Wuhan Desheng Biochemical Technology Co., Ltd

On August 14, 2026, the National Healthcare Security Administration officially released the "Guidelines for the Approval of Inspection Medical Service Price Projects (Trial)" (hereinafter referred to as the "Inspection Medical Service Approval Guidelines"), which is the 40th and last batch of medical service price project approval guidelines, marking the basic formation of a unified and standardized medical service price project system nationwide. The guidelines cover major areas such as clinical testing, transfusion and blood type, microbiology and parasites, molecular diagnosis, biochemistry, and immunology, with a total of 662 main items, 114 additional items, and 7 extension items. As a core supplier in the field of in vitro diagnostic (IVD) reagent raw materials, Hubei Xindesheng Material Technology Co., Ltd. believes that this policy adjustment will have a profound impact on the industry, and high-quality and highly stable diagnostic raw materials will play a more critical role under the new price system. 1.  Policy core: Same inspection and same price, pricing not differentiated according to inspection methods The guidelines for inspection projects adhere to a service-oriented approach, with the core change being the principle of no longer setting up separate main projects based on inspection methodology. Taking glucose testing as an example, in the past, most regions established different price items based on different testing methods such as dry chemistry, enzyme method, and enzyme electrode method. However, the new guidelines unify the "glucose testing fee" and no longer distinguish between testing methods, achieving the same testing and price. At the same time, the guidelines clearly stipulate that the consumption of basic material resources required for testing, including reagents, quality control solutions, calibration solutions, etc., shall be included in the pricing cost of testing items, and medical institutions shall not charge patients separately. This means that downstream inspection agencies and IVD reagent production enterprises will face further pressure in cost control, and higher requirements will be put forward for the stability, purity, and cost-effectiveness of raw materials. 2. Industry impact: Raw material quality becomes the key to reducing costs and increasing efficiency Under the new rule of "same test, same price", the fees for inspection items will no longer have price differences due to methodological differences, and the ability to control reagent costs will directly affect the profit margins of medical institutions and reagent manufacturers. This has prompted the entire IVD industry chain to pay more attention to the quality and cost efficiency of upstream raw materials - high-purity and highly stable diagnostic raw materials can help reduce batch differences, lower duplicate detection rates, improve the accuracy and consistency of test results, and thus achieve better economic benefits within the established fee framework. As pointed out in the guidelines, the in vitro diagnostic reagent market in China has continued to grow in recent years, with a market size of approximately 130 billion yuan by 2025. The standardization and unification of national inspection price items will effectively lead the high-quality development of inspection disciplines and promote mutual recognition of inspection results. In this process, the technical strength and product quality of upstream raw material suppliers will become an important foundation to support the high-quality development of the industry. 3. New Desheng: Using high-quality raw materials to assist the industry in responding to new regulations Hubei Xindesheng Material Technology Co., Ltd. has long focused on the field of IVD reagent raw materials, deeply cultivating the research and development, production, and sales of core products such as blood vessel additives, biological buffering agents, chemiluminescence reagents, color reagents, enzyme preparations, etc. The company was formerly known as Wuhan Desheng Biochemical, established in 2005. After years of technological accumulation and continuous innovation, it has grown into a core enterprise in the field of IVD reagent raw materials in China. In response to the industry changes brought about by this policy adjustment, New Desheng's core product system can provide strong support for downstream customers: Biological buffer series: The company relies on the advantages of chemical synthesis technology to form a matrix of more than 50 products such as Tris, HEPES, MOPS, etc., with a stable purity of over 99%, and can customize indicators according to customer application scenarios. High purity buffering agents provide a stable reaction environment for diagnostic reagents, helping to ensure the accuracy and inter batch consistency of test results. Enzyme Preparation Series: The company has developed a new generation of high-purity and highly stable enzyme preparations, including key indicator detection materials such as lactate dehydrogenase (LDH), uricase (UO), creatine kinase isoenzyme (CKMB), etc. Enzyme preparations with high activity and stability can effectively enhance the detection sensitivity and specificity of the reagent kit, helping downstream reagent manufacturers achieve better product performance within the established fee framework. Color developing substrate series: TOOS, MAOS and other products are benchmarked against international standards, with some indicators surpassing them, helping reagents improve detection indicators and reduce background interference. Blood collection tube additives: Heparin lithium, Heparin sodium, EDTA dipotassium, tripotassium, serum separation gel and other blood sample pretreatment product systems, widely used in clinical laboratory and other fields. The company has two R&D and production bases in Gedian and Huanggang (70 acres), with an annual production capacity of 5000 tons for all categories. With solid technical strength and a sound quality control system, Hubei Xindesheng was successfully selected as a single champion enterprise in the manufacturing industry of Hubei Province in 2026, marking that the company has reached the forefront of the IVD reagent raw material subdivision track in China. The release of the inspection project approval guidelines marks a new stage of unified and standardized management of medical service pricing projects nationwide. For the IVD reagent raw material industry, the importance of quality, stability, and cost-effectiveness will be further highlighted. Hubei Xindesheng Material Technology Co., Ltd. will adhere to craftsmanship and quality, continuously increase research and development investment, empower the development of IVD in vitro diagnostics industry with more stable products and more professional technical support, and help the industry achieve high-quality development in the new policy environment.

1. Why is CK-MB higher in children than in adults? In clinical biochemical testing, creatine kinase isoenzyme (CK-MB) is an important indicator for evaluating myocardial injury. Many inspectors have found that when using heparin lithium anticoagulant blood collection tubes to collect blood samples from children, the phenomenon of CK-MB detection values being significantly higher than that of adults. This phenomenon is not due to the higher incidence rate of myocardial injury in children, but is closely related to multiple factors in the use of blood collection vessels. 2. Core cause analysis (1) The intrinsic effect of heparin lithium anticoagulant on CK-MB detection Research has shown that there is a significant difference in CK-MB detection results between heparin lithium anticoagulant plasma and serum. The correlation between CK-MB values measured by heparin lithium anticoagulant plasma and serum test results is poor. The literature clearly states that items such as CK-MB should not be measured using heparin lithium anticoagulant plasma samples. This means that the heparin lithium blood collection tube itself will cause certain interference with CK-MB detection, which exists in different populations, but is more prominent in children. (2) Insufficient filling of blood collection tubes - the primary factor for elevated CK-MB in children There is a significant difference in blood collection between children and adults. Adult blood collection tubes are usually designed with a blood collection volume of 4ml, while pediatric blood collection volumes are generally 3ml. When the heparin lithium blood collection tube fails to reach the recommended filling volume, the vacuum pressure inside the tube becomes too high and the relative concentration of heparin increases, which can exacerbate red blood cell rupture (hemolysis) and release high concentrations of intracellular contents. Research has confirmed that insufficient filling of blood collection tubes can lead to significant changes in enzymatic indicators such as CK and GGT. Another study suggests that short drawn heparin lithium tubes may not be suitable for testing projects such as CK. Children have small blood volume and thin blood vessels, making blood collection difficult and more prone to insufficient blood collection. Insufficient filling leads to high heparin concentration, while indicators such as CK-MB in plasma increase with increasing heparin concentration. This is precisely the pathophysiological mechanism by which elevated CK-MB levels in heparin lithium blood collection tubes are more common in children than in adults. (3) Hemolysis is the direct driving force behind the pseudo elevation of CK-MB Hemolysis is the direct cause of false elevation of CK-MB. Red blood cells contain high concentrations of enzymes such as creatine kinase (CK), which are released into the plasma after hemolysis, leading to artificially elevated detection values. Due to crying, lack of cooperation, and thin blood vessels during blood collection in children, the difficulty and operation time of puncture are high, and the high vacuum pressure caused by insufficient filling of blood collection vessels makes the risk of hemolysis in children's specimens much higher than that in adults. Research has shown that blood samples in heparin lithium tubes are more sensitive to hemolysis, and a hemolysis index exceeding 20 can interfere with CK-MB detection. 3. Response suggestions (1) Select specialized blood collection tubes suitable for children's blood collection It is recommended to use micro blood collection tubes specifically designed for children in clinical practice. These products have a reasonable blood collection volume design, accurate matching of anticoagulant content and blood collection volume, which can effectively avoid the problem of high heparin concentration caused by insufficient filling. (2) Standardize blood collection procedures Ensure that the blood collection tube is filled to the recommended blood volume; After blood collection, gently invert and mix 6-8 times to avoid severe shaking; Soothe the patient's emotions before blood collection, choose a suitable blood collection site, and try to be as precise as possible. (3) Establish a reference system for children's plasma testing Given the differences in CK-MB and other parameters between heparin lithium anticoagulant plasma and serum, it is recommended that clinical laboratories gradually establish a reference range for biochemical testing of pediatric plasma to avoid misjudging plasma test results based on serum standards. Hubei Xindesheng Material Technology Co., Ltd. is a high-tech enterprise specializing in the field of IVD reagent raw materials. It was selected as a single champion enterprise in the manufacturing industry of Hubei Province in 2025. The company was founded in 2005 and specializes in the research, development, production, and sales of core products such as blood vessel additives, biological buffering agents, and chemiluminescence reagents. In terms of heparin lithium products, the potency of Desheng heparin lithium is ≥ 150IU/mg. The company adheres to the product concept of "precision, stability, and innovation", and continues to provide high-quality anticoagulant raw materials such as heparin lithium for blood collection tube production enterprises. We are well aware that high-quality raw materials are the foundation of precise testing. Desheng will continue to use a rigorous scientific research attitude and strict quality control to help clinical testing become more accurate and reliable.

1, Why choose Tris when there are so many pH regulators? In the design of industrial ink formulations, the selection of pH regulators may seem simple, but it actually involves balancing multiple technical parameters such as buffering capacity, surface activity, compatibility, and long-term stability. Common pH regulators include ammonia water, triethanolamine (TEA), sodium hydroxide, various Good's buffers, etc. So, what makes Tris buffer stand out as the preferred choice for high-end ink formulations such as inkjet ink and digital printing ink? 2, Tris's molecular structure code: one molecule, two functions The molecular formula of Tris (trihydroxymethylaminomethane) is C ₄ H ₁₁ NO ∝, with a central carbon atom as the core, connecting three hydroxymethyl groups (- CH ₂ OH) and one primary amino group (- NH ₂). This structure endows Tris with a unique dual function: Primary amino (- NH ₂): Provides alkalinity and pH buffering ability, pKa=8.06 (25 ℃), effective buffering range pH 7.0-9.0 Three hydroxymethyl groups (- CH ₂ OH): endow molecules with polarity and surface activity, enabling them to possess both wetting and dispersing functions One molecule plays both the role of pH regulator and surfactant - this is the core reason why Tris is difficult to replace in ink formulations. 3, The Four Major Technical Functions of Tris in Ink 3.1 pH buffering: ensuring long-term stability of ink The pH value of ink directly affects the solubility stability of dyes, the dispersion state of pigments, and the service life of print heads. The effective buffering range of Tris is pH 7.0-9.0-4, which precisely covers the suitable pH range for most industrial inks (usually 6-10). More importantly, the Tris buffer system can continuously maintain pH stability during long-term ink storage - something that volatile bases such as ammonia cannot achieve (ammonia volatilization can cause a continuous decrease in pH). 3.2 Pigment dispersion control: ensuring dispersion effect from the source The synthesis (coupling reaction) stage of pigments is crucial in the production of pigment based inks. Research has shown that when using simple ammonia instead of Tris, appropriate dispersion effects cannot be achieved. The mechanism lies in: The pH will change rapidly during the coupling reaction process Tris, as a pH buffer under alkaline conditions, can inhibit pH mutations Thereby controlling the uniform growth of pigment particles Provide favorable conditions for the adsorption of dispersant polymers on the surface of pigment particles In contrast, Good's buffer with buffering effect in more acidic regions is difficult to achieve appropriate dispersion effect. 3.3 Surface Activity: Improving Wetting and Penetration The three hydroxymethyl groups in Tris molecule give it a certain surface activity. In ink formulations, Tris can: Reduce the surface tension of ink and improve its wettability to printing media Promote the uniform spreading of ink on different media surfaces such as paper, fabric, plastic, etc Improve the clarity and color saturation of printed materials 3.4 Metal ion compatibility: does not interfere with the reaction system Tris does not chelate with common metal ions such as Ca ² ⁺ and Mg ² ⁺, and does not deprive the ink formulation of any metal cofactors that may be required. At the same time, Tris itself does not introduce metal ions such as sodium and potassium, avoiding the problem of metal ion contamination that traditional inorganic bases may cause. 4, Tris vs other pH regulators: Technical parameter comparison Comparison Dimension Tris ammonia water Triethanolamine Sodium hydroxide Buffer Capacity ★★★★★ ★ ★★★ ★ Extremely Low without tall low Nothing surface activity have Nothing have Nothing Introduction of metal ions Nothing Nothing Nothing introduction of Na ⁺ Long term pH stability Excellent Poor good general Recommended addition amount 0.1%-2%- — — —   5, Process suggestions 5.1 Recommended addition amount of Tris According to patent literature, the content of Tris in ink compositions is usually 0.1% to 2% (by mass), preferably 0.3% to 1.5%. The specific amount of addition needs to be determined through experiments based on the initial pH, target pH, and buffering capacity requirements of the ink system. 5.2 Process precautions Dissolving sequence: It is recommended to add Tris in the early stage of ingredient preparation to ensure sufficient dissolution before adding other components PH adjustment: Tris itself is weakly alkaline. If further pH adjustment is needed, it can be used in conjunction with Tris HCl buffer system- Dark storage: Tris buffer is prone to absorbing carbonase-4 from the air, and should be sealed and stored in the dark after preparation Temperature effect: The pKa of Tris varies with temperature (Δ pKa/℃ ≈ -0.031), and pH shift should be noted in high temperature environments Hubei Xindesheng Material Technology Co., Ltd. has been specializing in the research and production of Tris for more than ten years. The product purity is stable at over 99%, with batch differences ≤ 1%, which can meet the consistency and reliability requirements of industrial ink formulations for Tris raw materials. The company has an independent R&D team that can assist customers in formula adaptation and process optimization. We welcome R&D departments of various ink companies to call or write to discuss technical issues.

With the rapid development of in vitro diagnostics (IVD) industry towards real-time and convenient direction, dry chemistry method has been increasingly widely used in the field of blood lipid detection due to its advantages of easy operation, small sample size, and fast results. As an important member of the new Trinder's reagent, MAOS (N-ethyl-N - (2-hydroxy-3-sulfopropyl) -3,5-dimethylaniline sodium salt monohydrate) plays a crucial role in color development in this technical pathway. 1, Basic principles of dry chemical method for blood lipid testing Dry chemistry method uses solid-phase reagent technology to solidify chemical reagents onto a carrier. Taking blood lipid testing as an example, when a blood sample is dropped onto the test strip sampling area, lipid components such as cholesterol and triglycerides in the sample are oxidized by corresponding enzymes, producing hydrogen peroxide (H ₂ O ₂). H ₂ O ₂ undergoes oxidative coupling reaction with chromogenic substrates under the catalysis of peroxidase (POD), generating colored dyes. The analyzer can quantitatively calculate the content of the analyte by detecting the color intensity of the reaction endpoint. 2, The mechanism of MAOS in blood lipid test strips MAOS is a highly water-soluble derivative of aniline sodium salt, which participates in color development as a hydrogen donor in the Trinder reaction. Under the catalysis of peroxidase, MAOS undergoes oxidative coupling reaction with 4-aminoantipyrine (4-AAP) to produce a green blue colored substance. The intensity of this colorimetric reaction is directly proportional to the concentration of the target substance in the sample, which is the basis for achieving quantitative detection. At present, there are multiple lipid testing products in China that use dry chemistry methods and incorporate MAOS into the core reaction system. For example, in the approved blood lipid multi assay kit (dry chemistry method), the reaction layers of high-density lipoprotein cholesterol (HDL-C), triglycerides (TG), and total cholesterol (TCH) all contain MAOS (20mmol/L). The total cholesterol test strip (dry chemistry) also uses MAOS as the core color developing component. The market registration and clinical application of these products have verified the feasibility and reliability of MAOS in dry chemical blood lipid testing. 3, The technical advantages of MAOS applied to blood lipid test strips The reason why MAOS can play a good role in blood lipid test strips is mainly based on the following technical characteristics: High absorption wavelength effectively reduces interference. The maximum absorption wavelength of MAOS oxidation products can reach 630nm. The absorption wavelength of endogenous interfering substances such as bilirubin in blood samples is mainly concentrated in the visible light range of 380-530nm. The absorption wavelength of MAOS products precisely avoids this range, which can effectively reduce the interference of complex components in the sample on the detection results, especially suitable for blood lipid detection projects that require high accuracy. High color sensitivity, suitable for trace detection. MAOS has a high molar absorption intensity and high detection sensitivity, and can quickly develop color under low concentration target conditions. This characteristic enables it to meet the sensitivity requirements of dry chemical methods for color reactions. Wide pH adaptability range ensures enzyme activity. The color reaction of MAOS has a wide adaptability range to the pH of the reaction system. Blood lipid testing involves various enzymes such as cholesterol esterase, cholesterol oxidase, peroxidase, etc., and the activity of these enzymes is sensitive to the pH of the reaction environment. The wide pH adaptability of MAOS helps maintain the catalytic activity of various enzymes and ensures the accuracy of detection results. High water solubility, suitable for solid phase carriers. As a highly water-soluble derivative of aniline, MAOS has good solubility. In the preparation process of dry chemical test strips, reagents need to be impregnated or coated on a carrier in solution form and dried and cured. The high water solubility of MAOS contributes to its uniform distribution and effective fixation on solid-phase carriers. Hubei Xindesheng Material Technology Co., Ltd. is deeply engaged in the field of IVD reagent raw materials and has nearly 20 years of research and production experience. The purity of MAOS chromogenic substrate produced by the company is ≥ 99%, and the product appearance is pure white crystal powder with good water solubility and stable process. The product has been widely used in various types of in vitro diagnostic kits. The company has two R&D and production bases in Gedian and Huanggang (70 acres), with an annual production capacity of 5000 tons for all categories.