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.
引用
收藏
页码:511 / 518
页数:8
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