Respiratory Infections
Respiratory diseases remain the world’s most deadly communicable disease1. While most respiratory infections can resolve on their own, some infections, such as COVID-19 disease can be a serious threat for infants, the elderly, and the immunocompromised.
1. The top 10 causes of death (who.int)
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Background
Since the start of the COVID-19 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 remain important.
Traditional PCR tests performed in a central lab are very accurate, but take a considerable time to complete, and rapid antigen tests are fast but lack sensitivity and accuracy2.
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 ICUs /ED settings in hospitals etc.
2. Lee J, Song JU, Shim SR. Comparing the diagnostic accuracy of rapid antigen detection tests to real time polymerase chain reaction in the diagnosis of SARS-CoV-2 infection: A systematic review and meta-analysis. J Clin Virol. 2021;144:104985. doi:10.1016/j.jcv.2021.104985
Our Solution
PCR test delivering accurate results in less than 20 minutes.
Enabled by its silicon chip technology, our ultra-fast COVID-19 PCR Test combines the speed of a rapid antigen test with the performance of trusted PCR-based testing.
Within 20 minutes of registering on site, patients receive their result, with the real-time PCR itself taking less than 12 minutes.
The clinical performance study in Europe has demonstrated that the miDiagnosticsTM COVID-19 Test is highly sensitive (95,5%) and specific (94,9%) in the general population, rising to 98.6% and 96.5% respectively in symptomatic patients3.
miDiagnosticsTM COVID-19 Test is CE-IVD marked and recently gained CTDA approval. It is not FDA-cleared. The test is for professional use only.
3. Bos DAG, Lagrou K, Verbakel JY. Prospective Performance Evaluation of the miDiagnostics COVID-19 PCR Test for Rapid SARS-CoV-2 Detection on Nasopharyngeal Swabs. J Clin Microbiol. 2023;61(5):e0187122. doi:10.1128/jcm.01871-22
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 performs the temperature cycling and optical detection, processes data and communicates the test result.
Key Benefits.
Unique silicon chip technology allowing for ultra-fast PCR
Closed reaction chamber limits risk of contamination
High clinical performance with 98% accuracy
Customer documentation
“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. ”
