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Effectiveness and use of reverse transcriptase polymerase chain reaction point of care testing in a large-scale COVID-19 surveillance system
被引:5
作者:
Mack, Christina D.
[1
]
Wasserman, Erin B.
[1
]
Hostler, Christopher J.
[2
,3
,4
]
Solomon, Gary
[5
]
Anderson, Deverick J.
[2
,4
]
Walton, Patti
[6
]
Hawaldar, Kalyani
[1
]
Myers, Emily
[5
]
Best, Michele
[7
]
Eichner, Daniel
[8
]
Mayer, Thom
[9
,10
]
Sills, Allen
[5
]
机构:
[1] IQVIA, Real World Solut, Durham, NC USA
[2] Duke Univ, Sch Med, Duke Ctr Antimicrobial Stewardship & Infect Preve, Durham, NC USA
[3] Durham VA Hlth Care Syst, Infect Dis Sect, Durham, NC USA
[4] Infect Control Educ Major Sports LLC, Chapel Hill, NC USA
[5] Natl Football League, Player Hlth & Safety Dept, New York, NY USA
[6] Williamson Med Ctr, Lab Serv & Occupat Hlth, Franklin, TN USA
[7] Univ Maryland Med Syst, Dept Pathol, Baltimore, MD USA
[8] Sports Med Res & Testing Lab, Univ Res Pk, Salt Lake City, UT USA
[9] Duke Univ, Sch Med, Durham, NC USA
[10] Natl Football League Players Assoc, Washington, DC USA
关键词:
agile analytics;
COVID-19;
diagnostic concordance;
diagnostics;
emergency use authorization;
infectious disease surveillance;
point-of-care testing;
real-world data;
real-world evidence;
SARS-CoV-2;
NATIONAL FOOTBALL LEAGUE;
SARS-COV-2;
D O I:
10.1002/pds.5424
中图分类号:
R1 [预防医学、卫生学];
学科分类号:
1004 ;
120402 ;
摘要:
Background Rapid COVID-19 testing platforms can identify infected individuals at the point of care (POC), allowing immediate isolation of infected individuals and reducing the risk of transmission. While lab-based nucleic acid amplification testing (NAAT) is often considered the gold standard to detect SARS-CoV-2 in the community, results typically take 2-7 days to return, rendering POC testing a critical diagnostic tool for infection control. The National Football League (NFL) and NFL Players Association deployed a new POC testing strategy using a newly available reverse transcriptase polymerase chain reaction (RT-PCR) rapid test during the 2020 season, and evaluated diagnostic effectiveness compared to other available devices using real-world population surveillance data. Methods RT-PCR POC test results were compared to NAAT results from same-day samples by calculation of positive and negative concordance. Sensitivity analyses were performed for three subgroups: (1) individuals symptomatic at time of positive test; (2) individuals tested during the pilot phase of rollout; and (3) individuals tested daily. Results Among 4989 same-day POC/NAAT pairs, 4957 (99.4%) were concordant, with 93.1% positive concordance and 99.6% negative concordance. Based on adjudicated case status, the false negative rate was 0.2% and false positive rate was 2.9%. In 43 instances, the immediate turnaround of results by POC allowed isolation of infected individuals 1 day sooner than lab-based testing. Positive/negative concordance in sensitivity analyses were relatively stable. Conclusion RT-PCR POC testing provided timely results that were highly concordant with lab-based NAAT in population surveillance. Expanded use of effective RT-PCR POC can enable rapid isolation of infected individuals and reduce COVID-19 infection in the community.
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页码:511 / 518
页数:8
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