1.Clinical Effect and Imaging Evaluation of Tendon-Management and Patella-Movement Therapeutic Manipulation for Patellofemoral Arthritis:A Randomised Controlled Trial
Jinguang GU ; Guangcheng WEI ; Yong ZHAO ; Yongli DONG ; Zechuan ZHUO ; Aolin SUN ; Weikai QIN
Journal of Traditional Chinese Medicine 2025;66(13):1350-1356
ObjectiveTo evaluate the therapeutic effect and mechanism of tendon-management and patella-movement therapeutic manipulation in the treatment of patellofemoral arthritis based on imaging evaluation. MethodsTotally 126 patients with patellofemoral arthritis were recruited and divided into a treatment group and a control group according to a randomised numerical table. The control group received routine sodium hyaluronate injection once a week for a total of 5 times; the treatment group received tendon-management and patella-movement therapeutic manipulation three times a week for four weeks. We compared the Western Ontario and McMaster University osteoarthritis index score (WOMAC), visual analogue scale (VAS), imaging indicators including patellar external displacement distance, patellofemoral fit angle, lateral patellofemoral angle, and patellofemoral index, and overall effectiveness evaluation between the two groups before and one week after treatment. ResultsThe total effective rate of the treatment group (45/54, 83.33%) was significantly higher than that of the control group (36/54, 66.67%,P<0.05). One week after the end of treatment, the VAS scores and WOMAC scores of both groups were lower than those before treatment in the same group (P<0.01), and the patellofemoral index and patellofemoral fit angle of the treatment group decreased compared with that of the control group (P<0.05). Compared with the pre-treatment, the distance of patellar external displacement, patellofemoral index, and patellofemoral fit angle decreased in the treatment group 1 week after the end of treatment, and the patellofemoral fit angle decreased in the control group (P<0.05). ConclusionThe therapeutic manipulation of tendon-management and patella-movement can correct the degree of patellar external displacement, alleviate joint pain symptoms, improve joint function, and achieve the goal of treating patellofemoral arthritis.
3.Early clinical outcomes of 3D-printed individualised customised prostheses in hip revision combined severe bone defect.
Hong-Ping WANG ; Ming-You WANG ; Xiao-Qin YANG ; Zhuo-Dong TANG ; Xun-Zhou SONG ; Yu-Ping LAN
China Journal of Orthopaedics and Traumatology 2025;38(2):163-169
OBJECTIVE:
To explore the early clinical outcomes of 3D printed individualised customised prostheses for in hip revision in patients with combined severe bone defects.
METHODS:
Twenty-two patients from January 2021 to May 2023 underwent hip revision using 3D printed personalised customised prostheses were retrospective analyzed, including 10 males and 12 females, age 28 to 78 with a mean of (58.9±12.8) years old. All of patients were combined with severe bone defects (Parprosky type Ⅲ). Among of them, 9 patients had periprosthetic infections and 13 patients had aseptic prosthesis loosening. All patients were treated with a 3D printed personalised prosthesis protocol, patients with the periprosthetic infection received a second stage revision after infection control. The operation time, preoperative waiting time, intraoperative and postoperative complications were recorded, and the clinical efficacy were evaluated at the final follow-up using the visual analogue scale (VAS) for pain, the Harris hip score.
RESULTS:
One patient was lost to follow-up and the remaining 21 patients were followed up for 10 to 15 with a mean of (12.91±1.44) months after surgery. All patients completed surgery as planned, with an operative time of 135 to 390 with a mean of (165.4±39.3) minutes and a preoperative waiting time of 7 to 16 with a mean of (10.5±3.3) days. Regarding patient complications:one patient had a severe intraoperative periprosthetic femoral fracture due to the combination of severe osteoporosis; one patient had an intraoperative greater trochanteric femur fracture. At the latest follow-up, all patients had good position of the custom-made prosthesis and no loosening of the prosthesis;all patients had good wound healing and no local redness or swelling. The total Harris score at the final follow-up (85.86±7.04) was significantly improved compared to the preoperative (44.86±2.36), P<0.001. The VAS at the last follow-up (2.19±0.87) was significantly improved compared with preoperative (7.41±0.96), P<0.001.
CONCLUSION
The clinical efficacy of 3D-printed personalised customised prosthesis in combined severe bone defect hip revision is satisfactory, but due to the increased preoperative waiting time of the patients and certain risks, certain indications should be mastered when applying in the clinic.
Humans
;
Male
;
Female
;
Printing, Three-Dimensional
;
Middle Aged
;
Aged
;
Adult
;
Retrospective Studies
;
Hip Prosthesis
;
Arthroplasty, Replacement, Hip
;
Reoperation
;
Prosthesis Design
;
Treatment Outcome
4.Predictive value of preoperative inflammatory response indicators for incisional infection after spinal surgery.
Wei LIANG ; Rui-Li ZHUO ; Shao-Dong SUN
China Journal of Orthopaedics and Traumatology 2025;38(2):183-187
OBJECTIVE:
To explore the clinical significance of preoperative neutrophil to lymphocyte ratio (NLR), platelet to lymphocyte ratio (PLR), and C-reactive protein (CRP) to albumin (ALB) ratio in spinal surgery patients with postoperative incision infection.
METHODS:
A total of 373 patients who underwent spinal surgery were collected and devided into two groups according to the postoperative incision infection situation. Among them, 65 cases in the incision infection group included 34 males and 31 females with a mean age of (56.01±9.78) years old;308 cases in the non incision infection group included 157 males and 151 females with a mean age of (55.54±10.19) years old. Blood cell analyzer was applied to detect neutrophils, lymphocytes, and platelets, and calculate NLR and PLR;immunoturbidimetry was applied to measure serum CRP and ALB levels and calculate CRP/ALB ratio;receiver operating characteristic (ROC) curve was applied to analyze the predictive value of preoperative NLR, PLR, and CRP/ALB ratio for postoperative spinal incision infection;Logistic multivariate regression was applied to analyze the influencing factors of incision infection after spinal surgery.
RESULTS:
The NLR(4.92±1.13), PLR (119.32±22.74), CRP/ALB ratio (10.19±2.51), operation time (3.02±0.64) h, history of diabetes 38.46%(25/65), and the proportion of patients with implant 32.31%(21/65) in the incision infection group were higher than those in the non incision infection group 3.72±0.81, 90.58±20.16, 7.23±2.21, (2.26±0.51) h, 16.88%(53/308), 11.69%(36/308), there were statistical differences(P<0.05). The AUC of preoperative NLR, PLR, and CRP/ALB ratio alone and in combination for predicting postoperative incision infection after spinal surgery was 0.786, 0.806, 0.839, and 0.926, respectively. Preoperative NLR, PLR, and CRP/ALB ratio were independent risk factors for postoperative incision infection in spinal surgery(P<0.05).
CONCLUSION
The determination of preoperative NLR, PLR, and CRP/ALB ratio is beneficial for early prediction of postoperative spinal incision infection, and the combined detection of the three can further improve the accuracy of the prediction results.
Humans
;
Male
;
Female
;
Middle Aged
;
Aged
;
C-Reactive Protein/metabolism*
;
Surgical Wound Infection/etiology*
;
Adult
;
Spine/surgery*
;
Inflammation
;
Preoperative Period
5.Comparison of application and efficacy of domestic HURWA and imported Smith & Nephew Cori robots in total knee arthroplasty.
Ming-You WANG ; Zhuo-Dong TANG ; Yu-Ping LAN ; Heng XIAO ; Ming-Li WANG ; Xun-Zhou SONG ; Hong-Ping WANG
China Journal of Orthopaedics and Traumatology 2025;38(10):1027-1036
OBJECTIVE:
Investigation on the clinical application of HURWA robot and Smith & Nephew Cori robot in total knee arthroplasty(TKA).
METHODS:
A retrospective analysis was performed on 84 patients with knee osteoarthritis who underwent robotic-assisted TKA (RATKA) between June 2023 and March 2025. According to the different robotic systems used, the patients were divided into the domestic HUARUN robotic-assisted total knee arthroplasty group (HRATKA group) and the Smith & Nephew Cori robotic-assisted total knee arthroplasty group (CRATKA group). There were 42 patients in the HRATKA group, including 16 males and 26 females; the age ranged from 56 to 73 years old, with an average of (64.70±8.30) years old;the body mass index (BMI) was (25.10±2.30) kg·m-2;21 cases were on the right side and 21 cases on the left side;in terms of Kellgren-Lawrence(K-L) classification, there were 15 cases of Grade Ⅲ and 27 cases of Grade Ⅳ;the disease duration ranged from 3 to 25 years, with an average of (15.5±7.5) years. The CRATKA group also included 42 patients, with 14 males and 28 females;the age ranged from 58 to 74 years old, with an average of (65.60±7.50) years old;the BMI was (24.50±2.70) kg·m-2; 20 cases were on the right side and 22 cases on the left side;regarding K-L classification, there were 11 cases of Grade Ⅲ and 31 cases of Grade Ⅳ;the disease duration ranged from 2 to 26 years, with an average of (16.5±8.8) years. Collect general data of all patients, including age, gender, height, weight, surgical site, K-L classification, incision length, and operation time. To evaluate prosthesis position, compare the frontal tibia component (FTC) angle, lateral femoral component (LFC) angle, lateral tibia component (LTC) angle, and frontal femoral component angle between the two groups of patients after surgery. Measure the deviation of the hip-knee-ankle (HKA) angle to assess lower limb alignment. Additionally, compare the following indicators between the two groups:Knee Society Score (KSS), Visual Analogue Scale (VAS) for pain, knee range of motion (ROM), hemoglobin (HB) level, hematocrit (HCT) level, complication rate, and in-hospital satisfaction.
RESULTS:
All patients successfully completed the surgery as scheduled, and all were followed up after the operation. The follow-up period ranged from 5 to 17 months with an average of (11.2±6.1) months. There were 4 cases of venous thrombosis in the HRATKA group and 3 cases in the CRATKA group;each group had 2 cases of wound exudation. No mechanical-related complications, pulmonary embolism, or other severe complications occurred. Comparison of the incision length and hospital stay between the HRATKA group and the CRATKA group showed no statistically significant difference (P>0.05). The operation time in the HRATKA group was (96.80±7.10) minutes, which was longer than that in the CRATKA group (90.10±8.80) minutes, and the difference was statistically significant (P<0.05). In the HRATKA group, the HKA angle was (178.93±1.11) degree, the FFC angle was (89.00±0.91)°, and the LFC angle was (7.31±2.17) degree;the corresponding values in the CRATKA group were (178.05±1.34)°, (87.88±1.74)°, and (10.60±2.84) degree respectively. The differences in these three indicators between the two groups were all statistically significant (P<0.05). However, there were no statistically significant differences in the FTC angle or LTC angle between the two groups (P>0.05). There was also no statistically significant difference in the total perioperative blood loss between the two groups (P>0.05). At 3 days after surgery, the VAS score for movement in the HRATKA group (5.95±1.45) points was higher than that in the CRATKA group (4.50±0.97) points, with a statistically significant difference (P<0.05);at 90 days after surgery, there was no statistically significant difference in the movement VAS score between the two groups (P>0.05). Additionally, no statistically significant differences were observed between the two groups in the KSS, ROM at 3 and 90 days after surgery, or satisfaction degree during hospitalization (all P>0.05).
CONCLUSION
The domestic HURWA robot demonstrates excellent performance in osteotomy efficiency and lower limb alignment recovery. The Smith & Nephew Cori robot has a significant advantage in soft tissue assessment and joint stability optimization. Both robotic systems offer high-quality surgical treatments that significantly improve short-term knee function.
Humans
;
Male
;
Female
;
Arthroplasty, Replacement, Knee/instrumentation*
;
Aged
;
Middle Aged
;
Retrospective Studies
;
Robotic Surgical Procedures/methods*
;
Osteoarthritis, Knee/surgery*
6.Immunophenotypic Characteristics of Bone Marrow Granulocytes and Their Clinical Significance in Patients with Multiple Myeloma.
Ning-Fang WANG ; Chong-Shan ZHAO ; Dong-Dong ZHANG ; Zhuo-Wen CAI ; Fang-Fang CAI ; Fang LIU ; Peng-Hao ZHAO
Journal of Experimental Hematology 2025;33(2):447-454
OBJECTIVE:
To explore the immunophenotypic characteristics of bone marrow granulocytes (G) and their clinical significance in patients with multiple myeloma (MM).
METHODS:
The granulocyte immunophenotypes of bone marrow in 70 MM patients (MM group) and 40 anemia patients (control group) were detected by flow cytometry, and its correlation with clinical characteristics was further analyzed. Univariate and multivariate regression analysis were used to screen factors that affected prognosis.
RESULTS:
The CD56+G%, CD13+G%, CD22+G% and CD117+G% in MM group were higher than those in the control group (all P <0.05). CD56+G% and CD117+G% in CR+VGPR group were significantly lower than those in PR+MR+PD group (both P <0.05). The CD10+G% in RISS Ⅲ stage and Ca2+ ≥2.65 mmol/L groups were increased (both P <0.05). The CD56+G% in elevated lactate dehydrogenase, β2-microglobulin≥5.5 mg/L and hemoglobin <85 g/L groups were increased (all P <0.05), while the CD117+G% in high-risk cytogenetic positive group was decreased (P <0.05). The expression rate of CD molecules on granulocytes was divided into low (L) and high (H) groups according to the median value. The overall survival (OS) of the LCD56+G%, LCD13+G% and LCD22+G% groups was significantly prolonged (all P <0.05). CD13+G% and CD22+G% were independent risk factors for OS in MM patients (HR=0.443, 0.410, both P <0.05).
CONCLUSION
The CD56+G%, CD10+G% and CD117+G% are closely correlated with clinical features in MM patients, while CD13+G% and CD22+G% are closely correlated with prognosis. Detection of CD molecules expression on granulocytes may be used to evaluate prognosis and guide treatment.
Humans
;
Multiple Myeloma/immunology*
;
Granulocytes/immunology*
;
Prognosis
;
Immunophenotyping
;
Male
;
Bone Marrow
;
Female
;
Flow Cytometry
;
Middle Aged
;
Aged
;
Clinical Relevance
7.A practice guideline for therapeutic drug monitoring of mycophenolic acid for solid organ transplants.
Shuang LIU ; Hongsheng CHEN ; Zaiwei SONG ; Qi GUO ; Xianglin ZHANG ; Bingyi SHI ; Suodi ZHAI ; Lingli ZHANG ; Liyan MIAO ; Liyan CUI ; Xiao CHEN ; Yalin DONG ; Weihong GE ; Xiaofei HOU ; Ling JIANG ; Long LIU ; Lihong LIU ; Maobai LIU ; Tao LIN ; Xiaoyang LU ; Lulin MA ; Changxi WANG ; Jianyong WU ; Wei WANG ; Zhuo WANG ; Ting XU ; Wujun XUE ; Bikui ZHANG ; Guanren ZHAO ; Jun ZHANG ; Limei ZHAO ; Qingchun ZHAO ; Xiaojian ZHANG ; Yi ZHANG ; Yu ZHANG ; Rongsheng ZHAO
Journal of Zhejiang University. Science. B 2025;26(9):897-914
Mycophenolic acid (MPA), the active moiety of both mycophenolate mofetil (MMF) and enteric-coated mycophenolate sodium (EC-MPS), serves as a primary immunosuppressant for maintaining solid organ transplants. Therapeutic drug monitoring (TDM) enhances treatment outcomes through tailored approaches. This study aimed to develop an evidence-based guideline for MPA TDM, facilitating its rational application in clinical settings. The guideline plan was drawn from the Institute of Medicine and World Health Organization (WHO) guidelines. Using the Delphi method, clinical questions and outcome indicators were generated. Systematic reviews, Grading of Recommendations Assessment, Development, and Evaluation (GRADE) evidence quality evaluations, expert opinions, and patient values guided evidence-based suggestions for the guideline. External reviews further refined the recommendations. The guideline for the TDM of MPA (IPGRP-2020CN099) consists of four sections and 16 recommendations encompassing target populations, monitoring strategies, dosage regimens, and influencing factors. High-risk populations, timing of TDM, area under the curve (AUC) versus trough concentration (C0), target concentration ranges, monitoring frequency, and analytical methods are addressed. Formulation-specific recommendations, initial dosage regimens, populations with unique considerations, pharmacokinetic-informed dosing, body weight factors, pharmacogenetics, and drug-drug interactions are covered. The evidence-based guideline offers a comprehensive recommendation for solid organ transplant recipients undergoing MPA therapy, promoting standardization of MPA TDM, and enhancing treatment efficacy and safety.
Mycophenolic Acid/administration & dosage*
;
Drug Monitoring/methods*
;
Humans
;
Organ Transplantation
;
Immunosuppressive Agents/administration & dosage*
;
Delphi Technique
8.3D printed Mg-incorporated polycaprolactone scaffolds for repairing rat skull defects
LI Xiaoye ; LI Qiang ; DAI Zhuo ; DING Meng ; DONG Heng ; DONG Qiangsheng ; BAI Jing ; MOU Yongbin
Journal of Prevention and Treatment for Stomatological Diseases 2024;32(4):249-256
Objective:
To evaluate the bone repair effect of 3D-printed magnesium (Mg)-loaded polycaprolactone (PCL) scaffolds in a rat skull defect model.
Methods:
PCL scaffolds mixed with Mg microparticles were prepared by using 3D printing technology, as were pure PCL scaffolds. The surface morphologies of the two scaffolds were observed by scanning electron microscopy (SEM), and the surface elemental composition was analyzed via energy dispersive spectroscopy (EDS). The physical properties of the scaffolds were characterized through contact angle measurements and an electronic universal testing machine. This study has been reviewed and approved by the Ethics Committee. A critical size defect model was established in the skull of 15 Sprague-Dawley (SD) rats, which were divided into the PCL group, PCL-Mg group, and untreated group, with 5 rats in each group. Micro-CT scanning was performed to detect and analyze skull defect healing at 4 and 8 weeks after surgery, and samples from the skull defect area and major organs of the rats were obtained for histological staining at 8 weeks after surgery.
Results:
The scaffolds had a pore size of (480 ± 25) μm, a fiber diameter of (300 ± 25) μm, and a porosity of approximately 66%. The PCL-Mg scaffolds contained 1.0 At% Mg, indicating successful incorporation of Mg microparticles. The contact angle of the PCL-Mg scaffolds was 68.97° ± 1.39°, indicating improved wettability compared to that of pure PCL scaffolds. Additionally, compared with that of pure PCL scaffolds, the compressive modulus of the PCL-Mg scaffolds was (57.37 ± 8.33) MPa, demonstrating enhanced strength. The PCL-Mg group exhibited the best bone formation behavior in the skull defect area compared with the control group and PCL group at 4 and 8 weeks after surgery. Moreover, quantitative parameters, such as bone volume (BV), bone volume/total volume (BV/TV), bone surface (BS), bone surface/total volume (BS/TV), trabecular thickness (Tb.Th), trabecular number (Tb.N) and bone mineral density (BMD), of skull defects were better than those in the other groups, indicating the best bone regeneration effect. H&E, Goldner, and VG staining revealed more mineralized new bone formation in the PCL-Mg group than in the other groups, and H&E staining of the major organs revealed good biosafety of the material.
Conclusion
PCL-Mg scaffolds can promote the repair of bone defects and have clinical potential as a new scaffold material for the repair of maxillofacial bone defects.
9.Significance of Serum β-NGF and TRAIL Testing in Clinical Diagnosis and Prognosis Assessment in Patients with Pulmonary Heart Disease Complicated with Pulmonary Artery Hypertension
Wenhui TANG ; Huiling YING ; Jing DUAN ; Zhuo DONG ; Xinyi YOU
Journal of Modern Laboratory Medicine 2024;39(4):131-137
Objective To explore the significance of serum β-nerve growth factor(β-NGF)and tumor necrosis factor-related apoptosis-inducing ligand(TRAIL)testing in clinical diagnosis and prognosis assessment in patients with pulmonary heart disease(PHD)complicated with pulmonary artery hypertension(PAH).Methods A 1:1 case-control study was conducted in Daxing District People's Hospital of Beijing from January 2019 to June 2022,in which 86 patients with PHD complicated with PAH and 86 patients with isolated PHD were selected as case group and control group.Retrospective analysis was conducted.The case group was divided into mild PAH group(n=39),moderate PAH group(n=25)and severe PAH group(n=22)according to pulmonary artery systolic pressure(PASP).Meanwhile,the case group was divided into good prognosis group(n=75)and poor prognosis group(n=11)based on the outcomes after one year of discharge.Demographic data and laboratory examination indicators of study subjects were collected,and serum β-NGF and TRAIL levels were measured using enzyme-linked immunosorbent assay(ELISA).Pearson product-moment correlation analysis was used to assess the relationship among β-NGF,TRAIL and PASP.Logistic regression analysis was performed to identify factors influencing PAH in patients with PHD.ROC curve was used to evaluate the diagnostic value of β-NGF and TRAIL for PAH.Cox proportional hazards regression analysis was carried out to assess the relationship among β-NGF,TRAIL and poor prognosis in patients with PHD complicated with PAH,and ROC curve was used to evaluate its predictive value for poor prognosis.Result Compared with control group,the duration of PHD in case group was longer(8.63±1.27 years vs 5.49±1.15 years),and serum β-NGF level(26.97±8.25 ng/ml vs 22.14±7.32 ng/ml)and TRAIL level(2.83±0.76 ng/ml vs 1.71±0.68 ng/ml)were increased,with significant differences(t=17.006,4.064,10.183,all P<0.05).Serum β-NGF and TRAIL had certain diagnostic values for PAH in PHD patients,with AUC of 0.842 and 0.838,respectively.And the combined diagnostic AUC was 0.920,which was higher than that of single indicators(Z=3.416,3.508,all P<0.05).Serum β-NGF(23.26±5.13 ng/ml,27.83±5.57 ng/ml,32.57±6.02 ng/ml)and TRAIL(2.24±0.65 ng/ml,2.89±0.71 ng/ml,3.81±0.90 ng/ml)levels among patients with mild PAH,moderate PAH,severe PAH were sequentially elevated,and the differences were significant(F=20.624,31.972,all P<0.05).Serum β-NGF and TRAIL were positively associated with PASP(r=0.673,0.659,P<0.05).Serum β-NGF(36.34±8.05 ng/ml)and TRAIL(3.49±1.01 ng/ml)levels in poor prognosis group were higher compared to good prognosis group(25.59±7.28 ng/ml,2.73±0.89 ng/ml),and the differences were significant(t=4.516,2.604,all P<0.05).Logistic regression analysis showed that,the PHD duration[OR(95%CI):1.784(1.135~2.806)],β-NGF[OR(95%CI):1.976(1.108~3.523)]and TRAIL[OR(95%CI):1.866(1.123~3.101)]were independent risk factors for occurrence of PAH in patients with PHD(all P<0.05).Multivariate COX proportional risk regression results showed that PHD duration[OR(95%CI):1.167(1.082~1.364)],β-NGF[OR(95%CI):1.322(1.134~1.649)],TRA-IL[OR(95%CI):1.259(1.087~1.590)]were independent risk factors for poor prognosis in patients with PHD complicated with PAH(all P<0.05).Serum β-NGF and TRAIL could predict the poor prognosis in patients with PHD complicated with PAH,with AUC of 0.863 and 0.881,respectively.The combined diagnostic AUC was 0.907,which was higher than that of single indicators(Z=2.905,3.128,all P<0.05).Conclusion Elevated serum β-NGF and TRAIL were independent risk factors for PAH and were associated with severity of PAH.Early combined detection of β-NGF and TRAIL can improve the diagnostic value for PAH and predict poor prognosis of patients.
10.Preparation and performance evaluation of S100B time-resolved fluorescence immunoassay kit
Dong-Qing FENG ; Bu-Zhuo XU ; Shu-Hong LUO ; Yu-Nan WU ; Zhuo ZHANG ; Hao TANG ; Yi-Ming WENG ; Ruo-Pan HUANG ; Xu-Dong SONG
Chinese Medical Equipment Journal 2024;45(1):47-55
Objective To develop a time-resolved fluorescent immunoassay kit for the rapid,accurate and quantitative detection of S100B protein in serum and to evaluate its performance.Methods The test strip was prepared using time-resolved fluorescent microsphere-labeled anti-S100B polyclonal antibody and rabbit IgG antibody,labeling pads,sample pads,S100B nitrocellulose films and absorbent paper,and an S100B time-resolved fluorescence immunoassay kit was obtained by assembling the cartridge.The performance of the kit developed was evaluated by standard curve,accuracy,minimum detection limit,linear interval,specificity,reproducibility and stability.The reference intervals of 199 pieces of healthy human serum and plasma samples from a certain region were detected with the kit,and the clinical performance of the kit and Roche Elecsys S100 kit was tested by synchronous blind method to assess the consistency of the results of the two kits for 142 samples.Results The S100B time-resolved fluorescence immunoassay kit had the standard curve beingy=(1.133 02+1.752 24)/[1+(x/1.082 20)×(-0.603 52)]-1.752 24,R2=0.999 08 and the linear range being[0.05,30]ng/mL,which met the requirements of the relative deviation of the accuracy within±15%,the minimum detection limit not hgier than 0.05 ng/mL,the relative deviation of specificity within±15%and the coefficient of variation of intra-and inter-batch difference less than 15%.The stability test results indicated that the kit was valid for 12 months at 2-30 ℃ conditions.The reference intervals of serum and plasma samples measured by the kit were both lower than 0.3 ng/mL.Clinical trials showed that the results by the kit and Roche Elecsys S100 Assay Kit were in high agreement(Kappa=0.906 1>0.80)and met the requirements.Conclusion The kit developed detects the concentration of S100B protein in serum quickly,accurately and quantitatively,and provides references for the diagnosis and treatment of neurological diseases,autoimmune diseases,cerebrovascular diseases and etc.[Chinese Medical Equipment Journal,2024,45(1):47-55]


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