Objective To build anautoverification system for hematology analysis system and validate the system based on commercialized labXpert software.Methods Preliminary validation rules was established base on 41 Items of International Consensus Review Rules and instructions for Mindray CAL8000 auto hematology analyzer,and input the rules into labX pert sample validation system.999 clinical samples were collected from Beijing Hospital Ministry of Health to test the preliminary rules and parameters including false positive rate,false negative rate and autoverification pass rate were calculated,based on which to adjust and customize the original protocol.Then 15 934 samples were tested,respectively,for autoverification by calculating the autoverification pass rate,proportion of manual verification and microscopic verification.Autoverification were compared as well as the turnover time (TAT,timefrom receipt of sample to report of result) before and after application of autoverification system.Results Preliminary verification results showed that false negative rates in both hospitals were less than 2％,and the false negative mainly caused by low promyelocytic cells value (blasts and promyelocytes less than 3 ％),abnormal erythrocyte morphology,and abnormal platelet morphology.No sample with excess blasts or percentage of blasts and promyelocytes higher 3％ with tested with false negative result,indicating relatively low clinical risks.Both hospitals reported with relatively high false positive rates,up to nearly 18％,using preliminary programs,which may affect the autoverification rate of the system.Based on the analyzing result of false positive results,the program was adjusted to significantly reduce the false positive rate while remaining the false negative rate low,therefore resulted with 4 remarkable increase of autoverification pass rate.Over 10,000 samples were tested with improved program,and the autoverification pass rates for hospital was 78.4 ％,respectively.Primary reason causing failure of autoverification included increased IMG％,flag for immature cells and WBC exceeding set limit.Application of system reduced the TAT by 5 min (P＜0.05).Conclusion Autoverificationsystem using Mindray CAL8000 auto hematology analyzer andlabXpert has been confirmed effective in reducing TAT and enhancing working efficiency while remaining low false negative rate.The autoverification pass rate tested 75％,which suggested that laboratory workers can spare more time on reexamination of abnormal samples for better blood routine report.

ObjectiveTo establish a enzyme-linked immunosorbent assay (ELISA) method for detecting the β-amyloid peptide 42 ( Aβ42 ) and explore its clinical meaning for diagnosis and treatment in the early stages of the alzheimer disease ( AD).Methods Using the Aβ42 single chain variable fragment constructed by phage antibody library display system as coat antibody,associated with the Aβ42 polyclonal antibody acquired by Aβ42 immunized rabbit and HRP labeled goat anti rabbit IgG to establish ELISA method for detecting the Aβ42 in peripheral blood.The method was used it to test the Aβ42 in 120 vascular dementia VD) or cerebral vessel infarction patients and 120 AD patients and 120 controls.The methodology performance were evaluated.ResultsThe inter and intra coefficient of variable (CV) of this self-established ELISA method was 3.6％ and 3.5％,6.8％ and 7.1％ respectively.The recovery rate was 97.2％ -103.1％.The linear range was 0.050 - 2 μg,/L.Its reactivity decreased ＜ 12％ when it was put in both 37 ℃ for 6 days and 4 ℃ for 6 months.Compared with the Belgium INNOTEST reagent by testing 90 samples simultaneously,the results of self-established method was (0.207 ± 0.039 ) μg/L,the results of INNOTEST was (0.206± 0.038 ) μg/L; the regression equation was Y =1.011X - 0.003,R2 =0.979,P ＜0.01.The Aβ42 in blood of AD group was (0.247 ± 0.032 ) μg/L,VD or cerebral vessel infarction group was (0.173 ±0.028) μg/L,control group was (0.172 ±0.032) μg/L.The Aβ42 in AD group was higher than that in the VD or cerebral vessel infarction group and control group (q =18.867,18.907respectively,P ＜ 0.01 ).The cut off value was 0.212 μg/L decided by the receiver operating characteristic (ROC) curve.The reference interval was 0 -0.212 μg/L.The sensitivity of this ELISA method was 86.7％(104/120) and specificity was 90.8％ (218/240).ConclusionsThe ELISA method for detecting Aβ42 in peripheral blood established by the study is sensitive and specific and has good precision and stability.It could provide a new effective criterion and support for the early diagnosis and treatment of the AD patients.

Objective:To explore the levels of vitamin A(VA) and vitamin D(VD) in blood of children with tic disorder (Tic disorder, TD) and their associations with tic symptoms severity and clinical types, so as to provide evidence for better prevention and treatment of TD.Methods:A total of 245 children with TD from September 2018 to April 2019 in the department of child Health care, affiliated hospital of qingdao university were enrolled as the case group and 63 healthy children who underwent routine physical examination at the same time as the control group. The levels of VA and VD were measured and their relationship with the severity of tic symptoms and clinical types were analyzed.Results:(1)The VD level of the case group was significantly lower than that of the control group ((23.72±8.87) μg/L , (26.61±7.59) μg/L, t=-2.24, P=0.03), and the proportion of insufficiency or even lack (37.31%, 75/201) was higher than the control group (15.79%, 9/57) (χ 2=9.37, P=0.002). (2)According to the Yale global tic severity scale(YGTSS), the children in the case group were divided into mild TD group, and moderate-to-severe TD group. ①There were significant differences in serum VA and VD levels in mild TD group, moderate-to-severe TD group and the control group ( F=29.79, P<0.01; F=10.90, P<0.01). Among them, the content of VA and VD in moderate-to-severe TD group were lower than those in mild TD group and control group (VA: (0.29±0.06)mg/L, (0.35±0.06)mg/L, (0.34±0.06)mg/L; VD: (21.01±8.30)μg/L, (25.84±8.76)μg/L, (26.61±7.59)μg/L). ②VA and VD levels of children with TD were negatively correlated with the severity of symptoms ( r=-0.325; P<0.01; r=-0.228; P=0.001). (3)According to DSM-V classification criteria, TD children were divided into PTD group, CTD group and TS group. ①There was no significant difference in serum VA level among different clinical types of TD children ( F=0.87, P=0.46). ②The levels of serum VD were different among the four groups ( F=4.13, P=0.007). Among them, the VD level in TS group was the lowest, and its content was significantly lower than that in control group ((21.83±7.60)μg/L, (26.61±7.59)μg/L, P<0.05)). The prevalence of insufficient or even lack of serum VD in children with different subtypes of TD was higher than that in the control group (χ 2=10.88, P=0.01). Conclusion:Vitamin D deficiency exists in children with TD. The level of vitamin A and vitamin D in serum of children with TD is related with the severity of tic symptoms.The VD level is related with clinical type of TD.

Objective:To explore the construction of a Logistic prediction model and countermeasures for type 2 diabetic nephropathy based on clinical data.Methods:The patients with type 2 diabetic nephropathy admitted to Shijiazhuang Second Hospital from September 2019 to September 2021 (study group) were selected and the patients were selected according to a 1∶1 ratio using individual matching (control group), each group with 200 patients. Single and multiple factors analysis were used to analyze the factors influencing type 2 diabetic nephropathy, and Logistic regression equation models were developed to verify their predictive value.Results:Logistic regression equation model showed that the course of type 2 diabetes, glycosylated hemoglobin (HbA 1c), fasting plasma glucose (FPG), homocysteine (Hcy), urinary microalbumin, and serum creatinine (Scr) were high risk factors for type 2 diabetic nephropathy ( P<0.05). The results of Logistic regression model evaluation showed that the model was established with statistical significance, and the coefficients of the regression equations had statistically significant differences. The Hosmer-Lemeshow goodness-of-fit test showed that the model fitting effect was good. Logistic regression model was used to statistically analyzed the data set, and the receiver operating characteristic (ROC) curve of type 2 diabetic nephropathy was drawn, the area under the curve was 0.949(95% CI 0.922 - 0.968), the prediction sensitivity was 81.50%, the specificity was 95.50%, the calibration curve showed that the predicted results was in good agreement with the observed results. Conclusions:The independent predictors of type 2 diabetic nephropathy involve HbA 1c, FPG, Hcy, urinary microalbumin. The Logistic prediction model based on these predictors has reliable predictive value and can help guide clinical diagnosis and treatment.

Objective To understand the current status of research on lung cancer immunotherapy to provide a reference for further investigation and future topic selection in this field. Methods CiteSpace visualization analysis software was used to analyze 400 Chinese studies in CNKI and 5 001 English studies in the Web of Science database from 2005 to 2021, with "lung cancer" and "immunotherapy" as keywords. Keyword co-occurrence analysis was performed on 17 English studies of "Lung Cancer" "Immunotherapy" and "Single cell sequencing" in the Web of Science database. Results "Non-small cell lung cancer" "immunosuppressants" "PD-L1" "dendritic cells" and "cytokine-induced killer cells" are current research hotspots in lung cancer immunotherapy. Monoclonal antibody drugs including nivolumab, pembrolizumab, atezolizumab, and durvalumab are hotspot drugs. Immunotherapy combined with chemotherapy as well as PD-L1 expression have become the focus of continuous research. The majority of studies on lung cancer immunotherapy are conducted in the United States, followed by China. Conclusion Lung cancer immunotherapy has gradually become a research hot spot in China. In the future, in-depth research is needed to provide cutting-edge directions for lung cancer immunotherapy.

Pulmonary inflammatory myofibroblastic tumor (PIMT) is a rare lung tumor that is poorly understood by clinicians. Based on the data of patients with PIMT in our center, a comprehensive search and a brief summary analysis of previous reports of the disease were carried out in this article. PIMTs were more likely to be present in male patients and in the right lung, and their clinical and radiographic findings were heterogeneous. Surgery is the most important treatment method, and complete resection is of great significance to the prognosis of patients. Targeted therapy represented by crizotinib may be helpful for patients with positive ALK mutations.

Objective To investigate the effects of high concentration of semen samples in detection by fully automated sperm quality analyzer for sperm concentration,progressive motility(PR),non-progressive motility(NP)and percentage of immotile sperm(IM).Methods The semen samples from the patients who visited the reproductive clinic in our hospital from February 2023 to May 2023 were analyzed using the fully automated sperm quality analyzer.A total of 155 semen samples with initial sperm concentration ≥100× 106/mL and semen volume ≥1.5 mL were set as the high concentration semen group(group A).The semen samples with self seminal plasma dilution group(group B)and 37 ℃ normal saline dilution group(group C)were prepared with their own seminal plasma and normal saline at 1∶2 dilution ratio respectively.The sperm concentration of group A was detected by the manual method as the control.The sperm concentration and motility parameters of each group were detected.The differences of sperm concentration and the values of PR,NP and IM among the group A,B and C were analyzed.The correlations between sperm concentration and PR,NP and IM were also assessed.Results The sperm concentration of group A was significantly lower than that of the control group and groups B and C(all P＜0.05).There was no statistically significant difference for the results between group B and group C(P＞0.05).The PR in group C was significantly lower than that in groups A and B(all P＜0.05),and there was no significant difference of PR between group A and group B(P＞0.05).The values of NP in group A was significantly higher than that in groups B and C(all P＜0.05),and there was no significant difference in NP between group B and group C(P＞0.05).The IM in group A was significantly lower than that in groups B and C(all P＜0.05),and there was no statistical difference of IM values between group B ang group C(P＞0.05).Conclusion The direct analysis of undiluted semen samples with high sperm concentration may lead to lower results of sperm concentration,increased percentage of NP sperm and decreased percentage of IM sperm.The dilution of semen samples may improve the accuracy of the detec-tion results.The dilution with 37 ℃ normal saline can lead to decrease of the percentage of PR sperm.The self seminal plasma should be recommended as the first choice of diluent for the semen samples with high sperm concentration.

Objective To explore the association between iron metabolism indexes and the risk of gestational diabetes mellitus(GDM)in pregnant women with advanced age.Methods A total of 292 pregnant women,whose age were≥35 years old and gave birth in Taicang First People's Hospital from April 2021 to April 2023,were retrospectively included and divided into GDM group and non-GDM group.The differences of iron metabolism indexes[serum ferritin(SF),serum iron(SI)and hemoglobin(Hb)]measured from the 20 to 24 weeks of gestation were compared between the two groups.Multivariable Logistic regression model was used to explore the association of SF,SI and Hb with GDM.Based on the data of single nucleotide polymorphism from IEU OpenGWAS(http://gwas.mr-cieu.ac.uk/)and FinnGen datasets,two samples Mendelian randomization analysis were conducted to explore the causal relationship between iron metabolism indexes and GDM by using the methods of Inverse Variance Weighted(IVW).Results In the maximally ad-justed multi-factor logistic models,the statistically significant association between SF measured from 20 to 24 weeks of gestation and the risk of GDM was found[odds ratio(95％confident interval)=1.02(1.01-1.04),P=0.001].The association between Hb and GDM was marginally significant[odds ratio(95％confident interval)=1.04(1.00-1.07),P=0.044],but no association between SI and GDM reached statistical significance.However,Mendelian randomization analysis showed there was no significant evidence for causal association between SF,Hb and GDM.Conclusion SF examined at 20 to 24 weeks of gestation could be used as a biomarker of GDM in the pregnant women with advanced age,but no evidence supported the causal association between SF and GDM.

Objective:To develop radiopharmaceuticals for targeted alpha therapy (TAT), a simple and useful 225Ac- 213Bi generator was developed to provide a short half-life α-emitter 213Bi. Methods:DIPEX resin was used as the stationary phase of the generator, a Sep-Pak Alumina N Plus Light Cartridge column was utilized as the column to construct the generator, and hydrochloric acid was used as the eluent. The γ spectrometer was used to determine the purity of the eluted 213Bi and verify the method to measure the radioactivity of 225Ac and 213Bi by using radioisotope calibrators. The elution curves of the generator at various settings were analyzed to find the best elute and storage conditions. Results:Using commercial 225Ac, 100 mg DIPEX resin and a Sep-Pak Alumina N Plus Light Cartridge column, a 225Ac- 213Bi generator with a column volume of 0.35 ml was constructed, which could be eluted 213Bi with a syringe drenched with hydrochloric acid. The produced 213Bi was pure, and the measured half-life was (45.75±0.12) min, which was consistent with the theoretical value (45.6 min). CRC ? calibrators with setting numbers of #086 and #018 could measure the activity of 225Ac and 213Bi with the average errors of -2.6% and + 0.2% respectively. The eluent for the 225Ac- 213Bi generator was 2 mol/L hydrochloric acid, of which 320 μl was required only to get 90% elution yield. The generator was recommended to be stored directly in the eluent to avoid drying. Conclusion:The 225Ac- 213Bi generator can be constructed to obtain 213Bi for TAT.

Objective:To study the effect of water improvement on urinary arsenic methylation metabolism in population exposed to arsenic through drinking water.Methods:A cluster sampling method was used to select drinking water type arsenism areas in Bayannur City, Inner Mongolia Autonomous Region. Permanent residents lived in the arsenism areas for more than 10 years were selected as the survey subjects. Urine samples ( n = 874, 111, 145) were collected in 2004 (before water improvement), 2014 (4 years after water improvement) and 2017 (7 years after water improvement), respectively, and some subjects were followed up in 2014 and 2017. High performance liquid chromatography-inductively coupled plasma mass spectrometry (HPLC-ICP-MS) was used to detect different forms of arsenic metabolites in urine [inorganic arsenic (iAs), monomethylarsonic acid (MMA), dimethylarsenic acid (DMA)], and total arsenic (tAs), the iAs percentage (iAs%), MMA percentage (MMA%), DMA percentage (DMA%), monomethylation rate (PMI), dimethylation rate (SMI), and the ratio of MMA to DMA (MMA/DMA) were calculated. The content and distribution of urinary arsenic metabolites in people exposed to arsenic before and after water improvement were compared and analyzed. Results:Compared with 2004, the levels of iAs, MMA, DMA, tAs and iAs% in urine of arsenic exposed population in 2014 were lower ( Z =-14.12,-12.79,-14.27,-14.21,-6.90, P < 0.001), the levels of MMA%, DMA% and PMI were higher ( Z =-3.22,-2.91,-6.90, P < 0.05); in the same drinking water arsenic exposed population, compared with 2004, the levels of iAs, MMA, DMA, tAs and iAs% in urine ( n = 48) were lower ( Z =-5.57,-5.53,-5.54,-5.55,-2.86, P < 0.05) in 2014, and PMI level was higher ( Z =-2.86, P = 0.004). Compared with 2014, the levels of iAs% and MMA/DMA in urine of arsenic exposed population in 2017 were lower ( Z =-4.97,-2.25, P < 0.05), the levels of MMA, DMA, tAs, DMA%, PMI and SMI were higher ( Z =-4.01,-5.39,-4.77,-4.61,-4.97,-2.25, P < 0.05); in the same drinking water arsenic exposed population, compared with 2014, the level of iAs% in urine ( n = 28) was lower ( Z =-2.87, P = 0.004) in 2017, the levels of DMA% and PMI were higher ( Z =-2.32,-2.87, P < 0.05). Conclusion:Water improvement could significantly reduce the levels of urinary arsenic metabolites iAs, MMA, DMA and tAs and increase the level of DMA% in arsenic exposed population.