Hostname: page-component-586b7cd67f-2plfb Total loading time: 0 Render date: 2024-11-25T21:31:53.771Z Has data issue: false hasContentIssue false
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: [email protected]

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.

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)