Rapid on-site testing in the context of time-critical pandemic events: Mobile units and safety laboratories

The corona pandemic situation poses the greatest challenges for employers both now and in the future. They bear the corporate and human responsibility for the health and jobs of their employees.

At the same time, they must ensure the long-term survival of their companies with the productivity that is essential for this. The ability to detect and prevent the unnoticed spread of the SARS-CoV-2 infection within their own company at a very early stage is therefore of the utmost importance.

With the highly specialized Fraunhofer epiLab, the Fraunhofer IBMT has already contributed its many years of biotechnological experience in several deployments for current use against the SARS-CoV-2 virus.

Following the pooling of PCR tests for SARS-CoV-2 infections carried out in April and May 2020 in senior citizen and nursing homes in the Saarland, all Fraunhofer IBMT employees were able to voluntarily test for SARS-CoV-2 antibodies directly in the mobile laboratory at their workplace at the end of May 2020 and beginning of June 2020.

The Bischoff & Scheck AG, Rheinmünster, Germany, now also offers its employees a voluntary test for SARS-CoV-2 antibodies on June 18, 2020. In cooperation with a physician in private practice, the tests can be carried out in the mobile epidemiological laboratory (epiLab) directly in the company, so to speak, and of course in a targeted and highly efficient manner, taking into account the applicable hygiene regulations.

The test persons enter the mobile epiLab after hand disinfection with a mouth/nose protection. There, they only have to stretch their hand through a lock system into the laboratory section, where the medical staff takes a drop of blood from their finger and places it on the test cassette of the antibody test kit. The test persons then leave the epiLab through the rear exit of the mobile laboratory, thus ensuring a “one-way street” system.

Within only 20 minutes, the test detects the immunoglobulins IgM and IgG, which are found in the blood of the affected persons in case of an infection with the corona virus.

Thus, an acute or previous infection with SARS-CoV-2 can be detected and direct measures such as PCR testing and further serological tests can be initiated. The gain in time and information can thus, under certain circumstances, cushion or mitigate external interventions in companies and institutions.

Mobile safety laboratories – a speciality of Fraunhofer researchers

The mobile epiLab was developed originally within the project “Labor-der-Zukunft – Laboratory of the Future” funded by the government of Saarland. The maintenance of the epiLab is co-financed by the Federal Agency of Environment by the execution of sampling for the project “Environmental Specimen Bank – Human Samples”.

Since nine years now it is travelling, collecting samples for the Federal Agency of Environment. The staff was trained in the past in professional handling of high-infectious sample material during a project for vaccine development against viruses (“Global HIV Vaccine Research Cryorepository (GHRC)”) which was funded by the Bill & Melinda Gates Foundation within the “Collaboration of AIDS Vaccine Discovery (CAVD)”, attracting highly international attention.

The IBMT epiLab consists of separated areas for test passenger services (20 sqm) with one-way route guidance, a fully equipped sample taking and testing laboratory area (16 sqm) under biological security level S2 (according to BioStoffV) with personnel air lock and separated cryostorage area for immediate processing of the taken samples, performance of (here) SARS-CoV-2 antibody testing, cryopreservation if applicable and archiving of the collected samples.

So tested subject groups and medical staff during the sample taking and research personnel are separated completely by personnel air lock and the risk of infection during the sample taking is reduced to a minimum. Beside the guarantee for a safe sample taking, the epiLab is furthermore completely and functionally equipped for the generation of the pools and the execution of the antibody tests on-site.

After successful completion of this special project, established study protocols can easily be transferred to German-wide or world-wide high-throughput testings. Especially the usage and validation of the epiLab for completion of pool tests and quick tests permits a wide-range testing in countries or regions without laboratory infrastructure.

 
Background-information to Fraunhofer IBMT expertise

Beside the expertise in the development of mobile laboratory units for use in the field of biomonitoring and the collection of primary human sample material – also infective patient samples – Fraunhofer IBMT has available a highly qualified pool of staff to carry out Proof-of-Concept-studies in a short time.

In the main department “Medical Biotechnology” under the leadership of the virologist Prof. Dr. Hagen von Briesen the working group “Cellular Bioprocessing” is established. Since many years advanced platforms for collecting, preparing, conserving and distributing bioreagents and clinical samples for world-wide networks are being developed there.

This includes optimized processes of sample development and reconditioning and their cryopreservation. In this context a global HIV-cryorepository with safety level S3 has been established at Fraunhofer IBMT during the global initiative for development of an HIV-vaccine (Collaboration for AIDS Vaccine Discovery – CAVD) which is financially supported by the Bill & Melinda Gates foundation and the Saarland government.

The laboratory areas and the attached cryobank for bioreagents are subject to a certified quality assurance programme which controls the activities according to the guidelines of GCLP (Good Clinical Laboratory Practice) and DIN EN ISO 9001:2015. Here, HIV-1-pseudo-viruses and infectious molecular HIV-1-clones are produced or cell-based tests as neutralisation and immune assays are carried out. Also, cell-based assays are developed, optimised and validated here.

Thereby, the main department “Medical Biotechnology” offers a platform for further development and clinical testing of new diagnostics, vaccines and new therapies. Furthermore, the governments “Environmental Specimen Bank – human samples” is established within the working group “Biomonitoring & Biobanks”.

Since years Fraunhofer’s mobile laboratory is called into action there for the regular German-wide collection of human primary material. The laboratories of this working group is also certified according to DIN EN ISO 9001:2015 and additionally the epiLab are accredited according to DIN EN ISO/IEC 17025 for controlling in the field of “health care – medical laboratory examinations within the context of medical studies.

Dipl.-Betriebswirt (FH) Markus Michel
Head of Business Area Laboratory Technology
Fraunhofer-Institut für Biomedizinische Technik IBMT
Joseph-von-Fraunhofer-Weg 1
66280 Sulzbach, Germany
Phone +49 6897 9071-111
markus.michel@ibmt.fraunhofer.de