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.
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miDiagnostics is introducing a COVID-19 PCR real-time molecular test – the current gold standard in functionality without compromise of accuracy.
A powerful tool for pandemic management.
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 disposable PCR card, and processed in a compact reader that performs ultra-fast temperature cycling and optical detection. The risk of cross-contamination and is minimized thanks to the one-time use of the disposable PCR card per patient.
Menu can be expanded towards other respiratory indications, sexual transmitted diseases and any other molecular test that could merit the benefits of decentralization, diagnostic accuracy, and ease of use
How it works
How it works.
Swab Sample
Validated for use with nasopharyngeal and oropharyngeal dry swabs.
PCR Card
A small volume of the sample (5µl) is placed on the disposable PCR Card containing the silicon chip.
Reader
The multiple use, portable reader reads the PCR Card, processes data and communicates the test result.
Key Benefits
Unique silicon chip technology allowing for ultra-fast PCR
Viral inactivation and closed reaction chamber limits risk of contamination and cross-infection
High clinical performance with 98% accuracy
“miDiagnostics has the potential to disrupt and transform the industry by making diagnostic information available to clinician and patient alike.”
“Its easy-to-use and cost-efficient test will revolutionize point-of-care testing by directly engaging with patients and enabling speedy intervention.”
“Proud to be leading a top team and together with our numerous partners to make a significant contribution to healthcare in general.”
“As a Non-Executive Director on miDiagnostics’ Board, I have been privileged to witness its continued development. I am very proud to see many years of hard work coming to fruition and providing value, facilitating the return to a normal way of life, with potential to move high quality testing closer to the patient.”
“This technology could aid the management of outbreaks in challenging settings, such as nursing homes and home care environments, allowing healthcare professionals to adjust their management decisions at the point of care. ”
