Rapid Implementation of a SARS-CoV-2 Diagnostic Quantitative Real-Time PCR Test with Emergency Use Authorization at a Large Academic Safety Net Hospital.
COVID-19
SARS-CoV-2
clinical diagnostics
coronavirus
emergency use authorization
pathology and laboratory medicine
Journal
Med (New York, N.Y.)
ISSN: 2666-6340
Titre abrégé: Med
Pays: United States
ID NLM: 101769215
Informations de publication
Date de publication:
18 12 2020
18 12 2020
Historique:
received:
09
04
2020
revised:
24
04
2020
accepted:
01
05
2020
pubmed:
25
8
2020
medline:
25
8
2020
entrez:
25
8
2020
Statut:
ppublish
Résumé
Significant delays in the rapid development and distribution of diagnostic testing for SARS-CoV-2 (COVID-19) infection have prevented adequate public health management of the disease, impacting the timely mapping of viral spread and the conservation of personal protective equipment. Furthermore, vulnerable populations, such as those served by the Boston Medical Center (BMC), the largest safety net hospital in New England, represent a high-risk group across multiple dimensions, including a higher prevalence of pre-existing conditions and substance use disorders, lower health maintenance, unstable housing, and a propensity for rapid community spread, highlighting the urgent need for expedient and reliable in-house testing. We developed a SARS-CoV-2 diagnostic medium-throughput qRT-PCR assay with rapid turnaround time and utilized this Clinical Laboratory Improvement Amendments (CLIA)-certified assay for testing nasopharyngeal swab samples from BMC patients, with emergency authorization from the Food and Drug Administration (FDA) and the Massachusetts Department of Public Health. The in-house testing platform displayed robust accuracy and reliability in validation studies and reduced institutional sample turnaround time from 5-7 days to less than 24 h. Of over 1,000 unique patient samples tested, 44.1% were positive for SARS-CoV-2 infection. This work provides a blueprint for academic centers and community hospitals lacking automated laboratory machinery to implement rapid in-house testing. This study was supported by funding from the Boston University School of Medicine, the National Institutes of Health, Boston Medical Center, and the Massachusetts Consortium on Pathogen Readiness (MASS CPR).
Sections du résumé
BACKGROUND
Significant delays in the rapid development and distribution of diagnostic testing for SARS-CoV-2 (COVID-19) infection have prevented adequate public health management of the disease, impacting the timely mapping of viral spread and the conservation of personal protective equipment. Furthermore, vulnerable populations, such as those served by the Boston Medical Center (BMC), the largest safety net hospital in New England, represent a high-risk group across multiple dimensions, including a higher prevalence of pre-existing conditions and substance use disorders, lower health maintenance, unstable housing, and a propensity for rapid community spread, highlighting the urgent need for expedient and reliable in-house testing.
METHODS
We developed a SARS-CoV-2 diagnostic medium-throughput qRT-PCR assay with rapid turnaround time and utilized this Clinical Laboratory Improvement Amendments (CLIA)-certified assay for testing nasopharyngeal swab samples from BMC patients, with emergency authorization from the Food and Drug Administration (FDA) and the Massachusetts Department of Public Health.
FINDINGS
The in-house testing platform displayed robust accuracy and reliability in validation studies and reduced institutional sample turnaround time from 5-7 days to less than 24 h. Of over 1,000 unique patient samples tested, 44.1% were positive for SARS-CoV-2 infection.
CONCLUSIONS
This work provides a blueprint for academic centers and community hospitals lacking automated laboratory machinery to implement rapid in-house testing.
FUNDING
This study was supported by funding from the Boston University School of Medicine, the National Institutes of Health, Boston Medical Center, and the Massachusetts Consortium on Pathogen Readiness (MASS CPR).
Identifiants
pubmed: 32838351
doi: 10.1016/j.medj.2020.05.001
pii: S2666-6340(20)30003-9
pmc: PMC7235561
doi:
Types de publication
Journal Article
Research Support, N.I.H., Extramural
Langues
eng
Pagination
152-157.e3Subventions
Organisme : NHLBI NIH HHS
ID : R01 HL133350
Pays : United States
Commentaires et corrections
Type : CommentIn
Informations de copyright
© 2020 Elsevier Inc.
Déclaration de conflit d'intérêts
The authors declare no competing interests.
Références
JAMA. 2020 Mar 17;323(11):1061-1069
pubmed: 32031570
N Engl J Med. 2020 Mar 19;382(12):1177-1179
pubmed: 32074444
JAMA. 2020 Apr 21;323(15):1437-1438
pubmed: 32150622
JAMA. 2020 May 12;323(18):1843-1844
pubmed: 32159775