Fraunhofer IBMT’s mobile epidemiological laboratory (epiLab), designed in cooperation with vehicle manufacturer Bischoff & Scheck within the project “Labor-der-Zukunft - Laboratory of the Future”, is in use these days for nationwide early detection and prevention of SARS-CoV-2-infections within nursing homes in the county of Saarland. So the Fraunhofer expertise supports essentially the fight against the world wide Corona pandemic. The necessary consumable materials are supplied by the Fraunhofer-internal Anti-Corona-fund.

The highly specified Fraunhofer epiLab started its mission on April 21^st, 2020 within a remarkable network consisting of university clinic and institutes through the county of Saarland. Fraunhofer IBMT contributes his long-time biotechnological experience against SARS-CoV-2 and makes a significant contribution within a consortium supported by the Saarland Ministry of Social Affairs, Health, Families and Women testing on SARS-CoV-2-infections within nursery homes in Saarland. The Institute of Virology of the University Clinic in Homburg, the Blood Donor Centre Saar-Palatinate on Winterberg, the Helmholtz-Institute for Pharmaceutical Research Saarland (HIPS), the State Agency of Consumer Protection and the Fraunhofer Institute for Biomedical Engineering IBMT are testing with a pooling method selected nursery homes in Saarland.

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 testing, cryopreservation 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.

In 80% of all cases, SARS-CoV-2-infections proceed in a mild or non-severe manner. The risk for a severe or deadly procedure increases strongly with age as further risk factors by pre-existing illness accrue. The part of over-sixties adds to about a fourth of all affected patients in Germany, 86% of COVID-19 deaths were 70 years or older. The most endangered circle are over 80 year old persons, here the highest mortality rates are observed. With increasing age, many of these high-risk patients are hosted in nursery homes. In Saarland e. g. approximately 50% of the deaths belong to this group of persons.

Therefore, a complete screening of all nursery institutions is urgent. Though, enough validated virus-genome based tests are not available. A pool testing with subsequent single testing can produce relief. Beside the conservation of resources, the validation of antibody-based test is also of particular significance: hereby, recovered and virus-free
serum converter are detected, which are protected from a new infection by their own immune system. This circle of persons is very important in the health and nursery system.

Fraunhofer expertise supports pool testings

The Fraunhofer Institute for Biomedical Engineering IBMT, as part of the Saarland project team, is in charge with two Proof-of-Concept studies in cooperation with the Institute of Virology (Saarland University Clinic) and the Saarland government. On one side with pooling the samples to save resources of SARS-CoV-2-tests (savings of costs and lack of availability of tests). In case the pool is positive, this pool will be dissolved and each sample will be tested individually. The higher the positive rate, the higher the amount of pools which have to be tested further. Therefore, this screening approach is all the more favourable and preventive, the earlier it starts as the prevalence of the infection increases in time. Therefore, samples of all persons will be taken by medical staff trained for sample testing. The generation of the pools is taking place in the laboratories of Fraunhofer IBMT as well as on site in the Fraunhofer’s mobile laboratory (epiLab). Within 24 hours after the sample taking, the samples will be sent for analysis to authorised diagnostic laboratories and checked. Only samples in positive pools will be checked further on single-person level. The validation of antibody-quick-tests will be carried out on recovered persons identified by single testings, which are not any more infective.
 

 
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 working group is also certified according to DIN EN ISO 9001:2015 and additionally the epiLab is 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.