Evaluation of the Roche-SD Biosensor rapid antigen test: Antigen is not reliable in detecting SARS-CoV-2 at the early stage of infection with respiratory symptoms

Abstract

We evaluated a rapid antigen test against SARS-CoV-2 virus (Roche-SD Biosensor; RSDB-RAT) in children and adults with respiratory symptoms compared to those with non-respiratory symptoms or asymptomatic. Also the performance of RSDB-RAT with respect to the duration of respiratory symptoms was assessed. A viral cross-reactivity panel was included. RSDB-RAT was reliable in detecting SARS-CoV-2 in children and adults if the respiratory symptoms had endured 1-7 days. If the respiratory symptoms had lasted less than 1 day, the sensitivity was significantly lower. No cross-reactivity with other respiratory viruses was observed.

Evaluation of the new 2.0 version of the Roche SARS-CoV-2 Rapid Antigen Test

“…We have earlier evaluated the old Roche Diagnostics SARS-CoV-2 RAT version with the same study setting, and we can observe that the RAT version 2.0 seems to be even more sensitive and specific than the old version, as shown in Table 1 ( Flinck et al, 2022 ). The new and the old RAT versions were not compared in parallel in this study due to scanty residual samples, which is a limitation of this study.…”

“…All NAAT positive samples were reactive for both targets. **Only the adult (age ≥15 years) cases (N = 154) were included from the data earlier published by Flinck et al (2022) . When evaluating the samples with NAAT Ct values ≤30 , only the results obtained by Cobas® SARS-CoV-2 NAAT were included (N = 63, of which Ct value was ≤30 in 58); CI, 95% confidence interval.…”

Can variants, reinfection, symptoms and test types affect COVID-19 diagnostic performance? A large-scale retrospective study of AG-RDTs during circulation of Delta and Omicron variants, Czechia, December 2021 to February 2022

“…An explanation is that test results in individuals infected with the Omicron variant are positive for a shorter period of time than in those infected with the Delta variant [16]. In data collected in 2020, the risk of a false negative AG-RDT result was elevated when testing at an early stage of infection [17]. Our results based on field data show that antigen tests may be even less reliable at an early stage of an Omicron infection, supporting earlier analytical results of lower sensitivity for Omicron in asymptomatic individuals and during the early symptomatic period [18].…”

Efficiency analysis of rapid antigen test based SARS-CoV-2 in hospital contact tracing and screening regime: test characteristics and cost effectiveness

“…When integrated into a tailored infection control strategy, RATs have been shown to facilitate swift identification and isolation of individuals infected with SARS-CoV-2 [ 25 , 26 ]. However, their effectiveness in screening asymptomatic individuals remains uncertain [ 27 , 28 ].…”