Mobidiag PCR and Antibody Tests Offer Comprehensive Diagnostic Solution for Detection of Coronavirus

(Espoo, Finland) 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 the company’s already available antibody test, Anti-SARS-CoV-2 Rapid Test that Mobidiag is distributing from its joint venture partner, Autobio Diagnostics Co., Ltd. (Zhengzhou, Henan, China). With this, Mobidiag is now able to commercially offer a comprehensive diagnostic solution for novel coronavirus infections for hospital and lab based settings.

The Novodiag COVID-19 and Amplidiag COVID-19 molecular diagnostic tests are 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 earlier been granted Emergency Use Authorization in Finland, Sweden and France. 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 allows 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. In addition, Novodiag solution is a closed system which ensures the protection of laboratory staff and healthcare professionals from possible contamination. The user-friendly nature of the system means that the Novodiag system can also be used in high risk and hard-to-reach areas and decentralized settings without the need for highly trained personnel.

The Amplidiag COVID-19 assay complements the Novodiag COVID-19 on demand test. 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 optimized sample screening process with automated DNA/RNA extraction and PCR plate setup.

In addition to these molecular tests, Mobidiag 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-SARS-CoV-2 Rapid Test is manufactured by Mobidiag’s joint venture partner, Autobio Diagnostics. Due to the high demand for diagnostic devices and tests globally, Mobidiag has ensured that its supply chain and manufacturing capabilities are robust and able to support its customers. This includes, for example, the sourcing and acquisition of various consumables to cover the complete workflow from sample collection to the results (e.g. in-house production of enzymes and the development of the company’s proprietary mNAT Medium sample buffer and collection tubes).

“With the CE-IVD mark approvals for our Novodiag COVID-19 and Amplidiag COVID-19 molecular diagnostic tests and our distribution of the Anti-SARS-CoV-2 Rapid antibody test, Mobidiag is now able to provide a complete diagnostic solution for the detection of COVID-19 infections across the life cycle of the virus,” said Tuomas Tenkanen, CEO of Mobidiag.