Sample sets of the National Register., Wolfram Scheible für Nationales Register © Wolfram Scheible für Nationales Register

The National Register Biobank

Sample Collection at the National Register

Significant research results require a reliable and at all times verifiable data and sample basis.

In order to eliminate multiple registration and to enable the performance of long-term studies, the National Register collects data and samples in an individual-related way. It is based on a procedure that has been reviewed in terms of data protection laws. The biosample database, i.e. BDAT-DB, of the National Register for Congenital Heart Defects exclusively includes sample-specific data. Data are entered into the BDAT-DB via web-based forms. All available sample-specific data such as date of entry, date of release, number, concentration, sample quality etc. are recorded.

Samples and Sample Collection

  • Blood and Saliva Samples for DNA Extraction

    Two Ways

    Taking of a saliva sample © | Dmitry Lobanov
    Taking of a saliva sample

    The Register collects samples from single patients, so-called “trios” (patient plus birth parents) and from single families with an accumulation of congenital heart disease. There are two ways of sample collection:

    • Type A for collecting samples from patients who are already registered in the Register, as well as for collecting samples from patients’ family members
      Patients or, in the case of minors, patients’ legal guardians are contacted and receive an informed consent form. Individuals who have consented to participate receive an individual-related sample collection set and an envelope for sending the samples to the laboratory. Saliva samples can be taken by the participants themselves.
    • Type B for collecting samples from patients (and relatives, if applicable) who do not yet participate in the register
      Cooperating clinics and pediatric cardiologists in private practice receive a “blanco sample set” (for taking both blood and saliva samples) from the National Register. These include barcoded sample containers with sample information sheets and informed consent forms, which are linked by an interim code. If a test person consents samples are taken during a medically indicated examination. The signed informed consent forms and the medical data (medical reports, findings, surgical reports) are sent to the National Register. Samples and informed consent forms can be reassigned by the Register administration at a later time.

    Using postpaid boxes (corresponding to standard P650), the treating physician, or the hospital, sends EDTA monovettes without cooling measures by mail to the sample laboratory. Sample sets are sent to the laboratory without cooling by the hospital or cardiologist (type B) or directly by the patient (type A), using standard mail.

  • Plasma, Serum and RNA Samples

    Asservation to the Highest Standards

    Control monitor on a sample fridge of the Central Biobank Charité (ZeBanC). © Wolfram Scheible für Nationales Register
    Control monitor on a sample fridge of the Central Biobank Charité (ZeBanC).

    Specific sample sets are compiled for the collection of plasma, serum and RNA and provided to the participating clinics. The processing steps meet current standards. For this purpose, binding standard operating procedures (SOPs) and workflows are defined and adjusted where necessary. The samples or aliquots of the samples are stored at minus 80 degrees Celsius by the participating clinics.

  • Tissue Samples

    Residual Material from Heart Surgery and Catheter Biopsies

    Staff members of the ZeBanC while filling a nitrogen tank. © Wolfram Scheible für Nationales Register
    Staff members of the ZeBanC while filling a nitrogen tank.

    In many cases, cardiac surgery yields residual tissue that has to be removed for the surgical procedure. Usually this residual material is disposed of. Residual material can also result from evaluations of catheter biopsies. Such samples are asservated in order to perform studies on subjects such as cardiac gene expression. This requires written informed consent by patients of legal age or, in the case of minors, by the legal guardians.

    Once taken, the samples are either quick-freezed in liquid nitrogen and then stored in either cryotanks (N2 gas phase, minus 160 degrees Celsius) or minus 80 degrees Celsius freezers. Alternatively, they are fixated in formalin and embedded in paraffin.

    In the case of cryo storage, tanks, freezers or trunks have to be equipped with monitoring systems (alarms, temperature control and temperature recording). The National Register Study Management supports clinics with setting up the infrastructure and with establishing the required cold chain (transport from the surgery to the storage tank, sorting and eliminating of samples). The National Register Study Management reviews the adherence to SOPs and workflows within the scope of regular on-site visits.

    Participating clinics are provided with specific sample sets for the collection of tissue samples by the National Register Study Management. These include the required informed consent forms, as well as barcoded cryo vessels and sample information sheets. All participating institutions are provided with online access to the BDAT-DB.


Informed Consent of Sample Donors

The collection and processing of biosamples according to the highest standards for your research project requires the sample donors’ written informed consent.

Central Sample Processing

Head of Research PD rer. nat. Thomas Pickardt talking to colleagues from the ZeBanC. © Wolfram Scheible für Nationales Register
Head of Research PD rer. nat. Thomas Pickardt talking to colleagues from the ZeBanC.

For blood sample processing, as well as the extraction and storage of DNA samples, the Register collaborates with the Central Biobank Charité, Berlin, headed by Prof. Dr. med. Michael Hummel. Data such as the date of arrival, date of processing, quality and volume/concentration, transfer of aliquots to research institutions etc. are documented and electronically recorded there, while continuously being entered into the National Register’s database.

Robot-assisted DNA extraction © Wolfram Scheible für Nationales Register
Robot-assisted DNA extraction

The processing and storage of samples at the ZeBanC is based on a contract compliant with the Federal Data Protection Act (§ 11 Collection, processing or use of individual-related data by order). Staff members of the laboratory do not have access to the samples. Neither the samples’ origin (identifying data) nor the phenotype (medical data) is known to them. It is the National Register’s sole responsibility to control the samples’ use. For the DNA extraction from EDTA blood or saliva, an automated procedure (Promega/Tecan) is usually used. DNA samples are aliquoted and stored at minus 20 degrees Celsius.

Current Sample Inventory

Interested researchers can check the current overview to find out if and to what extend the available sample collections and their phenotypic properties correspond with their research objectives. This overview is based on our IDAT, MDAT and BDAT databases. Data are presented in anonymous form. No conclusions about the samples’ origin or sample donors’ identity can be drawn.

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