Shen Yang Bokan Biotechnology Co.,Ltd
Shenyang Baokang Bioengineering Co., Ltd

The development of vacuum blood collection in China and the launch of the fifth generation of new pr

The birth of vacuum blood collection system (vacuum blood collection vessel and vacuum blood collection needle) is mainly based on the following points:

① To ensure the quality of blood samples in medical experiments;

② To prevent the cross infection of blood borne infectious diseases and reduce the pain of repeated puncture of blood recipients;

③ It is suitable for automatic laboratory testing, quality control and specimen management. Also because in the process of continuously meeting the above requirements, products and product technology have been gradually improved.

Although vacuum blood collection technology was first introduced and used in the United States, its products only entered the Chinese market in 1995. Before 1994, there were relevant vacuum blood collection technology and product design registered in the national patent office and obtained patents. Chengdu Ruiqi science and Technology Industry Co., Ltd. was the first one to formulate and record the product standards of vacuum blood collection system in China. In 1996, the company recorded the enterprise standards of "vacuum blood collection" and "vacuum blood collection needle" in the state and Sichuan Provincial Bureau of technology supervision, and later became the supporting enterprise for the promotion of vacuum blood collection technology in the "ten years and one hundred items" promotion plan of the Ministry of health.

After more than ten years of application and promotion, the use of vacuum blood collection system has been quite popular at present, but the industry standard of vacuum blood collection in China will be formally implemented on August 1, 2008. Up to now, the product standards of various vacuum blood collection enterprises in China are different, so the quality is quite different. According to the composition of products and the adaptability of product technology and laboratory medicine technology, the products seen in the market can be roughly divided into five generations.

The first generation product is composed of ordinary glass tube and natural rubber plug, and the color code does not meet the requirements of the industry regulations. The scalp needle blood sampling needle is used, and the vacuum degree cannot be accurately quantified;

The second generation product is composed of glass tube and butyl rubber plug treated with silicone oil on the inner wall. The vacuum degree can be quantified and the specifications of tube containing additives are increased, but the quality of additives is poor;

The third generation product is composed of glass tube or pet tube and medical butyl rubber plug with anti splashing helmet. The quality of additives is significantly improved. The stability of chemical components after serum separation is concerned. Inert serum separation rubber tube is introduced. The influence of atmospheric pressure on vacuum is also concerned. Special products suitable for different altitude areas are introduced;

On the basis of summing up the quality of the third generation products, the fourth generation products have made a qualitative analysis of the material structure used in the products, as well as the adaptability of the products in the automatic experimental barcode information management, LS or HS, the optional increase of blood sampling needle and the visible function of blood return, etc., which have a great development in the applicability;

The fifth generation of products is to meet the technical requirements of experimental medicine, at the same time, from the aspects of production technology and raw material modification of products, to solve the compatibility problems between product materials and blood, such as platelet aggregation and release, enzyme activity inhibition, pyrogen pollution, etc., so as to achieve the equal amount of blood information transmission among patients, blood samples and laboratories The results are more real and reliable. The main quality and technology items of the fifth generation and fourth generation products are compared as follows:


                                                      Comparison of the quality of the fifth and fourth generation vacuum blood vessels

Comparison items

The fourth generation of vacuum blood collection

The fifth generation of vacuum blood collection

Test tube material and performance

Glass tube: silicate or phosphate glass, poor thermal stability, large coefficient of thermal expansion, easy to lead to leakage of vacuum at the nozzle, poor chemical resistance. Plastic pipe: pure polyethylene terephthalate (PET), easy to absorb water, resulting in the volume reduction or drying of water additives. For oxygen, the air tightness is poor, and the vacuum holding time is relatively short.

Glass tube: borate glass, good thermal stability, small coefficient of thermal expansion, stable size, good chemical resistance. Plastic pipe: special modified PET, with biological inertia, very low water absorption, good air tightness, relatively long vacuum retention time.

Treatment method and effect of inner wall of vacuum tube

In general, the inner wall is treated with silicone oil. When used, the platelets in anticoagulant samples are easy to aggregate and release, the red blood cells are easy to aggregate and settle and are not easy to disperse, the count repeatability of cells and platelets is poor, and the distribution curve of cell volume and width is not stable. Hemolysis often occurs in blood clotting samples, with silk hanging on the wall, blood sticking, blood sticking at the mouth of the tube, and fibrinogen secondary coagulation easily causes the instrument to plug the needle and hole.

The properties of the inner wall of the vacuum tube are similar to those of the inner wall of the blood vessel. Blood cells and platelets are easy to mix and disperse, cell count and platelets count are stable, and cell volume width distribution curve has good repeatability. The walls and orifices of blood clotting specimens are clean, without hemolysis, blood viscosity, hanging of silk, and plugging of needles.

Additives in the tube and their application effect

Anticoagulants are generally prepared with analytical grade and common reagent preparation method. Platelets are easy to aggregate and release, hemolysis or shrinkage of red blood cells, and the distribution curve of platelet width and red blood cell width is not stable. There is no quality standard for coagulants, there are many kinds of coagulants, including trace elements, heavy metals and other impurities, which have an impact on the test methods of enzymes and catalytic reactions, interfere with the analysis of trace components, and are prone to instrument hole plugging and needle plugging.

Anticoagulants meet the requirements of pharmacopoeia or chromatographic purity. They are prepared according to the formula of biochemical agents. PH and osmotic pressure meet the biochemical and physiological values of blood. The distribution curve of blood cell and platelet width is stable without hemolysis. The purity of the coagulant is high, and nano powder or porous dispersion is often used, which has no effect on the test results and does not block the hole.

Serum separating glue and its application effect

The multi-purpose liquid organosilicon material has poor barrier to water and air. It is easy to be structured during the placing process, resulting in the inability to separate serum and blood cells during centrifugation. The centrifugal force is more than 2200g, which can not effectively block the chemical exchange between blood cells and serum. The specimen has a short preservation time, and even some of the indicators have no significant difference with the non separated rubber tube.

With butyl gum or saturated polyester, it has good barrier to water and gas, good cold and heat resistance, no structure, and good thixotropy. Generally, it only needs 1200-1800g to separate serum and blood cells. The samples can be stored for more than 7 days, and the blood K +, blood glucose and blood glucose can be measured, and the results are still stable.

Dimensions and labels

The size of vacuum blood collection vessel can not fully meet the requirements of centrifuge automation instrument. The label has no bar code or bar code, but its universality is poor.

The size of vacuum tube is basically standardized, which can meet the requirements of various automatic instruments. The label has a barcode to meet the requirements of users, and can meet the requirements of information management

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