1.Development and evaluation of hepatitis B virus RNA detection method based on microfluidic chip-based digital PCR
Qunfang HUANG ; Rubing XIE ; Yanping LAN ; Zhen XUN ; Can LIU ; Qishui OU
Chinese Journal of Laboratory Medicine 2025;48(1):103-109
Objective:To establish a microfluidic chip-based digital PCR (cdPCR) method for detecting hepatitis B virus (HBV) RNA and evaluate its application in patients with chronic HBV infection.Methods:A total of 135 patients with chronic HBV infection were recruited from the First Affiliated Hospital of Fujian Medical University and stratified into two groups based on HBV DNA levels: HBV DNA>100 IU/ml ( n=85) and HBV DNA≤100 IU/ml ( n=50). Additionally, healthy individuals and subjects infected with other viruses ( n=15) served as controls. Primers and probes targeting the HBV pre-C/C region were designed to optimize the microfluidic cdPCR method, and its linear range, limit of detection (LOD), specificity, and precision were assessed. Serum HBV RNA levels were measured using the self-developed method and two commercial kits. Pearson correlation was applied to evaluate the relationships between HBV RNA and other HBV markers. Results:The optimized microfluidic cdPCR method featured a denaturation time of 10 seconds, an annealing/extension temperature of 62 ℃, and primer and probe concentrations of 0.3 μmol/L and 0.2 μmol/L, respectively. The method demonstrated a linear range of 103-10? copies/ml and an LOD of 102 copies/ml. The intra-assay coefficient of variation ( CV) for plasmid standards at 10? and 10? copies/ml were 1.06% and 0.82%, respectively, while the inter-assay CVs were 0.75% and 0.44%. Specificity analysis confirmed the absence of positive signals in sera from healthy controls and subjects infected with other pathogens. In the HBV DNA>100 IU/ml group, the detection rate of the self-developed cdPCR method was 81.18% (69/85), significantly higher than the 64.71% (55/85) achieved by commercial kit B ( P<0.016 7). However, in the HBV DNA≤100 IU/ml group, no significant differences were observed among the three methods ( P>0.05). HBV RNA levels were positively correlated with HBV DNA ( r=0.67), hepatitis B surface antigen ( r=0.53), and hepatitis B e antigen ( r=0.44) (all P<0.001). Conclusion:A microfluidic cdPCR assay for the quantitative detection of HBV RNA has been successfully developed. This assay demonstrates high sensitivity, specificity, and robust detection capability, even for low HBV DNA-concentration samples.
2.Research on Construction of Evaluation Index System for Organizational Resilience of County Medical Alli-ance:Based on the Dual Resilience Analysis Framework and Health System Resilience Theory Framework
Chi ZHOU ; Qunfang HUANG ; Xiaoling LIN ; Xu LI ; Jingchun CHEN
Chinese Hospital Management 2025;(9):57-62
Objective To construct an evaluation index system of organizational resilience of county medical alliance,and to propose countermeasures and suggestions for the enhancement of organizational resilience and operational effectiveness of county medical alliance.Methods The initial evaluation index system was constructed based on literature research and semi-structured interviews.Two rounds of Delphi expert consultation combined with critical value method refined the evaluation indexs.Evaluation index weights were determined via analytic hierarchy process and multiplicative weighting.The system was empirically tested using Zhejiang Province data.Results 21 experts completed consultations.Then the evaluation index system of county medical alliance organizational resilience was formed,which contains 5 first-level indexes,15 second-level indexes and 43 third-level indexes,containing 19 subjective and 24 objective evaluation indexs.The overall evaluation score of the organizational resilience of county medical alliance in Zhejiang Province was 73.97,which was at the average level of resilience.Conclusion The evaluation index system of organizational resilience of county medical alliance fits in with the national development plan to promote the construction of county high-quality,efficient and integrated medical and healthcare service system,and can provide effective measurement tools and theoretical references for the organizational capacity of county medical alliance and their maturity evaluation.
3.Diagnostic value of peripheral blood cell analysis-derived 5 new parameters on chronic hepatitis B, liver cirrhosis and hepatocellular carcinoma
Xinyao YANG ; Xin YANG ; Xinrong LU ; Qunfang HUANG ; Bin YANG ; Can LIU ; Qishui OU ; Zhen XUN
Chinese Journal of Laboratory Medicine 2025;48(7):917-923
Objective:To investigate the laboratory diagnostic value of 5 new blood routine indexes in chronic hepatitis B (CHB), liver cirrhosis and hepatocellular carcinoma (HCC).Methods:The retrospective study included 65 patients with chronic HBV infection, 72 patients with liver cirrhosis and 163 patients with HCC recruited at Liver Disease Center in First Affiliated Hospital of Fujian Medical University, as well as 52 healthy controls recruited from the Physical Examination Center of the First Affiliated Hospital of Fujian Medical University from October 2022 to April 2023. Five new parameters [early granulated cell percent (EGC%), early granulated cell absolute count (EGC#), microcytic anemia factor (MAF), leukocyte estimate(corrected)from the DIFF optical channel (WDOP) and leukocyte estimate(corrected)from the NRBC optical channel (WNOP)] were detected by UniCel DxH 900 blood cell analyzer. Univariate analysis of the expression levels of the 5 new parameterswere compared among CHB, liver cirrhosis and HCC groups. Pearson correlation analysis was used to explore the correlation between the 5 new parameters and HBV-related markers in CHB and Child-Pugh score in liver cirrhosis. Receiver operating characteristic (ROC) curve and AUC were used to estimate the diagnostic capacity of the 5 new blood routine indexes in CHB, liver cirrhosis and HCC.Results:In patients with CHB, the levels of EGC% ( Z=4.613, P<0.001) and EGC# ( Z=4.220, P<0.001) were higher than those of healthy controls; EGC# was positively correlated with HBsAg and HBeAg (both P<0.05). In patients with cirrhosis, the level of MAF ( Z=-4.928, P<0.001) was lower than that of healthy controls, and Child-Pugh score was found to be negatively correlated with MAF ( r=-0.349, P<0.05). In HCC patients, WDOP ( Z=2.45, P=0.017) and WNOP ( Z=2.90, P=0.017) levels were higher in patients with tumor volume>3 cm 3 than those in patients with volume ≤3 cm 3. The AUCs of combination of 5 new parameters to diagnose CHB, liver cirrhosis and HCC were 0.901 (95% CI 0.830-0.973, P<0.001), 0.946 (95% CI 0.909-0.984, P<0.001), and 0.904 (95% CI 0.858-0.950, P<0.001). Conclusions:The 5 new parameters based on peripheral blood cell analysis have good clinical value in the diagnosis of CHB, liver cirrhosis and HCC diseases.
4.Research on Construction of Evaluation Index System for Organizational Resilience of County Medical Alli-ance:Based on the Dual Resilience Analysis Framework and Health System Resilience Theory Framework
Chi ZHOU ; Qunfang HUANG ; Xiaoling LIN ; Xu LI ; Jingchun CHEN
Chinese Hospital Management 2025;(9):57-62
Objective To construct an evaluation index system of organizational resilience of county medical alliance,and to propose countermeasures and suggestions for the enhancement of organizational resilience and operational effectiveness of county medical alliance.Methods The initial evaluation index system was constructed based on literature research and semi-structured interviews.Two rounds of Delphi expert consultation combined with critical value method refined the evaluation indexs.Evaluation index weights were determined via analytic hierarchy process and multiplicative weighting.The system was empirically tested using Zhejiang Province data.Results 21 experts completed consultations.Then the evaluation index system of county medical alliance organizational resilience was formed,which contains 5 first-level indexes,15 second-level indexes and 43 third-level indexes,containing 19 subjective and 24 objective evaluation indexs.The overall evaluation score of the organizational resilience of county medical alliance in Zhejiang Province was 73.97,which was at the average level of resilience.Conclusion The evaluation index system of organizational resilience of county medical alliance fits in with the national development plan to promote the construction of county high-quality,efficient and integrated medical and healthcare service system,and can provide effective measurement tools and theoretical references for the organizational capacity of county medical alliance and their maturity evaluation.
5.Development and evaluation of hepatitis B virus RNA detection method based on microfluidic chip-based digital PCR
Qunfang HUANG ; Rubing XIE ; Yanping LAN ; Zhen XUN ; Can LIU ; Qishui OU
Chinese Journal of Laboratory Medicine 2025;48(1):103-109
Objective:To establish a microfluidic chip-based digital PCR (cdPCR) method for detecting hepatitis B virus (HBV) RNA and evaluate its application in patients with chronic HBV infection.Methods:A total of 135 patients with chronic HBV infection were recruited from the First Affiliated Hospital of Fujian Medical University and stratified into two groups based on HBV DNA levels: HBV DNA>100 IU/ml ( n=85) and HBV DNA≤100 IU/ml ( n=50). Additionally, healthy individuals and subjects infected with other viruses ( n=15) served as controls. Primers and probes targeting the HBV pre-C/C region were designed to optimize the microfluidic cdPCR method, and its linear range, limit of detection (LOD), specificity, and precision were assessed. Serum HBV RNA levels were measured using the self-developed method and two commercial kits. Pearson correlation was applied to evaluate the relationships between HBV RNA and other HBV markers. Results:The optimized microfluidic cdPCR method featured a denaturation time of 10 seconds, an annealing/extension temperature of 62 ℃, and primer and probe concentrations of 0.3 μmol/L and 0.2 μmol/L, respectively. The method demonstrated a linear range of 103-10? copies/ml and an LOD of 102 copies/ml. The intra-assay coefficient of variation ( CV) for plasmid standards at 10? and 10? copies/ml were 1.06% and 0.82%, respectively, while the inter-assay CVs were 0.75% and 0.44%. Specificity analysis confirmed the absence of positive signals in sera from healthy controls and subjects infected with other pathogens. In the HBV DNA>100 IU/ml group, the detection rate of the self-developed cdPCR method was 81.18% (69/85), significantly higher than the 64.71% (55/85) achieved by commercial kit B ( P<0.016 7). However, in the HBV DNA≤100 IU/ml group, no significant differences were observed among the three methods ( P>0.05). HBV RNA levels were positively correlated with HBV DNA ( r=0.67), hepatitis B surface antigen ( r=0.53), and hepatitis B e antigen ( r=0.44) (all P<0.001). Conclusion:A microfluidic cdPCR assay for the quantitative detection of HBV RNA has been successfully developed. This assay demonstrates high sensitivity, specificity, and robust detection capability, even for low HBV DNA-concentration samples.
6.Diagnostic value of peripheral blood cell analysis-derived 5 new parameters on chronic hepatitis B, liver cirrhosis and hepatocellular carcinoma
Xinyao YANG ; Xin YANG ; Xinrong LU ; Qunfang HUANG ; Bin YANG ; Can LIU ; Qishui OU ; Zhen XUN
Chinese Journal of Laboratory Medicine 2025;48(7):917-923
Objective:To investigate the laboratory diagnostic value of 5 new blood routine indexes in chronic hepatitis B (CHB), liver cirrhosis and hepatocellular carcinoma (HCC).Methods:The retrospective study included 65 patients with chronic HBV infection, 72 patients with liver cirrhosis and 163 patients with HCC recruited at Liver Disease Center in First Affiliated Hospital of Fujian Medical University, as well as 52 healthy controls recruited from the Physical Examination Center of the First Affiliated Hospital of Fujian Medical University from October 2022 to April 2023. Five new parameters [early granulated cell percent (EGC%), early granulated cell absolute count (EGC#), microcytic anemia factor (MAF), leukocyte estimate(corrected)from the DIFF optical channel (WDOP) and leukocyte estimate(corrected)from the NRBC optical channel (WNOP)] were detected by UniCel DxH 900 blood cell analyzer. Univariate analysis of the expression levels of the 5 new parameterswere compared among CHB, liver cirrhosis and HCC groups. Pearson correlation analysis was used to explore the correlation between the 5 new parameters and HBV-related markers in CHB and Child-Pugh score in liver cirrhosis. Receiver operating characteristic (ROC) curve and AUC were used to estimate the diagnostic capacity of the 5 new blood routine indexes in CHB, liver cirrhosis and HCC.Results:In patients with CHB, the levels of EGC% ( Z=4.613, P<0.001) and EGC# ( Z=4.220, P<0.001) were higher than those of healthy controls; EGC# was positively correlated with HBsAg and HBeAg (both P<0.05). In patients with cirrhosis, the level of MAF ( Z=-4.928, P<0.001) was lower than that of healthy controls, and Child-Pugh score was found to be negatively correlated with MAF ( r=-0.349, P<0.05). In HCC patients, WDOP ( Z=2.45, P=0.017) and WNOP ( Z=2.90, P=0.017) levels were higher in patients with tumor volume>3 cm 3 than those in patients with volume ≤3 cm 3. The AUCs of combination of 5 new parameters to diagnose CHB, liver cirrhosis and HCC were 0.901 (95% CI 0.830-0.973, P<0.001), 0.946 (95% CI 0.909-0.984, P<0.001), and 0.904 (95% CI 0.858-0.950, P<0.001). Conclusions:The 5 new parameters based on peripheral blood cell analysis have good clinical value in the diagnosis of CHB, liver cirrhosis and HCC diseases.
7.Development and Empirical Study of the Organizational Resilience Evaluation Scale of County-level Medical Community
Qunfang HUANG ; Jiajun LI ; Xu LI ; Xiaoling LIN ; Jingchun CHEN ; Chi ZHOU
Chinese Hospital Management 2024;44(10):34-37,48
Objective To develop and empirically validate the County Medical and Health Community Organizational Resilience Evaluation Scale to verify its reliability and validity,and to provide a reference for the management practice of organizational resilience in medical and health communities.Methods The health system resilience framework and the dual resilience analysis framework were used as the content framework of this scale,and the initial scale was formed by literature review reference and interviews,and two rounds of correspondence to 21 experts were conducted to form the County Medical and Health Community Organizational Resilience Evaluation Scale.In October-November 2023,the medical staff of six medical and health communities in Zhejiang Province were sampled to conduct the survey,and SPSS 25.0 software was applied to process the data.Results The internal consistency Cronbach's alpha coefficient of the scale was 0.97,and the Cronbach's alpha coefficients of the five dimensions ranged from 0.67~0.92(P<0.001);the folded half reliability was 0.95,and the alpha coefficients of the two parts were 0.94.The results of the exploratory factor analysis showed that the KMO was 0.95,and that each dimension of the constructed Organizational Resilience Scale and the total score of the scale were positively correlated with the total score of the Strategic Flexibility Scale(P<0.01).Conclusion The Organizational Resilience Measurement Scale designed has good reliability and reference value,and may provide a tool for assessing organizational resilience in county medical and health communities in the future.
8.Development and Empirical Study of the Organizational Resilience Evaluation Scale of County-level Medical Community
Qunfang HUANG ; Jiajun LI ; Xu LI ; Xiaoling LIN ; Jingchun CHEN ; Chi ZHOU
Chinese Hospital Management 2024;44(10):34-37,48
Objective To develop and empirically validate the County Medical and Health Community Organizational Resilience Evaluation Scale to verify its reliability and validity,and to provide a reference for the management practice of organizational resilience in medical and health communities.Methods The health system resilience framework and the dual resilience analysis framework were used as the content framework of this scale,and the initial scale was formed by literature review reference and interviews,and two rounds of correspondence to 21 experts were conducted to form the County Medical and Health Community Organizational Resilience Evaluation Scale.In October-November 2023,the medical staff of six medical and health communities in Zhejiang Province were sampled to conduct the survey,and SPSS 25.0 software was applied to process the data.Results The internal consistency Cronbach's alpha coefficient of the scale was 0.97,and the Cronbach's alpha coefficients of the five dimensions ranged from 0.67~0.92(P<0.001);the folded half reliability was 0.95,and the alpha coefficients of the two parts were 0.94.The results of the exploratory factor analysis showed that the KMO was 0.95,and that each dimension of the constructed Organizational Resilience Scale and the total score of the scale were positively correlated with the total score of the Strategic Flexibility Scale(P<0.01).Conclusion The Organizational Resilience Measurement Scale designed has good reliability and reference value,and may provide a tool for assessing organizational resilience in county medical and health communities in the future.
9.Development and Empirical Study of the Organizational Resilience Evaluation Scale of County-level Medical Community
Qunfang HUANG ; Jiajun LI ; Xu LI ; Xiaoling LIN ; Jingchun CHEN ; Chi ZHOU
Chinese Hospital Management 2024;44(10):34-37,48
Objective To develop and empirically validate the County Medical and Health Community Organizational Resilience Evaluation Scale to verify its reliability and validity,and to provide a reference for the management practice of organizational resilience in medical and health communities.Methods The health system resilience framework and the dual resilience analysis framework were used as the content framework of this scale,and the initial scale was formed by literature review reference and interviews,and two rounds of correspondence to 21 experts were conducted to form the County Medical and Health Community Organizational Resilience Evaluation Scale.In October-November 2023,the medical staff of six medical and health communities in Zhejiang Province were sampled to conduct the survey,and SPSS 25.0 software was applied to process the data.Results The internal consistency Cronbach's alpha coefficient of the scale was 0.97,and the Cronbach's alpha coefficients of the five dimensions ranged from 0.67~0.92(P<0.001);the folded half reliability was 0.95,and the alpha coefficients of the two parts were 0.94.The results of the exploratory factor analysis showed that the KMO was 0.95,and that each dimension of the constructed Organizational Resilience Scale and the total score of the scale were positively correlated with the total score of the Strategic Flexibility Scale(P<0.01).Conclusion The Organizational Resilience Measurement Scale designed has good reliability and reference value,and may provide a tool for assessing organizational resilience in county medical and health communities in the future.
10.Development and Empirical Study of the Organizational Resilience Evaluation Scale of County-level Medical Community
Qunfang HUANG ; Jiajun LI ; Xu LI ; Xiaoling LIN ; Jingchun CHEN ; Chi ZHOU
Chinese Hospital Management 2024;44(10):34-37,48
Objective To develop and empirically validate the County Medical and Health Community Organizational Resilience Evaluation Scale to verify its reliability and validity,and to provide a reference for the management practice of organizational resilience in medical and health communities.Methods The health system resilience framework and the dual resilience analysis framework were used as the content framework of this scale,and the initial scale was formed by literature review reference and interviews,and two rounds of correspondence to 21 experts were conducted to form the County Medical and Health Community Organizational Resilience Evaluation Scale.In October-November 2023,the medical staff of six medical and health communities in Zhejiang Province were sampled to conduct the survey,and SPSS 25.0 software was applied to process the data.Results The internal consistency Cronbach's alpha coefficient of the scale was 0.97,and the Cronbach's alpha coefficients of the five dimensions ranged from 0.67~0.92(P<0.001);the folded half reliability was 0.95,and the alpha coefficients of the two parts were 0.94.The results of the exploratory factor analysis showed that the KMO was 0.95,and that each dimension of the constructed Organizational Resilience Scale and the total score of the scale were positively correlated with the total score of the Strategic Flexibility Scale(P<0.01).Conclusion The Organizational Resilience Measurement Scale designed has good reliability and reference value,and may provide a tool for assessing organizational resilience in county medical and health communities in the future.

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