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

Autor:	Regev-Yochay G; Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel.; Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel., Kriger O; Clinical Microbiology, Sheba Medical Center, Ramat-Gan, Israel., Mina MJ; Harvard Chan School of Public Health, Harvard, Boston, MA, USA., Beni S; Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel., Rubin C; Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel., Mechnik B; Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel., Hason S; Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel., Biber E; Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel., Nadaf B; Infection Prevention & Control Unit, Sheba Medical Center, Ramat-Gan, Israel., Kreiss Y; Sackler School of Medicine, Tel Aviv University, Tel-Aviv, Israel.; Central Management, Sheba Medical Center, Ramat-Gan, Israel., Amit S; Clinical Microbiology, Sheba Medical Center, Ramat-Gan, Israel.
Jazyk:	angličtina
Zdroj:	Infection control and hospital epidemiology [Infect Control Hosp Epidemiol] 2022 Mar 02, pp. 1-20. Date of Electronic Publication: 2022 Mar 02.
DOI:	10.1017/ice.2022.3
Abstrakt:	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.
Databáze:	MEDLINE
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