miDiagnostics launches its CE-IVD certified ultra-fast COVID-19 PCR Test
The Test is now available for use across Europe and other countries that accept CE-IVD marking, providing a powerful pandemic and endemic management tool in industries where fast and reliable decentralized testing is crucial. With the launch of its first product, miDiagnostics enters the commercial phase, marking an important milestone in the company’s development.
Ultra-fast and reliable COVID testing on a micro-chip
miDiagnostics’ COVID-19 PCR Test is based on unique silicon chip technology from imec (Leuven, Belgium) and developed in close collaboration with Johns Hopkins University. The miniaturization of the RT-qPCR process makes it possible to diagnose COVID-19 infections with the accuracy, sensitivity, and reproducibility of a traditional PCR test, but with the convenience and speed of an antigen test. Within 30 minutes of registering on site, patients receive their result, with the real-time PCR itself taking less than 15 minutes.
The test’s workflow is extremely simple: after a nasopharyngeal swab, the sample is dissolved in a buffer solution, mixed with detection mix, loaded onto a PCR card, and processed in a compact reader that performs ultra-fast temperature cycling and optical detection. The risk of cross-contamination is minimized thanks to the use of disposable PCR cards.
The performance of the new ultra-fast PCR Test was confirmed in a large independent clinical study, led by Prof. Dr. Jan Verbakel of KU Leuven (Belgium). A total of 766 study subjects were tested for SARS-CoV-2 with both miDiagnostics’ Test and a traditional RT-PCR used in a centralized setting. Over 300 of these subjects were found to be SARS-CoV-2 positive, representing a broad range of viral loads (expressed as the Ct or “cycle threshold” value of the test). miDiagnostics’ Test showed excellent equivalence with the results obtained from the reference method.
A powerful tool for pandemic management
Since the start of the pandemic, testing has proven to be key to enabling restrictions to be eased. Even entering the endemic phase, routine testing and surveillance for SARS-CoV-2 will remain important. Traditional PCR tests performed in a central lab are very accurate, but take a long time to complete, and rapid antigen tests are fast but lack sensitivity and accuracy. This has driven the demand for rapid decentralized PCR testing, performed in satellite laboratories at the point of care or in locations where there is a need for on-demand testing, like airports, large corporations, UCI / ED settings in hospitals etc.
The current CE-IVD marking means miDiagnostics’ COVID-19 Test is now available for use by lab professionals in all countries that accept CE-IVD. Its optimized workflow, compact design, and ultra-fast and reliable results make it optimally suited for use in a decentralized testing approach. For example, its added value in the travel sector was demonstrated recently in the successful pilot study performed at Brussels Airport.