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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.
Mack, Christina D; Wasserman, Erin B; Hostler, Christopher J; Solomon, Gary; Anderson, Deverick J; Walton, Patti; Hawaldar, Kalyani; Myers, Emily; Best, Michele; Eichner, Daniel; Mayer, Thom; Sills, Allen.
  • Mack CD; Real World Solutions, IQVIA, Durham, North Carolina, USA.
  • Wasserman EB; Real World Solutions, IQVIA, Durham, North Carolina, USA.
  • Hostler CJ; Duke Center for Antimicrobial Stewardship and Infection Prevention, Duke University School of Medicine, Durham, North Carolina, USA.
  • Solomon G; Infectious Diseases Section, Durham VA Health Care System, Durham, North Carolina, USA.
  • Anderson DJ; Infection Control Education for Major Sports, LLC, Chapel Hill, North Carolina, USA.
  • Walton P; Player Health and Safety Department, National Football League, New York City, New York, USA.
  • Hawaldar K; Duke Center for Antimicrobial Stewardship and Infection Prevention, Duke University School of Medicine, Durham, North Carolina, USA.
  • Myers E; Infection Control Education for Major Sports, LLC, Chapel Hill, North Carolina, USA.
  • Best M; Laboratory Services and Occupational Health, Williamson Medical Center, Franklin, Tennessee, USA.
  • Eichner D; Real World Solutions, IQVIA, Durham, North Carolina, USA.
  • Mayer T; Player Health and Safety Department, National Football League, New York City, New York, USA.
  • Sills A; Department of Pathology, University of Maryland Medical System, Baltimore, Maryland, USA.
Pharmacoepidemiol Drug Saf ; 31(5): 511-518, 2022 05.
Article in English | MEDLINE | ID: covidwho-1777608
ABSTRACT

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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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Humans Language: English Journal: Pharmacoepidemiol Drug Saf Journal subject: Epidemiology / Drug Therapy Year: 2022 Document Type: Article Affiliation country: Pds.5424

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Full text: Available Collection: International databases Database: MEDLINE Main subject: COVID-19 Type of study: Diagnostic study / Experimental Studies / Observational study / Prognostic study Limits: Humans Language: English Journal: Pharmacoepidemiol Drug Saf Journal subject: Epidemiology / Drug Therapy Year: 2022 Document Type: Article Affiliation country: Pds.5424