The Central Research Institute of Epidemiology within Rospotrebnadzor has announced the world’s first isothermal test, AmpliSens SC2-IT, designed to minimize false negatives in detecting coronavirus. This development marks a milestone in rapid viral diagnostics and comes from a national lab program focused on robust, domestic testing solutions.
Unlike many LAMP-based systems that scan a single genomic region, this test targets two separate, relatively stable regions of the SARS-CoV-2 genome. By focusing on regions of the S gene that show low variability, AmpliSens SC2-IT increases the likelihood of successful detection even when the virus undergoes mutation. If one region mutates, the second region can still indicate the presence of the virus, creating a built-in redundancy that strengthens overall test reliability.
Officials say the dual-target approach not only maintains a high sensitivity but also substantially reduces the chance of a false negative result. In practice, this means laboratories can have greater confidence in negative findings when clinical symptoms point to infection, potentially shortening the time to appropriate patient management decisions.
Results from the test are obtainable within roughly 20 to 25 minutes, providing a rapid alternative to conventional PCR workflows. This speed, combined with strong specificity, supports quick triage and timely intervention in clinical settings and public health surveillance alike. The test has been fully calibrated for use within Russia’s existing laboratory diagnostic framework, with all components manufactured at the Central Research Institute of Epidemiology. This domestic production capability helps ensure supply stability and reduces dependence on international materials, reinforcing the country’s capacity to sustain testing efforts for the population.
Earlier announcements highlighted parallel progress from the Rospotrebnadzor Pasteur Research Institute, which introduced a diagnostic system capable of detecting the hepatitis B virus even at very low viral loads. The ability to identify infection under conditions where standard methods may fail can be critical for early intervention and protecting liver health during chronic infection.
Overall, the introduction of the AmpliSens SC2-IT test represents a significant step in advancing rapid, reliable viral detection within national laboratories. By leveraging dual-target isothermal chemistry, the approach aligns with modern diagnostic goals: fast results, robust performance in the face of viral evolution, and independent supply chains that strengthen public health readiness for current and future outbreaks.