The Finnish molecular diagnostics company announced it has received CE-IVD markings for its Novodiag Covid-19 and Amplidiag Covid-19 molecular diagnostic tests for the early detection of the SARS-CoV-2 virus.
These tests complement Mobidiag’s already available antibody test, Anti-SARS-CoV-2 Rapid Test, that the company is distributing from its joint venture partner in China, Autobio Diagnostics. Mobidiag said it is now able to commercially offer a comprehensive diagnostic solution for novel coronavirus infections for hospital and lab based settings and that, due to the high demand for diagnostic devices and tests globally, the company has ensured that its supply chain and manufacturing capabilities “are robust” and able to support its customers. This includes the sourcing and acquisition of various consumables to cover the complete workflow from sample collection to the results, such as inhouse production of enzymes and the development of our proprietary mNAT Medium sample buffer and collection tubes.
The Novodiag Covid-19 and Amplidiag Covid-19 molecular diagnostic tests are claimed to be able to rapidly and reliably detect Covid-19 infections at an early stage in patients with signs and symptoms of respiratory infection. They have already been granted emergency use authorisation in Finland, Sweden and France. Mobidiag said the tests have been designed using dual targets of SARS-CoV-2 (orf1ab & N genes) to include at least one conserved region and one specific region to mitigate the effects of genetic drift and avoid cross-reaction with other endemic coronaviruses.
The Novodiag Covid-19 assay is said to allow qualitative determination of SARS-CoV-2 (orf1ab and N genes) directly from nasopharyngeal swabs; the test operates using the Novodiag rapid ‘sample-in, result-out’ system, allowing the on demand fully automated detection of Covid-19 in approximately one hour. The Amplidiag Covid-19 assay complements the former on demand test. According to the company, based on well-established high-throughput qualitative PCR technology, 48 samples can be processed in less than three hours while running on Mobidiag’s Amplidiag Easy platform, which enables to clinicians an optimised sample screening process with automated DNA/RNA extraction and PCR plate setup.
In addition to these molecular tests, Mobidiag said it is distributing an antibody test allowing qualitative determination of Anti-SARS-CoV-2 (IgG and IgM antibodies of SARS-CoV-2) in human serum, plasma or whole blood in less than 15 minutes without any instrumentation. The Anti-SARSCoV-2 Rapid Test is manufactured by Mobidiag’s joint venture partner in China, Autobio Diagnostics.