1.Discussion on Scientific Connotation of Vital Qi Strengthening for Detoxification Therapy in Treatment of Community-acquired Pneumonia Based on Theory of "Vital Qi Deficiency and Toxic Stasis"
Hanxiao WANG ; Zheyu LUAN ; Haotian XU ; Xin PENG ; Ziming DANG ; Kun YANG ; Qianqian WANG ; Jihong FENG
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):226-234
Community-acquired pneumonia (CAP) refers to an infectious inflammation of the lung parenchyma (including the alveolar wall,that is,the broad pulmonary interstitium) acquired outside the hospital. Its common pathogens include streptococcus pneumoniae,respiratory viruses, mycoplasma pneumoniae, and so on. The related factors for the occurrence and development of CAP include patient characteristics (immune function,mucus production and clearance function,coagulation function,physical condition, and comorbidity) and pathogen characteristics (susceptibility,virulence,and antibiotic resistance). The pathogenesis of CAP lies in immune deficiency,pathogen invasion,inflammatory response disorder,mucus production and clearance disorder, coagulation disorder, and so on. The pathogenesis of CAP in traditional Chinese medicine can be described as "vital Qi deficiency and toxic stasis". Vital Qi deficiency (lack of immunity) is the potential pathogenesis of the disease and easy to be invaded by external pathogens (respiratory pathogens). Toxic stasis (inflammatory disorder,mucus production and clearance disorder,and coagulation dysfunction) is the key pathogenic factor. Vital Qi deficiency and toxic stasis are intermingled in a state of deficiency and excess,which suggests that the treatment of CAP lies in strengthening vital Qi and eliminating pathogenic factors. This involves strengthening vital Qi in the whole process to consolidate body resistance and nourish promordial Qi. It also involves clearing heat,eliminating phlegm,removing dampness,and dispelling stasis to dispel pathogenic toxins based on the syndrome differentiation. Its action mechanism is to regulate immune and inflammatory responses,resist pathogens,and improve mucus production and clearance, as well as coagulation disorders. Starting from the key pathogenesis of CAP,"vital Qi deficiency and toxic stasis", this paper discussed the pathogenesis of CAP and summarized the action mechanism of vital Qi strengthening for detoxification in its treatment. It is intended to complement the theoretical system by identifying "vital Qi deficiency and toxic stasis" as the key pathogenesis underlying CAP and the scientific connotation of treating CAP with vital Qi strengthening for detoxification,thereby providing insights for its clinical application.
2.Active Ingredients of Traditional Chinese Medicine Regulate Ferroptosis to Inhibit Breast Cancer: A Review
Yan LIU ; Zhenyao YANG ; Chengzhi WANG ; Jiuxian LI
Chinese Journal of Experimental Traditional Medical Formulae 2026;32(4):299-306
Breast cancer (BC), a common malignant tumor in women, is characterized by high incidence and mortality rates, posing a serious threat to women's life and health. Currently, the commonly used treatments for BC include surgery, radiotherapy, chemotherapy, molecular targeted therapy, and endocrine therapy. Although radiotherapy and chemotherapy can effectively kill tumor cells and inhibit the proliferation and differentiation of tumor cells, they can induce adverse reactions such as hematopoietic dysfunction and impaired immune function. The other treatment methods also have problems such as drug resistance, high recurrence rates, reduced quality of life, and poor clinical efficacy. Therefore, it is urgent to explore new drugs with better efficacy and lower toxicity. Ferroptosis is a form of iron-dependent, non-apoptotic programmed cell death triggered by lipid peroxidation. In recent years, ferroptosis has become a hot topic in the field of cancer treatment and has been gradually proven to effectively inhibit the proliferation and metastasis of BC cells, reduce the drug resistance of BC to chemotherapy drugs, and enhance the sensitivity of BC to radiotherapy. Traditional Chinese medicine (TCM), with multiple components, multiple targets, and mild side effects, is widely used in the treatment of BC. A large number of studies have shown that active ingredients of TCM, such as saponins, flavonoids, terpenoids, phenols, and polysaccharides, can inhibit the proliferation and metastasis of BC cells by modulating ferroptosis-related pathways. These include iron metabolism, lipid metabolism, cystine/glutamate antiporter system Xc-/glutathione/glutathione peroxidase 4, Specifically, these ingredients elevate the levels of lipid peroxidation, reactive oxygen species, malondialdehyde, and Fe2+ in BC cells, thereby inducing ferroptosis-mediated suppression of tumor progression. This article reviews the relevant literature at home and abroad in recent years, summarizes the mechanisms of ferroptosis in regulating BC and the research progress in the active components of TCM targeting ferroptosis in the intervention of BC, aiming to provide ideas for the development of new drugs for the treatment of BC.
3.Ameliorative effects and mechanisms of Buyang huanwu decoction and its active fractions on non-alcoholic fatty liver disease
Jinbiao YANG ; Xingtong CHEN ; Yunyue ZHOU ; Ruihong YANG ; Qiao WANG ; Shuang XUE ; Yukun ZHANG ; Wenying NIU
China Pharmacy 2026;37(3):299-304
OBJECTIVE To investigate the effects and mechanisms of Buyang huanwu decoction (BYHWD) and its active fractions in ameliorating non-alcoholic fatty liver disease. METHODS BYHWD and its effective fractions obtained through ethanol precipitation, as well as 30% ethanol, 50% ethanol, and 75% ethanol fractions (namely, the CC effective fraction, 30YC effective fraction, 50YC effective fraction, and 75YC effective fraction), were prepared. These preparations were administered to rats via intragastric administration to prepare corresponding drug-containing serum (blank serum and simvastatin-containing serum were prepared using the same protocol). Human L02 hepatocytes were divided into control group, model group, simvastatin-containing serum group, BYHWD-containing serum group, CC-containing serum group, 30YC-containing serum group, 50YC-containing serum group, and 75YC-containing serum group. Except for the control group, other groups were given 0.2 mol/L oleic acid for 24 h to induce a lipid accumulation model, and then intervened with 20% drug-containing serum/blank serum for 24 h. The lipid deposition in cells was observed, and the proportion of lipid droplet area was calculated; the levels of triglycerides (TG) and indicators of oxidative stress [malondialdehyde (MDA), superoxide dismutase (SOD)] as well as liver function [alanine amino- transferase (ALT), aspartate amino-transferase (AST)] in cells were detected; protein and mRNA expressions of AMP-activated protein kinase (AMPK)/sterol regulatory element-binding protein-1 (SREBP-1)/glycerol-3-phosphate acyltransferase (GPAT) signaling pathway were also measured. RESULTS Compared with the control group, cells in the model group exhibited severe cellular steatosis, with a significantly increased proportion of lipid droplet area, as well as the elevated levels of TG, ALT, AST, and MDA in cells, along with significantly up-regulated mRNA and protein expression levels of SREBP-1 and GPAT (P<0.05). The level of SOD, mRNA expression of AMPK, as well as the protein phosphorylation level of AMPK were decreased significantly (P<0.05). Compared with the model group, cellular steatosis was alleviated in all drug-containing serum groups, and the levels of most of the aforementioned quantitative indicators were significantly reversed (P<0.05). CONCLUSIONS BYHWD and its active fractions can exert a therapeutic effect on improving non-alcoholic fatty liver disease by regulating the AMPK/SREBP-1/GPAT signaling pathway, inhibiting oxidative stress responses, and reducing lipid deposition.
4.Mechanism of drug-containing serum of Dianxianqing granules in inhibiting microglial ferroptosis
Guangkun FAN ; Yue QI ; Jixian WANG ; Wei CHEN ; Chunpeng XIA ; Yihang WANG ; Yue ZHAO ; Yang AN
China Pharmacy 2026;37(3):317-323
OBJECTIVE To explore the potential mechanism by which drug-containing serum of Dianxianqing granules (DXQ) inhibits microglial ferroptosis. METHODS Male SD rats were given normal saline and Dianxianqing granules solution via intragastric administration to prepare normal serum and DXQ, respectively. Mice microglia BV2 cells were collected and successfully transfected with a negative control small interfering RNA (si-NC), and then they were included in the si-NC group and cultured under normal conditions. Cells successfully transfected with small interfering RNA targeting glutathione peroxidase 4 (GPX4) (si-GPX4) were divided into the si-GPX4 group, the CsA group (treated with 1 μmol/L cyclosporine A), and the DXQ- L, DXQ-M and DXQ-H groups (treated with 5%, 7% and 10% DXQ, respectively). These groups were subsequently treated with their corresponding drug solutions and ferroptosis inducer Erastin (10 μmol/L). The intracellular levels of total iron ions, glutathione (GSH), reactive oxygen species (ROS), and the expression of mitochondrial superoxide were determined in each group after 48 h of treatment. Additionally, mitochondrial membrane potential, the opening degree of mitochondrial permeability transition pore (MPTP), and mRNA expressions of GPX4 and cyclophilin D (CypD) were detected. Furthermore, the expressions of ferroptosis-related proteins[GPX4, transferrin receptor 1 (TfR1) and ferritin heavy chain 1 (FTH1)], as well as MPTP-related proteins [adenine nucleotide translocator (ANT), cytochrome C (CytC), mitochondrial calcium uniporter (MCU) and CypD] were assessed. RESULTS Compared with si-NC group, the levels of total iron ions and ROS, the expression level of mitochondrial superoxide, the opening degree of MPTP, protein and its mRNA expressions of CypD as well as protein expressions of TfR1 and MCU were increased or up-regulated significantly (P<0.01); however, GSH content, mitochondrial membrane potential, protein and mRNA expressions of GPX4, and protein expressions of FTH1, ANT and CytC were decreased or down-regulated significantly (P<0.01). Compared with the si-GPX4 group, the cells in the DXQ-M, DXQ-H groups showed a general improvement in the above quantitative indicators (P<0.01 or P<0.05). CONCLUSIONS DXQ can enhance antioxidant capacity by activating the GSH/GPX4 pathway, regulate the expressions of TfR1 and FTH1 protein to correct iron ion homeostasis, inhibit excessive opening of MPTP to improve mitochondrial function, and ultimately suppress microglial ferroptosis.
5.Quality evaluation of Qingwen hufei granules based on fingerprints combined with multi-component content determination
Huiying ZHOU ; Yuan WANG ; Yani WANG ; Yun YANG ; Bo WANG ; Shuanzhu YANG ; Liping CAO ; Hong ZHANG ; Kaihua LONG
China Pharmacy 2026;37(3):338-343
OBJECTIVE To provide a scientific basis for the quality evaluation and clinical application of Qingwen hufei granules. METHODS Fourteen batches of Qingwen hufei granules were used as samples to establish high-performance liquid chromatography (HPLC) fingerprints using the Similarity Evaluation System for Chromatographic Fingerprint of Traditional Chinese Medicine (2012 Edition). The chromatographic peaks were identified and the similarity was evaluated. Cluster analysis (CA), principal component analysis (PCA), and orthogonal partial least squares-discriminant analysis (OPLS-DA) were used to conduct chemical pattern recognition analysis on the 14 batches of samples. Meanwhile, the contents of neochlorogenic acid (NGA), chlorogenic acid (CHA), cryptochlorogenic acid (CGA), forsythoside A (FTA), 3,5-O-dicaffeoylquinic acid (3,5-O- DA), 4,5-O-dicaffeoylquinic acid (4,5-O-DA), and angoroside C (AGC) in the samples were determined by HPLC. RESULTS The methodological investigation results of both the fingerprint and the content determination complied with the relevant requirements. Fourteen common peaks were indicated in the HPLC fingerprints of the 14 batches of samples, and 7 of them were identified [NGA (peak 2), CHA (peak 3), CGA (peak 5), FTA (peak 11), 3,5-O-DA (peak 12), 4,5-O-DA (peak 13), and AGC (peak 14)]; the similarity of each sample was greater than 0.94. The results of CA and PCA showed that the samples could be classified into 3 categories; the results of OPLS-DA indicated that peak 4 (unknown), peak 11 (FTA), peak 8 (unknown), peak 9 (unknown), and peak 1 (unknown) were the differential components. The content ranges of NGA, CHA, CGA, 3,5-O-DA, FTA, 4,5-O-DA and AGC in the 14 batches of samples were 0.210 4-0.458 7, 0.269 1-0.506 3, 0.228 1-0.461 1, 0.443 9-1.044 6, 0.066 7-0.155 7, 0.062 8-0.143 8, and 0.057 4-0.105 7 mg/g, respectively. CONCLUSIONS The HPLC fingerprint and multi-component content determination methods established in this study are efficient and reliable, and can be used for the quality evaluation of Qingwen hufei granules.
6.Impact of X-ray irradiation on stored platelets and their mitochondrial function
Na WANG ; Ning AN ; Xiaoying WANG ; Dongyan YANG ; Xiaole ZHANG ; Yajuan WANG ; Jie CHEN ; Xingbin HU ; Chen CHEN
Chinese Journal of Blood Transfusion 2026;39(1):16-23
Objective: To investigate the effects of clinical routine X-ray irradiation dose (average irradiation dose: 29.7±0.54 Gy) on the function, apoptosis, activation state and mitochondrial function of platelets during in vitro storage, so as to provide experimental evidence for optimizing platelet irradiation strategies. Methods: A paired experimental design was adopted. Platelets were collected from 12 healthy donors, and each sample was equally divided into the irradiated group and the control group (non-irradiated). All samples were stored for 5 days under standard platelet preservation conditions (22±2℃, continuous oscillation). Flow cytometry was used to detect platelet count, apoptosis rate (Annexin V+ positive rate), activation markers (CD62P, PAC-1, CD42b) and reactive oxygen species (ROS) level. Meanwhile, mitochondrial-specific probes were used to evaluate changes in mitochondrial count, membrane potential and adenosine triphosphate (ATP) content. Additionally, transmission electron microscopy (TEM) was employed to observe the ultrastructure of platelets, with a focus on mitochondrial morphology, platelet membrane integrity and granule distribution. Results: Within 5 days of storage, the platelet count was (841±89.16)×10
/L in the irradiated group and (824.5±92.88)×10
/L in the control group, with no statistically significant difference between the two groups (P=0.54). The apoptosis rate was (4.94±1.39) % in the irradiated group and (5.50±0.83) % in the control group, showing no significant difference (P=0.31). For activation indicators, the CD62P expression rate was (24.32±7.57) % in the irradiated group versus (25.21±8.13) % in the control group (P=0.43). The PAC-1 positive rates were (12.15±4.43) % and (11.75±3.40) % in the irradiated group and control group, respectively (P=0.44). The CD42b expression rates were (12.14±4.43) % and (11.75±3.4) % in the two groups, respectively (P=0.47). The ROS levels were (31.98±8.1) % and (30.64±5.89) % in the two groups, respectively (P=0.45). No significant differences were found in the above indicators. For mitochondrial function indicators, the mitochondrial count was (55.88±11.49) % in the irradiated group and (53.5±7.24) % in the control group (P=0.57). The ATP contents were (42.45±5.29) % and (41.58±9.50) % in the irradiated group and control group, respectively (P=0.77). The relative membrane potential values were (59.53±10.89) % and (57.49±6.54) % in the two groups, respectively (P=0.47). No significant difference were observed on the mitochondrial function-related indicators. TEM further confirmed that the ultrastructure of platelets in the irradiation group was intact, the mitochondrial morphology was normal, and no pathological changes such as swelling or vacuolization were observed. Conclusion: This study evaluated the impact of conventional-dose X-ray irradiation on platelet storage quality, confirming that this dose does not significant impair platelet count, apoptosis rate, activation status, or mitochondrial function. This finding provides important experimental evidence for the clinical promotion of X-ray irradiation technology and suggests its potential as a safe alternative to γ irradiation. Future studies could further expand the sample size and extend the observation period to verify the effects of X-ray irradiation on long-term platelet storage and post-transfusion in vivo survival rate.
7.Perioperative immune dynamics and clinical outcomes in patients undergoing on-pump cardiac surgery
Zhiyuan CHENG ; Xinyi LIAO ; Juan WU ; Ping YANG ; Tingting WANG ; Qinjuan WU ; Wentong MENG ; Zongcheng TANG ; Jiayi SUN ; Jia TAN ; Jing LIN ; Dan LUO ; Hao WANG ; Chaonan LIU ; Jiyue XIONG ; Liqin LING ; Jing ZHOU ; Lei DU
Chinese Journal of Blood Transfusion 2026;39(1):31-43
Objective: To characterize perioperative dynamic changes in immune-cell phenotypes and inflammatory cytokines in patients undergoing CPB (cardiopulmonary bypass) cardiac surgery, and to explore their associations with postoperative outcomes. Methods: In this prospective cohort study, 120 adult patients who underwent elective cardiac surgery under CPB at West China Hospital from May 2022 to March 2023 were enrolled. Perioperative immune-cell phenotypes and concentrations of 40 inflammation-related cytokines were measured. The primary outcomes were the sequential organ failure assessment (SOFA) score at 24 h after surgery and ΔSOFA (the peak SOFA score within 48 h after surgery minus the preoperative SOFA score). Secondary outcomes included major adverse cardiovascular events (MACE), acute kidney injury (AKI), respiratory failure, severe liver injury, and infection. Results: The mean age of enrolled patients was 57±10 years. Of these, 52% (62/120) were male and 90% (108/120) underwent valve surgery. During the rewarming to the end of CPB, neutrophil counts rapidly increased (7.39×10
/L vs preoperative 3.07×10
/L, P<0.001), with significant upregulation of CD11b (7.30×10
/L vs preoperative 3.05×10
/L, P<0.001) and CD54 (7.15×10
/L vs preoperative 2.99×10
/L, P<0.001). Lymphocyte counts increased at the end of CPB (1.75×10
/L vs preoperative 1.12×10
/L, P<0.001) but decreased significantly at 24 h after surgery (0.59×10
/L vs preoperative 1.12×10
/L, P<0.001). Plasma analysis showed that multiple pro-inflammatory cytokines increased during CPB and remained elevated up to 24 h after surgery; five chemokines and the anti-inflammatory cytokine IL-10 peaked at the end of CPB. The SOFA score increased from 1 (1, 2) preoperatively to 7 (5, 10) at 24 h after surgery, with a ΔSOFA of 6 (4, 8). Within 30 days after surgery, 48 patients (40.0%) developed AKI, 17 (14.2%) developed infection, 4 (3.3%) developed severe liver injury, 3 (2.5%) developed respiratory failure, and 3 (2.5%) experienced MACE. During the 2-year follow-up, 8 patients (6.7%) experienced MACE and 5 (4.2%) died. Conclusion: Multi-organ dysfunction is common after cardiac surgery under CPB (median ΔSOFA, 6), accompanied by perioperative activation of multiple immune-cell subsets and upregulation of pro-inflammatory, anti-inflammatory, and chemotactic mediators. This study provides data-driven evidence and research clues for further investigation of the associations between CPB-related immune perturbations and postoperative organ dysfunction and clinical outcomes.
8.Analysis of factors influencing temporary deferral and return to donation due to abnormal blood pressure in pre-donation screening
Jin YANG ; Li SUN ; Qiyong BI ; Jingyao WANG ; Yong WANG
Chinese Journal of Blood Transfusion 2026;39(1):56-61
Objective: To analyze the demographic characteristics, return donation patterns, and risk of adverse reactions among donors temporarily deferred due to blood pressure abnormalities, so as to provide an evidence-based foundation for optimizing pre-donation blood pressure screening strategies, enhancing donor retention, and ensuring blood supply safety. Methods: Data from 2.939 million donor instances were collected through the Information Management System at the Beijing Red Cross Blood Center between January 2015 and August 2025. The analysis specifically focused on the 11 600 instances of donors temporarily deferred due to abnormal blood pressure, examining demographic characteristics (age, and gender) and donation-related features (number of donations, donation site, and type of donation). Further analysis was conducted on the return donation patterns, including the return rate, time interval to return, and the incidence, type, and severity of adverse reactions among returned donors. Results: Distribution of abnormal blood pressure: Among the 11 600 instances of abnormal blood pressure, the prevalence was significantly higher in males (0.48%, 10 111/2 086 909) than in females (0.17%, 1 465/852 090). The 46-55 age group had the highest prevalence (0.88%, 2 925/329 235), and the differences across age groups were statistically significant. The prevalence was, higher among repeat donors (0.41%, 5 242/1 276 452) than first-time donors (0.38%, 6 334/1 662 547). The prevalence at mobile donation sites outside the blood center (0.06%, 350/596 104) was higher than fixed donor centers (0.50%, 10 225/2 052 290) and group donation drives (0.34%, 1 001/290 608). Return donations: A total of 19.49% (2 256 out of 11 576) deferred donors returner and successfully donated. Among these donors, 36.17% (816 out of 2 256) returned within 7 days, while the highest proportion of returns was observed within 31-182 days (25.44%, 574/2 256). A higher return rate was observed among male donors (20.17%, 2 039/1 0111) compared to female donors (14.81%, 217/1 465). The return rate for repeat donors (43.02%, 2 255/5 242) was significantly higher than that of first-time donors (0.02%, 1/6 334). Individual donors showed a higher return rate (20.95%, 1 986/9 479) than group donors (12.88%, 270/2 097), with all differences being statistically significant (P<0.05). The differences in return rates across age groups were not statistically significant (P>0.05). Adverse reactions: The incidence of adverse reactions after return was 0.09% (2/2 256), significantly lower than the overall adverse reaction incidence during the same period (0.20%, 5 981/2 938 999). Both adverse reactions were local reaction (category A1, pain or bruising at the puncture site), with no reported cases of systemic vasovagal reactions (VR) or severe adverse events. Conclusion: The current blood pressure screening criteria may lead to the unnecessary deferral of eligible donors. The risk of adverse reactions is extremely low among returned donors who were deferred for abnormal blood pressure. A relaxation of the blood pressure screening criteria is therefore suggested, coupled with the optimization of donation site environment and blood pressure measurement procedure with reference to expert consensus to enhance donor retention and blood supply safety.
9.Analysis of high-frequency plateletpheresis on age-dependent bone metabolism in female donors
Huibin ZHONG ; Huaheng LI ; Wei YANG ; Jieting HUANG ; Zhen WANG ; Fenfang LIAO ; Yongmei NIE
Chinese Journal of Blood Transfusion 2026;39(1):97-102
Objective: To explore whether the long-term and frequent use of citrate anticoagulants negatively affects the bone metabolism balance of female frequent plateletpheresis donors, so as to better protect their health. Methods: A total of 65 female plateletpheresis donors and 55 female whole-blood donors from Guangzhou Blood Center (May to December 2024) were enrolled as experimental and control groups respectively, stratified into age subgroups (18-39 years and 40-60 years). Serum levels of 25-hydroxyvitamin D [25(OH)D], procollagen type I N-terminal propeptide (PINP), osteocalcin (OC), and type I collagen carboxy-terminal telopeptide (CTX) were measured. Differences in bone metabolism markers between experimental and control groups across age subgroups were compared. ANOVA was used to analyze dose-response relationships between donation age, annual apheresis donation frequency, and biochemical indicators. Results: In the 40-60 age subgroup, 25(OH)D levels were significantly lower in the experimental group (P<0.05), exhibiting a linear increase with age and a linear decrease with annual donation frequency. No significant differences in CTX or PINP levels were observed between experimental and control groups in either age subgroup. Conclusion: High-frequency plateletpheresis donation does not disrupt bone metabolic balance in female donors. However, it is associated with reduced vitamin D levels in female donors aged >40 years, potentially increasing the risk of osteoporosis. Vitamin D supplementation is recommended for high-frequency female plateletpheresis donors in this age group.
10.Preliminary study on an improved method for constructing internal quality control framework of ELISA
Youbin DUAN ; Rui WANG ; Le CHANG ; Changwen QIU ; Zhiqiang LI ; Gengrui CHEN ; Jingjuan YANG ; Qing HE ; Lunan WANG
Chinese Journal of Blood Transfusion 2026;39(1):103-108
Objective: To propose an improved method for constructing the internal quality control (IQC) framework for ELISA assays and validate its efficacy by statistically analyzing IQC data from nine blood center laboratories. Methods: 1) IQC data was collected from nine blood centers and analyzed using a domestic HBsAg ELISA detection kit as an example. 2) Differences between IQC values across batches within Blood Center 1 were assessed. 3) Statistical analyses were performed on batch usage, number of batches used, days of use, number of QC points, batch-specific means, and coefficients of variation (CV) across all nine centers. 4) Using the improved construction method for IQC framework, provisional and permanent frames were established for batches within Blood Center 1 and Blood Center 9, followed by outlier determination. Results: 1) Statistically significant differences were observed in IQC data between batches within Blood Center 1 (P<0.01). It is recommended that both the control material/reagents and the control chart framework be replaced simultaneously. 2) There were substantial differences among 9 blood centers regarding the control material/reagent lot numbers used, the number of QC runs per batch, and the QC values for identical lots. Therefore, individual laboratories should establish their own IQC chart frameworks. 3) The improved IQC framework construction method for ELISA assays is as follows: provisional frames are established via frame-shifting, using the pre-experimental mean and cumulative coefficient of variation (CV) from the preceding batch. For batches used >20 days with >20 QC points, permanent frames are constructed by aggregating in-control data accumulated over ≥20 days with ≥20 points to calculate cumulative mean and standard deviation. The provisional and permanent frames constructed by this method identified all 26 extreme outliers across Blood Centers 1 and 9 as out-of-control. Among the 218 general outliers, 10 were classified as normal by the provisional frames, while the remainder were designated as warnings or out-of-control. This method effectively monitors assay stability. Conclusion: Based on the statistical analysis of IQC practices across blood centers of varying scales, combined with the inherent characteristics of ELISA assays and the batch-to-batch instability of reagents/QC materials, it is recommended to reconstruct QC charts upon lot changes. The proposed method—utilizing frame-shifting for provisional frames and establishing permanent frames based on cumulative data—is applicable to blood center laboratories of differing sizes and effectively monitors the stability of the ELISA assay process.

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