1.Instrumentation of occupational medical examination institutions in Guangdong Province
Chaoting ZHAO ; Chanchan QI ; Jianming TAN ; Xiaoyi LI ; Ruiyan HUANG ; Jiabin CHEN
China Occupational Medicine 2025;52(5):570-573
Objective To understand the instrument distribution and capacities of inter-laboratory comparisons among occupational medical examination (OME) institutions in Guangdong Province. Methods A total of 291 OME institutions in Guangdong Province that were within the validity period of filing in June 2024 and 101 OME institutions that participated in inter-laboratory comparisons in 2023 were selected as the study subjects. Their filing categories, instrument distribution and external quality assessment in laboratories were collected and analyzed. Results The location of 291 OME institutions distributed in 21 prefectural-level cities in the province, mainly in the Pearl River Delta (PRD) region, accounting for 68.4% of the total. The public hospitals, private medical institutions, the center for disease control and prevention and occupational disease prevention and treatment institutions (hereinafter referred to as "occupational prevention institutions") accounted for 61.2%, 28.5% and 10.3%, respectively. The filing rates for physical factors, chemical factors, and dust categories among OME institutions were 91.1%, 86.9%, and 86.6%, respectively. The average number of institutional instruments, from high to low, was 53.8, 38.8 and 38.2 per unit in occupational prevention institutions, private medical institutions and public hospitals, respectively. The passing rates of inter-laboratory comparisons among OME institutions of external quality assessment in laboratories among OME institutes in Guangdong Province, from high to low were occupational prevention institutions, public hospitals and private medical institutions (96.2% vs 86.8% vs 73.0%, P<0.05). Conclusion The regional distribution of OME institutes in Guangdong Province is unbalanced, mainly concentrated in the PRD region. Low overall level of OME capacity is found in public hospitals and private medical institutions. Leading by the occupational prevention institutions, public hospitals and private medical institutions should strengthen the development and investment in OME hardware, in order to improve the OME level.
2.Establishment and Performance Evaluation of Method for Detecting Serum Soluble fms Like Tyrosine Kinase-1 Based on Biotin-avidin System Time-resolved Fluorescence Immunoassay
Yuhua TAN ; Ting YU ; Haijia YU ; Gaocheng LI ; Jianming FENG
Journal of Modern Laboratory Medicine 2025;40(2):186-190,201
Objective To establish a biotin-avidin system time-resolved fluorescence immunoassay(BAS-TRFIA)for detecting serum soluble fms-like tyrosine kinase-1(sFlt-1)and evaluate its performance.Methods A BAS-TRFIA was established to quantitatively determine the concentration of sFlt-1 in the serum of pregnant women,which based on the microplate was coated with streptavidin.The monoclonal antibody to capture sFlt-1 was labeled by biotin,and the detection of sFlt-1 monoclonal antibody was labeled by europium.The performance indicators such as lower limit of detection,biological limit of detection,functional sensitivity,precision,linearity,interference test,cross-reaction test,and high dose hook effect of the method were evaluated.A total of 106 remaining serum samples from pregnant women with no hemolysis,jaundice and lipemia at more than 9 weeks were detected by BAS-TRFIA and electrochemiluminescence for methodological comparison study,and the correlation of the comparison test results was analyzed by linear regression.Results The optimal reaction time of the sample was 90 min.The lower limit of detection was 1.00pg/ml.The biological limit of detection was 10.00pg/ml,and the functional sensitivity was 10.00pg/ml.The intra-assay CV and inter-assay CV were both within 5%,and the linear range was 20.00 to 40 000.00pg/ml.The relative bias of the detection results of the 17 interfering samples with interfering substances added to the low-concentration and high-concentration quality controls and the basic samples was within-4.94%~4.24%.The high dose hook effect was not found in sFlt-1 samples up to 150 000pg/ml.When the concentration of sFlt-1 in the sample was 105.40~40 972.00pg/ml,the linear regression equation of BAS-TRFIA and electrochemiluminescence(ECL)detection results was Y=1.086 7X+17.946(r=0.994 4,t=96.26,P<0.05).Conclusion The quantitative detection of sFlt-1 by BAS-TRFIA has high sensitivity,good precision,wide linear range,strong anti-interference ability,and good correlation with the detection results of reference methods,which is valuable for clinical application.
3.Development and Performance Evaluation of A Reagent for Detecting of 17α-hydroxyprogesterone in Dried Blood Spots on Filter Paper Fixed on Blood Spots Stent by Auto TRFIA-4 Automatic Fluorescence Immunoanalyzer
Yuhua TAN ; Ting YU ; Haijia YU ; Meixin CHEN ; Jingling XIE ; Jianming FENG
Journal of Modern Laboratory Medicine 2025;40(5):182-188
Objective To develop a reagent for detecting of 17α-hydroxyprogesterone(17α-OHP)in dried blood spots on filter paper fixed on vascular stent by Auto TRFIA-4 automatic fluorescence immunoanalyzer and evaluate its performance.Methods The microwell plate was coated with the sheep anti-rabbit IgG antibody as microwell reaction plate,the rabbit anti-human 17α-OHP antibody was diluted as intermediate antibody,and the 17α-OHP-bovine serum albumin conjugate was labeled by europium as europium marker.The concentration of 17α-OHP in dried blood spots on filter paper fixed on blood spots stent was quantitatively detected by Auto TRFIA-4 automatic fluorescence immunoanalyzer.The analysis sensitivity,accuracy,linearity,precision,specificity and stability were evaluated,and whether they met the requirements of the formulated industry standards were evaluated.A total of 227 neonatal heel blood filter paper samples from newborns who were born 72 hours after birth and within 7 days and fully breastfeeding were selected for reagent comparison test.The consistency was analyzed by χ2 test,Kappa test,t test,linear correlation analysis,regression analysis,Bland-Altman method analysis and predictive bias analysis of medical decision level,P<0.05 indicated statistically significant difference.Results The optimal coating concentration of sheep anti-rabbit IgG antibody was 3 μg/ml.The optimal dilution ratio of rabbit anti-human 17α-OHP antibody was 1∶1 500.The optimal dilution ratio of 17α-OHP europium marker mother liquor was 1∶2 500.The limit of blank,limit of detection,limit of quantification was 0.75,1.08 and 1.99 nmol/L,respectively.The relative deviations of the standard check test were within±15.00%,and the average recovery rate was 92.36%.The linear correlation coefficient was 0.997 1 in the range of 2.00 to 300.00nmo/L.The intra-assay and inter-assay coefficients of variation were all within 10.00%.The cross-reactivity rates of 100.00 ng/ml progesterone,17α-hydroxypreg nenolone and 11-deoxycortisol were within 0.089%to 0.64%.The performance of stability test met the requirements.The total coincidence rate was 100%compared with the results of contrast reagent.The quantitative results were highly correlated with the contrast reagent(r=0.999 4,tr=452.02,P<0.05).Conclusion The self-developed reagent has the advantages of high sensitivity,good accuracy,wide linear range,good precision,high specificity and good stability,which meets the requirements of the formulated industry standards,and has high correlation and consistency with the result of contrast reagent,which meets the needs of clinical detection.
4.Establishment and Performance Evaluation of Method for Detecting Serum Soluble fms Like Tyrosine Kinase-1 Based on Biotin-avidin System Time-resolved Fluorescence Immunoassay
Yuhua TAN ; Ting YU ; Haijia YU ; Gaocheng LI ; Jianming FENG
Journal of Modern Laboratory Medicine 2025;40(2):186-190,201
Objective To establish a biotin-avidin system time-resolved fluorescence immunoassay(BAS-TRFIA)for detecting serum soluble fms-like tyrosine kinase-1(sFlt-1)and evaluate its performance.Methods A BAS-TRFIA was established to quantitatively determine the concentration of sFlt-1 in the serum of pregnant women,which based on the microplate was coated with streptavidin.The monoclonal antibody to capture sFlt-1 was labeled by biotin,and the detection of sFlt-1 monoclonal antibody was labeled by europium.The performance indicators such as lower limit of detection,biological limit of detection,functional sensitivity,precision,linearity,interference test,cross-reaction test,and high dose hook effect of the method were evaluated.A total of 106 remaining serum samples from pregnant women with no hemolysis,jaundice and lipemia at more than 9 weeks were detected by BAS-TRFIA and electrochemiluminescence for methodological comparison study,and the correlation of the comparison test results was analyzed by linear regression.Results The optimal reaction time of the sample was 90 min.The lower limit of detection was 1.00pg/ml.The biological limit of detection was 10.00pg/ml,and the functional sensitivity was 10.00pg/ml.The intra-assay CV and inter-assay CV were both within 5%,and the linear range was 20.00 to 40 000.00pg/ml.The relative bias of the detection results of the 17 interfering samples with interfering substances added to the low-concentration and high-concentration quality controls and the basic samples was within-4.94%~4.24%.The high dose hook effect was not found in sFlt-1 samples up to 150 000pg/ml.When the concentration of sFlt-1 in the sample was 105.40~40 972.00pg/ml,the linear regression equation of BAS-TRFIA and electrochemiluminescence(ECL)detection results was Y=1.086 7X+17.946(r=0.994 4,t=96.26,P<0.05).Conclusion The quantitative detection of sFlt-1 by BAS-TRFIA has high sensitivity,good precision,wide linear range,strong anti-interference ability,and good correlation with the detection results of reference methods,which is valuable for clinical application.
5.Development and Performance Evaluation of A Reagent for Detecting of 17α-hydroxyprogesterone in Dried Blood Spots on Filter Paper Fixed on Blood Spots Stent by Auto TRFIA-4 Automatic Fluorescence Immunoanalyzer
Yuhua TAN ; Ting YU ; Haijia YU ; Meixin CHEN ; Jingling XIE ; Jianming FENG
Journal of Modern Laboratory Medicine 2025;40(5):182-188
Objective To develop a reagent for detecting of 17α-hydroxyprogesterone(17α-OHP)in dried blood spots on filter paper fixed on vascular stent by Auto TRFIA-4 automatic fluorescence immunoanalyzer and evaluate its performance.Methods The microwell plate was coated with the sheep anti-rabbit IgG antibody as microwell reaction plate,the rabbit anti-human 17α-OHP antibody was diluted as intermediate antibody,and the 17α-OHP-bovine serum albumin conjugate was labeled by europium as europium marker.The concentration of 17α-OHP in dried blood spots on filter paper fixed on blood spots stent was quantitatively detected by Auto TRFIA-4 automatic fluorescence immunoanalyzer.The analysis sensitivity,accuracy,linearity,precision,specificity and stability were evaluated,and whether they met the requirements of the formulated industry standards were evaluated.A total of 227 neonatal heel blood filter paper samples from newborns who were born 72 hours after birth and within 7 days and fully breastfeeding were selected for reagent comparison test.The consistency was analyzed by χ2 test,Kappa test,t test,linear correlation analysis,regression analysis,Bland-Altman method analysis and predictive bias analysis of medical decision level,P<0.05 indicated statistically significant difference.Results The optimal coating concentration of sheep anti-rabbit IgG antibody was 3 μg/ml.The optimal dilution ratio of rabbit anti-human 17α-OHP antibody was 1∶1 500.The optimal dilution ratio of 17α-OHP europium marker mother liquor was 1∶2 500.The limit of blank,limit of detection,limit of quantification was 0.75,1.08 and 1.99 nmol/L,respectively.The relative deviations of the standard check test were within±15.00%,and the average recovery rate was 92.36%.The linear correlation coefficient was 0.997 1 in the range of 2.00 to 300.00nmo/L.The intra-assay and inter-assay coefficients of variation were all within 10.00%.The cross-reactivity rates of 100.00 ng/ml progesterone,17α-hydroxypreg nenolone and 11-deoxycortisol were within 0.089%to 0.64%.The performance of stability test met the requirements.The total coincidence rate was 100%compared with the results of contrast reagent.The quantitative results were highly correlated with the contrast reagent(r=0.999 4,tr=452.02,P<0.05).Conclusion The self-developed reagent has the advantages of high sensitivity,good accuracy,wide linear range,good precision,high specificity and good stability,which meets the requirements of the formulated industry standards,and has high correlation and consistency with the result of contrast reagent,which meets the needs of clinical detection.
6.Expert consensus on clinical application of 177Lu-prostate specific membrane antigen radio-ligand therapy in prostate cancer
Guobing LIU ; Weihai ZHUO ; Yushen GU ; Zhi YANG ; Yue CHEN ; Wei FAN ; Jianming GUO ; Jian TAN ; Xiaohua ZHU ; Li HUO ; Xiaoli LAN ; Biao LI ; Weibing MIAO ; Shaoli SONG ; Hao XU ; Rong TIAN ; Quanyong LUO ; Feng WANG ; Xuemei WANG ; Aimin YANG ; Dong DAI ; Zhiyong DENG ; Jinhua ZHAO ; Xiaoliang CHEN ; Yan FAN ; Zairong GAO ; Xingmin HAN ; Ningyi JIANG ; Anren KUANG ; Yansong LIN ; Fugeng LIU ; Cen LOU ; Xinhui SU ; Lijun TANG ; Hui WANG ; Xinlu WANG ; Fuzhou YANG ; Hui YANG ; Xinming ZHAO ; Bo YANG ; Xiaodong HUANG ; Jiliang CHEN ; Sijin LI ; Jing WANG ; Yaming LI ; Hongcheng SHI
Chinese Journal of Clinical Medicine 2024;31(5):844-850,封3
177Lu-prostate specific membrane antigen(PSMA)radio-ligand therapy has been approved abroad for advanced prostate cancer and has been in several clinical trials in China.Based on domestic clinical practice and experimental data and referred to international experience and viewpoints,the expert group forms a consensus on the clinical application of 177Lu-PSMA radio-ligand therapy in prostate cancer to guide clinical practice.
7.Performance of multi-modality and multi-classifier fusion models for predicting radiation-induced oral mucositis in patients with nasopharyngeal carcinoma.
Yue HU ; Yu ZENG ; Linjing WANG ; Zhiwei LIAO ; Jianming TAN ; Yanhao KUANG ; Pan GONG ; Bin QI ; Xin ZHEN
Journal of Southern Medical University 2024;44(12):2434-2442
OBJECTIVES:
To evaluate the performance of different multi-modality fusion models for predicting radiation-induced oral mucositis (RIOM) following radiotherapy in patients with nasopharyngeal carcinoma (NPC).
METHODS:
We retrospectively collected the data from 198 patients with locally advanced NPC who experienced RIOM following radiotherapy at the Affiliated Tumor Hospital of Guangzhou Medical University from September, 2022 to February, 2023. Based on oral radiation dose-volume parameters and clinical features of NPC, basic classification models were developed using different combinations of feature selection algorithms and classifiers and integrated using a multi-criterion decision-making (MCDM)-based classifier fusion (MCF) strategy and its variant, the H-MCF model. The basic classification models, MCF model, the H-MCF model with a single modality or multiple modalities and other ensemble classifiers were compared for performances for predicting RIOM by assessing the area under the ROC curve (AUC), accuracy, sensitivity, and specificity.
RESULTS:
The H-MCF model, which integrated multi-modality features, achieved the highest accuracy for predicting severe RIOM with an AUC of 0.883, accuracy of 0.850, sensitivity of 0.933, and specificity of 0.800.
CONCLUSIONS
Compared with each of the individual classifiers, the multimodal multi-classifier fusion algorithm combining clinical and dosimetric modalities demonstrates superior performance in predicting the incidence of severe RIOM in NPC patients following radiotherapy.
Humans
;
Nasopharyngeal Carcinoma/radiotherapy*
;
Nasopharyngeal Neoplasms/radiotherapy*
;
Retrospective Studies
;
Stomatitis/diagnosis*
;
Algorithms
;
Radiation Injuries/diagnosis*
;
Female
;
Male
;
ROC Curve
8.Comparison of treatments and outcomes between early and late antibody-mediated rejection after kidney transplantation
Jinghong TAN ; Wenrui WU ; Longshan LIU ; Qian FU ; Jun LI ; Chenglin WU ; Jianming LI ; Wenyu XIE ; Huanxi ZHANG ; Changxi WANG
Chinese Journal of Organ Transplantation 2024;45(9):614-621
Objective:To explore the impact of early and late antibody-mediated rejection (AMR) on treatment options and allograft outcomes after kidney transplantation (KT).Methods:From January 2013 to December 2022, the study retrospectively enrolled 141 KT allograft recipients receiving allograft biopsy and diagnosed as AMR according to the Banff 2019 criteria. Recipients with a diagnosis of AMR within 30 days post-KT were classified into early AMR group (n=19) while the remainders assigned as late AMR group (n=122). The outcome endpoints included recipient survival rate, death-censored graft survival rate, follow-up estimated glomerular filtration rate (eGFR) and immunodominant donor-specific antibody (DSA) intensity. Wilcoxon's test was utilized for assessing the differences in eGFR and DSA intensity while Kaplan-Meier curve and Log-rank test were employed for evaluating graft survival impact. Treatment regimens for AMR were collected and categorized.Results:The median follow-up duration was 2.6(1.2, 5.2) year. No graft failure was noted in early AMR group while 44 recipients in late AMR group experienced graft failure, with 34 cases (77.2%) due to AMR progression. The 5-year death-censored graft survival rate was significantly better in early AMR group than that in late AMR group [100% vs 60.1%(50.5%, 71.6%), P=0.002]. The one-year change in eGFR for early AMR group was significantly superior to that of late AMR group [19.3(-2.6, 38.1) vs -3.3(-14.0, 5.4), P=0.001]. One-year mean fluorescent intensity (MFI) of early AMR group was 1 158(401.5, 3 126.5). It was significantly lower than that when diagnosed with early AMR [3 120.5(2 392.8, 9 340.0)] and one-year MFI of late AMR group [8 094(2 251.5, 13 560.5)] ( P=0.005, P<0.001). Early AMR group primarily received standard treatment (3/19, 15.8%) and regimens centered on rituximab and/or bortezomib (7/19, 43.8%). Late AMR group mainly received standard (16/122, 13.1%) or intensified regimens (9/122, 7.4%) and regimens focused upon rituximab and/or bortezomib (32/122, 26.2%) and MP monotherapy (21/122, 17.2%). Conclusion:The outcome for early AMR is significantly better than that for late AMR. For early AMR, early and robust immunosuppression is recommended. For late AMR, early detection and timely treatment are crucial and individualized strategies should be implemented.
9.Primary adrenal small cell neuroendocrine carcinoma complicated with renal venous carcinoma thrombus: a case report
Xiaohao XU ; Xiao TAN ; Yongshuo LIU ; Xin WANG ; Hanbo YANG ; Jianming WANG
Chinese Journal of Urology 2023;44(7):540-541
Primary adrenal small cell neuroendocrine carcinoma is clinically rare. This article reported a patient, who was diagnosed as primary adrenal small cell neuroendocrine carcinoma complicated with renal vein cancer thrombus, and underwent laparoscopic left adrenal + left kidney + left renal vein tumor embolectomy.The carcinoma relapsed after 19 months of follow-up after surgery. The patient and his family refused further treatment.
10.Incidence and related factors of umbilical venous catheter tip migration
Guanchu CHEN ; Hua CHUAN ; Ting YANG ; Jianming TANG ; Xiao TAN ; Tingting YIN ; Hongxia GAO
Chinese Journal of Perinatal Medicine 2023;26(2):121-126
Objective:To analyze the incidence and the related factors of umbilical vein catheter (UVC) tip migration within 7 d after umbilical vein catheterization.Methods:This prospective study involved neonates who were successfully indwelled with UVCs in the Department of Neonatology of Gansu Provincial Women and Child-care Hospital from June 2020 to December 2021. The position of the UVC tip, length of umbilical stump, body weight, and abdominal circumference were recorded after the UVCs were inserted successfully, and the changes in these four data at 2, 24, 48, 72 h, and 7 d after catheterization were analyzed and compared. All the subjects were divided into the non-migrate group, inward migration group, and outward migration group. Chi-square test, Mann-Whitney U test, or Kruskal Wallis H test were used for statistical analysis. Results:A total of 157 newborns were enrolled, with 51 cases in the inward migration group, 62 cases in the outward migration group, and 44 cases in the non-migrate group. There were no significant differences among the three groups regarding gestational age, birth weight, gender, born through cesarean section, age at the time of catheterization, use of sedation, and feeding modes (all P>0.05). The migration rates of UVCs tip at 2, 24, 48, 72 h, and 7 d after catheterization were 0, 27.4% (43/157), 27.2% (31/114), 25.3% (21/83), and 29.0% (18/62), respectively. The cumulative migration rates at 24, 48, 72 h, and 7 d were 27.4% (43/157), 47.1% (74/157), 60.1% (95/157), and 72.0% (113/157), respectively. Compared with the non-migrate group, the inward migration group had a shorter umbilical cord stump at 24 and 48 h [0.5 cm (0.4-0.5 cm) vs 0.6 cm (0.5-0.8 cm); 0.4 cm (0.3-0.5 cm) vs 0.5 cm (0.5-0.6 cm), Z=-5.55 and -3.69, both P<0.05], less abdominal circumference increment at 48 and 72 h [0.6 cm (0.5-1.0 cm) vs 0.9 cm (0.7-1.2 cm); 0.6 cm (0.3-0.9 cm) vs 0.9 cm (0.7- 1.3 cm), Z=-2.03 and -2.09, both P<0.05)], and more weight loss percentage [-4.7% (-6.0%--3.6%) vs -3.1% (-3.7%--2.2%); -6.0% (-7.5%--5.0%) vs -3.9% (-5.1%--2.4%), Z=-3.75 and -2.96, both P<0.05]. The abdominal circumference increased more in the outward migration group at 24, 48, 72 h, and 7 d than those in the non-migrate group [1.6 cm (0.9-1.9 cm) vs 0.7 cm (0.5-0.9 cm); 1.5 cm (1.2-1.8 cm) vs 0.9 cm (0.7-1.2 cm); 1.7 cm (1.3-1.9 cm) vs 0.9 cm (0.7-1.3 cm); 1.6 cm (1.1-1.9 cm) vs 0.9 cm (0.6-1.3 cm), Z=-4.82, -4.79, -3.74, and -3.09, all P<0.05]. Conclusion:The incidence of UVC tip migration is high, which could be affected by dryness and retraction of the umbilical cord stump and the change in neonatal abdominal circumference and body weight.

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