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Accepted manuscript

Real World Performance of SARS-CoV-2 Antigen Rapid Diagnostic Tests in Various Clinical Settings

Published online by Cambridge University Press:  02 March 2022

Gili Regev-Yochay*
Affiliation:
Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel
Or Kriger
Affiliation:
Clinical Microbiology, Sheba Medical Center, Ramat-Gan, Israel
Michael J. Mina
Affiliation:
Harvard Chan School of Public Health, Harvard, Boston, MA, USA
Sharon Beni
Affiliation:
Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel
Carmit Rubin
Affiliation:
Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel
Bella Mechnik
Affiliation:
Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel
Sabrina Hason
Affiliation:
Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel
Elad Biber
Affiliation:
Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel
Bian Nadaf
Affiliation:
Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel
Yitshak Kreiss
Affiliation:
Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel Central Management, Sheba Medical Center, Ramat-Gan, Israel
Sharon Amit
Affiliation:
Clinical Microbiology, Sheba Medical Center, Ramat-Gan, Israel
*
Corresponding author: Gili Regev-Yochay, Bitan 16, Sheba Medical Center, Tel-Hashomer, Ramat-Gan, Israel, Tel: 972-3-5303372 email: gili.regev@sheba.health.gov.il

Abstract

Objective:

To assess the validity of Antigen rapid diagnostic tests (Ag-RDT) for SARS-CoV-2 as decision support tool in various hospital-based clinical settings.

Design:

Retrospective cohort study among symptomatic and asymptomatic patients and Healthcare workers (HCW).

Setting:

A large tertiary teaching medical center serving as a major COVID-19 hospitalizing facility.

Participants and Methods:

Ag-RDTs’ performance was assessed in three clinical settings: 1. Symptomatic patients and HCW presenting at the Emergency Departments 2. Asymptomatic patients screened upon hospitalization 3. HCW of all sectors tested at the HCW clinic following exposure.

Results:

We obtained 5172 samples from 4595 individuals, who had both Ag-RDT and quantitative real-time PCR (qRT-PCR) results available. Of these, 485 samples were positive by qRT-PCR. The positive percent agreement (PPA) of Ag-RDT was greater for lower cycle threshold (Ct) values, reaching 93% in cases where Ct-value was <25 and 85% where Ct-value was <30. PPA was similar between symptomatic and asymptomatic individuals. We observed a significant correlation between Ct-value and time from infection onset (p<0.001).

Conclusions:

Ag-RDT are highly sensitive to the infectious stage of COVID-19 manifested by either high viral load (lower Ct) or proximity to infection, whether patient is symptomatic or asymptomatic. Thus, this simple-to-use and inexpensive detection method can be used as a decision support tool in various in-hospital clinical settings, assisting patient flow and maintaining sufficient hospital staffing.

Type
Original Article
Copyright
© 2022 by The Society for Healthcare Epidemiology of America. All rights reserved.

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