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    30 April 2022, Volume 37 Issue 4
    Re-understanding about the rational application of clinical laboratory determination technologies for COVID-19 diagnosis
    OU Tong, ZHANG Bing, ZHANG Xiuming
    2022, 37(4):  303-308.  DOI: 10.3969/j.issn.1673-8640.2022.04.001
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    Corona virus disease 2019(COVID-19) epidemic has seriously endangered human health and economic and social development. Accurate etiological determination in clinical laboratories is a prerequisite for epidemic prevention and control. At present,clinical laboratory determination technologies for severe acute respiratory syndrome coronavirus-2 mainly include nucleic acid,antibody and antigen determinations. Nucleic acid determination is a gold standard for the COVID-19 diagnosis with high sensitivity and specificity,but it has high requirements for personnel technical needs and experimental conditions. Antibody determination can be used as a supplement for nucleic acid determination to reduce missed determination and monitor the disease progress,while universal vaccination will affect the interpretation of antibody determination results,like false positivity. Antigen determination is convenient and fast,which can be operated at home,but its sensitivity is greatly affected by the disease process and viral load. In order to improve the efficiency of large-scale population screening,the National Health Commission has successively issued 5-in-1,10-in-1,and 20-in-1 mixed sampling technologies. However,the multiplication of preservation solution in the mixed sampling tube will result in virus dilution and increase the missed determination probability,and mixed sampling also aggravates the workload of epidemiological investigation and subsequent confirmation of the positive specimen in primary screening. With the progress of the COVID-19 epidemic,the SARS-CoV-2 continues to mutate,and the clinical laboratory determination technologies are gradually enriched and improved. Accurate analysis and judgment of the advantages and disadvantages of existing determination technologies and their application scenarios are conducive to the scientific prevention and control of the epidemic. This review will analyzes the following key clinical laboratory determination technical issues and put forward application suggestions,including the “mixed sampling” and “mixed determination” in nucleic acid determination,the impact of virus mutation on the performance of nucleic acid determination,the advantages and disadvantages of “endogenous” and “exogenous” internal standards in nucleic acid determination,the clinical significance and application scenarios of antigen determination and the value of antibody determination after vaccination.

    Research progress of new tumor molecular markers in the age of precision medicine:from accurate diagnosis to precision chemotherapy
    GAO Feng
    2022, 37(4):  309-312.  DOI: 10.3969/j.issn.1673-8640.2022.04.002
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    Malignant tumors have evolved into a severe hazard to human health. Between China's tumor diagnosis and treatment and those of Europe,America and other developed countries,there is still a significant disparity. Early determination and accurate comprehensive diagnosis and treatment are essential for achieving the aim of a healthy China. However,there can be no proper therapy without an accurate diagnosis. Accurate diagnosis is based on a thorough understanding of tumor features and their evolution. The discovery of new tumor molecular features has changed tumor diagnostic and treatment concepts and strategies in the recent years,presenting a new opportunity and challenge in the area of tumor diagnosis and therapy. New tumor marker molecules are increasingly becoming more essential in clinical tumor diagnosis,recurrence,metastasis monitoring and prognosis.

    Research progress on the role of estrogen receptor in osteosarcoma
    SUN Xiaodan, LIU Yiwen, HE Yiqing, DU Yan, ZHANG Guoliang, GAO Feng, YANG Cuixia
    2022, 37(4):  313-318.  DOI: 10.3969/j.issn.1673-8640.2022.04.003
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    Estrogen receptor(ER) belongs to the nuclear receptor superfamily,which mainly binds with the ligand estrogen to activate transcription of its target genes. The interaction of ER with estrogen could actively recruit co-regulator factors to influence transcription of ER-dependent genes. ER not only plays a role in promoting sexual organ maturation,parasexual development and maintaining sexual function,but also participates in the regulation of tumor cell growth,drug resistance,epithelial-mesenchymal transformation(EMT) and metastasis during the occurrence and development of tumors. ER is expressed at a low level in osteosarcoma. Regulating the expression level or activity of ER can effectively change the expression of estrogen/ER-dependent transcription factors and affect the invasion,metastasis,drug sensitivity and growth characteristics of tumors. This review focuses on the research progress of ER in the occurrence,development and treatment of osteosarcoma in the recent years,trying to provide new insights for clinic.

    Inhibitory effects of antiestrogen on the proliferation and CCL2 expression of osteosarcoma cells
    SUN Xiaodan, XU Jing, LIU Yiwen, HE Yiqing, DU Yan, ZHANG Guoliang, GAO Feng, YANG Cuixia
    2022, 37(4):  319-324.  DOI: 10.3969/j.issn.1673-8640.2022.04.004
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    Objective To investigate the effects of antiestrogen(tamoxifen)on the proliferation and the expression level of CC chemokine ligand (CCL)2 of osteosarcoma cells. Methods The difference of estrogen receptor(ER) expression between osteosarcoma cells(143B,U-2OS) and osteoblast(hFOB1.19) was observed. CCK8 experiment and plate colony formation assay were used to observe the effects of tamoxifen on the proliferation of osteosarcoma cells. The relative expression levels of inflammatory factors,IL-6,IL-8,TGF-β,CCL2 and CCL5 in osteosarcoma cells were determined by fluorescence quantitative polymerase chain reaction(PCR). The effects of tamoxifen on CCL2 expression of osteosarcoma cells in cell culture medium were determined by enzyme-linked immunosorbent assay(ELISA). Results The expression level of ER mRNA in osteosarcoma cells(143B,U-2OS) was lower than that in osteoblast(hFOB1.19). Tamoxifen could inhibit the proliferation of osteosarcoma cells. Tamoxifen could inhibit the expressions of inflammatory factors,IL-6,IL-8,TGF-β,CCL2 and CCL5,especially the chemokine CCL2 in osteosarcoma cells. Conclusions Tamoxifen could inhibit the proliferation of osteosarcoma cells and the expression of CCL2,suggesting that it might be used as a adjuvant drug for postoperative chemotherapy of osteosarcoma.

    Application value of fecal SDC2 gene methylation determination in the auxiliary diagnosis of colorectal cancer
    GONG Zhiyun, JIANG Minglei, SHI Weizhong, LU Renquan, GUO Lin
    2022, 37(4):  325-329.  DOI: 10.3969/j.issn.1673-8640.2022.04.005
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    Objective To investigate the value of methylation determination of fecal adhesin syndecan 2(SDC2) gene in the auxiliary diagnosis of colorectal cancer. Methods Totally,51 patients with colorectal cancer(colorectal cancer group),22 patients with adenoma(adenoma group) and 39 healthy subjects(healthy control group) were enrolled. The stool and serum samples of all the subjects were collected to determine fecal SDC2 gene methylation and serum carcinoembryonic antigen(CEA) and carbohydrate antigen 19-9(CA19-9)levels. Among them,26 fecal samples were pretreated by P12 automatic sample pretreatment instrument and manual method,and the correlation of the determination results after pretreatment by the 2 methods was compared. Pearson correlation analysis and kappa test were used to evaluate the correlation and consistency between the 2 methods. Results The methylation positive rate of fecal SDC2 gene in colorectal cancer group was higher than those in adenoma group and healthy control group(P<0.01). In colorectal cancer group,the methylation positive rate of fecal SDC2 gene was higher than those of serum CEA and CA19-9(P<0.01). There was no statistical significance in methylation positive rate of fecal SDC2 gene between patients with colorectal cancer stage Ⅰ-Ⅳ(P>0.05). The methylation positive rate of fecal SDC2 gene in patients with colorectal cancer stage Ⅰ-Ⅲ was higher than those of CEA and CA19-9 in serum(P<0.01). Receiver operating characteristic(ROC) curve analysis showed that the areas under curves(AUC) of the methylation of fecal SDC2 gene,serum CEA,serum CA19-9 and the combined determination for colorectal cancer diagnosis were 0.965,0.694,0.567 and 0.976,respectively. Serum CEA combined with the methylation of fecal SDC2 gene can increase the positive rate of colorectal cancer to 90.2%(46/51). There was a positive correlation between the determination results of P12 automatic sample pretreatment instrument and manual method(r=0.994,P<0.001),and the consistency was good(kappa=0.845,P<0.001). Conclusions The methylation of fecal SDC2 gene has high sensitivity and specificity,which can be used as an auxiliary diagnosis of colorectal cancer,and it also has high clinical value in early colorectal cancer screening.

    Clinical value of the SorCS1 gene promoter methylation determination in patients with colorectal cancer
    LIU Kai, ZHANG Peiru, XIE Suhong, GUO Lin, LU Renquan
    2022, 37(4):  330-335.  DOI: 10.3969/j.issn.1673-8640.2022.04.006
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    Objective To investigate the clinical value of the SorCS1 gene promoter methylation determination in patients with colorectal cancer. Methods Cancer and adjacent tissues from 17 colorectal cancer patients were collected. The MassARRAY platform was used to determine the levels of gene promoter methylation in cancer tissues and adjacent tissues of patients with colorectal cancer,and the genes with different promoter methylation between cancer tissues and adjacent tissues were screened out and then compared with the Cancer Genome Atlasc(TCGA) database. Meanwhile,the methylation levels of SEPT9 gene were determined. The difference (Δ) determined by subtracting the determination value of gene promoter methylation in adjacent tissue from that in cancer tissue indicated the difference. Results A total of 2 genes(SorCS1 and CASR) were screened out. The levels of SorCS1,CASR and SEPT9 methylation in colorectal cancer tissues were higher than those in adjacent cancer tissues(P<0.001). The comparison with TCGA database revealed that the expressions of SorCS1 gene were lower in patients with bladder urothelial carcinoma,cervical squamous cell carcinoma,colon adenocarcinoma,glioblastoma multiforme,rectum adenocarcinoma and stomach adenocarcinoma than that in healthy controls(P<0.05),while the promoter methylation level of SorCS1 gene was higher in colon adenocarcinoma,rectum adenocarcinoma and lung adenocarcinoma than that in healthy controls(P<0.05). The difference of CASR gene expression between colorectal cancer patients and healthy controls was not statistically significant(P>0.05),and the data of CASR gene promoter methylation was not available in TCGA database. The differences between ΔSorCS1 and SEPT9 gene promoter methylation levels in colorectal cancer patients were associated with tumor stage,and those in progression stage(Ⅲ-Ⅳ) were higher than those in early stage(Ⅰ-Ⅱ)(P<0.05). The gene promoter methylation differences were also associated with lymph node metastasis,and the higher level of ΔSorCS1 and SEPT9 gene promoter methylation levels appeared in the group of lymph nodes with metastasis than those without metastasis(P<0.05),independent of sex,age,tumor site and maximum diameter of tumors(P>0.05). However,there was no statistical significance in ΔCASR between different clinicopathological characteristics of patients(P>0.05). The positive rate of SorCS1 gene methylation was 82.35%(14/17),while that of SEPT9 gene methylation was 70.58%(12/17),respectively. The positive rate of combined determination was 88.24%(15/17). Conclusions SorCS1 gene promoter methylation determination has a high positive rate in colorectal cancer patients,and it is complementary to SEPT9 gene promoter methylation,which can be a potential new molecular marker for colorectal cancer development.

    Clinical significance of combined determination of serum HER-2 and CD44 in colorectal cancer
    CHEN Si, LIU Hua, LIU Yiwen, HE Yiqing, ZHANG Guoliang, YANG Cuixia, DU Yan, GAO Feng
    2022, 37(4):  336-341.  DOI: 10.3969/j.issn.1673-8640.2022.04.007
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    Objective To investigate the roles of serum human epidermal growth factor receptor-2(HER-2)and cluster of differentiation 44(CD44) in patients with colorectal cancer. Methods The levels of serum HER-2 and CD44 were determined by enzyme-linked immunosorbent assay in 38 colorectal cancer patients before and 2-3 d after operation,35 patients with benign colorectal diseases(benign disease group) and 36 healthy subjects(healthy control group). The general data of all the subjects were collected. The correlation between serum HER-2 and CD44 levels in colorectal cancer patients was analyzed by Pearson correlation analysis. The efficiencies of each marker and combined determination in the auxiliary diagnosis of colorectal cancer were evaluated by receiver operating characteristic(ROC) curve. Results The preoperative serum HER-2 levels in colorectal cancer group were higher than those in benign colorectal disease and healthy control groups(P<0.05,P<0.000 1). The preoperative serum CD44 levels in colorectal cancer group were higher than those in healthy control group(P<0.05). Serum CD44 levels between colorectal cancer and benign colorectal disease group had no statistical significance(P>0.05). The levels of serum HER-2 in colorectal cancer group were closely related to Ras mutation and peripheral nerve invasion(P<0.05),and they were not related to serum CD44 levels(P>0.05). Serum HER-2 and CD44 levels were not related to age,sex,tumor type,tumor size,TNM stage,lymph node metastasis and vascular invasion(P>0.05). According to the results of ROC curve analysis,the areas under curves(AUC) of HER-2,CD44,carcinoembryonic antigen(CEA),carbohydrate antigen 19-9(CA19-9) determinations and the combined determination in colorectal cancer diagnosis were 0.779,0.692,0.620,0.634 and 0.837,respectively. Postoperative levels of serum CD44 were reduced compared to preoperative levels in colorectal cancer group(P<0.000 1),whereas no statistical significance was observed in serum HER-2 levels before and after operation(P>0.05). Conclusions Serum HER-2 and CD44 levels are correlated in colorectal cancer patients. The combined determination of them may play a role in colorectal cancer auxiliary diagnosis and therapeutic monitoring.

    Role of MAPK/ERK signaling pathway in reversing endocrine resistance of breast cancer
    YE Jingwen, SHEN Yunyue, LIU Yiwen, HE Yiqing, DU Yan, ZHANG Guoliang, GAO Feng, YANG Cuixia
    2022, 37(4):  342-348.  DOI: 10.3969/j.issn.1673-8640.2022.04.008
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    Objective To investigate the role of mitogen-activated protein kinase (MAPK)/extracellular regulated protein kinase (ERK) signaling pathway in reversing endocrine resistance of breast cancer. Methods Tamoxifen-resistant breast cancer cell lines,MCF-7/TAMR and T47D/TAMR,were established by human breast cancer cell lines,MCF-7 and T47D. The differences of cell proliferation and the expression of related MAPK/ERK signaling pathway molecules between MCF-7 and MCF-7/TAMR,T47D and T47D/TAMR were investigated. The suppressive effect of mitogen-activated protein kinase(MEK) inhibitor U0126 on MAPK/ERK signaling pathway in MCF-7/TAMR and T47D/TAMR was observed through the analysis of cell proliferation,cell cycle and transfactor expression. Results Compared with naïve MCF-7 or T47D cells,the proliferation and colony formation were increased (P<0.05,P<0.000 1),and the expression of related MAPK/ERK signaling pathway molecules [phosphorylated extracellular regulated protein kinase(pERK),ERK and c-MYC] was strongly increased. Suppressing MAPK/ERK signaling pathway by MEK inhibitor U0126,the growth of MCF7/TAMR or T47D/TAMR was decreased (P<0.000 1),and cell cycle was arrested. The relative gene expression of transcription factors,steroid receptor coactivator-1(SRC-1),E26 oncogene homolog-2(ETS-2) and c-JUN,and the expressions of their proteins were decreased by MEK inhibitor U0126(P<0.01). Conclusions The inhibition of MAPK/ERK signaling pathway could reverse the endocrine resistance of breast cancer cells,which can provide a reference for the treatment of patients with endocrine resistant breast cancer.

    Mechanism of IL-8/miR-182 positive feedback regulatory axis in non-small cell lung cancer
    ZHAO Mingna, ZHANG Chenzi, HONG Qiushuang, LOU Jiatao
    2022, 37(4):  349-355.  DOI: 10.3969/j.issn.1673-8640.2022.04.009
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    Objective To investigate the interaction between interleukin-8(IL-8) and microRNA-182(miR-182) in non-small cell lung cancer(NSCLC) and the mechanism of promoting the proliferation and migration of NSCLC. Methods A total of 40 patients with NSCLC(NSCLC group) were enrolled to collect preoperative serum samples and intraoperative cancer tissues and adjacent tissues. Another 40 healthy subjects(healthy control group) were enrolled as well. Serum IL-8 level and the expression level of miR-182 in cancer and adjacent tissues were determined. Cytological experiments were performed to analyze the effects of miR-182 and IL-8 on proliferation and migration of human NSCLC cell line A549,the regulatory effect of IL-8 on miR-182 and the signaling pathway of miR-182 affecting IL-8 expression. Results Serum IL-8 level in NSCLC group was higher than that in healthy control group(P<0.01). The relative expression of miR-182 in cancer tissues of NSCLC patients was higher than that in adjacent tissues(P<0.01). IL-8 promoted the proliferation and migration of A549 cells through miR-182. IL-8 up-regulated the expression of miR-182 through signal transducer and activator of transcription 3(STAT3). MiR-182 up-regulated IL-8 expression by regulating nuclear factor-κB(NF-κB) signaling pathway. Conclusions Both IL-8 and miR-182 are highly expressed in NSCLC patients,and the positive feedback regulatory axis of IL-8/STAT3/miR-182/NF-κB/IL-8 promotes the occurrence and development of NSCLC.

    Distribution and drug resistance of respiratory infection pathogens in patients with lung cancer after chemotherapy
    WANG Jianying, WANG Shanshan, ZHU Jun, HUANG Xiaochun, WAN Yuxiang, LIU Yun
    2022, 37(4):  356-359.  DOI: 10.3969/j.issn.1673-8640.2022.04.010
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    Objective To investigate the composition and drug resistance of respiratory infection pathogens in patients with lung cancer after chemotherapy,and to provide a reference for clinical treatment. Methods The pathogens were isolated from 170 respiratory infection patients with lung cancer after chemotherapy from January 2015 to April 2020,and drug susceptibility test was conducted. Results Among the 202 non-repetitive isolates,127(62.9%)isolates were Gram-negative bacteria. The top 3 pathogens were Pseudomonas aeruginosa(35 isolates,17.3%),Acinetobacter baumannii(28 isolates,13.9%) and Klebsiella pneumoniae(26 isolates,12.9%). There were 56(27.7%) isolates of Gram-positive bacteria,of which the detection rate of Staphylococcus aureus was the highest(35 isolates,17.3%). There were 19(9.4%) isolates of fungi. Drug susceptibility test showed that Pseudomonas aeruginosa,Acinetobacter baumannii and Klebsiella pneumoniae had drug resistance rate to carbapenems(22.8%,40.7% and 3.8%,respectively). The drug resistance rate of Staphylococcus aureus to penicillin was 88.6%. Gram-positive bacteria were not yet resistant to vancomycin and linezolid. The detection rate of methicillin-resistant Staphylococcus aureus(MRSA) was 28.6%. Conclusions The main pathogens isolated from respiratory infection patients with lung cancer after chemotherapy are Gram-negative bacteria,and the drug resistance is serious. Rational drugs should be used in clinic.

    Influence of vancomycin combined with meropenem on serum TNF-α,PCT,IL-6 and peritoneal fluid WBC count in PDRP patients
    ZHAI Shana, SUN Qinghai, YU Yongwu, YE Fang, LIU Maodong
    2022, 37(4):  360-364.  DOI: 10.3969/j.issn.1673-8640.2022.04.011
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    Objective To analyze the therapeutic effect of vancomycin combined with meropenem to treat peritoneal dialysis-related peritonitis(PDRP) and the influence of serum tumor necrosis factor-alpha(TNF-α),procalcitonin(PCT),interleukin(IL)-6 levels and peritoneal fluid white blood cell(WBC) count. Methods A total of 96 patients with PDRP were enrolled,and they were classified into study group(48 cases) and control group(48 cases) by random number table method. The study group was given vancomycin combined with meropenem,and the control group was given vancomycin combined with ceftazidime. Before treatment,the first bag of PDRP patients' peritoneal dialysate was collected,and bacterial culture and drug susceptibility test were performed. The changes of serum TNF-α,PCT and IL-6 levels before and after treatment were compared. Results Gram-positive bacteria,Gram-negative bacteria and other isolates(unexplained) accounted for 60.4%,29.2% and 10.4% in study group,and Gram-positive bacteria,Gram-negative bacteria and other isolates(unexplained) accounted for 56.3%,31.3% and 12.5% in control group,respectively. The distribution of isolates between the 2 groups had statistical significance(P>0.05). The results of drug susceptibility test suggested that the drug resistance rates of Gram-positive bacteria to vancomycin,linezolid and moxifloxacin were low,and the drug resistance rate of Gram-negative bacteria to meropenem was low. After 21 d of treatment,the cure rate of study group was 91.67%,which was higher than that of control group(81.25%)(P<0.05). Serum TNF-α,PCT,IL-6 levels and peritoneal fluid WBC count in study group decreased more significantly than those in control group(P<0.05). Conclusions The prognosis of PDRP patients using vancomycin combined with meropenem is better. Serum TNF-α,PCT,IL-6 levels and peritoneal fluid WBC count can be used as the indicators for PDRP efficacy monitoring.

    Diagnosis and clinical characteristics of acute myeloid leukemia with BCR-ABL1 accompanied by FLT3-ITD and multiple gene mutations
    CHEN Yuemei, JIN Yongmei, ZENG Tingting, JIANG Nenggang, LIAO Hongyan
    2022, 37(4):  365-369.  DOI: 10.3969/j.issn.1673-8640.2022.04.012
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    Objective To investigate the diagnosis and treatment of acute myeloid leukemia(AML) with BCR-ABL1 accompanied by FLT3-ITD and multiple gene mutations,and to provide a reference for studying the clinical characteristics and prognosis of this rare AML subtype. Methods A case of de novo AML with BCR-ABL1 accompanied by FLT3-ITD and other multiple gene mutations was analyzed retrospectively,and the results of clinical laboratory indicators were summarized. Results Bone marrow morphology suggested acute leukemia. The immuno-phenotypes of the blast cells were CD13+,CD33+,CD34+(partial),CD117+ and HLA-DR+. Karyotype analysis showed the existence of BCR-ABL1 fusion gene product formed by t(9;22). There were FLT3-ITD mutations and missense mutations in DNMT3A,BCOR,IDH2,BCORL1 and RUNX1 genes by gene mutation screening. Combined with the historical clinical laboratory test results,this case was diagnosed as AML with BCR-ABL1. The patient received imatinib,decitabine,homoharringtonine and cytarabine hydrochloride chemotherapy and anti-infection treatment. The overall vital signs were stable,and the patient was discharged for follow-up. Conclusions Limited cases of AML with BCR-ABL1 have been reported,and there are no standardized options for the diagnosis and treatment. The MICM classifications,especially cytogenetics and molecular biology screening,have been crucial for the diagnosis and prognostic monitoring of AML with BCR-ABL1.

    Establishment and evaluation of CD157-based 4-color PNH assay for neutrophil and monocyte by flow cytometry
    HONG Jun, RAO Yongcai
    2022, 37(4):  377-381.  DOI: 10.3969/j.issn.1673-8640.2022.04.015
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    Objective To validate the feasibility of CD157-based 4-color flow cytometry for paroxysmal nocturnal hemoglobinuria(PNH) clone determination,and to propose a non-FLAER alternative for PNH clone determination. Methods The intra- and inter-assay precisions of the CD157 flow cytometry for PNH clone determination were validated. CD157 flow cytometry,FLAER and CD55/CD59 methods were used to determine 45 samples of PNH patients with different clone sizes. The efficiency of the 3 methods for PNH diagnosis was evaluated.. Results The intra- and inter-assay precisions [coefficients of variation(CV)] for neutrophil and monocyte were 0.07%-3.01%,0.19%-7.19%,0.28%-4.95% and 0.27%-7.98%,respectively. There was no statistical significance between CD157 flow cytometry and FLAER for neutrophil and monocyte PNH clone determination (P>0.05). There was a good correlation between the 2 methods (r2>0.99) and a good consistency,and the average deviations for neutrophil and monocyte PNH clone determination were 0.13% and 0.07%. The sensitivities of CD157 flow cytometry and FLAER in predicting PNH (100.0%) were higher than that of CD55/CD59 method (94.0%). Conclusions CD157 flow cytometry has good performance,which can be used as a FLAER alternative for PNH clone determination.

    Adaptive Monte Carlo method for top-down assessment of measurement uncertainty
    WANG Zhifang, LI Yabo, LIANG Man, AN Shuqi, HAN Yanlin
    2022, 37(4):  382-386.  DOI: 10.3969/j.issn.1673-8640.2022.04.016
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    Objective To investigate the feasibility of adaptive Monte Carlo method(aMCM)for top-down uncertainty assessment. Methods In case of uncertainty assessment based on top-down assessment in clinical laboratories,aMCM was used for verification. If the absolute difference between aMCM and top-down assessment results was less than the specified numerical tolerance,the verification was passed. The aMCM verification program was developed by MatLab software. Results The absolute difference between the results evaluated by aMCM and the top-down assessment was less than the specified numerical tolerance,and the top-down assessment was verified by aMCM. Conclusions The established aMCM can be used to verify the uncertainty evaluation results of the top-down assessment.

    Survey on the consistency of complete blood cell count results in three regions of the Yangtze River Delta,China
    YANG Xue, XU Chong, SONG Ying, ZHAO Qiang, MIAO Yingbo, WANG Qing, ZHOU Jing
    2022, 37(4):  387-391.  DOI: 10.3969/j.issn.1673-8640.2022.04.017
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    Objective To know the comparability and consistency of the complete blood cell count(CBC) results of different hematology analyzers in three regions of the Yangtze River Delta,China,and to provide a reference for mutual recognition of CBC results in relevant regions. Methods Totally,2 batches of weakly fixed fresh whole blood samples were transported to 25 clinical laboratories in Qingpu District(Shanghai),Wujiang District(Jiangsu) and Jiashan District(Zhejiang). The results of different items were analyzed,and the differences in results between different hematology analyzers were analyzed statistically. Results a For the 2 batches of investigation products,the means and ranges of 5 items were white blood cell(WBC) count 4.04×109/L,0.30×109/L and 8.47×109/L,1.41×109/L,red blood cell(RBC) count 4.11×1012/L,0.21×1012/L and 5.50×1012/L,0.31×1012/L,hemoglobin(Hb)128.42 g/L,6.80 g/L and 166.61 g/L,7.20 g/L,hematocrit(HCT)41.97%,9.72% and 52.67%,10.64%,platelet(PLT) count 170.34×109/L,20.40×109/L and 269.82×109/L,32.00×109/L,respectively. The consistency of RBC count and Hb items in the 25 laboratories was better than the others. There was no statistical significance in the CBC results of clinical laboratories in Sysmex system(18 laboratories) and Mindray system(4 laboratories)(P>0.05),which showed a good consistency. There was statistical significance in the HCT and PLT count between Horiba system(3 laboratories) and others(P<0.05). Conclusions The CBC results of clinical laboratories in the three regions of Qingpu,Wujiang and Jiashan tend to be comparable and consistent totally. However,there were still differences in some results of different hematology analyzers. It was recommended to use the same hematology system to facilitate mutual recognition of CBC test results in the three regions.

    Research status of Actinotignum schaalii
    SHANG Xipeng, LI Sha, DU Jinghui, LIU Xu
    2022, 37(4):  392-395.  DOI: 10.3969/j.issn.1673-8640.2022.04.018
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    Actinotignum schaalii is facultative anaerobic Gram-positive Actinobacillus. With the improvement of clinical laboratory culture conditions and the wide usage of matrix-assisted laser desorption ionization time-of-flight mass spectrometry(MALDI-TOF MS),the detection rate of Actinotignum schaalii is increasing,and it is found that it is closely related to urinary tract infection. It is not sensitive to antibiotics commonly used,such as co-trimoxazole and quinolone,in the treatment of urinary tract infection,and it is sensitive to beta-lactamase. Actinotignum schaalii is a novel pathogen of urinary tract infection,and there has been no report on Actinotignum schaalii in China. In order to better understand Actinotignum schaalii,this review summarizes and expounds relevant reports abroad.

    Research progress of coagulation factor Ⅴ and its association with hemorrhage and thrombosis
    LI Keke, XIAO Yang
    2022, 37(4):  396-399.  DOI: 10.3969/j.issn.1673-8640.2022.04.019
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    Coagulation factor(F) Ⅴ is an essential factor to participate in the initial phase of coagulation,which plays a role in the production of thrombin. It is recently suggested that FⅤ also harbors anticoagulant properties. Different mutations in the FⅤ gene(F5) cause bleeding or thrombosis. F5 dysfunction mutations often lead to bleeding. For example,patients with hereditary coagulation factor Ⅴ deficiency(FⅤD) often show different degrees of bleeding. However,F5 gain-of-function mutations are prone to thrombosis. FLeiden mutation is the most common genetic risk factor for venous thrombosis in Caucasians. This review mainly focuses on the research progress of the association of FⅤ with hemorrhage and thrombosis.