Pre-donation blood bag system containing an anticoagulant, and a blood bag system including the pre-donation blood bag system

Abstract

The present invention relates to a pre-donation blood bag system including a pre-donation blood bag filled with whole blood when blood is taken out, an anticoagulant added to the whole blood in the pre-donation blood bag, and a sample container automatically filled with whole blood from the pre-donation blood bag only at a laboratory for blood analysis. The pre-donation blood bag system is part of a blood bag system. The present invention also relates to a corresponding method for taking out blood by the pre-donation blood bag system and a corresponding method for analyzing the whole blood of each donor.

Description

Technical Field

[0001] The present invention relates to a pre-donation blood bag system including a pre-donation blood bag for filling whole blood during blood collection, wherein filling whole blood from the pre-donation blood bag into a sample container for blood analysis can occur only within a laboratory and not at the blood donation site, and an anticoagulant is added to the whole blood in the pre-donation blood bag. The pre-donation blood bag system is part of a blood bag system. Furthermore, corresponding methods for blood collection using the pre-donation blood bag system and corresponding methods for analyzing the whole blood of each donor are proposed.

Background Art

[0002] Blood products are stored in hospitals, blood banks, and other medical facilities for use in transfusions. Various blood products are obtained from the whole blood donation of donors in order to administer blood components according to the needs of patients. On the one hand, by separating, the risks of side effects and incompatibilities are greatly reduced. On the other hand, separating blood into its components means that the optimal state of each of these components can be obtained in terms of shelf life, storage stability, and effectiveness.

[0003] As part of blood donation, whole blood is first collected from individual donors. During blood donation, the blood of each donor, so-called whole blood, is sent to a closed blood bag system. The blood bag system is designed to first collect whole blood into a whole blood bag (sometimes also called a collection bag), perform a processing or separation process, and transfer the individual blood components thus obtained to individual connection bags (transfer bags). The blood from the donor is separated into its components. The separation is performed by centrifugation. During centrifugation, an upper layer of plasma, in some cases a thinner intermediate layer known as the "buffy coat layer" containing white blood cells and platelets, and a lower layer of erythrocytes (red blood cells) are obtained.

[0004] White blood cells need to be separated. This is done by filtration, either before or after the separation step by centrifugation. Furthermore, a virus inactivation step can be performed on whole blood or individual blood products. In many applications (such as those in the present invention), the blood bag system is designed so that it can be strictly associated with only one donor.

[0005] The above method requires carefully labeling the sample container so that it can be clearly associated with the donor and the corresponding blood bag system.

[0006] Numerous different blood bag systems are known for collecting, separating, and storing blood components. Generally, a closed - sterilized blood bag system such as a Fenwal type is used to collect whole blood and separate it into blood components. This system includes a relatively large whole - blood bag for collecting the blood donation, and a filter and one or more transfer bags connected to the whole - blood bag by connecting tubes.

[0007] Various blood bag systems generally have in common that whole blood flows from the donor to the whole - blood bag without using an external pump or similar device. For this reason, blood collection involves inserting a venous access device, such as a venipuncture needle, into the donor's vein and collecting blood from the donor through the venous access device. The needle is connected to the tube via an adapter, through which the whole blood enters the whole - blood bag. The venous access device such as a venipuncture needle, the tube, and the bag form the blood bag system, which is pre - sterilized and discarded after single use.

[0008] The whole - blood bag contains an anticoagulant because the blood begins to clot after some time and starts to adhere to or clot on the walls of the plastic surface it contacts. The anticoagulants used need to be registered in the European Pharmacopoeia. These are typically CPD (citrate - phosphate - dextrose) or ACD (acid - citrate - dextrose).

[0009] In any blood collection technique or blood bag system, an important consideration is to ensure that the blood bag system is not contaminated by bacteria or other foreign substances in the air that can compromise the sterility of the blood bag system. Therefore, the sterility of the prior art blood bag systems described above is ensured by not exposing the interior of the flow path and the bag to the external environment or by minimizing such exposure. Such systems are generally referred to as "closed systems."

[0010] Each time blood is donated, the donor's whole blood is tested for blood type and the presence of pathogens such as viruses and bacteria in the donor's blood. Typically, testing of the collected blood requires taking one or more samples per donor at or near the time of blood collection. However, it is not desirable to remove a sample from the whole blood bag while exposing the collected blood in the whole blood bag to the external environment. Also, the anticoagulant in the whole blood bag often interferes with the analysis.

[0011] At the time of whole blood donation, in addition to collecting the blood on-site during donation, filling the sample container required for analysis at the laboratory is usually also done simultaneously. The sample container contains an anticoagulant so that the proteins in the blood do not precipitate until they are examined at the laboratory. The anticoagulant can be Na-citrate, CPD (citrate-phosphate-dextrose), CP2D (citrate-phosphate-2-dextrose), CPDA (citrate-phosphate-dextrose-adenine), or ACD ("acid-citrate-dextrose"). The sample container is proposed, for example, in Patent Document 1.

[0012] In one embodiment, blood is collected in an extended section of the supply line to the whole blood bag for sample collection. When the desired volume of blood for sample collection has been collected in the extended tube section, the supply line to the whole blood bag is closed between the whole blood bag and the extended section, the needle is removed from the donor, and the blood in the tube section is transferred to the sample container. Such a blood bag system has proven to be less suitable for the present application.

[0013] A blood bag system for cord blood has been proposed, for example in Patent Document 2, for the collection of cord blood. Here, the whole blood bag functions as a freezing bag and the extended tube section functions as a reservoir area.

Prior Art Documents

Patent Documents

[0014]

Patent Document 1

Patent Document 2

Summary of the Invention

Problems to be Solved by the Invention

[0015] Known techniques generally function satisfactorily, but efforts to provide improvements continue, particularly with regard to blood bag systems that enable a higher degree of automation in the field of blood collection and blood product recovery. The present invention aims to simplify and automate the analysis of whole blood and to simplify and systematize the sample collection process.

Means for Solving the Problems

[0016] These and other objects are solved by the subject matter of the independent claims. Preferred embodiments are the subject matter of the dependent claims or are described below.

[0017] The object of the present invention is to enable the extraction of blood from a pre-donation bag as part of a blood bag system into a sample container to be carried out not locally at the blood collection site anymore, but centrally and preferably automatically at a laboratory during or at the time of blood processing, a pre-donation bag system and a blood bag system including the pre-donation bag system.

[0018] The pre-donation bag system includes at least one pre-donation bag, a venipuncture adapter, and a blood collection line. (a) A first tube section sealable from the blood collection line as a supply section from the blood collection line to the pre-donation bag, and (b) A second tube section as a supply section from the blood collection line to a further part of the blood bag system, for example a whole blood bag (the whole blood bag is not part of the pre-donation bag system), in particular a direct supply section to the whole blood bag. The pre-donation bag or the first tube section or both contain an anticoagulant for whole blood, and the anticoagulant is EDTA. In particular, the anticoagulant is K2-EDTA (dipotassium EDTA) and / or K3-EDTA (tripotassium EDTA). Also, the sample container does not need to contain an anticoagulant.

[0019] For example, the first tube section and the second tube section branch from the blood collection line. Also, the second tube section can be the same line as the blood collection line, called the second tube section after branching from the first tube section, and conversely, the first tube section can be the same line as the blood collection line, called the first tube section after branching from the second tube section.

[0020] One advantage of filling sample containers in a unified manner is that the process steps can be managed. Since a large amount of donor information is stored in the database of the blood donation service provider, this can be called upon so that the number and type of tests required, and thus the determination of the sample containers to be filled, can only be made after comparing with the available data. Another advantage is the unification and automatic sealing of pre-donation bags. The risk of the bag being exposed to air is much lower than when the bag is sealed or separated at the blood donation site.

[0021] For transportation and subsequent filling of the sample containers, an appropriate anticoagulant is provided to the whole blood in the pre-donation bag of the blood bag system that will later be filled with the sample containers. This prevents the blood from clotting. Surprisingly, EDTA, especially K2-EDTA and / or K3-EDTA, has been proven to be a suitable anticoagulant for whole blood in the pre-donation bag. K2- or K3-EDTA can be used in infectious disease and blood group serology laboratories, as well as in PCR analysis and molecular blood typing tests. These laboratories perform a large number of tests (e.g., more than 10), and it is necessary to switch all of them to the same anticoagulant.

[0022] A further feature of each of the blood bag system and the pre-donation bag system as part of the blood bag system in the present invention is that the anticoagulant in the whole blood of the pre-donation bag is different from that in the whole blood bag. Therefore, it is necessary to be able to collect the whole blood in the pre-donation bag so that the anticoagulant for the pre-donation bag and the whole blood in which the anticoagulant is dissolved do not come into contact with the donor or the donor's blood or the whole blood in the whole blood bag. In particular, it is necessary to avoid contact or mixing with the whole blood in the whole blood bag. Also, CPD, CPDA1, and / or CP2D can be used, for example, as anticoagulants in whole blood bags.

[0023] The present invention further relates to a method of collecting whole blood by means of a blood bag system, wherein the whole blood provided with an anticoagulant or a part thereof in the pre-donation blood bag is filled into one or more sample containers after transporting the pre-donation blood bag to a laboratory, which is preferably automated, and the sample containers are supplied to an analysis or each sample container is supplied to a different analysis.

[0024] The number of sample containers per pre-donation blood bag can be determined as a function of the donor and in comparison with the database entry for the donor. For example, the database can be used to determine which types of analysis are required for each donor and how many sample containers are needed therefor. A pre-donation blood bag or a blood bag system is assigned to each donor. By means of automation, the exact number of sample containers can be selected, unnecessary sample containers can be avoided, and the sample containers can be arranged for the same test or a series of the same tests for different donors. For example, a first-time donor will undergo more tests and thus more sample containers will be required. Furthermore, the work steps of filling and labeling the sample containers at the blood donation site are avoided.

Brief Description of the Drawings

[0025] The present invention will be described with reference to the following figures, but is not limited thereto.

Figure 1

Figure 2

Modes for Carrying Out the Invention

[0026] In the present invention, the sampling of whole blood is not performed from the whole blood bag itself. Instead, the blood flow path of the whole blood is clamped in front of the whole blood bag. The whole blood collected from the donor is first guided to a sample bag (pre-donation blood bag) through, for example, a T-shaped branch or a Y-shaped branch, until the blood flow path of the pre-donation blood bag is closed by a closing portion that is initially open and later closed, particularly in the region of the first tube section. Then, the blood flow path of the whole blood bag is opened by a closing portion that is initially closed and later opened, particularly in the region of the second tube section, to fill the whole blood bag.

[0027] In this embodiment, the disposable tube set is used as part of a blood bag system. This is arranged in the main flow path from the blood collection line to the second tube section, with the first tube section as a "dead end" and the pre-donation blood bag, the first tube section, and the adapter for the sample container serving as the sampling point. Next, for example, the lid of the adapter is opened, a sample container in the form of a sample tube is inserted into the adapter, and the membrane of the sample container is pierced with the needle of the adapter to collect blood from the pre-donation blood bag. Thereafter, the whole blood flows into the attached sample container, for example, under negative pressure, through the sampling point.

[0028] In one embodiment of the present invention, the internal volume of the pre-donation blood bag is 10 - 50 mL, particularly 25 - 35 mL, or includes the volume of the whole blood described above. In particular, the concentration of the anticoagulant in the whole blood is 1.2 - 2 mg / mL, preferably 1.4 - 1.8 mg / mL, for example, about 1.6 mg / mL. The anticoagulant in the pre-donation blood bag enables the desired tests to be performed on the whole blood in the sample container at the testing laboratory with a time delay. The anticoagulant used in the pre-donation blood bag in the present invention does not interfere with the analysis at the testing laboratory and thus behaves neutrally in the tests.

[0029] The anticoagulant is in the pre-donation blood bag or in the first tube section, preferably towards the pre-donation blood bag beyond the closing portion of the first tube section. 1. As a liquid, for example, dissolved in water 2. As a coating, that is, immobilized as part of the inner wall coating 3. As a solid (for example, as a tablet), and / or 4. It can exist as a solid or a liquid in a capsule that is opened by external pressure or dissolution.

[0030] The anticoagulant is, for example, (a) Applied as a solid to the inner surface of the first tube section or the inner surface of a sample tube inserted into the first tube section, and / or (b) Can be applied as a solid to the inner surface of the pre - donation blood bag.

[0031] In one embodiment of the present invention, the anticoagulant is dissolved in water and introduced into the pre - donation blood bag. Thereby, when whole blood flows into the pre - donation blood bag, for example, due to the pressure in the donor's blood stream, EDTA is easily dispersed into the whole blood.

[0032] Also, the anticoagulant can be immobilized on the inner wall of the pre - donation blood bag and / or the tube section, or on a small tube inserted into the tube section towards the pre - donation blood bag after the sealing part (closing part). When the immobilized EDTA comes into contact with whole blood, the EDTA dissolves. The inner wall is coated, for example, by spray drying.

[0033] Also, an appropriate amount of the anticoagulant can exist in solid form in the pre - donation blood bag, and the anticoagulant can also dissolve into the whole blood, in some cases assisted by shaking the pre - donation blood bag, as soon as the whole blood flows into the pre - donation blood bag and contacts the anticoagulant.

[0034] Also, for example, the tablets in the pill chamber can be inserted into the tube section (the first tube section) towards the pre-donation bag, through which whole blood flows and passes, and then shaken (manually or on a mixing scale) as necessary, and dissolve. Also, the tablets can simply be placed inside the pre-donation bag.

[0035] In other embodiments, the anticoagulant is introduced into a capsule form that needs to be dissolved by contact of the shell with whole blood or mechanically broken open so that the anticoagulant is released into the pre-donation bag or the supply line thereto. For example, the capsule breaks when the supply line to the pre-donation bag is closed behind the position of the capsule. It is necessary to prevent backflow in the direction of the donor or the whole blood bag.

[0036] In particular, the first tube section has a closure (preferably initially open and later sealable). The anticoagulant is preferably placed only within the first tube section behind the closure and / or within the pre-donation bag (behind the closure of the first tube section).

[0037] A valve or closure in the form of a mechanical fastener in the supply line to the pre-donation bag that can be closed and reopened only as necessary prevents backflow of EDTA or whole blood containing EDTA. This effectively prevents the anticoagulant from coming into contact with the whole blood in the donor and / or the whole blood bag.

[0038] In one embodiment, the closure of the first tube section is initially closed in the basic position and can then be opened, and when closed for the second time, it is particularly irreversibly closed, i.e., it cannot be opened for the second time. Alternatively, the closure is initially open in the basic position and is particularly irreversibly closed when first closed, and then cannot be opened for the second time.

[0039] The second tube section can, for example, have a breaking part with a predetermined breaking point within the second tube section as a closing part, which, when mechanically broken, releases the flow through the second tube section into the whole blood bag. Similarly, but less preferably, the breaking part can also be arranged in the first tube section. An example of a possible design of a breaking part as a closing part that can be irreversibly opened can be found in German Patent Application Publication No. 3030020.

[0040] The integrated sample container filling can be realized in various ways. In one embodiment, the pre-blood donation bag is separated from the rest of the blood bag system by sterile welding (in particular, between the closing part of the first tube section and the pre-blood donation bag), whereby both ends are closed by welding or, when viewed from the pre-blood donation bag, the supply line can be separated behind the closing part. The welding is performed, for example, by heating and compressing the tube section in a specific area, and the separation is performed, for example, by punching in the welding area or forming a cut-off line to weaken the material in the welding area. In this way, both tube ends are sealed by welding.

[0041] Thereafter, the sample containers are centralized at the testing facility and filled with the blood from the pre-donation bags. This step can be performed automatically. For this purpose, first, the specific formulation number or identification display of the pre-donation bag is read out, the desired number of sample containers is determined, and thereby, for example, by providing an identification display that can be assigned to a donor to each sample container, the sample containers can always be clearly assigned to individual blood donations. This can be done by labeling or by assigning sample identification displays and / or donor identification displays in a database. Thereafter, whole blood mixed with EDTA is transferred from the pre-donation bag to the sample containers. One option for filling the sample containers is to use an adapter as described above, which can also be used for manual filling of the sample containers. However, it is also possible to fill the containers directly using a tube or a cannula. The cannula can be used to puncture the pre-donation bag for collecting the sample. Contamination by foreign blood must be avoided.

[0042] If desired, the pre-donation bag system can also form a separation part from the rest of the blood bag system, especially between the clamp of the second tube section and the whole blood bag, by sealing the second tube section on both sides by sterile welding (such as as described above), for example, by punching or pre-stamping a separation line to weaken the material to form a separation in the welded area, so that it can be separated by welding.

[0043] Figure 1 shows a diagram of the pre-donation bag system 1. The pre-donation bag system 1 includes a pre-donation bag 2, a venipuncture needle 3, and a blood collection tube 4 from the venipuncture needle 3 to the first Y-shaped connection part 5, and the flow from the blood collection tube 4 continues from the first Y-shaped connection part 5 to the first tube section 6, and the first tube section 6 ends in the pre-donation bag 2.

[0044] The other arm of the Y-shaped connection part 5 is connected to the second tube section 14 that leads to the whole blood bag 21.

[0045] The venous puncture needle 3 is connected to the free end of the blood collection line 4 via a venous puncture adapter 16 and is used to collect whole blood from a donor. The venous puncture needle 3 is enclosed in a removable tapered cap 15. Further, the protective bell portion 17 can be moved along the blood collection tube 4 and engaged with the adapter at the end of the blood collection tube, so that the protective bell portion 16 surrounds and holds the venous puncture needle 3 and the cap 15 inside.

[0046] The second tube section 14 branches from the blood collection line 4 at the other arm of the Y-shaped connection 5. A part of the Y-shaped connection 5 is a breaking portion 18 inserted into the arm of the Y-shaped connection, which blocks the flow through the arm of the Y-shaped connection 5. The breaking portion 18 has a hollow sleeve and an olive portion 19 at the end that closes the sleeve in the flow direction. The sleeve is tightly fitted by a collar to the arm of the Y-shaped connection at the other end. By bending the end of the arm, the olive portion can be broken along a predetermined breaking point, and the flow of whole blood can be released through the sleeve into the second tube section 14.

[0047] The olive portion 19 remains at the end of the arm of the Y-shaped portion, which prevents the olive portion 19 from being washed into the second tube section 14. On the other hand, for example, the outer periphery of the olive portion has ridges that allow blood to pass through the comb-shaped grooves of the olive portion. The breaking portion 18 is optional and can be inserted in the same way into the first tube section 6 or the arm of the Y-shaped connection 5 connected to the first tube section 6.

[0048] Furthermore, the second tube section 14 is provided with a tube clamp 20 that is initially open and can be re-closed later, which is intended to be closed after the whole blood bag 21 (see FIG. 2) is sufficiently filled to prevent the backflow of whole blood.

[0049] EDTA in tablet form is introduced into the pill chamber 8 of the first tube section 6. By flowing through, the tablet dissolves and releases the EDTA into the whole blood, so that the whole blood in the pre-donation bag 2 is finally stabilized by the anticoagulant EDTA.

[0050] Via the second Y-shaped connection 9, the sample collection adapter 11 communicates with the pre-donation bag 2 via the sample collection tube section 10 on a part of the first tube section. When the lid 12 of the sample collection adapter 11 is opened, a sample container with a partition can be inserted into the cylindrical cavity of the sample collection adapter 11. Due to the negative pressure in the sample container, the sample container is filled with whole blood containing an anticoagulant. Similarly, additional sample containers, for example in the form of sample collection tubes, can be automatically labeled and filled at the laboratory, i.e., not at the blood collection site. And these are collected and supplied to a plurality of corresponding tests. The arms of the Y-shaped connection are each part of a corresponding tube section.

[0051] Figure 2 schematically shows a blood bag system including the pre-donation bag system 1 of Figure 1 (however, here the sample collection adapter 11 is directly connected to the pre-donation bag 2 via the sample collection tube section 10 without the second Y-shaped connection).

[0052] Through the venous puncture needle 3, the donor's whole blood is induced into the blood bag system during blood collection. The first tube section 6 after the Y-shaped connection 5 guides the donor's whole blood into the pre-donation bag 2, and the second tube section 14 guides it into the whole blood bag 21. First, the whole blood collected through the venous puncture needle 3 passes through the blood collection tube 4 and the Y-shaped connection 5, enters the first tube section 6, and enters the pre-donation bag 2 through the irreversible clamp 7. The "irreversible clamp" 7 means that it is open (preferably) in the basic state, or it is closed in the basic state and can be opened, but in both configurations, it cannot be opened again after the first closure. The pre-donation bag 2 is connected to the adapter 11 through the sample collection tube section 10, which is intended to fill the sample container. The adapter 11 can be opened to expose a cylindrical guide and has a needle for penetrating the partition inside. As soon as the pre-donation bag 2 is sufficiently filled, the irreversible clamp 7 is closed, and the reversible clamp 20 of the second tube section 14 is opened, or the olive part 19 is also broken. Here, the whole blood flows only into the whole blood bag 21, which is also often called the blood collection bag. It is also possible to place only the initially closed clamp 20 or only the break part 18 inside or on the second tube section.

[0053] When processing into individual formulations, the whole blood in the whole blood bag 21 is first centrifuged. Then, the components are separated, and the red blood cells in the red blood cell bag 22, the plasma in the plasma bag 23, and the platelets (remaining in the whole blood bag 21) are separated. In Germany, only leukocyte-depleted blood products or products with a very low leukocyte content can be sold according to the specifications of the Paul Ehrlich Institute, a federal authority. Leukocyte depletion means removing leukocytes from the product. Generally, as shown in Figure 2, a filter 25 is used to remove leukocytes from the red blood cell concentrate, and the leukocyte content per unit of the filtered product is 10 in the bag 24 for leukocyte-depleted red blood cell concentrates. -6Make it less than white blood cells. The surface-modified polyester fiber can be used as a filter medium. Filtration is performed by adsorption of white blood cells. A bag 24 for a white blood cell-depleted red blood cell concentrate is provided with an additive solution.

Claims

1. A blood bag system comprising a pre-donation bag system (1) and at least one whole blood bag (21), wherein the pre-donation bag system (1) comprises at least a pre-donation bag (2), a venipuncture adapter (16), and a blood collection line (4), (a) A first tube section (6) that can be sealed to the blood collection line (4), which serves as a supply section from the blood collection line (4) to the pre-donation bag (2), and (b) Including a second tube section (14) as a supply section from the blood collection line (4) to the whole blood bag (21), A blood bag system wherein the pre-donation bag or the sealable first tubular section or both contain a first anticoagulant for whole blood, the first anticoagulant being EDTA, and the pre-donation bag (2) or the sealable first tubular section includes an adapter (11) for filling one or more sample containers, and the whole blood bag (21) contains a second anticoagulant, which is one or more of CPD, CPDA1 and CP2D, rather than EDTA, unlike the first anticoagulant.

2. The blood bag system according to claim 1, wherein the first anticoagulant is K2-EDTA or K3-EDTA or both.

3. The first anticoagulant is (a) Applied as a solid to the inner surface of the first tube section, or applied as a solid to a small tube inserted into the sealable first tube section, (b) Applied as a solid to the inner surface of the pre-donation bag (2), (c) The blood bag system according to claim 1, which is both (a) and (b).

4. The blood bag system according to claim 1, wherein the first anticoagulant is dissolved in water and introduced into the pre-donation blood bag (2).

5. The blood bag system according to claim 1, wherein the pre-donation bag (2) has a volume of 10 to 50 mL.

6. The blood bag system according to claim 1, wherein the first anticoagulant is introduced into the whole blood of the pre-donated blood bag (2) in an amount that obtains a concentration of 1.2 mg / mL or more.

7. The blood bag system according to claim 1, wherein the first anticoagulant is introduced as a pill or tablet into the pre-donation bag (2) or the sealable first tubing section.

8. The blood bag system according to claim 1, wherein the sealable first tubular section and the pre-donation bag (2) are formed to be dead ends.

9. The blood bag system according to claim 1, wherein the sealable first tubing section has a closure (7) that is initially open and later sealable.

10. The first tube section (6) has a rupture portion within the first tube section (6) having a predetermined rupture point, which, when mechanically ruptured, releases flow through the sealable first tube section to the pre-donation bag system, or The second tube section (14) has a rupture portion (18) within the second tube section (14) having a predetermined rupture point, which, when mechanically ruptured, releases the flow to the whole blood bag (21) through the first tube section, or The blood bag system according to claim 1, which is both of the above.

11. The blood bag system according to claim 1, wherein the sealable first tube section includes a sealable closure (7), and the first anticoagulant is placed only in the sealable first tube section behind the closure or only in the pre-donation bag (2).

12. The blood bag system according to claim 1, wherein a reversible clamp is positioned on the second tube section (14) for opening and closing again.

13. The blood bag system according to claim 1, wherein a clamp is positioned on the second tube section (14), which is initially closed and can be opened and then reversibly or irreversibly closed again.

14. A method for collecting whole blood using a blood bag system according to one or more of claims 1 to 13, wherein the whole blood provided with the first anticoagulant or a portion thereof in the pre-donation bag (2) is transported to a laboratory and then filled into one or more sample containers by means of the adapter (11), the sample containers being supplied for analysis, or each of the sample containers being supplied for different analyses.

15. The number of sample containers per pre-donation bag (2) is determined as a donor function and in comparison with a database entry for the donor, and the sample containers and their number are labeled with respect to the tests selected by the database entry, sample containers from different donors. The method according to claim 14, wherein only one defined blood bag system is assigned to each donor, is automatically sorted based on the labeling, and is compiled with respect to the same test or a set of the same tests for the different donors.

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