wuhan, China. A rapid expansion in cases affecting most countries around the globe led to major changes in the way people live their daily lives. In the United Kingdom, the Department of Health and Social Care directed healthcare providers to establish additional resources to manage the anticipated surge in cases that could overwhelm the health services. A priority area was testing for SARS-CoV-2 RNA and its detection by qualitative RT-PCR.DESIGN: A laboratory workflow twinning research environment with clinical laboratory capabilities was implemented and validated in the University of Birmingham within 4 days of the project initiation. The diagnostic capability was centred on an IVD CE-marked RT-PCR kit and designed to provide surge capacity to the nearby Queen Elizabeth Hospital. The service was initially tasked with testing healthcare workers (HCW) using throat swabs, and subsequently the process investigated the utility of using saliva as an alternative sample type.RESULTS: Between the 8th April 2020 and the 30th April 2020, the laboratory tested a total of 1282 HCW for SARS-CoV-2 RNA in throat swabs. RNA was detected in 54 % of those who reported symptoms compatible with COVID-19, but in only 4% who were asymptomatic.CONCLUSION: This capability was established rapidly and utilised a cold-chain free methodology, applicable to a wide range of settings, and which can provide surge capacity and support to clinical laboratories facing increasing pressure during periods of national crisis.
AB - BACKGROUND: In January 2020 reports of unidentified severe respiratory illness were described in Wuhan, China. A rapid expansion in cases affecting most countries around the globe led to major changes in the way people live their daily lives. In the United Kingdom, the Department of Health and Social Care directed healthcare providers to establish additional resources to manage the anticipated surge in cases that could overwhelm the health services. A priority area was testing for SARS-CoV-2 RNA and its detection by qualitative RT-PCR.DESIGN: A laboratory workflow twinning research environment with clinical laboratory capabilities was implemented and validated in the University of Birmingham within 4 days of the project initiation. The diagnostic capability was centred on an IVD CE-marked RT-PCR kit and designed to provide surge capacity to the nearby Queen Elizabeth Hospital. The service was initially tasked with testing healthcare workers (HCW) using throat swabs, and subsequently the process investigated the utility of using saliva as an alternative sample type.RESULTS: Between the 8th April 2020 and the 30th April 2020, the laboratory tested a total of 1282 HCW for SARS-CoV-2 RNA in throat swabs. RNA was detected in 54 % of those who reported symptoms compatible with COVID-19, but in only 4% who were asymptomatic.CONCLUSION: This capability was established rapidly and utilised a cold-chain free methodology, applicable to a wide range of settings, and which can provide surge capacity and support to clinical laboratories facing increasing pressure during periods of national crisis.
KW - Betacoronavirus/genetics
KW - Clinical Laboratory Techniques/methods
KW - Coronavirus Infections/diagnosis
KW - Humans
KW - Pandemics
KW - Pneumonia, Viral/diagnosis
KW - RNA, Viral/blood
KW - Saliva/virology
KW - Surge Capacity
KW - United Kingdom
KW - Workflow
UR - http://www.scopus.com/inward/record.url?scp=85085366216&partnerID=8YFLogxK
U2 - 10.1016/j.jcv.2020.104469
DO - 10.1016/j.jcv.2020.104469
M3 - Article
C2 - 32474371
SN - 1386-6532
VL - 128
JO - Journal of Clinical Virology
JF - Journal of Clinical Virology
M1 - 104469
ER -