Table of Content

30 October 2021, Volume 36 Issue 10

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Epidemic status and challenges of important human parasitic diseases in China

CHEN Jiaxu, CAI Yuchun, AI Lin, SONG Peng, CHEN Muxin, CHEN Shaohong, LU Yan, ZHOU Xiaonong

2021, 36(10):  993-1000.  DOI: 10.3969/j.issn.1673-8640.2021.010.001

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China has made remarkable achievements in the prevention and control of human parasitic diseases,becoming the first country in the elimination of lymphatic filariasis. Malaria has been eliminated in China,which is approved by World Health Organization in 2021. Schistosomiasis in many provinces reaches the standard of transmission interruption or elimination. The infection rate of soil-transmitted nematode drops to a new historical low. However,the population of its infection is still tens of millions. Foodborne parasitic diseases,such as clonorchiasis sinensis,still pose a great threat to food safety in China. Although the vector-borne and zoonotic parasitic diseases have been controlled to some extent,the epidemic continues and relapses. The incidence of opportunistic parasitic diseases has increased in the population with immunodeficiency,and the cases of imported parasitic diseases have also increased. The review focuses on the results of parasitic diseases' prevention and control in China,understanding the epidemic status of important human parasitic diseases,analyzing the transmission risks and challenges of human parasitic diseases' prevention and control,so as to provide a reference for the health administrative department formulating the strategies and measures of parasitic diseases' prevention and control in the new period,and to provide epidemiological datum reference for the diagnosis and treatment of clinical parasitic diseases.

Clinical laboratory examinations for parasitic diseases

CAI Qi, WANG Jianbiao

2021, 36(10):  1001-1007.  DOI: 10.3969/j.issn.1673-8640.2021.010.002

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Clinical laboratory examinations for parasitic diseases play an important role in the diagnosis of parasitic diseases. Clinical laboratory examinations for parasitic diseases include pathogenic examinations,immunological examinations and molecular biological examinations. Although the traditional parasitological examination is intuitive and accurate,it has some limitations. With the rapid development of medical technologies,parasite laboratory examination technology has also made great progress. Immunological examinations and molecular biological examinations have good sensitivities,specificities and repeatabilities. This review summarizes and introduces clinical laboratory examination technologies for parasitic diseases.

Retrospective analysis of a case of green neutrophil and monocyte inclusions with malaria pigment

GUO Ping, CHANG Jinghua, WANG Jianbiao

2021, 36(10):  1008-1011.  DOI: 10.3969/j.issn.1673-8640.2021.010.003

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Objective To analyze the clinical symptom and laboratory examinations of a case of green neutrophil and monocyte inclusions with malaria pigment retrospectively,and to improve the understanding of this case. Methods Through the clinical and pathologic findings,including complete blood counts,C-reactive protein,biochemical examination,malaria parasite antigen test,malaria parasite morphological examination and oil red O staining,the clinical symptom and laboratory examinations' characteristics were analyzed combined with literatures. Results The patient presented with high fever and joint pain as the initial clinical symptoms. Platelet count was 12×10⁹/L,the percentage of neutrophil was 82.7%,and C-reactive protein was >200 mg/L,accompanied by liver and renal dysfunction. Plasmodium falciparum was detected on peripheral blood smear. Green inclusions and malaria pigment were found in neutrophils and monocytes at the later stage of treatment,and the oil red O staining of green inclusions was positive. Conclusions The presence of green inclusions and malaria pigment is an important indication for the prognosis of severe malaria,which should be warned to clinicians.

Role of risk stratification and prognosis of sST2 in acute coronary syndrome patients after percutaneous coronary intervention

DU Kun, YAN Jianhua, CHEN Ming, YANG Junyao, ZHANG Guanghui

2021, 36(10):  1020-1025.  DOI: 10.3969/j.issn.1673-8640.2021.010.007

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Objective To analyze the role of risk stratification and prognosis of soluble growth stimulating express gene 2（sST2） in patients with acute coronary syndrome（ACS） after percutaneous coronary intervention（PCI）. Methods A total of 285 patients with ACS were enrolled,which included 84 cases of unstable angina（UA）,86 cases of non-ST-segment elevation myocardial infarction（NSTEMI） and 115 cases of ST-segment elevation myocardial infarction（STEMI）. The control group consisted of 80 patients with suspected ACS due to chest pain. All the patients underwent emergency PCI within 12 h of onset. The Gensini scoring system was used to score the degree of vascular lesions. Risk assessment was performed using the Global Registry of Acute Coronary Events（GRACE） scoring system upon admission. The sST2 and other biomarkers were determined. All the patients were followed for 6 months to record whether major adverse cardiovascular events（MACE） occurred or not during the follow-up period. Results The level of serum sST2 in ACS group was higher than that in control group（P<0.001）,and there was statistical significance among UA,NSTEMI and STEMI groups（P<0.05）. The results of binary Logistic regression analysis showed that serum sST2,amino-terminal pro-B-type natriuretic peptide（NT-proBNP）,cardiac troponin I（cTnI）,left ventricular ejection fraction（LVEF） and GRACE score were independent risk factors of MACE in ACS patients [odds ratios（OR） were 1.004,1.019,0.995,0.898 and 1.009]. The results of Kaplan-Meier survival curve showed that ACS patients with low expression of sST2 combined with low GRACE score had the highest overall survival rate,and those with high expression of sST2 combined with high GRACE score had the lowest overall survival rate. Conclusions Serum sST2 level in patients with ACS is related to the severity of myocardial ischemia and necrosis. It at admission is an independent risk factor for MACE in ACS patients. The indicator,sST2,may be a new biomarker for cardiac injury.

Relationship between the expressions of CLIC4 and SNHG3 and the prognosis of patients with Stage Ⅰ-Ⅱ ovarian cancer

XUE Yan, WANG Jiajia, WANG Fuxiang, REN Qiuwei

2021, 36(10):  1026-1032.  DOI: 10.3969/j.issn.1673-8640.2021.010.008

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Objective To investigate the relationship between the expressions of chloride intracellular channel protein 4（CLIC4）and small nucleolar RNA host gene 3（SNHG3）and the prognosis of patients with Stage Ⅰ-Ⅱ ovarian cancer. Methods A total of 113 patients with Stage Ⅰ-Ⅱ ovarian cancer（ovarian cancer group） and 76 patients with benign ovarian tumors（control group） were enrolled. The expression of CLIC4 was determined by immuno-histochemistry. The relative expression of SNHG3 was determined by real-time fluorescence quantitative polymerase chain reaction（PCR）. The general clinical data were collected. The relationship between the expressions of CLIC4 and SNHG3 and the prognosis of ovarian cancer（survival） was evaluated by Kaplan-Meier survival curve analysis. The influence factors for the prognosis of Stage Ⅰ-Ⅱ ovarian cancer were analyzed by Cox ratio regression analysis. Results The high and positive expression rate of CLIC4,the percentage of CLIC4 by immunohistochemistry and the relative expression of SNHG3 in ovarian cancer group were higher than those in control group （P<0.001）. The high expression of CLIC4 was related to the pathological type （serous carcinoma）,histological grade （G2 or G） and clinical stage （Stage Ⅱ） of patients with Stage Ⅰ-Ⅱ ovarian cancer （P<0.05）. There was statistical significance in the expression of CLIC4 in patients with serous cancer,mucinous cancer and endometrioid cancer （P=0.000）,and there was no statistical significance between the other pathological types （P>0.05）. The high expression of SNHG3 was related to the histological grade and clinical stage of ovarian cancer （P<0.05）. The overall survival rate （OS） and disease progression-free survival rate （PFS） of CLIC4 high expression group were lower than those of CLIC4 low expression group （P<0.05）. The OS and PFS of SNHG3 high expression group were lower than those of SNHG3 low expression group （P<0.05）. Carbohydrate antigen 125 （CA125）,human epididymis protein 4 （HE4）,CLIC4,SNHG3,histological grade and clinical stage were influencing factors for the prognosis （survival） of patients with Stage Ⅰ-Ⅱ ovarian cancer. Conclusions The high expressions of CLIC4 and SNHG3 are correlated with the clinical characteristics and prognosis of Stage Ⅰ-Ⅱ ovarian cancer. CLIC4 and SNHG3 are influence factors for the prognosis and survival of Stage Ⅰ-Ⅱ ovarian cancer patients.

Plasma ADAMTS-7 level and its relationship with prognosis in patients with acute ischemic stroke

LI Jinyi, LI Chunlei, JIA Yonglin, JIA Dongpei

2021, 36(10):  1033-1038.  DOI: 10.3969/j.issn.1673-8640.2021.010.009

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Objective To investigate plasma a disintegrin and metalloprotease with thrombospondin motif-7（ADAMTS-7）level and its relationship with prognosis in patients with acute ischemic stroke（AIS）. Methods A total of 101 patients with AIS were enrolled. The level of plasma ADAMTS-7 was determined before treatment and on the 2nd,4th and 8th days after treatment. The general clinical data of all the patients were collected,and they were classified into good prognosis group and poor prognosis group according to the prognosis of patients. Receiver operating characteristic（ROC）curve was used to evaluate the efficiency of plasma ADAMTS-7 in evaluating the prognosis of patients with AIS. Logistic regression analysis was used to evaluate the risk factors of AIS prognosis. ROC curve,calibration curve and decision tree curve analysis were used to evaluate the clinical value of the prognostic evaluation model. Results There was statistical significance in age,fasting plasma glucose（FPG）,total cholesterol（TC）,the National Institute of Health Stroke Scale（NIHSS） score and onset-treatment time between good prognosis group and poor prognosis group（P<0.05）. There was no statistical significance between the 2 groups for the other items（P>0.05）. The plasma ADAMTS-7 levels in poor prognosis group on the 4th and 8th days of treatment were higher than those in good prognosis group（P<0.05）. The plasma ADAMTS-7 levels in poor prognosis group and good prognosis group showed a decreasing trend with treatment time prolonging,and the decrease degree of plasma ADAMTS-7 levels in poor prognosis group was lower than that in good prognosis group（P<0.05）. ROC curve analysis showed that the area under curve（AUC） of plasma ADAMTS-7 on the 8th day of treatment for evaluating the prognosis of AIS was 0.864,which was bigger than those before treatment（0.636）,on the 2nd day of treatment（0.572） and on the 4th day of treatment（0.660）（P<0.001）. Logistic multivariate regression analysis showed that FPG,NIHSS score,onset-treatment time and plasma ADAMTS-7 on the 8th day of treatment were risk factors for the prognosis of patients with AIS [odds ratios（OR） were 1.801,1.707,8.531 and 1.172,respectively]. ROC curve analysis showed that the AUC,optimal cut-off value,sensitivity and specificity of the prognostic evaluation model for evaluating the prognosis of patients with AIS were 0.963,0.72,96.43% and 91.78%,respectively. Conclusions The level of plasma ADAMTS-7 on the 8th day of treatment is closely related to the prognosis of patients with AIS. The prognostic evaluation model based on ADAMTS-7 on the 8th day of treatment plays a role in predicting the prognosis of AIS.

Changes of serum diamine oxidase,D-lactic acid and endotoxin in patients with schizophrenia

JIN Weifeng, LI Ping, CHEN Shuzi, SUN Jiaqi, FANG Wei, LI Dan, ZHU Liping, ZHU Lili, LIN Ping

2021, 36(10):  1039-1041.  DOI: 10.3969/j.issn.1673-8640.2021.010.010

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Objective To investigate the roles of serum diamine oxidase,D-lactic acid and endotoxin in the assessment of intestinal barrier injury in patients with schizophrenia. Methods A total of 296 schizophrenia patients and 99 healthy subjects were enrolled,and serum diamine oxidase,D-lactic acid and endotoxin levels were determined. The 296 schizophrenia patients were classified according to ages（≤51-year-old and >51-year-old groups） and sex. Results The levels of serum diamine oxidase,D-lactic acid and endotoxin in schizophrenia group were higher than those in healthy control group（P<0.05）. There was no statistical significance in serum diamine oxidase,D-lactic acid and endotoxin between ≤51-year-old and >51-year-old groups and between males and females（P>0.05）. Conclusions Serum diamine oxidase,D-lactic acid and endotoxin can be used to assess the intestinal barrier function in patients with schizophrenia.

Comparison of different-brand tandem mass spectrometers for newborn screening of genetic metabolic diseases

TANG Chengfang, WEI Qingxiu, QIN Jianrong, TANG Fang, LIU Sichi, JIANG Xiang, HUANG Yonglan

2021, 36(10):  1042-1046.  DOI: 10.3969/j.issn.1673-8640.2021.010.011

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Objective To investigate the comparability and clinical acceptability of the screening results of neonatal genetic metabolic diseases with different tandem mass spectrometry determination systems. Methods The QSight 210MD tandem mass spectrometer（referred to as QSight 210MD） and the UPLC I-Class Xevo TQD tandem mass spectrometer（referred to as Xevo TQD） were used to determine the levels of amino acids,free carnitine and acyl carnitine in dried blood spot samples of 40 newborns. According to the EP9-A2 document of the Clinical and Laboratory Standards Institute（CLSI）,the intra-assay and inter-assay precisions,correlation and clinical acceptabilities of QSight 210MD and Xevo TQD were evaluated. Results The intra-assay and inter-assay precisions of each comparison project of QSight 210MD and Xevo TQD were both <7%,which met the clinical requirements. Between QSight 210MD and Xevo TQD,except for glutaryl carnitine（C5DC）,caproyl carnitine（C6） and octanoyl carnitine（C8）,r were <0.975,and r were >0.975 for the other items. The relative systematic error（SE%） of all the items was <1/2 allowable total error（TEa） of the national inter-room quality assessment,which was clinically acceptable. Conclusions Except for C5DC,C6 and C8,between QSight 210MD and Xevo TQD,the results of the other neonatal genetic metabolic disease screening items have good correlations,which can meet the clinical requirements. For the items that are not comparable,it is necessary to establish different reference intervals for different determination systems.

Relationship between serum AMH,FSH,InhB and sperm parameters

LIU Xiuju, LI Gaochi, YANG Hongmei, LIN Jianchun

2021, 36(10):  1047-1049.  DOI: 10.3969/j.issn.1673-8640.2021.010.012

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Objective To analyze the relationship between serum anti-Müllerian hormone（AMH）,follicle-stimulating hormone（FSH） and inhibin B（InhB）and sperm parameters,and to investigate the roles of serum AMH,FSH and InhB in the diagnosis of male infertility. Methods According to the results of sperm parameters and testicular biopsy,97 patients were classified into obstructive azoospermia（15 cases）,non-obstructive azoospermia（12 cases） and oligoasthenospermia（70 cases）,and 122 males with qualified semen quality were enrolled as control group. The total sperm count,sperm concentration,sperm motility,forward movement sperm rate and serum AMH,FSH and InhB were analyzed for their correlations. Results Compared with control group and obstructive azoospermia group,serum levels of AMH,FSH and InhB in non-obstructive azoospermia and oligoasthenospermia had statistical significance（P<0.05）. AMH was positively correlated with total sperm count,sperm concentration,sperm motility and forward movement sperm rate（r=0.227,0.215,0.111 and 0.120,P<0.05）. FSH was negatively correlated with total sperm count and sperm concentration（r=-0.125 and -0.236,P<0.05）. There were positive correlations between InhB and total sperm count,sperm concentration（r=0.232 and 0.166,P<0.05）. Conclusions The determinations of serum AMH,FSH and InhB can provide a reference for the diagnosis and treatment of male infertility.

Roles of peripheral blood inflammatory factors and coagulation indicators in endometriosis patients with pelvic adhesion

WANG Zhifeng, ZHOU Yang, DING Yina, DANG Jianhong, HU Dian, JIN Zhijun

2021, 36(10):  1050-1054.  DOI: 10.3969/j.issn.1673-8640.2021.010.013

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Objective To investigate the roles of peripheral blood inflammatory factors and coagulation indicators in endometriosis patients with pelvic adhesion. Methods A total of 58 endometriosis patients were enrolled as observation group,and 41 patients with benign ovarian cysts were enrolled as control group. According to the presence or absence of pelvic adhesion,the observation group was classified into pelvic adhesion group（47 cases） and non-pelvic adhesion group（11 cases）. The levels of peripheral blood inflammatory factors [tumor necrosis factor-alpha（TNF-α）,interleukin（IL）-6 and IL-8] and coagulation indicators [activated partial thromboplastin time（ATPP）,prothrombin time（PT）,platelet（PLT） and fibrinogen（Fib）] were determined. The correlation between inflammatory factors,coagulation indicators and pelvic adhesion was compared by Spearman correlation analysis. The roles of inflammatory factor and coagulation indicator single and combined determinations in pelvic adhesion were evaluated by receiver operating characteristic（ROC） curve. Results The levels of TNF-α,IL-6,IL-8 and Fib in observation group were higher than those in control group（P<0.05）,while PT was shorter than that in control group（P<0.05）. There was no statistical significance in APTT and PLT between observation and control groups（P>0.05）. The levels of TNF-α,IL-6,IL-8 and Fib in pelvic adhesion group were higher than those in non-pelvic adhesion group（P<0.05）,while PT was shorter than that in non-pelvic adhesion group（P<0.05）. There was no statistical significance in APTT and PLT between pelvic adhesion group and non-pelvic adhesion group（P>0.05）. TNF-α,IL-6,IL-8 and Fib were positively correlated with pelvic adhesion scores（r=0.679,0.524,0.645 and 0.655,P<0.05）,while PT was negatively correlated with pelvic adhesion（r=-0.598,P<0.001）. The areas under curves of TNF-α,IL-6,IL-8,PT and Fib and the combined determination were 0.785,0.830,0.807,0.734,0.662 and 0.983,respectively. Conclusions The combined determination of TNF-α,IL-6,IL-8,PT and Fib are closely related to the endometriosis and pelvic adhesion,which can be used as auxiliary diagnosis indicators for pelvic adhesion.

Influence of Helicobacter pylori infection on serum gastric function related indicators and peripheral blood inflammatory cells in different ages

WANG Yanhong, PANG Xunlei, SHEN Guifang, LI Li, FEI Sujuan

2021, 36(10):  1055-1059.  DOI: 10.3969/j.issn.1673-8640.2021.010.014

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Objective To investigate the determination results of serum gastric function related indicators and peripheral blood inflammatory cells in different age patients with Helicobacter pylori（Hp） infection. Methods A total of 1 807 healthy subjects of different ages were enrolled and classified into <40-year-old group（1 273 cases） and ≥40-year-old group（534 cases）,and they were classified into Hp positive group and Hp negative group. Routine blood test,pepsinogen（PG） Ⅰ,PG Ⅱ,gastrin 17（G17） were determined. Results In Hp positive group,the proportion of males of ≥40-year-old was higher than that of females（P<0.05）. The white blood cell count,lymphocyte count and neutrophil count were lower in <40-year-old group than those in ≥40-year-old group（P<0.05）,but PG Ⅰ and G17 were higher（P<0.05）. In Hp negative group,white blood cell count,monocyte count,lymphocyte count and neutrophil count were lower in <40-year-old group than those in ≥40-year-old group（P<0.05）,but PG Ⅰ,PG Ⅱ and G17 were higher（P<0.05）. In ≥40-year-old group,white blood cell count,lymphocyte count,PG Ⅰ,PG Ⅱ and G17 were higher in Hp positive group than those in Hp negative group,but PGⅠ/PGⅡ was lower（P<0.05）. In the <40-year-old group,white blood cell count,neutrophil count,PG Ⅰ,PG Ⅱ and G17 were higher in Hp positive group than those in Hp negative group（P<0.05）,and PGⅠ/PGⅡ was lower（P<0.05）. Pearson correlation analysis results showed that white blood cell count,neutrophil count,PG Ⅰ,PG Ⅱ and G17 were positively related to Hp infection in <40-year-old group（r values were 0.075,0.064,0.286,0.396 and 0.323,P<0.05）,and PGⅠ/PGⅡ was negatively correlated with Hp infection（r=-0.213,P<0.05）. White blood cell count,lymphocyte count,PG Ⅰ,PG Ⅱ and G17 were positively related to Hp infection in ≥40-year-old group（r values were 0.121,0.111,0.203,0.316 and 0.126,P<0.05）,and PGⅠ/PGⅡ was negatively correlated with Hp infection（r=-0.253,P<0.05）. Multivariate linear regression analysis results showed that PG Ⅱ and G17 had statistical significance in <40-year-old group（P<0.05）,and PG Ⅱ,white blood cell count and PGⅠ/PGⅡ had statistical significance in ≥40-year-old group（P<0.05）. Conclusions The levels of serum gastric function related indicators and peripheral blood inflammatory cells are different in different age patients with Hp infection,which can provide a reference for early screening of gastric cancer.

Isotope dilution liquid chromatography tandem mass spectrometry candidate reference method for serum testosterone

SUN Hewei, JU Yi, ZHU Lingfeng, LI Qing, JIN Zhonggan, ZHANG Sujie

2021, 36(10):  1064-1069.  DOI: 10.3969/j.issn.1673-8640.2021.010.016

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Objective To establish a candidate reference method for the determination of human serum testosterone based on liquid chromatography tandem mass spectrometry（LC-MS/MS）,and to use it into assessing the trueness of clinical method（microparticle chemiluminescence immunoassay）. Methods Testosterone-2,3,4-¹³C₃ was added as internal standard. Serum samples were treated with hexane-ethyl acetate（50∶50,volume fraction）. The upper layer was dried with nitrogen flow. The residual were reconstituted with mobile phase and analyzed by LC-MS/MS. Serum testosterone concentration was calculated by 5-point bracketing method. The isotope dilution liquid chromatography tandem mass spectrometry（ID-LC-MS/MS）（carryover,specificity,linearity,imprecision,accuracy） was validated according to the Clinical and Laboratory Standards Institute（CLSI） C62-A and EP15-A3. The trueness of microparticle chemiluminescence immunoassay was evaluated according to CLSI EP9-A3. Results The ID-LC-MS/MS with 5 min total run time and without carryover was validated over a concentration range of 0.034-22.000 ng/mL,and the specificity was good. The within-run imprecision was ≤2.3%,and the between-run imprecision was ≤2.2%. The bias of analyzing the candidate reference material SRM971（Level male）was 0.2%. The relative biases of analyzing 2017 RELA-A and 2017 RELA-B were -2.9% and -3.3%,respectively. The uncertainty for 2017 RELA-A was 0.11 ng/mL. The linearity between ID-LC-MS/MS and microparticle chemiluminescence immunoassay was good（r=0.963）. However,its average relative bias was large,which total average relative bias was -24.4%,the average relative bias of low concentration group（≤1 ng/mL） was -62.4%,and the average relative bias of high concentration group（>1 ng/mL） was 6.3%. Conclusions The ID-LC-MS/MS established successfully for serum testosterone has good precision and accuracy,with simple preparation and short analysis time and may be used as a candidate reference method.

Inhibition and mechanism of tannic acid on biofilm formation in Klebsiella pneumoniae

ZHOU Yanxia, JIN Dongfang

2021, 36(10):  1070-1073.  DOI: 10.3969/j.issn.1673-8640.2021.010.017

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Objective To study the inhibition and its mechanism of tannic acid on biofilm formation in Klebsiella pneumoniae. Methods Totally,3 isolates of carbapenem-resistant Klebsiella pneumoniae（CRKP） and 1 sensitive isolate KP 13883 were chosen. Minimum inhibitory concentrations（MIC） of imipenem and meropenem were determined by broth micro-dilution method,and the biofilm formation ability was evaluated using 96-well plate crystal violet staining method with or without tannic acid. The morphological differences of biofilm were obtained by scanning electron microscopy before and after the treatment of tannic acid. Real-time fluorescence quantitative polymerase chain reaction（PCR） was used to determine the expression of biofilm-related genes（mrkA,luxS and wbbM） in the presence and absence of tannic acid. Results The 3 CRKP isolates showed decreased susceptibilities to imipenem and meropenem,and the MIC were ≥64 μg/mL. Tannic acid could decrease the growth and biofilm formation ability of CRKP（P<0.05）,which was further confirmed by scanning electron microscopy. The results of real-time fluorescence quantitative PCR showed that tannic acid could reduce the expression of quorum sensing related gene luxS and lipopolysaccharide related gene wbbM. Conclusions Tannic acid could decrease the biofilm formation ability of CRKP.

Development of the national standard materials of testosterone in frozen human serum

YU Ting, SHEN Min, QU Shoufang, SUN Nan, SUN Jing, HUANG Jie

2021, 36(10):  1074-1077.  DOI: 10.3969/j.issn.1673-8640.2021.010.018

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Objective To establish the national standard materials of testosterone in frozen human serum,to evaluate the accuracy,and to promote the standardization of testosterone assay. Methods Serum samples without lipemia,hemolysis and jaundice were collected. After multiple filtration sterilization,serum pools were packed into ampoules in 2-level candidate materials and were stored in -70 ℃. The homogeneity for candidate material was evaluated by single factor analysis of variance,and the stability was evaluated by linear regression analysis. The values of candidate material were assigned by reference method,and the uncertainty was calculated. The commutability was evaluated. Results The F values of homogeneity for candidate material level Ⅰ and level Ⅱ were 1.448 5 and 1.569 6,respectively. All of them were <F_0.05. The stabilities of level Ⅰ and level Ⅱ can be last at least 30 d at -20 ℃. The assigned values of level Ⅰ and level Ⅱ were（0.22±0.05）ng/mL（k=2） and （3.67±0.16）ng/mL （k=2）,respectively. The values were all within 95% confidence interval,which showed that the commutability was good. Conclusions The homogeneity,stability and commutability of candidate material are good,and their values are assigned accurately and reliably. They can be used as national standard.

Research progress in the separation of serum lipoprotein subfractions and lipoprotein（a）

ZOU Jihua, ZHANG Wei, SHEN Min, ZHANG Man, TU Minmin, WANG Huimin, ZHOU Houqing

2021, 36(10):  1078-1086.  DOI: 10.3969/j.issn.1673-8640.2021.010.019

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Cardiovascular disease （CVD）still persists as the leading cause of morbidity and mortality all over the world. Serum lipoproteins are highly heterogeneous lipoproteins,which are composed of the particles that have different sizes,compositions and functions. Thus,lipoprotein subfractions and lipoprotein（a）[Lp（a）] are considered as important CVD risk factors. The clinical significance of measuring lipoprotein subfractions and Lp（a） is greater than traditional low-density lipoprotein cholesterol（LDL-C） and high-density lipoprotein cholesterol（HDL-C）determinations. In clinical practice,accurate and standardized laboratory diagnosis is crucial for the management of dyslipidemia and CVD prevention. Unifying the classification of lipoprotein subfractions and achieving complete separation of Lp（a） in order to achieve good traceability of lipoprotein subfractions and Lp（a） is essential. This review will summarize and discuss the separation technology of lipoprotein subfractions and Lp（a）.