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Pandemic Preparedness Capabilities

Evaluation of a novel rapid diagnostic platform for infectious diseases


PI(s)/Head responsible for the resource:

Mikael Åberg

Host organisation(s):

Uppsala University

Resource description:

Our aims are to evaluate and provide a rapid, high-performance diagnostic platform. This platform, capable of detecting and identifying an active infection, can be utilized either via a user-friendly microfluidic chip or a high-throughput test that does not require instruments. The testing is performed on a nasal swab sample and examined for the presence of one or several viral or bacterial genomes in single- or multiplex. The project capitalizes on our experiences from the recent pandemic and our expertise in padlock probe technology, which is being applied at the point of care for the first time.

Research findings:

During this project, Readily’s product development team has made significant advancements in improving the sensitivity and reliability of the rapid diagnostic test. By increasing the number of padlock probes - key components that help detect specific pathogens - the test’s ability to identify infections with greater accuracy has been enhanced. Each probe has undergone rigorous testing to ensure it precisely detects the intended target, both in laboratory conditions and in real-world clinical samples provided by the KI research partner.

The test has been successfully evaluated for detecting several major respiratory viruses, including SARS-CoV-2, Influenza A (H1 and H3), Influenza B and RSV. This ensures that the platform can provide reliable results across a broad spectrum of respiratory infections.

To streamline production, Readily have tested multiple manufacturing processes, optimizing each reagent used in the molecular detection method. Every component of the test has been refined to ensure seamless production, and batch records have been finalized. A key innovation in the product is the use of dried reagents, which eliminates the need for cold storage and simplifies both transportation and handling for users such as us and KI. The drying process has been thoroughly tested and optimized to maintain test performance.

Looking ahead, the manufacturing processes will continue to improve, aiming to reduce manual steps and enhance scalability. Additionally, Readily is implementing an electronic quality management system (eQMS) in 2025, with the goal of achieving ISO13485 certification in 2026 - a crucial step toward regulatory approval.

A large number of clinical samples have been collected and analyzed using qPCR by the Smed-Sörensen lab, providing valuable data for assessing the analytical performance of the test. The high-throughput version of the testing platform has been ordered and will soon be delivered to SciLifeLab and KI, where further evaluations will be conducted on these samples.

Impact on prepardness for future pandemics:

The platform is designed to support healthcare professionals working directly with patients, clinical staff analyzing test results, individuals conducting at-home testing, and researchers studying respiratory infections or vaccine efficacy. By making rapid, accurate testing more accessible, the aim is to improve disease detection and patient care across various settings.

Contact information:

Mikael Åberg
Researcher
Email: Mikael.Aberg@medsci.uu.se