1.Immunogenicity, safety and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years
Dingyan YAO ; Yingping CHEN ; Fan DING ; Xiaosong HU ; Zhenzhen LIANG ; Bo XING ; Yifei CAO ; Tianqi ZHANG ; Xilu WANG ; Yuting LIAO ; Juan YANG ; Huakun LYU
Chinese Journal of Preventive Medicine 2024;58(1):25-32
Objective:To evaluate the immunogenicity, safety, and immune persistence of the sequential booster with the recombinant protein-based COVID-19 vaccine (CHO cell) in healthy people aged 18-84 years.Methods:An open-label, multi-center trial was conducted in October 2021. The eligible healthy individuals, aged 18-84 years who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, were recruited from Shangyu district of Shaoxing and Kaihua county of Quzhou, Zhejiang province. All participants were divided into three groups based on the differences in prime-boost intervals: Group A (3-4 months), Group B (5-6 months) and Group C (7-9 months), with 320 persons per group. All participants received the recombinant COVID-19 vaccine (CHO cell). Blood samples were collected before the vaccination and after receiving the booster at 14 days, 30 days, and 180 days for analysis of GMTs, antibody positivity rates, and seroconversion rates. All adverse events were collected within one month and serious adverse events were collected within six months. The incidences of adverse reactions were analyzed after the booster.Results:The age of 960 participants was (52.3±11.5) years old, and 47.4% were males (455). The GMTs of Groups B and C were 65.26 (54.51-78.12) and 60.97 (50.61-73.45) at 14 days after the booster, both higher than Group A′s 44.79 (36.94-54.30) ( P value<0.05). The GMTs of Groups B and C were 23.95 (20.18-28.42) and 27.98 (23.45-33.39) at 30 days after the booster, both higher than Group A′s 15.71 (13.24-18.63) ( P value <0.05). At 14 days after the booster, the antibody positivity rates in Groups A, B, and C were 91.69% (276/301), 94.38% (302/320), and 93.95% (295/314), respectively. The seroconversion rates in the three groups were 90.37% (272/301), 93.75% (300/320), and 93.31% (293/314), respectively. There was no significant difference among these rates in the three groups (all P values >0.05). At 30 days after the booster, antibody positivity rates in Groups A, B, and C were 79.60% (238/299), 87.74% (279/318), and 90.48% (285/315), respectively. The seroconversion rates in the three groups were 76.92% (230/299), 85.85% (273/318), and 88.25% (278/315), respectively. There was a significant difference among these rates in the three groups (all P values <0.001). During the sequential booster immunization, the incidence of adverse events in 960 participants was 15.31% (147/960), with rates of about 14.38% (46/320), 17.50% (56/320), and 14.06% (45/320) in Groups A, B, and C, respectively. The incidence of adverse reactions was 8.02% (77/960), with rates of about 7.50% (24/320), 6.88% (22/320), and 9.69% (31/320) in Groups A, B, and C, respectively. No serious adverse events related to the booster were reported. Conclusion:Healthy individuals aged 18-84 years, who had completed primary immunization with the inactivated COVID-19 vaccine 3 to 9 months before, have good immunogenicity and safety profiles following the sequential booster with the recombinant COVID-19 vaccine (CHO cell).
2.A Prediction Model for Colorectal Adenoma and Colorectal Cancer Based on Routine Test
Junsheng LIN ; Ziling YING ; Zhengyuan HUANG ; Xianjin ZHU ; Yingping CAO ; Pingxia LU
Cancer Research on Prevention and Treatment 2024;51(5):353-360
Objective To analyze the routine test parameter levels of patients with colorectal adenoma and colorectal cancer,and develop a prediction model.Methods A total of 580 patients diagnosed with colorectal adenoma(117 patients)and colorectal cancer(463 patients)were included in the retrospective study.The patients were randomly divided into two groups according to a 7:3 ratio:a training set with 406 cases and a validation set with 174 cases.Logistic regression analysis was used to establish a prediction model,and a nomogram was drawn.The model′s discrimination,calibration,and clinical applicability were evaluated using receiver operating characteristic curve(ROC),calibration plot,and decision curve analysis(DCA).Results Univariate logistic regression analysis identified 13 potential predictors:age,fecal occult blood test(FOBT),fibrinogen(FIB),thrombin time(TT),albumin(ALB),white blood cell value(WBC),neutrophil count(NEUT#),hematocrit value(HCT),mean corpuscular hemoglobin(MCH),red cell distribution width(RDW),platelet count(PLT),mean platelet volume(MPV),and activated partial thromboplastin time(APTT).Multivariate logistic regression analysis showed MPV,FIB,ALB,FOBT,TT,and HCT were risk factors for colorectal cancer in patients with colorectal adenoma(P<0.05).A nomogram was constructed based on these predictors to build a prediction model.The AUC of the ROC curve was 0.915 for colorectal cancer in the training set and 0.836 in the validation set.Calibration plots demonstrated high prediction accuracy and good model calibration.DCA results indicated the prediction model provided greater net benefit compared with the extreme models at threshold probabilities of approximately 55%-95%.Conclusion The developed prediction model exhibits satisfactory discrimination,calibration,and clinical applicability.The model can serve as an auxiliary tool in distinguishing between colorectal adenoma and colorectal cancer in patients.
3.Clinical value evaluation of rapid detection method for the hematopoietic stem/progenitor cell of peripheral blood using the automated hematology analyzer
Meihua WANG ; He ZHUANG ; Chenqing ZHANG ; Zhiqiang XIE ; Pingli YU ; Yingping CAO
Chinese Journal of Laboratory Medicine 2020;43(4):489-494
Objective:To explore the performance and clinical application value of a rapid detection method for the hematopoietic stem/progenitor cell of peripheral blood using the automated hematology analyzer.Methods:Methodology validation and retrospective study. Collected sample from Fujian Medical University Union Hospital from January 2015 to December 2018, the peripheral blood of 4 patients with acute myeloid leukemia was first treated, and one healthy donor′s peripheral blood stem cell collection 5 times diluent, for the methodology validation. And the peripheral venous blood and 5-fold dilutions of peripheral blood stem cell collection, from 23 patients with hematopoietic stem cell transplantation and 22 healthy donors of allogeneic peripheral blood stem cell transplantation, used for consistency retrospective analysis. In the linear test, each of the peripheral blood and HPC collecting solutions from blood cell separator, which known CD34 +cell concentration, that was high-value samples for the expected upper limit (H) . Another low-value sample is normal saline (L) . According to the multiple proportion dilution, HPC was detected and regressed consistency test specimens were 126, EDTA-K 2 anticoagulant venous blood 78 and peripheral blood stem cell 48. Venous blood was collected at the same time, one tube of blood routine and HPC detection, the other tube flow cytometry (FCM) detection of CD34 +cells. Stem cell collection was diluted 5 times with sterilized saline and divided into two tubes. One tube was used to count whole blood cells and HPC, the other tube was used to detect CD34 +cells by FCM. The test results of the two instruments were compared, and the deviation was evaluated. Results:The background counting was 0×10 9/L and the carryover rate was 0.1%, conformed to the quality requirements of hematology analyzer, and the repeatability study imprecision ranged between 4.7%-18.8%. HPC of peripheral venous blood linear range (0-27.201×10 9/L), Stem cell collection was diluted 5 times linear range (0-0.878×10 9/L). The results of 126 samples detected by the hematology analyzer and FCM were compared. The correlation coefficient r2=0.960 1. When WBC>10×10 9/L, the results of the two instruments have a good consistency. The slope is between 0.95 and 1.05, and the relative bias is less than 30%. Conclusions:This study suggests that the hematology analyzer has a good linear range for detecting HPC, and has a good correlation with FCM. The hematology analyzer has the advantages of no pretreatment, convenient operation, a wide range of applications in detecting HPC specimens.
4.Molecular characteristics of qnrS1-positive Escherichia coli resistant to quinolone
Jiangqing HUANG ; Zhichang ZHAO ; Yao CHEN ; Yingping CAO ; Bin LI
Chinese Journal of Microbiology and Immunology 2019;39(8):565-571
Objective To analyze the molecular characteristics of qnrS-positive Escherichia coli ( E. coli) strains resistant to quinolone. Methods A total of 57 qnrS1-positive clinical isolates were collect-ed from Fujian Medical University Union Hospital. Plasmid-mediated quinolone resistance ( PMQR) genes [qnrA, qnrB, qnrC, qnrD, aac(6′)-Ib-cr, qepA and oqxAB] andβ-lactamase genes (blaCTX-M-1, blaCTX-M-2, blaCTX-M-8 , blaCTX-M-9 , blaSHV and blaTEM ) were detected by PCR and then sequenced. Agar dilution method was used to analyze the antimicrobial susceptibility of the qnrS1-positive strains. Phylogenetic analysis was conducted using PCR. Multilocus sequence typing ( MLST) was performed for phenotyping. Enterobacterial repetitive intergenic consensus-polymerase chain reaction ( ERIC-PCR) was used to evaluate the genetic sim-ilarity between those isolates. Transferability of the qnrS1 genes carried by the 57 strains was examined by conjugation test with the sodiumazide-resistant E. coli J53 as the recipient strain. Mutations in the quinolone resistance-determining regions ( QRDR) in those strains were analyzed by PCR. Results All of the qnrS1-positive E. coli strains showed high resistance to quinolones. PMQR genes were harbored by 14 (24. 6%) isolates. Extended spectrum β-lactamases (ESBLs)-producing isolates accounted for 68. 4%. Mutations in the QRDR of gyrA, gyrB, parC and parE genes were found in 56 (98. 2%) strains and the most frequent point mutations were S83L (89. 5%) in gyrA gene, S80I (54. 4%) in parC gene and P415V (28. 1%) in parE gene. The qnrS1 gene was successful transferred from 13 (22. 8%) isolates to E. coli J53 by conjuga-tion. Five plasmid incompatibility groups were detected. Phylogenetic analysis showed that there were 36 (63. 2%), 13 (22. 8%), 1 (1. 8%) and 7 (12. 3%) isolates belonging to groups A, B1, B2 and D, respectively. The 57 qnrS1-positive E. coli strains were assigned to 50 ERIC types and 39 sequence types ( ST) based on the results of ERIC-PCR and MLST. Conclusions Mutations in the QRDR in E. coli strains were associated with qnrS1 gene and might play a critical role in the dissemination of quinolone-resistant bacteria.
5.Retrospective analysis on outpatient visitors′parvovirus B19 infection in Fuzhou area from 2011 to 2016
Siyan CHEN ; Xiaoli ZHANG ; Yinping YOU ; Yingping CAO
Chinese Journal of Laboratory Medicine 2018;41(2):171-174
Objective To investigate the outpatient visitor′s B19 infection in Fuzhou area, study the correlation between B19 virus infection and clinical diseases.Methods The infection status of B19V IgM and IgG in 22 089 outpatient visitors in Fuzhou area from 2011 to 2016 has been retrospectively analyzed.The patients were divided into different groups according to sex,age,different pregnant outcomes, healthy people and hematopoietic system diseases.Results The positive rate in 22 089 patients of B19V IgM was 4.5%(998/22 089)and the IgG positive rate was 36.9%(8 155/22 089); The positive rate of B19V IgM in female patients(4.8%,546/11 374)was higher than male patients(4.2%,452/10 715)(χ2=4.333,P<0.05); The middle-aged and elderly patients IgG positive rate(53.6%,3 629/6 772;54.3%,1 542/2 838)were significantly higher than infants,children and young people(36.0%,989/2 747;25.4%,237/934;20.0%,1 758/8 797); The positive rate of IgM in adverse pregnancy outcomes (8.2%,20/245)was higher than normal pregnant women(3.3%,23/688)(χ2=9.548,P<0.05).In pancytopenia,thrombocytopenia and anemia patients, the positive rates of B19V IgG were 39.8%(165/415),38.1%(297/780)and 35.4%(81/226)respectively, all of which were higher than that in the healthy people(14.4%,78/543)(χ2=80.127,88.626,43.461; P<0.05).Conclusions The outpatient visitor′s infection rate of B19V in Fuzhou is high.B19V is a common virus who can lead to adverse pregnancy outcomes.What′s more, it also can lead to pancytopenia, thrombocytopenia, anemia or other related hematopoietic diseases.
6.Early diagnostic value of galactomannan test to invasive pulmonary aspergillosis in patients with non- neutropenia
Jianlin ZHOU ; Yingping CAO ; Xiaoli ZHANG ; Lihua ZHANG ; Meihua WANG
Chinese Journal of Laboratory Medicine 2018;41(11):837-840
Objective To evaluate the early diagnostic value of galactomannan ( GM ) test in bronchoalveolar lavage fluid ( BALF ) to invasive pulmonary aspergillosis ( IPA ) in patients with non-neutropenia.Methods A total of 199 patients with suspected IPA were enrolled in the Department of Critical Care Medicine and Respiration of the Union Hospital of Fujian Medical University from January 2016 to October 2017, these patients excluded neutropenia .The patients were divided into IPA group and non-IPA group according to the European Organization for Research and Treatment of Cancer /Infectious Diseases Mycoses Study Group ( EORTC/MSG ) consensus.BALF and serum GM tests were performed in both groups.SPSS 20.0 statistical software was used to analyze the results of both IPA group and non-IPA group.Results The GM index in BALF and serum of IPA group was 2.41 ±2.19 and 0.65 ±1.08 respectively.The former is higher than the latter , the difference was statistically significant ( u=8.27,P<0.0005 ) . The GM index in BALF and serum of non-IPA group was 0.37 ±0.33 and 0.2 ±0.15 respectively, compared with the IPA group, the difference were statistically significant (u=11.18 and 7.07, P<0.0005).When the cut-off of GM was equal or greater than 0.5, the sensitivity, positive predictive value and negative predictive value of GM test in BALF was 86.36%, 74.02%and 92.62% respectively , were significantly higher than those in serum (31.8%, 67.74%and 73.21%respectively).The specificity of GM test in BALF was 84.96%, which was lower than that in serum (92.48%).When the cut-off of GM was equal or greater than 1.0, the sensitivity, positive predictive value and negative predictive value of GM test in BALF was 66.66%, 84.61%and 85.03% respectively, significantly higher than those in serum ( 24.24%, 76.19%and 71.9% respectively ) . The specificity was similar ( 95.98%vs 96.24%) . Conclusions GM test in BALF has a highly sensitivity and specificity in patients with non-neutropenia, better than that in serum.It has high value for early diagnosis of IPA.
7.Prevalence of Plasmid-Mediated Quinolone Resistance Genes Among Escherichia coli in the Gut of Healthy People in Fuzhou, China.
Bin LI ; Yao CHEN ; Zhiyun WU ; Zhichang ZHAO ; Juan WU ; Yingping CAO
Annals of Laboratory Medicine 2018;38(4):384-386
No abstract available.
China*
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Escherichia coli*
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Escherichia*
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Prevalence*
8.Related research of immunosuppression in intermingled skin transplantation induced by B7-H1 expressed on auto-keratinocytes
Weidong CAI ; Ying BAI ; Xianjin ZHU ; Peizheng ZHENG ; Yingping CAO ; Guangyan ZHOU
Chinese Journal of Immunology 2017;33(2):174-177,185
Objective:To explore the role and mechanism of the B7-H1 expressed by auto-keratinocytes in the intermingled skin grafting model in vitro(MELC). Methods:The intermingled skin grafting model(MELC) was established in vitro. Flow cytometry was performed to detect the expressions of B7-H1 in keratinocytes. The expressions of PD-1 in lymphocytes were measured at the same time. The levels of IL-10,Foxp3 and GATA-3 mRNA in lymphocytes were detected by Real-time quantitative PCR. Results: Through flow eytometry,in the MELC with auto-keratinocytes,the expression of B7-H1 in auto-keratinocytes and the PD-1 in lymphocytes were rising trend and the rising rate was in time-dependent manners(P<0. 01). RT-PCR assay indicated that the relative levels of IL-10, Foxp3,GATA-3mRNA expression were significant raised and the rising rate was in time-dependent manners (P<0. 01). Conclusion:In the intermingled skin grafting model,the auto-keratinocytes could express B7-H1 to enhance the expression of PD-1 in T cells. When B7-H1 combined with PD-1,the Th2 cells and Foxp3+Tregs were induced and suppressed the immune response in the intermingled skin grafting model.
9.Study on the Resistance Mechanisms of Carbapenem-Resistant Klebsiella Oxytoca
Xiaohong XU ; Zhiyun WU ; Meili CAI ; Meihua WANG ; Ying CHEN ; Yingping CAO ; Bin LI
Journal of Modern Laboratory Medicine 2017;32(1):19-21
Objective To investigate the resistance mechanism of Carbapenem-Resistant Klebsiella oxytoca.Methods Car-bapenem-Resistant Klebsiellaoxytoca were collected from Fujian Medical University Union Hospital.The modified hodge test (MHT)was used for carbapenemase phenotype screening.The minimum inhibit concentration(MIC)was detected using agar dilution method for 1 7 drugs.PCR and DNA sequencing were used to detect commonβ-Lactamase genes and carbapene-mases genes.Conj ugation experiments demonstrated the transferability of the carbapenem-resistant determinants.Results 5 Carbapenem-Resistant Klebsiella oxytoca of 4 isolates were positive detected by MHT.Minimum inhibit concentration was detected by using agar dilution method for 17 drugs.More than 80% isolates were resistance to nine drugs.2 isolates conju-gated successfully of 5 Carbapenem-Resistant Klebsiella oxytoca Isolates.There were 2 isolates included carbapenemases gene (1 isolates were only IMP producers,1 isolate contained the IMP and KPC),3 isolates produce ESBLs gene.Conclution The due to CRE strains isolated from Fujian Medical University Union Hospital may be metallo-enzyme carbapenemase and KPC gene.And the isolate that produce two Carbapenem-Resistant gene had been found in this hospital.
10.Thinking and exploration of formative assessment in the clinical practice skills teaching of laboratory medicine
Meihua WANG ; Yingping CAO ; Peizheng ZHENG ; Jingxi ZHANG ; Xiaoli ZHANG ; Yuhong PAN ; Zhixin CHEN ; Pingli YU
Chinese Journal of Laboratory Medicine 2017;40(7):552-554
To combine more than 20 years of experience in clinical practice skills teaching of laboratory medicine, with the characteristics of laboratory medicine, the theory system of formative assessment has been constructed, to guide the clinical practice of the students.Based on the construction of network question bank, students make use of the network question bank self testing, to know whether they had got the stage goal, existing problems and future plan through self testing, so as to mobilize their enthusiasm and initiative to enhance their self-confidence.Under the formative assessment teaching system, students establish internship file information, including practice notes, weekly practice, group discussion, self testing results, the teacher and peer assessment information.Teachers set up QQ group, WeChat group with their students, the timely to get the question from students and to take appropriate measures improve teaching.Teachers had established and improved the long-term after graduation feedback mechanism, and formative assessment improved the teaching quality of the whole practice teaching benefits teachers as well as students.

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