LAUSR

Respiratory syncytial virus (RSV) is the most important virus that causes lower respiratory tract disease in children; efficient viral identification is an important component of disease prevention and treatment. Here, we developed and evaluated a ready‐to‐use (RTU) nucleic acid extraction‐free direct reagent for identification of RSV (RTU‐Direct test) in clinical samples. The limit of detection (LOD) of the RSV RTU‐Direct test was consistent with the LOD of the standard test using extracted nucleic acids. The virus inactivation ability of RTU‐Direct reagent was confirmed by viral infectivity assays involving RTU‐Direct‐treated samples containing RSV and human coronavirus OC43. RSV RNA stability was significantly better in RTU‐Direct reagent than in conventional virus transport medium (VTM) at room temperature and 4°C (p < 0.05). The clinical performance of the RTU‐Direct test was evaluated using 155 respiratory specimens from patients with suspected RSV infection. Positive agreement between the RTU‐Direct test and the VTM standard test was 100% (42/42); negative agreement was 99.1% (112/113), and the kappa statistic was 0.968 (p < 0.001). The distributions of Ct values did not significantly differ between the RTU‐Direct test and the standard test (p > 0.05). Overall, the RTU‐Direct reagent can improve the efficiency and biosafety of RSV detection, while reducing the cost of detection.