A method for the transfer of blood samples and a transportation product for the same

Abstract

The invention relates to a method that provides dry blood transfer in accordance with regulations so that blood samples can be transported over international and intercity distances, and a transportation product performing this method.

Description

[0001] A METHOD FOR THE TRANSFER OF BLOOD SAMPLES AND A TRANSPORTATION PRODUCT FOR THE SAME

[0002] TECHNICAL FIELD

[0003] The invention relates to a method that provides dry blood transfer in accordance with regulations so that blood samples can be transported and stored in solid form over international and intercity distances, and a transportation product performing this method.

[0004] PRIOR ART

[0005] Blood is the most commonly used biological sample for the field of molecular diagnostics. There are various regulations for transporting and storing blood samples over international and intercity distances:

[0006] - First, they must undergo tests that determine whether blood samples contain pathogenic agents. These tests must comply with the standards set in the country or region where the blood samples are collected.

[0007] - In international transports, blood samples are usually transported in accordance with the rules set by IATA (International Air Transport Association). These rules state that blood samples must be properly packaged, labeled, and documented.

[0008] - Blood samples may also be subject to temperature controls, which may require special transport conditions. These conditions may include specific temperature ranges to ensure that blood samples are transported intact.

[0009] - In intercity transport, the vehicles used during the transport of blood samples may need to have special conditions. For example, vehicles carrying blood samples may need to have temperature controls or follow different safety protocols depending on where the blood samples will be transported to.

[0010] All these regulations have been established to ensure the safety and effectiveness of blood samples during transportation. In order to avoid any problems during the transport of blood samples, it is important to comply with the relevant rules and regulations. For this reason, it is not possible to transport blood samples in liquid form over international and intercity distances. In blood sampling which is a widely used method, blood samples can be transported in accordance with international and intercity regulations in the form of dry blood.

[0011] Dry blood transfer is a method in which blood is transported in solid form (i.e., without separation of serum or plasma). Dry blood transfer is a safe and effective method of transporting blood samples. In order for this method to be used, all equipment and materials must be properly prepared and used. In addition, dry blood transfer

[0012] - should be able to be sent by mail in accordance with international regulations

[0013] - should be able to be archived for a long time

[0014] - when necessary, should allow DNA isolation in high amounts and purity and comply with the regulations.

[0015] Guthrie paper is a filter paper frequently used in international and intercity dry blood transfer. Using a special filtration technology, this paper separates the blood components such as serum and plasma and takes the form of a filter paper containing only the blood cells. Blood samples are applied to Guthrie paper by absorption, and the paper is labeled and properly packaged in accordance with certain rules and prepared for international and intercity transportation. The use of Guthrie paper for international and intercity dry blood transfer ensures safe and effective transport of blood samples. This paper allows blood samples to be transported in a dry state, thus reducing the risk of samples leaking or spoiling. Furthermore, Guthrie paper ensures that blood samples are properly filtered and labeled, making it easy to accurately identify and track samples.

[0016] While the use of Guthrie paper in international and intercity dry blood transfer provides many advantages, it also has some disadvantages. These disadvantages may include:

[0017] - Sensitivity: Blood samples applied to Guthrie paper can reduce the sensitivity of test results in some cases because they are taken in small quantities and spread over a limited area.

[0018] Pollution: Blood samples may cause contamination of the paper after being applied to the Guthrie paper. This can make the results misleading.

[0019] - Storage: Long-term storage of blood samples may cause degradation of certain components on Guthrie paper. This can cause the results to be misleading. - Standards: Blood samples on Guthrie paper must comply with certain standardization requirements. Failure to fully meet these requirements can result in misleading results.

[0020] Risk of contamination: Guthrie paper is susceptible to contamination by blood samples on paper. Therefore, anything that comes into contact with the paper can cause the results to be misleading.

[0021] In calculations, 1 drop of liquid is considered to be approximately 30 microliters (one thousandth of a milliliter). Routine molecular diagnostic tests require approximately 100-200 microliters (3-6 drops) of blood samples per sample. Therefore, the efficiency of existing systems is low.

[0022] It has been determined that new methods and products should be developed that eliminate the technical negativities and disadvantages in the relevant technical field and allow the transportation of long-term and high-volume dry blood samples.

[0023] BRIEF DESCRIPTION OF THE INVENTION

[0024] In the relevant technical field, there are regulations suitable for the transportation and storage of blood samples over international and intercity distances for molecular diagnosis. According to these regulations, it is not possible to store and transport blood samples over long distances in liquid form. Therefore, blood samples can be transported and stored as dry blood over long distances.

[0025] In the state of art, paper-based filters are often used so that dry blood can be transported and stored over long distances. These paper-based products have disadvantages such as contamination problems in the transportation of dry blood samples over long distances, the inability of paper to have reliable components for long-term storage, the risk of contamination and the fact that it does not allow the transportation of large quantities of samples.

[0026] In particular, paper-based filters cannot ensure that dry blood samples are transported and stored in large quantities. 1 drop of liquid is considered to be approximately 30 microliters (one thousandth of a milliliter); in routine molecular diagnostic tests, approximately 100 - 200 microliters (3-6 drops) of blood sample are needed per sample. While paper-based filters can only store and transport blood samples up to these values, they cannot function when more blood samples are required. Additionally, if some absorption occurs in blood samples, such that paper-based products cannot be used, loss of sample amount occurs. Therefore, the efficiency of existing systems is low.

[0027] The present inventors put forward a method that makes it possible to transport and store blood samples in high quantities and over long distances for the relevant technical field and to eliminate other mentioned technical problems. In order to achieve this, the present inventors argue that it is more appropriate to store and transport blood samples by performing absorption processes with chemical solutions, rather than storing and transporting them in absorbent paper-based products.

[0028] In addition, the present invention provides a product in which dry blood samples can be transported and stored with the use of said chemical solutions. Thanks to said product, it is possible to transfer a particularly high amount of blood samples. In addition, the risk of pollution and contamination, which is one of the technical disadvantages that may be encountered in paper-based products, is not possible in the product of the present invention.

[0029] DETAILED DESCRIPTION OF THE INVENTION

[0030] In this detailed description, the subject of the invention is related to a method for transporting and storing dry blood samples, and is described only with examples that will not create any limiting effect for a better understanding of the subject.

[0031] The method of the present invention is an alternative method to the paper-based filters that are frequently used in the art to transport and store blood samples in dry form. In the method of the present invention, blood samples are transported in dry form by forming chemical bonds with solutions.

[0032] Accordingly, the method of the present invention mainly comprises three main process steps:

[0033] - providing blood samples and adding them to the transportation product, - adding retaining powder to the transportation product in determined amounts to ensure that the blood sample becomes dry, and turning the blood into dry form due to the interaction between the blood sample and the retaining powder,

[0034] - after the transportation and storage of blood samples, adding the conversion solution for the reproduction of the blood sample in liquid form from the blood sample-retaining powder form and collecting liquid blood from the transportation product for molecular diagnosis.

[0035] In the calculations performed, 1 drop of liquid blood sample is approximately 30 microliters. In order to perform molecular diagnostic tests, a liquid blood sample of approximately 100 to 200 microliters, that is, 3-6 drops, is needed per sample. In some cases - when the tests are requested to be repeated - it is expected that there will be more liquid blood samples per sample. Since it can be difficult to repeatedly provide blood samples from long distances such as international and intercity distances, the development of a method that allows the transportation and storage of large quantities of blood samples is a need for the relevant technical field. In the method of the present invention, since liquid blood samples are provided in dry form by a chemical method, the addition of retaining powder and conversion solution (also called dispersion) as much as the amount of blood sample can make it possible to obtain large amounts of blood samples.

[0036] In the method of the present invention, sodium polyacrylate compound is used as the retaining powder. The sodium polyacrylate compound used as the retaining powder in this invention has the formula CsHyNaCh; and its molecular weight is 94.04 g / mol.

[0037] The reason why sodium polyacrylate compound is used as a retaining powder in the method of the present invention is that it is an anionic polyelectrolyte thanks to the negatively charged carboxylic groups it carries. Sodium polyacrylate, which comes into contact with the blood sample, increases the viscosity and forms a dense gel-shaped structure by elongating the chains attached to the anionic groups in its structure. One of the major advantages of sodium polyacrylate is that the release rate of molecularly bound blood samples is very low compared to other similar retaining molecules.

[0038] In a preferred embodiment, a process is carried out between the retaining powder and the liquid blood sample with a value between 0.3 and 0.6 g / ml. This ratio is critical because the increase in the amount of sodium polyacrylate compound in the mixture causes an increase in the undesired gelling rate. If a small amount of sodium polyacrylate is used, it is caused that the targeted amount of blood sample cannot be stored.

[0039] In the method of the present invention, a period of at least 30 minutes is needed after the retaining powder and the liquid blood sample are combined together. This is the time required for the targeted interactions between the retaining powder and liquid blood to occur.

[0040] In the method of the present invention, after storing and transporting them at international and intercity distances, dry blood samples must be brought into liquid form for molecular diagnostic procedures. It is possible to use at least one conversion solution to perform this process step. The conversion solution contains at least one magnesium-containing component. In a preferred embodiment, the conversion solution is a solution of MgCl2 at a concentration of 1 M. After MgCl2is added to the dry blood sample, it ensures that the gel in the dry blood-sodium polyacrylate gel structure is degraded and the blood sample is released from the structure. Since MgCl2 solutions are frequently used in PCR processes, which form the basis of DNA isolation and molecular studies, they do not show a negative effect in the following processes.

[0041] In a preferred embodiment, a process is carried out between the conversion solution and the liquid blood sample with a value between 0.3 and 0.6 ml / ml. A conversion solution within the mentioned value ranges can degrade the gel structure in targeted amounts and make it possible to obtain a free liquid blood sample.

[0042] Agarose gel electrophoresis, spectrophotometric or fluorometric methods can be used to determine the quality of DNA samples from the liquid blood sample obtained in the method of the present invention. In the studies, the present inventors have determined that the addition of magnesium-rich conversion solution to the dry blood form and the conversion solution-liquid blood sample mixture are suitable for the necessary DNA isolation processes.

[0043] In another aspect, the invention provides a transportation product that allows the implementation of the method characterized. In the art, the transportation and storage of dry blood samples was usually carried out on paper-based products. In the present invention, structures that can be called "cassettes" are used as transportation products.

[0044] The transportation product of the present invention comprises at least one compartment. The said compartment is the part where the retaining powder and blood sample used in the method for storage and transportation activities are trapped in the first place. If preferred, the number of compartments is more than one. Naturally, with the increase in the number of compartments, the amount of blood that can be stored and transported may increase.

[0045] If the transportation product of the present invention is preferred, it may comprise more than one independent compartment. In this way, it is possible to store and transport blood samples obtained from the same or different people in independent compartments.

[0046] The upper part of the transportation product of the present invention is open so that samples can be placed into the compartment part. Via the opening, the samples are placed into the transportation product and it comprises at least one lid to cover the upper part and to prevent the samples from spilling, scattering or mixing. Said cover is preferably of the same size as a lower part containing a compartment. The inside of the lid is hollow and is positioned above the lower part, allowing these compartments to be covered.

[0047] The transportation product of the present invention is of a simple structure; it comprises a lower part and at least one compartment in the lower part where blood samples and retaining powder are added for storage and transportation activities, and at least one lid that allows the compartments to be covered from the upper part, depending on the shape of the lower part.

[0048] The transportation product of the present invention is made of non-paper-based materials as in the art. It is preferably made of polymer materials or composite materials containing polymer material. In this way, technical problems, pollution, contamination and storage problems arising from the components of paper-based products are prevented. At least 10 mL of blood sample can be transported and stored with the transportation product of the present invention.

[0049] If the transportation product of the present invention is preferred, it can be produced easily and quickly by means of three-dimensional printer technology.

[0050] The elements within the transportation product of the present invention can be produced in different sizes or colors. If preferred, features such as text, code, name can be added to the elements.

[0051] The protection scope of the invention is specified in the appended claims and cannot be limited to what is described for illustrative purposes in this detailed description. It is clear that a person skilled in the art can present similar structures in the light of the above, without leaving the main scope of the invention.

Claims

CLAIMS1. A method for transporting and storing blood samples in solid form, wherein it can be stored and transported in absorbed form in solutions by forming chemical bonds with blood samples, characterized by comprising the process steps of: providing blood samples and adding them to the transportation product, adding retaining powder to the transportation product in determined amounts to ensure that the blood sample becomes dry, and turning the blood into solid form due to the interaction between the blood sample and the retaining powder, after the transportation and storage, adding the conversion solution for the production of the blood sample in liquid form from the blood sampleretaining powder form and collecting liquid blood from the transportation product for molecular diagnosis.

2. The method according to claim 1, characterized in that sodium polyacrylate compound is used as the retaining powder.

3. The method according to claim 2, characterized in that the ratio of the retaining powder amount to the blood sample is in the range of 0.3 to 0.6 g / ml.

4. The method according to one of the preceding claims, characterized in that interaction between the retaining powder and the blood sample is expected to occur for a period of at least 30 minutes.

5. The method according to one of the preceding claims, characterized in that said conversion solution is MgCh.

6. The method according to claim 5, characterized in that the ratio of the conversion solution amount to the blood sample is in the range of 0.3 to 0.6 ml / ml.

7. A transportation product wherein a method according to one of the preceding claims is carried out, characterized by comprising at least one compartment with an open upper part used as the element where the retaining powder and blood sample are trapped and which is used for transportation and storage activities in the method and at least one hollow lid in order to cover the compartment and to prevent spilling, scattering or mixing of the samples, and having components made of polymer-based materials.

8. The transportation product according to claim 7, characterized in that the number of said compartments is more than one.

9. The transportation product according to claim 8, characterized in that each of the compartments is independent.