Table of Content

28 February 2018, Volume 33 Issue 2

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Orginal Article

Combined determination of serum amyloid A protein,cystatin C and urinary albumin-to-creatinine ratio in the diagnosis of early diabetic nephropathy

ZHANG Rulin, WANG Hongming, PENG Xia, LI Jiayong, LI Li

2018, 33(2):  97-100.  DOI: 10.3969/j.issn.1673-8640.2018.02.001

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Objective To investigate the combined determination of serum amyloid A protein（SAA）,cystatin C（Cys C） and urinary albumin-to-creatinine ratio（ACR） in the diagnosis of early diabetic nephropathy（DN）. Methods A total of 100 patients with type 2 diabetes mellitus（T2DM） and 100 patients with early DN were enrolled,and 50 healthy subjects were enrolled as healthy control group. The levels of serum SAA and Cys C and urinary ACR were determined. Pearson correlation analysis was performed,and receiver operating characteristic（ROC） curve was used. Results Serum SAA and Cys C levels and urinary ACR increased in turn in healthy control,T2DM and DN groups（P<0.05）. Serum SAA and Cys C levels and urinary ACR in DN group were positively correlated（r=0.631 and 0.662,P<0.05）. The area under ROC curve of the combined determination of serum SAA,Cys C and urinary ACR was bigger than those of the combined determinations of 2 items and single determinations. Conclusions The combined determination of serum SAA,Cys C and urinary ACR has higher accuracy than those of single determinations in the diagnosis of early DN.

Anti-neutrophil cytoplasmic antibody determination for systemic vasculitis

TAN Liming, JIAO Anjun, FENG Xiaojing, XU Liuyue, TAN Fuyan, HE Siqi, LUO Heng, CHEN Juanjuan, JIANG Yongqing, LI Hua

2018, 33(2):  101-105.  DOI: 10.3969/j.issn.1673-8640.2018.02.002

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Objective To evaluate the role of anti-neutrophil cytoplasmic antibody（ANCA） determination for systemic vasculitis. Methods Indirect immunofluorescence（IIF） was performed to determine serum ANCA in 13 866 patients,and enzyme-linked immunosorbent assay（ELISA） was used to determine anti-myeloperoxidase（MPO） antibody and anti-protease 3（PR3） antibody. Results Among the 13 866 patients,there were 318 positive cases of ANCA,with the positive rate of 2.29%. There were 135（2.07%） males and 183（2.50%） females,and there was no statistical significance between the 2 groups（χ²=2.650,P>0.05）. The difference of the ANCA positive rate with different ages had statistical significance（χ²=28.978,P<0.01）. The positive rate of ANCA between males and females in different age groups had statistical significance（χ²=54.550,P<0.01;χ²=17.800,P<0.01）. The p-ANCA and c-ANCA and target antigen distribution had statistical significance（χ²=86.524,P<0.01）. Conclusions ANCA is potential in the diagnosis and treatment of vasculitis and autoimmune diseases,especially for ANCA-associated systemic vasculitis.

Establishment of the reference intervals of coagulation function in 0-3-year-old children

ZOU Chen, GAO Yuan

2018, 33(2):  106-109.  DOI: 10.3969/j.issn.1673-8640.2018.02.003

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Objective To establish the reference intervals of coagulation function in 0-3-year-old children. Methods Coagulation function was determined in 966 children of 0-3-year-old. The children were required without fever,inflammation,hematological diseases,digestive diseases,respiratory diseases,endocrine diseases,tumor or other genetic diseases and with normal growth. Prothrombin time（PT）,prothrombin time international normalized ratio（PT-INR）,activated partial thromboplastin time（APTT）,fibrinogen（Fib） and thrombin time（TT） were determined. According to age,the 966 children were classified into perinatal newborn （0-7 d）,newborn（8-30 d）,infant 1（1-6 months）,infant 2（7-12 months）,child 1（1-2 years） and child 2（2-3 years） groups. The parameters were analyzed statistically,and the reference intervals were evaluated. Results PT showed no statistical significance between 1-6 months and 7-12 months and between 1-2 years and 2-3 years old groups（P>0.05）. PT were 12.20-15.08s for 0-7 d,11.84-14.20s for 8-30 d,11.05-13.45s for 1-12 months and 10.92-12.68s for 1-3 years. PT-INR were 1.07-1.45 for 0-7 d,0.99-1.27 for 8-30 d,0.82-1.10 for 1-12 months and 0.83-1.10 for 1-3 years. APTT showed no statistical significance between 0-7 d and 8-30 d,between 7-12 months and 1-2 years and between 7-12 months and 2-3 years old groups（P>0.05）. APTT were 21.27-58.20s for 0-30 d,24.67-51.52s for 1-6 months and 24.01-43.73s for 7 months-3 years. Fib showed no statistical significance between 8-30 d and 1-6 months,between 7-12 months and 1-2 years and between 7-12 months and 2-3 years old groups（P>0.05）. Fib were 1.43-3.97g/ L for 0-7 d,1.58-3.72g/L for 8 d-6 months and 2.65-3.89g/L for 7 months-3 years. TT showed no statistical significance between 0-7 d and 8-30 d,between 0-7 d and 1-6 months,between 7-12 months and 1-2 years and between 7-12 months and 2-3 years old groups（P>0.05）. TT were 15.31-24.83s for 0 d-6 months and 15.83-23.39s for 7 months-3 years. Conclusions Children's coagulation function is in a continuous growing process. There are physiological changes for each parameter of coagulation function. Laboratories should establish suitable reference intervals according to age,in order to provide a reference for clinical diagnosis and treatment of coagulation system diseases,preoperative examination and anticoagulant monitoring.

Changes of haemostatic parameters in patients with different levels of subclinical hypothyroidism

GAO Fang, ZHANG Yunna, ZHAO Nairui, LI Cuiliu, YANG Xinxin

2018, 33(2):  110-114.  DOI: 10.3969/j.issn.1673-8640.2018.02.004

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Objective To investigate the changes of haemostatic parameters in patients with different levels of subclinical hypothyroidism（SH）. Methods A total of 95 patients with SH and 54 healthy subjects were enrolled. SH patients were classified into 2 groups according to thyroid-stimulating hormone（TSH） levels,and there were group A（mild SH group）（4.2 μIU/mL<TSH<10 μIU/mL） and group B（severe SH group）（TSH≥10 μIU/mL）. Thyroid function,metabolic syndrome and haemostatic parameters were compared and analyzed statistically. Results The levels of fibrinogen（Fib）,plasminogen activator inhibitor-1（PAI-1） and tissue plasminogen activator（t-PA） in group B were higher than those in healthy control group（P<0.05）,and activated partial thromboplastin time（APTT） and D-dimer（DD） were lower（P<0.05）. No statistical significance for haemostatic parameters was found between group A and healthy control group（P>0.05）. Serum free triiodothyronine（FT3）,free thyroxine（FT4） and TSH were not correlated with APTT（r=0.077,0.443 and 0.597）,Fib（r=0.093,-0.166 and 0.201）,DD（r=0.268,-0.382 and 0.205）,PAI-1（r=0.034,0.221 and 0.003）and t-PA（r=0.198,-0.471 and 0.145）. Conclusions The increasing of Fib,PAI-1 and t-PA and the decreasing of DD and APTT in severe SH group may lead to the occurrence of cardiovascular diseases.

Role of leukocyte phagocytosis bacterium in sputum smear specimens for the diagnosis of lower respiratory tract infection

CAO Huiling, HANG Ming, ZHAO Suying, YANG Lin, WU Ling, LI Min, WANG Xiaorong

2018, 33(2):  115-118.  DOI: 10.3969/j.issn.1673-8640.2018.02.005

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Objective To investigate the role of leukocyte phagocytosis bacterium in sputum smear specimens for the diagnosis of lower respiratory tract infection. Methods A total of 175 sputum smear specimens were collected. Immune pathological（phagocytosis or accompanying）between leukocyte and bacterium was observed through the smear with Gram stain directly. Bacterial culturing and drug susceptibility were performed. The patients' clinical data were collected. The consistency was evaluated to distinguish pathogenic bacterium colonization bacterium. Results Among the 175 cases,56.6% cases were above 70 years old,85.1% cases had infection,91.4% cases received antibiotic treatment before specimen collecting. There were 51 specimens（30%） with the phenomenon of bacterial phagocytosis or accompanying by leucocytes. The consistency with the results of culturing（84.3%） was higher than those without the phenomenon of bacterial phagocytosis or accompanying by leucocytes（58.1%,P<0.05）,and the diagnosis rate of pathogenic bacteria was higher as well （92.2% and 38.7%,P<0.05）. Conclusions Bacterial phagocytosis or accompanying by leucocytes in sputum smear specimens plays a role for the diagnosis of lower respiratory tract infection.

Thromboelastography-MA parameter in the diagnosis of acute coronary syndrome

LU Qiuya, LU Yide, SUN Aihua, MA Weiyun, ZHOU Yiqiong, WANG Xuefeng

2018, 33(2):  119-123.  DOI: 10.3969/j.issn.1673-8640.2018.02.006

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Objective To investigate the role of thromboelastography（TEG）-MA parameter in the early diagnosis of acute coronary syndrome（ACS）. Methods A total of 160 patients with ACS and 52 patients with stable angina pectoris（SAP） were enrolled. Routine blood test,cardiac markers,blood lipid,routine coagulation test and TEG were performed and determined. Receiver operating characteristic（ROC）curve was used to evaluate the diagnosis performance of each index. Binary Logistic regression analysis was used to define independent risk factors for ACS. Results The proportions of diabetes mellitus and hypertension were higher in ACS group than those in SAP group（P<0.05 and P<0.01）. The levels of cardiac troponin I（cTnI）,fibrinogen（Fib） and platelet（PLT） count were higher in ACS group than those in SAP group（P<0.01）. Except R parameter,TEG parameters had statistical significance between the 2 groups（P<0.01）. The area under curve（AUC） of TEG-MA parameter was 0.904. The optimal cut-off value for the diagnosis of ACS was 66.6 mm,while the sensitivity was 80.0%,and the specificity was 90.4%. Binary Logistic regression analysis showed that TEG-MA parameter was an independent risk factor and auxiliary diagnostic parameter for ACS. Conclusions TEG-MA parameter could be used as a predictor of PLT and Fib activation. Combined with cTnI and electrocardiography,TEG-MA parameter can be a parameter for the early diagnosis of ACS and could provide a reference for anti-PLT therapy.

Determinations of 5 kinds of trace elements by ICP-MS and establishment of reference intervals

XU Fengxian, YU Jiaping, WU Juanjuan

2018, 33(2):  127-131.  DOI: 10.3969/j.issn.1673-8640.2018.02.008

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Objective To establish an inductively coupled plasma mass spectrometry（ICP-MS） for the determinations of 5 kinds of trace elements [iron（Fe）,magnesium（Mg）,calcium（Ca）,zinc（Zn） and copper（Cu）] in whole blood. Methods After whole blood samples were fully mixed and diluted to 50 times with the solution containing Triton 100 and dilute nitric acid,adding germanium（Ge） as internal standard,an ICP-MS was established for determining 5 kinds of trace elements. A total of 495 whole blood samples of healthy subjects were collected. According to sex and age（≤16 years old and >16 years old groups）,the reference intervals were established. Results The standard curve linearities were good for 5 kinds of trace elements（r=0.999 6-1.000 0）. The within-run precision was 0.31%-3.62%,and the between-run precision was 1.37%-7.15%. The recovery rate was 98.2% -112.7 %. Each element had no statistical significance between males and females（P>0.05）,but there was statistical significance between ≤16 years old and >16 years old groups（P<0.05）. The reference intervals（x±2s） in ≤16 years old group were 30.2-43.4 mg/L for Mg,47.2-69.6 mg/L for Ca,320.6-466.0 mg/L for Fe,0.64 -1.36 mg/L for Cu and 3.1-6.8 mg/L for Zn,and those in >16 years old group were 27.0-43.6 mg/L,42.6-64.6 mg/L,275. 2-530.3 mg/L,0.40-1.58 mg/L and 4.3- 8.3 mg/L,respectively. Conclusions ICP-MS can determine Fe,Mg,Ca,Zn and Cu in whole blood simultaneously,with sensitivity,simple operation,stability and accuracy.

Determination of paraquat in plasma by HPLC-MS/MS

YUE Xiaojing, LI Wei, LI Pingfa

2018, 33(2):  132-138.  DOI: 10.3969/j.issn.1673-8640.2018.02.009

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Objective To establish high performance liquid chromatography-tandem mass spectrometry（HPLC-MS/MS） for the determination of paraquat in plasma. Methods Phenomenex Kinetex 2.6 μm HILIC （100.0 mm×2.1 mm） was selected as chromatographic column,mobile phase A was 1% formic acid aqueous solution （with 250 mmol/L ammonium formate）,and mobile phase B was acetonitrile. Gradient elution was performed,the flow rate was 0.35 mL/min,the sample volume was 10 μL,and the column temperature was 40 ℃. Electrospray ionization（ESI） source and positive ion multiple reaction monitoring scan mode were used. The mass-to-charge ratio（m/z）of paraquat select ion was 92.7→171.0,and the m/z of ethyl-paraquat selected ion was 107.0→185.1. The methodology（linear range,quantitative limit,accuracy,precision,selectivity,matrix effect and stability） was evaluated. Plasma specimens of 75 patients with acute paraquat poisoning were determined. Receiver operating characteristic（ROC） curve was used to assess plasma paraquat level for diagnosis. Results There was a linearity at the level of 54.28-13 190.00 ng/mL,and the linear equation was Y=0.000 1X+0.011 6（r²=0.998 3）. The within-run and between-run accuracies were 96.31%-120.04% and 104.43% at the quantitative limit levels. The bias between within-run and between-run accuracies and listed value were ±15% at the high,medium or low concentration. The within-run and between-run relative standard deviations（RSD） were <15% at the high,medium and low concentrations or quantitative limit levels. The selectivity and matrix effect of the method were assessed,and 6 blank matrix were selected randomly. The location of the paraquat peaks appeared without interference,and the method was selective. The coefficient of variation of matrix factor,which was normalized by internal standard,was <15% at the high or low concentration,and the matrix effect met related requirements. Specimens can be stable being placed within 1 d at room temperature,within 1 week at 2-8 ℃ refrigerator and within 1 month at -80 ℃ refrigerator and being stable after repeating freezing and thawing for 3 times. The median was 2 820（0-22 200） ng/mL. The median in survival group was higher than that in death group（P<0.05）. The area under ROC curve for plasma level of paraquat predicting outcome was 0.855. The optimal cut-off value was 2 431 ng/mL. Conclusions The established HPLC-MS/MS can be used to clinical routine determination for plasma level of paraquat.

Role of pleural effusion interferon-gamma release assay for the diagnosis of tuberculous pleural effusion： a Meta analysis

LI Huimin, MA Qingguang, LI Hongying

2018, 33(2):  139-146.  DOI: 10.3969/j.issn.1673-8640.2018.02.010

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Objective To evaluate the role of pleural effusion interferon-gamma release assay（IGRA） for the diagnosis of tuberculous pleural effusion. Methods Databases included PubMed,EMbase,Medline,the Cochrane Library（Issue 6,2015）,CNKI,WanFang Data and VIP,and related literature was searched from inception to July 1st,2016. Two reviewers screened literature according to the inclusion and exclusion criteria,extracted related data and assessed. Meta-Disc 1.4 software was used to perform Meta analysis. Pooled sensitivity,pooled specificity,pooled positive likelihood ratio,pooled negative likelihood ratio,pooled diagnostic odds ratio and area under curve（AUC） of summary receiver operating characteristic（SROC）curve was used to assess the diagnosis efficiency. Results A total of 27 studies involving 2 072 patients with pleural effusion were included. The pooled sensitivity,pooled specificity,pooled positive likelihood ratio,pooled negative likelihood ratio,pooled diagnostic odds ratio and the AUC of SROC curve were 0.85 [95% confidence interval（CI）0.83-0.87],0.85（95% CI 0.83-0.88）,5.37（95% CI 3.38-8.53）,0.16（95% CI 0.09-0.26） and 41.31（95% CI 17.48-97.61） and 0.930 0,respectively. Conclusions Pleural effusion IGRA plays a role for the diagnosis of tuberculous pleural effusion.

Susceptibility of tigecycline against carbapenems-resistant Klebsiella pneumoniae and Acinetobacter baumannii and susceptibility test

LIU Yan, YUAN Yinghua

2018, 33(2):  147-151.  DOI: 10.3969/j.issn.1673-8640.2018.02.011

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Objective To analyze the susceptibility of tigecycline against carbapenems-resistant Klebsiella pneumoniae and Acinetobacter baumannii and the methods for in vitro susceptibility test. Methods A total of 61 isolates,including 41 isolates of Acinetobacter baumannii and 20 isolates of Klebsiella pneumoniae,were collected in the Tenth People's Hospital of Tongji University from November 2013 to February 2014. The isolates were confirmed as carbapenems-resistant isolates by Vitek 2 compact automatic microbiological analysis system and disk diffusion method. The broth microdilution method,minimum inhibitory concentration（MIC） method and disk diffusion method were used to determine the susceptibility of tigecycline. Results For carbapenems-resistant Acinetobacter baumannii,the MIC₅₀ and MIC₉₀ of tigecycline by broth microdilution method were 2 and 4 mg/ L. According to the U. S. Food and Drug Administration（FDA） criterion,the resistance rate,intermediary rate and sensitivity rate were 7.3%,29.3% and 63.4%,respectively. Compared with broth microdilution method,the essential agreement（EA） and categorical agreement（CA） of MIC method were 97.6% and 87.8%,and there was no very major error（VME） and major error（ME）,and the minor error（mE） accounted for 12.2%. The CA of disk diffusion method was 24.4%,and there was no VME,the ME accounted for 7.3%,and the mE accounted for 68.3%. For carbapenems-resistant Klebsiella pneumoniae,the MIC₅₀ and MIC₉₀ of tigecycline by broth microdilution method were 1 and 2 mg/L. According to the FDA criterion,the resistance rate,intermediary rate and sensitivity rate were 5.0%,0.0% and 95.0%,respectively. Compared with broth microdilution method,the EA and CA of MIC method accounted for 95.0%. There was no VME and ME,and the mE accounted for 5.0%. The CA of disk diffusion method was 30.0%,VME and ME did not appear,and mE accounted for 70.0%. Conclusions Tigecycline against carbapenems-resistant Klebsiella pneumoniae has good antibacterial activity,while the antibacterial activity of carbapenems-resistant Acinetobacter baumannii decreases. For carbapenems-resistant Klebsiella pneumoniae,the MIC method could be used for routine clinical determination of tigecycline susceptibility or confirmation,while for carbapenems-resistant Acinetobacter baumannii,the results of MIC method need to be treated with caution,and should be confirmed by broth microdilution method if necessary. The evaluation indicators do not support the use of disk diffusion method for tigecycline susceptibility test.

Application of AVE-562 automated feces analyzer

BAO Yunwen, GU Kongzhen, XU Keqian

2018, 33(2):  152-155.  DOI: 10.3969/j.issn.1673-8640.2018.02.012

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Objective To evaluate the application of AVE-562 automated feces analyzer. Methods A total of 3 028 feces specimens were determined by manual microscopy and AVE-562 automated feces analyzer. The results of manual microscopy were as gold standard. Occult blood（OB） test results determined automatically by AVE-562 were compared with those of manual microscopy by OB test strip of Kangzhu Company. The sensitivity,specificity and accuracy were calculated. Results The coincidence rate was 97.85% for OB test of AVE-562 and OB test strip（kappa=0.918）. The sensitivities of red blood cell（RBC）,white blood cell（WBC）,parasite and fat globule were 86.05%,80.95%,72.00% and 91.89%,respectively. The specificities of RBC,WBC,parasite and fat globule were 99.63%,99.80%,99.73% and 99.86%,respectively. The accuracies of RBC,WBC,parasite and fat globule were 99.44%,99.54%,99.50% and 99.67%,respectively. The kappa values of RBC,WBC,parasite and fat globule were 0.810,0.827,0.703 and 0.930,respectively. Conclusions The results of RBC,WBC and other indices by AVE-562 automated feces analyzer and manual microscopy have good consistency. It is easy to operate for AVE-562 automated feces analyzer with application value.

External quality assessment for anaerobic bacterium detection in Shanghai

CHEN Rong, LIU Xuejie, XU Rong, GE Ping, WANG Jinghua

2018, 33(2):  156-159.  DOI: 10.3969/j.issn.1673-8640.2018.02.013

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Objective To study the development of anaerobic bacterium detection and its detection quality of Shanghai medical laboratories in recent years through anaerobic bacterium detection external quality assessment. Methods The feedback results of anaerobic bacterium detection external quality assessment in Shanghai Center for Clinical Laboratory（SCCL） from 2014 to 2017 were collected,and the consistency rate of anaerobic bacterium detection was analyzed. Results The number of laboratories participating SCCL anaerobic bacterium detection external quality assessment increased from 26 in 2014 to 43 in 2017（increasing rate 60.5%）. Only 1 laboratory failed in the 1st external quality assessment in 2014,and the qualification rate was 96.2%（25/26）. The qualification rate reached 100.0% from 2015 to 2017. A total of 25 isolates of anaerobic bacteria were delivered（covering 5 genera and 15 species）. There were 17 isolates identified with the consistency rate of 100.0%,of which Peptostreptococcus 100.0%（1/1）,Propionibacterium 100.0%（1/1）,Clostridium 88.9%（8/9）,Bacteroides 46.2%（6/13） and Prevotella 100.0%（1/1）. Conclusions The number of laboratories setting anaerobic bacterium detection in Shanghai increases year by year. The overall detection ability and accuracy rate of anaerobic bacterium detection are good and high,while some laboratories' performance still should be improved. Quality control in clinical laboratories is essential to assure accuracy.

Y chromosome detection for an azoospermia patient after sex-mismatched bone marrow transplantation

HU Ying, LIANG Xiannian, YU Jianhong, QIN Lingyun, WANG Yuming

2018, 33(2):  160-162.  DOI: 10.3969/j.issn.1673-8640.2018.02.014

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Objective To report a case of azoospermia after sex-mismatched bone marrow transplantation,and to analyze the results of Y chromosome detection. Methods Peripheral blood was collected. Chromosome karyotype analysis was performed according to an International System for Human Cytogenetic Nomenclature（ISCN）（2005）. Oral mucosa swab and peripheral blood AZF microdeletions of Y chromosome were detected by multiplex polymerase chain reaction（PCR）. Serum gonadal hormone levels were determined by chemiluminescence. Results The result of chromosome karyotype analysis was 46xx. The deletion was found for all AZF sites in peripheral blood,but the AZF sites in oral mucosa swab all existed. The levels of follicle-stimulating hormone and progesterone were increased. Conclusions AZF microdeletion of Y chromosome may be associated with sperm defect and male infertility. The detection of AZF microdeletion of Y chromosome should be used for azoospermia and oligospermia patients. Since chimerism,it is important to detect AZF microdeletion of Y chromosome both in peripheral blood and somatic cells for azoospermia patients after sex-mismatched bone marrow transplantation.

Research progress of cardiovascular disease risk assessment system

SHEN Yifeng, WU Jiong, GUO Wei, PAN Baishen

2018, 33(2):  163-169.  DOI: 10.3969/j.issn.1673-8640.2018.02.015

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Cardiovascular disease has become a huge threaten to human health,so it is necessary to assess the risk of cardiovascular disease and manage its risk factors. Since the 20th century,many countries and regions have conducted researches on cardiovascular disease risk factors in large scale,and have built some cardiovascular disease risk assessment systems,such as the Framingham risk score（FRS）,SCORE risk score,QRISK2 risk score and Chinese ischemic cardiovascular disease（ICVD） risk assessment model. However,since the difference of ethnic groups and regions,the application ranges of risk assessment systems,clinical variables,cardiovascular disease risk factors,end points and suitable crowd are different,and each system has its own characteristics. In this review,a comparison is made among current risk score systems.

Research progress of serological biomarkers for inflammatory bowel disease

ZENG Junxiang, PAN Xiujun, SHEN Lisong

2018, 33(2):  170-176.  DOI: 10.3969/j.issn.1673-8640.2018.02.016

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Inflammatory bowel disease（IBD）,including Crohn's disease（CD） and ulcerative colitis（UC）,is a chronic intestinal inflammation of unknown etiology. At present,the diagnosis of IBD is confirmed mainly by endoscopy and histopathologic examination of biopsies,and the invasiveness and difficult operations of such inspections make it necessary to find a non-invasive method that is more convenient,sensitive,affordable and efficient. Serological biomarkers may meet this demand and has become a focus of IBD research. This review summarizes recent research progress in the field of IBD,advance in traditional markers and some new types of markers such as anti-glycoprotein 2（GP2） antibody,anti-CUB and zona pellucida-like domain-containing protein 1（CUZD1） antibody,apoptosis inhibitor of macrophage（AIM） and serum-derived hyaluronan-associated protein（SAHP）.

Establishment of clinical reference measurement laboratory using blood cell analysis as an example

KANG Juan, WANG Huiru, SUN Jingsheng, WANG Jun, CHEN Wei

2018, 33(2):  177-181.  DOI: 10.3969/j.issn.1673-8640.2018.02.017

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Traceability is important to realize the accuracy and comparability of clinical results,and relies on the establishment of reference system. Clinical reference measurement laboratory as a part of reference system is crucial. The establishment and accreditation of clinical reference measurement laboratory are still in infancy stage at home and abroad. This review focuses on the establishment of blood cell analysis reference laboratory as an example,in order to introduce practical experience and emphasize the characteristics of reference laboratory,from the aspects of value traceability,quality control and quality management system.