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Laboratory diagnostics

"Molecular tests are pivotal in combating the COVID-19 pandemic"

6min
Published on October 28, 2020

The central laboratory of the Niels-Stensen-Kliniken group in Osnabrück wasted no time in setting up its own test facilities for the molecular detection of SARS-CoV-2. We spoke with Michael Erren, MD, Head of the Institute for Laboratory Medicine about his strategy and the importance of diagnostic molecular testing in fighting the pandemic.

Michael Erren, MD, head of the Institute for Laboratory Medicine in Osnabrück.
The automated VERSANT kPCR extraction module.
Michael Erren, MD, evaluates the analysis results for SARS-CoV-2 using the amplification and detection module of the PCR device.

  1. 1 CE-IVD labeled for diagnostic use in the EU. This instrument has not been FDA cleared or approved. This instrument has been authorized by the FDA under an EUA for use by authorized laboratories. This instrument has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This instrument is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner. Product availability varies by country and is subject to local regulatory requirements. The customer is responsible for validating the assay on instruments not listed in the kit’s “Instructions for Use”.

    The VERSANT® kPCR Molecular System AD is a QuantStudio™ 5 Dx real-time thermocycler (originally supplied by ThermoFisher) modified to run the MiPLX Software Solution (Siemens Healthineers).

    VERSANT and all associated marks are trademarks of Siemens Healthcare Diagnostics Inc., or its affiliates. All other trademarks and brands are the property of their respective owners.

  2. 2 CE-IVD labelled for diagnostic use in the EU. This test has not been FDA cleared or approved. This test has been authorized by the FDA under an EUA for use by authorized laboratories. This test has been authorized only for the detection of nucleic acid from SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics for the detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21. U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

  3. 3 For research use only in the USA. Product availability may vary from country to country and is subject to varying regulatory requirements. Please contact your local representative for availability.

    The statements by Siemens Healthineers customers described herein are based on results that were achieved in the customer’s unique setting. Since there is no “typical” hospital and many variables exist (e.g., hospital size, case mix, level of IT adoption) there can be no guarantee that other customers will achieve the same results.