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       2001, 16 (01): 48-48.  
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       2000, 15 (04): 255-255.  
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    Laboratory Medicine    1990, 5 (1): 62-64.  
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    Expert consensus on the clinical application of AFP,AFP-L3% and DCP using GALAD and GALAD-like models in hepatocellular carcinoma
    Clinical Laboratory Society of Chinese Association for Rehabilitation Medicine , Molecular Diagnostics Society of Shanghai Medical Association , Tumor Immunology Branch of Shanghai Society for Immunology , Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine , Shanghai Center for Clinical Laboratory, Clinical Laboratory Society of Chinese Association of Integrative Medicine , Clinical Laboratory Society of Shanghai Anticancer Association , Tumor Markers Society of Shanghai Anticancer Association
    Laboratory Medicine    2023, 38 (7): 607-623.   DOI: 10.3969/j.issn.1673-8640.2023.07.001
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    Primary hepatocellular carcinoma (HCC) is a prevalent world-wide malignancy. Half of the newly developed HCC occurs in China. Optimizing the strategies for high-risk surveillance and early diagnosis is pivotal for improving 5-year survival. Constructing the scientific non-invasive determination technologies feasible for medical and healthcare institutions is a key route for elevating the efficacies in HCC diagnosis and follow-up. Based on the international and Chinese guidelines,expert consensus statements,literatures and evidence-based clinical practice experiences,this consensus published by the Clinical Laboratory Society of Chinese Association for Rehabilitation Medicine puts forward the clinical implications,application subjects,determination techniques and result interpretations for GALAD and GALAD-like models based on alpha-fetoprotein (AFP),alpha-fetoprotein heterogeneity-L3%(AFP-L3%),and des-gamma-carboxy prothrombin(DCP). The compile of this consensus statement aims to address and push the reasonable model application of the triple-biomarker(AFP, AFP-L3%, DCP)determinations thus to maximize the clinical efficacies and help improving HCC high-risk surveillance,early diagnosis and prognosis.

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    Consensus on androgen testing in polycystic ovary syndrome
    Expert Group on the Consensus on Androgen Testing in Polycystic Ovary Syndrome China Association for Promotion of Health Science and Technology-Fertility Protection and Preservation Committee
    Laboratory Medicine    2023, 38 (3): 203-208.   DOI: 10.3969/j.issn.1673-8640.2023.03.001
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    Polycystic ovary syndrome(PCOS) is one of the most common endocrine disorders in reproductive-age females,frequently leading to female infertility. Hyperandrogenemia plays a role in the pathogenesis of PCOS. Hyperandrogenemia can be evaluated by biochemical tests or clinical signs. At present,there are some limitations of immunology-based testing methods for androgen,such as cross-reaction,poor accuracy in low-concentration samples and lack of comparability among different reagent manufacturers,leading to false positivity. With the advantages of high sensitivity,high specificity,wide linear range and the capability of simultaneous determination of multiple molecules,liquid chromatography-tandem mass spectrometry(LC-MS/MS) becomes a good choice for androgen testing. On the basis of published clinical and laboratory evidence,Beijing Obstetrics and Gynecology Hospital of Capital Medical University,China Association for Promotion of Health Science and Technology-Fertility Protection and Preservation Committee,along with the experts in the clinical laboratory,gynecological endocrinology and mass spectrometry application relevant field made this consensus,in order to provide professional guidance in PCOS androgen testing in clinical laboratories. The consensus includes recommendations on types and methods of androgen testing for PCOS and challenges of androgen testing with LC-MS/MS.

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    Interpretation and application of 15 quality control indicators in clinical laboratories
    KAN Lijuan, ZHANG Lijun, ZHANG Xiuming
    Laboratory Medicine    2022, 37 (10): 907-914.   DOI: 10.3969/j.issn.1673-8640.2022.010.001
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    The quality control indicators of clinical laboratories are essential in clinical laboratories as they enable the management to evaluate their performance objectively. As mentioned in the National Tertiary Public Hospitals Performance Evaluation Operational Manual (2022 edition),quality control indicators have been combined into performance appraisal system. Although 15 indicators from the Quality Control Indicators in Clinical Laboratory Service (2015) published by the National Health and Family Planning Commission,which are adopted in this manual,the interpretation of these indicators,the concepts of denominator and the numerator in the equations,as well as the datum acquisition methods are inconsistent,which leads to inaccurate results in performance evaluations between laboratories. This review makes the practice-based suggestions and opinions on interpreting and applying the 15 quality control indicators in clinical laboratories.

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    Consensus of method development and validation of liquid chromatography-tandem mass spectrometry in clinical laboratories
    Clinical Mass Spectrometry Committee, Chinese Medical Doctor Association of Laboratory Medicine
    Laboratory Medicine    2019, 34 (3): 189-196.   DOI: 10.3969/j.issn.1673-8640.2019.03.001
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    Liquid chromatography-tandem mass spectrometry (LC-MS/MS) is an emerging technology which has developed rapidly in recent years. It has combined the separation properties of liquid chromatography and the high sensitivity and specificity of mass spectrometry,which is widely applied in various areas,such as chemistry,biology,pharmaceutical science,food,clinic and environmental science. Especially in the field of clinical laboratory and diagnostics,LC-MS/MS used as a complement to traditional diagnostic techniques can often provide more accurate and reliable testing results in accurate and rapid diagnosis of diseases. In this review,some internationally published LC-MS/MS method validation guidelines,related literature and practical experience were summarized,and some key processes of LC-MS/MS development were introduced. Using 25-hydroxyvitamin D3[25(OH)D3] as an example,the key elements of method validation were reviewed,in order to provide a reference for the establishment,verification and implementation of LC-MS/MS.

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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
    Laboratory Medicine    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.

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    Laboratory Medicine    2021, 36 (7): 685-690.   DOI: 10.3969/j.issn.1673-8640.2021.07.001
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    Clinical application of serum folate and red blood cell folate determinations
    CHEN Pu, PAN Baishen
    Laboratory Medicine    2016, 31 (3): 232-236.   DOI: 10.3969/j.issn.1673-8640.2016.03.019
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    Folate deficiency is closely related to neural tube defect in newborns and megaloblastic anemia. The determinations of serum folate and red blood cell folate could be primary evidence for folate deficiency. However,the determination methods have not yet been standardized. This article will describe the biological characteristics of folate,the causes of folate deficiency,its epidemiological study,clinical manifestation,diagnostic cut-off values and the clinical application of folate determinations.

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    Laboratory Medicine    2019, 34 (4): 285-299.   DOI: 10.3969/j.issn.1673-8640.2019.04.001
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    Comparison of plasma exosome extraction methods
    LÜ Lihua, ZHU Lina, WANG Hao, YANG Wenjing, JIN Anli, WANG Beili, PAN Baishen, GUO Wei
    Laboratory Medicine    2020, 35 (12): 1224-1228.   DOI: 10.3969/j.issn.1673-8640.2020.12.005
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    Objective To compare the efficiency of ultracentrifugation,affinity membrane method and precipitation for extracting plasma exosome. Methods Plasma exosomes were extracted by 3 different methods,including ultracentrifugation,affinity membrane method and precipitation. Transmission electron microscopy,nano-flow cytometry,zetasizer nano were used to verify its morphology,particle size and distribution and Zeta potential. The western blot analysis was performed to measure the representative protein markers of exosomes. The bicinchoninic acid assay was utilized to measure concentration of exosomal protein. The ratio of particles number to protein concentration was analyzed to evaluate the extraction efficiency of exosomes. Results The transmission electron microscope showed exosomes extracted by ultracentrifugation and affinity membrane method as a saucer-like bilayer membrane structure,while the exosomes extracted by precipitation were mixed with PEG polymer and protein particles. The size of the exosomes were between 40-100 nm,while the mean diameter of the exosomes derived using affinity membrane method was larger than those using the ultracentrifugation and precipitation. Dynamic light scattering(DLS) analysis showed that the Zeta potential of exosomes was negative,which implied their membranous structure. However,exosomes size measured by DLS were larger than that by nano-flow cytometry. In addition,all the exosomes expressed representative protein markers. The precipitation produced the highest protein concentration and particles,and the ultracentrifugation gave exosomes the highest purity than the other 2 methods. Conclusions Exosomes can be extracted by ultracentrifugation,affinity membrane and precipitation. However,which extraction method should be used depends on the specific experimental requirements.

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    Determination of cholesterol in serum with cholesterol dehydrogenase
       2004, 19 (05): 403-405.  
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    Research progress on TMEM16F and related diseases
    WANG Chanjuan, ZHANG Jie, QIAO Rui
    Laboratory Medicine    2017, 32 (9): 831-836.   DOI: 10.3969/j.issn.1673-8640.2017.09.019
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    Transmembrane protein 16F(TMEM16F),also called Anoctamin(ANO)6,is a member of Anoctamin family,which is expressed in many types of cells. At present,the major functions of TMEM16F that have been demonstrated include:(1) Ca2+-dependent Cl- channel,which takes part in the regulation of cell volume;(2) Ca2+-regulated nonselective cation channel;(3) Ca2+-dependent phospholipid scramblase,which takes part in coagulation,cell apoptosis,bone mineralization and so on. Hence,at the basis of these functions,TMEM16F gene mutation is closely related with Scott syndrome,a rare inherit bleeding disease. The defect of TMEM16F can cause the dysfunction of bone mineralization and cell volume regulation. This review focuses on the structure and functions of TMEM16F,so as to show the role of TMEM16F in the physiopathologic mechanism,diagnosis and treatment of related diseases.

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    Establishment of the reference intervals of thyroid function for children in Shanghai
    LI Huaiyuan, JIANG Limin, QIAN Yueping, FU Qihua, LI Dong
    Laboratory Medicine    2016, 31 (12): 1045-1049.   DOI: 10.3969/j.issn.1673-8640.2016.12.008
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    Objective To establish the reference intervals of thyroid stimulating hormone(TSH),free triiodothyronine(FT3) and free thyroxine(FT4) for children in Shanghai.Methods A total of 720 healthy children of 4 d to 17 years old from 9 hospitals in Shanghai were enrolled from August 2014 to July 2015. These children were classified into 6 groups according to ages and 120 cases were in each group. After centrifugation,serum specimens were frozen at -20 ℃. The levels of TSH,FT3 and FT4were determined by Beckman Coulter DxI 800 automated immunoassay system. The reference intervals of TSH,FT3 and FT4 were established according to the Clinical and Laboratory Standards Institute(CLSI) C28-A3 and the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC) guidelines. Nonparametric methods were used to establish the 2.5th and 97.5th percentiles for reference intervals and 90% confidence interval. Results The ages of Group A-F were 4 d -<1 month,1-<12 months,1-<5 years,5-<10 years,10-<14 years and 14-17 years,respectively. The reference intervals of Group A were TSH 0.53-18.91 μIU/mL,FT3 2.42-5.67 pmol/L and FT4 11.85-33.81 pmol/L. The reference intervals of Group B were TSH 0.75-5.75 μIU/mL,FT3 4.21-8.16 pmol/L and FT4 9.40-19.54 pmol/L. The reference intervals of Group C were TSH 0.63-6.20 μIU/mL,FT3 3.54-6.90 pmol/L and FT4 9.32-18.40 pmol/L. The reference intervals of Group D were TSH 0.58-5.39 μIU/mL,FT3 3.97-7.83 pmol/L and FT4 10.65-19.23 pmol/L. The reference intervals of Group E were TSH 0.39-5.36 μIU/mL,FT3 4.27-8.55 pmol/L and FT4 9.80-19.64 pmol/L. The reference intervals of Group F were TSH 0.48-5.06 μIU/mL,FT3 3.14-6.15 pmol/L and FT4 9.57-18.27 pmol/L. There was statistical significance for reference interval distribution between Group A and B(Z>3). The TSH,FT3 and FT4 reference intervals for sex in all age groups showed no statistical significance(P>0.05). Conclusions The reference intervals of TSH,FT3 and FT4 are established for healthy children of 4 d to 17 years old in Shanghai. The reference intervals above can explain the results of thyroid function,which can improve the diagnosis,treatment and monitoring of hypothyroidism,hyperthyroidism,thyroiditis,goiter and thyroid neoplasm for children.

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    Status of clinical application of ionized calcium determination and corrected calcium concentration equation
    WU Jiong, PAN Baishen
    Laboratory Medicine    2016, 31 (7): 623-626.   DOI: 10.3969/j.issn.1673-8640.2016.07.019
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    Total calcium is consisted of ionized calcium and physiologically inactive calcium(mainly associated with albumin,as well as bicarbonate,citrate and lactate). Monitoring patients' calcium status is not straightforward, because both ionized and total calcium determinations are commonly available for clinical interpretation,and each has advantages and disadvantages. Total calcium is more convenient to be measured than ionized calcium,and is more frequently used by clinical laboratories. However,total calcium can not represent patients' calcium status correctly in some specific clinical situations. This review focuses on the research status of corrected calcium concentration equation,ionized calcium and total calcium.

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    Next generation sequencing in quality control and analysis of data
    YU Dong, GUO Yingjun
    Laboratory Medicine    2017, 32 (4): 255-261.   DOI: 10.3969/j.issn.1673-8640.2017.04.003
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    With the development of precision medicine in China,next generation sequencing (NGS) has been improved in clinical practice. Though NGS is a new technology in the field of clinical laboratory medicine,there is a few systematic laws,regulations and guidelines to regulate the development of NGS. Changhai Hospital is one of the first national trial units,which is applying NGS to the diagnosis and therapy of cancer. Now,it has conducted 2 NGS programs,which are genetic testing program and cancer individualized medication program. This review will focus on the problems from practice and provide a useful reference.

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    Identification of a new susceptibility gene variant EPB41 L4 A rs1455421289 in Chinese PTC patients by WES
    YAN An, GUAN Xuhuizi, YU Tian, MIAO Gang, ZHAO Yanyang
    Laboratory Medicine    2023, 38 (11): 1009-1014.   DOI: 10.3969/j.issn.1673-8640.2023.11.001
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    Objective To identify new susceptibility gene variants in Chinese papillary thyroid carcinoma(PTC) patients by whole exome sequencing(WES) combined with targeted analysis. Methods A total of 286 PTC patients who underwent surgery at Beijing Hospital from 2018 to 2020 were enrolled to identify mutation sites in PTC candidate genes,and 214 PTC patients who underwent surgery at Beijing Hospital from 2021 to 2022 were enrolled to calculate the mutation frequencies of these mutation sites. WES was used to determine peripheral blood leukocyte genomic DNA of all the subjects. Rare variants in protein-coding regions and flanking selective splicing sequences of 28 PTC candidate genes identified by genome-wide association study(GWAS) were identified using targeted analysis. The allele expression of mutation sites in tumor tissues and adjacent tissues was determined. Case-control association analysis was performed to assess the effect of mutation sites on PTC risk. Genotyping data for the controls were obtained from gnomAD,TOPMed,ChinaMAP and HUABIAO databases. Results Two extremely rare missense mutations were identified on the erythrocyte membrane protein band 4.1 like 4A(EPB41L4A) gene(rs1455421289 site c.163G>C:p.D55H and rs761977647 site c.855G>C:p.W285C),which could potentially affect protein function. Among the 286 PTC patients used to identify candidate gene mutation sites,3 patients carried rs1455421289 site c.163G>C:p.D55H mutation,and 1 patient carried the rs761977647 site c.855G>C:p.W285C mutation. The carry frequency of these 2 sites was <0.05% in all 4 control groups. Among the 214 PTC patients used to calculate mutation site mutation frequencies,1 patient carried rs1455421289 site c.163G>C:p.D55H mutation,and no rs761977647 site c.855G>C:p.W285C mutation was determined. The mutation frequency of EPB41L4A rs1455421289 was 0.8%(4/500),and rs761977647 had a mutation frequency of 0.2%(1/500). Moreover,the EPB41L4A rs1455421289 mutation resulted in significantly increased abundance of mutant mRNA compared to wild mRNA(P<0.01). The rs1455421289 site C.163G>C:p.D55H mutation resulted in significantly increased PTC risk compared to the 4 control groups [odds ratios(OR) were 40.3,85.4,213.5 and 541.1,95% confidence intervals(CI) were 4.5-361.5,9.5-765.4,57.2-797.2 and 98.7-2 960.8]. Conclusions Based on WES,a new susceptibility gene variant EPB41L4A rs1455421289 results in significantly increased risk of PTC.

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    Detection and prevention of common interference in turbidimetric immunoassay
    JIA Keke, SUN Wenyuan, NIE Rui, CUI Liyan
    Laboratory Medicine    2021, 36 (4): 362-368.   DOI: 10.3969/j.issn.1673-8640.2021.04.002
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    The accuracy of turbidimetric immunoassay is affected by a few interference factors,such as sample appearance,endogenous interference,hook effect and carry-over contamination. These interference factors may cause the results increasing or decreasing falsely and further affect clinical diagnosis and treatment monitoring. The laboratory staff should be familiar with common interference factors and mechanisms,communicate with doctors in time and identify,confirm and prevent possible interference,in order to reduce the occurrence of adverse events.

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    Research progress of gene polymorphisms of ADH1 B and ALDH2 and their related diseases
    ZHANG Xiaomin, LIU Jing, GAO Shichao, YANG Tingting, WANG Peichang
    Laboratory Medicine    2019, 34 (3): 271-275.   DOI: 10.3969/j.issn.1673-8640.2019.03.019
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    Alcohol dehydrogenase (ADH) and aldehyde dehydrogenase (ALDH)are key enzymes of alcohol metabolism in human liver,which constitute ethanol dehydrogenase oxidation system. ADH1B and ALDH2 are 2 important subtypes of ADH and ALDH,respectively. ADH1B and ALDH2 gene polymorphisms are associated with a variety of diseases,such as digestive system diseases,neurodegenerative disorders and metabolic diseases. In this review,the gene polymorphisms of ADH1B and ALDH2 and their related diseases are reviewed to provide new ideas for the prevention and diagnosis of diseases.

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    Methodology verification on the performance of BD FACSCantoⅡflow cytometry analyzer
    CHEN Shuying, CHEN Jian, LIN Yong, SHI Chaohui
    Laboratory Medicine    2016, 31 (5): 405-411.   DOI: 10.3969/j.issn.1673-8640.2016.05.014
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    Objective To verify the main performance of BD FACSCantoⅡflow cytometry analyzer. Methods According to the Clinical and Laboratory Standards Institute(CLSI)documents and projects provided from other literatures,the analytical performance of BD FACSCantoⅡflow cytometry analyzer was evaluated by precision,accuracy,linearity and reference range of common test items(peripheral blood lymphocyte subtypes:CD3+T cell,CD3+CD4+T cell,CD3+CD8+T cell,B cell and NK cell). The results were compared with the claims of manufacturers. Results The precision,accuracy,linearity and reference range of BD FACSCantoⅡflow cytometry analyzer in the determination of peripheral blood lymphocyte subtypes were in line with the performance parameters of manufacturers. Conclusions BD FACSCantoⅡflow cytometry analyzer has a good performance,accurate measurement and a high repeatability in the determination of peripheral blood lymphocyte subtypes,which can satisfy the need in clinics.

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    Determinations of serum amyloid A and C-reactive protein for the diagnosis of infectious diseases in children
    TIAN Yueru, LI Wei, YE Zhicheng, YANG Dan, XU Jin
    Laboratory Medicine    2017, 32 (5): 382-385.   DOI: 10.3969/j.issn.1673-8640.2017.05.008
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    Objective To investigate the combined determination of serum amyloid A (SAA) and C-reactive protein (CRP) for the diagnosis of infectious diseases in children. Methodse SAA and CRP levels were determined in 65 patients with viral infection,72 patients with bacterial infection and 60 healthy children (healthy control group),and white blood cell (WBC) count and differentiation were determined,and the neutrophil/lymphocyte ratio (NLR) was calculated. Receiver operating characteristic (ROC)curve was used to analyze the efficacy of SAA,CRP,SAA/CRP ratio,WBC count and NLR in the diagnosis of bacterial and viral infections. Results The levels of SAA,CRP,WBC count and NLR in bacterial infection group were higher than those in healthy control group (P<0.05),and SAA/CRP ratio was lower(P<0.05). The levels of SAA and SAA/CRP ratio were higher in viral infection group than those in healthy control group (P<0.05),and there was no statistical significance for CRP,WBC count and NLR compared with healthy control group(P>0.05). ROC curve showed that CRP had the best performance for the diagnosis of bacterial infection,and the area under ROC curve (AUC),sensitivity and specificity were 0.977,99.0% and 83.2%,respectively. SAA/CRP ratio had the best performance for the diagnosis of viral infection,and AUC,sensitivity and specificity were 0.916,87.7% and 89.4%. Conclusions SAA and CRP can be used as diagnostic parameters for bacterial infection. In viral infection,SAA increases more obviously than CRP,and SAA/CRP ratio is sensitive. The combined determination of SAA and CRP can determine the types of infections quickly and accurately,and can provide a reference for the early diagnosis and follow-up treatment.

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       2002, 17 (01): 33-34.  
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       2007, 22 (03): 353-354.  
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    Performance of Mindray automatic H50 glycohemoglobin analyzer
    ZHAO Zhiyun, YUAN Wenhua, SONG Yunxiao
    Laboratory Medicine    2017, 32 (12): 1137-1142.   DOI: 10.3969/j.issn.1673-8640.2017.12.016
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    Objective To evaluate the performance of Mindray automatic H50 glycohemoglobin analyzer,and to confirm whether it meets clinical requirements. Methods According to guidelines published by the People's Republic of China health industry standard YY/T1246—2014 Glycohemoglobin Analyzer,WS/T 461—2015 Measurement of Hemoglobin A1 and the Clinical and Laboratory Standards Institute(CLSI) EP5-A2,EP6-A and EP9-A3,the carryover rate,repeatability,within-run precision,between-run precision,within-laboratory precision,linearity,comparability with BIO-RAD VariantⅡ glycohemoglobin analyzer,trueness,sample stability,interference and glycated hemoglobin E(HbE) identification were evaluated. Results The carryover rate of H50 for the determination of glycated hemoglobin A1c(HbA1c) was low(-0.56%),and high-value samples were not carried to low-value samples. The results of repeatability showed that the coefficient of variation(CV) was <1%. The within-run precision,between-run precision and within-laboratory precision(CV) were <1%,which met the requirements of WS/T 461—2015. There was a wide linear range(4.2%-16.6%),which can cover the majority of samples. The samples after storing in cold environment(4 ℃) and room temperature(18-24 ℃) were stable for 6 d. According to the requirements of the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC),the absolute bias was within ±0.3% HbA1c. There was a positive relation with VariantⅡ(r=0.996). The expected bias at medical decision level was <1% below the requirements of the College of American Pathologists(CAP)(6%). Triglyceride(TG),bilirubin and glucose(Glu) had no interference to HbA1c. The extended model can effectively prompt for HbE. Conclusions H50 glycohemoglobin analyzer has good performance,which can meet clinical requirements.

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    Rule making of M protein recognition by serum protein electrophoresis and its application in M protein screening among healthy subjects
    XU Shuang, LU Jin, ZHAO Lei, PEI Lin, JIA Mei, RONG Rong
    Laboratory Medicine    2020, 35 (7): 668-672.   DOI: 10.3969/j.issn.1673-8640.2020.07.009
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    Objective To establish and verify the rule of M protein recognition by serum protein electrophoresis,and to investigate the role of this rule in screening M protein among healthy subjects. Methods According to related literatures,the rule of M protein recognition was established according to the region of M protein in serum protein electrophoresis. Serum protein electrophoresis was carried out in 312 random clinical serum samples. M protein was screened according to the established rule of M protein recognition,which was verified by immunofixation electrophoresis. Serum samples of 1 170 healthy subjects and 236 clinical samples excluding hematology,nephrology,rheumatology and immunology,bone tumor,hepatology and geriatrics were collected. Serum protein electrophoresis was performed on each sample. M protein was screened according to M protein recognition rule. Immunofixation electrophoresis was used to confirm and type suspicious samples. Results In the 312 random clinical serum samples,28 samples,including M peak or suspicious M peak,were screened by serum protein electrophoresis,among which 16(5.12%) samples were confirmed as M protein positive by immunofixation electrophoresis. One case was missed in serum protein electrophoresis,and the missed rate was 0.32%. The positive rate of M protein was 2.14%(25/1 170) in 1 170 healthy subjects. The positive rates of M protein were 2.64% in males and 1.82% in females. The positive rate of M protein in males was higher than that in females. Among the 25 M protein positive samples,the positive rate of IgG type M protein was the highest(60%),followed by IgM type(24%). Among the 236 clinical samples excluding hematology,nephrology,rheumatology and immunology,bone tumor,hepatology and geriatrics,10 cases had M protein,and the positive rate was 4.24%. ConclusionsThe established M protein recognition rule have a value in M protein recognition by serum protein electrophoresis,which is worth to be applied widely.

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    Clinical application of novel tumor biomarkers:prospects and challenges
    GAO Feng
    Laboratory Medicine    2023, 38 (4): 303-306.   DOI: 10.3969/j.issn.1673-8640.2023.04.001
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    Early diagnosis and individualized precise treatment are the keys to improve the survival rate and the quality of life and prolong the survival time of cancer patients. In the recent years,with the development of liquid biopsy technology,more and more novel tumor biomarkers have been found,showing potential in tumor diagnosis,prognostic judgment and treatment monitoring,and some indicators have been put into clinical practice. Future researches should focus on solving the problems that hinder the clinical transformation of novel tumor biomarkers,and promote more liquid biopsy indicators with clinical application prospects to optimize the diagnosis and treatment process of cancer patients,thereby reducing their disease burden.

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    Study on detecting assay for endoxin and β-1,3-D-glucan in serum
    WEN Ping
       2001, 16 (02): 96-97.  
    Abstract348)      PDF (78KB)(686)       Save
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    Research progress of sialic acid markers in tumor occurrence and development
    BIE Lihan, FANG Meng, LU Zhicheng, GAO Chunfang
    Laboratory Medicine    2020, 35 (12): 1304-1309.   DOI: 10.3969/j.issn.1673-8640.2020.12.025
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    In the occurrence and development of tumors,the abnormal expression of sialyltransferase can regulate the biological characteristics of tumor cells. Abnormal sialylation can enhance the adhesion and metastasis ability of tumor cells,and can enhance tumor resistance to chemotherapy drugs. The abnormal expression of sialyltransferase is also related to the tissue and organ specificity of tumor metastasis. Sialic acid-modified glycoproteins with abnormal structures are of value in the early diagnosis and prognostic evaluation of tumors,which makes it possible to find new tumor markers. This review introduces the related mechanisms of sialylation affecting tumor occurrence and development in the recent years and the role of serum sialic acid markers in tumor diagnosis and prognosis.

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    Role of plasma aldosterone to direct renin ratio in primary aldosteronism
    WU Bing, YU Fang, ZHANG Yong, ZHOU Yuntao, SHI Lu, TIAN Wei
    Laboratory Medicine    2019, 34 (2): 130-135.   DOI: 10.3969/j.issn.1673-8640.2019.02.008
    Abstract326)   HTML3)    PDF (836KB)(651)       Save

    Objective To investigate the role of plasma aldosterone to direct renin ratio(ADRR) in the diagnosis of primary aldosteronism(PA) and its optimal cut-off value. Methods A total of 222 hypertension patients were enrolled,and there were 33 cases of PA. Plasma aldosterone and renin were determined by chemiluminescence immunoassay. ADRR was calculated. Using receiver operating characteristic(ROC) curve,the role and cut-off value of ADRR for the diagnosis of PA were evaluated. Results The proportion of PA in hypertension patients was 14.86%(33/222). Plasma renin levels at both supine and upright positions in PA group were lower than those in hypertension group(P<0.05). ADRR in PA group was higher than that in hypertension group(P<0.05). ROC curve analysis showed that the areas under curves(AUC) of ADRR were 0.906(supine position)and 0.908(upright position). The optimal cut-off value of ADRR at supine position was 31.32. The sensitivity was 96.97%,and the specificity was 73.54%. However,the optimal cut-off value of ADRR at upright position was 27.57,the sensitivity was 81.82%,and the specificity was 86.77%. Conclusions Plasma ADRR is an effective index for PA screening,and the cut-off value 25 is optimal for screening ADRR at upright position.

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    Analysis on Mycoplasma pneumonia 23SrRNA gene mutation site and drug resistance phenotype
    YE Yun,LI Suliang,JIANG Ping,WANG Yao,YANG Chao
       2013, 28 (1): 11-16.   DOI: 10.3969/j.issn.1673-8640.2013.01.003
    Abstract942)   HTML    PDF (840KB)(806)       Save
    Objective To investigate the infection situation of Mycoplasma pneumonia(Mp)in patients with community-acquired respiratory tract infection and the molecular drug resistance mechanisms of macrolide,and to analyze the relationship between 23SrRNA gene mutation site of isolates resistant to Mp and drug resistance phenotype.   Methods A total of 400 throat swab specimens of community-acquired respiratory tract infection were cultured to isolate Mp,the clinical isolates were identified by nested polymerase chain reaction,and the in vitro antibiotic sensitivity test was performed for identifying macrolide-resistant isolates through the minimal inhibitory concentration(MIC).The sequences of macrolide-resistant 23SrRNA gene were detected. The sequences were compared to the corresponding sequences of M129. The relationship between mutation site and drug resistance phenotype was analyzed.  Results A total of 50 Mp were isolated from 400 throat swab specimens.Of the 50 isolates,32 isolates were susceptible to macrolide,and 18 isolates were resistant to macrolide.The 18 clinical isolates appeared mutation A2063G,A2064G and A2067G,separately. A2063G showed 14 ring macrolide resistance.A2064G showed 14 and 16 ring macrolide resistances. A2067G showed josamycin resistance.  Conclusions Mp to macrolide resistance is serious,and the mutation of 23SrRNA gene is a predominant mechanism that contributes to the macrolide resistance. Through the analysis of 23SrRNA gene mutation site and drug resistance phenotype,the clinical Mp drug resistance situation is obtained. The theoretical guidance for reasonable selection and application of antibiotics is provided.
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    Cited: Baidu(4)
    Complement deficiency and its associated diseases
    LI Shengjie, ZHANG Aiping, CAO Wenjun
    Laboratory Medicine    2015, 30 (2): 195-200.   DOI: 10.3969/j.issn.1673-8640.2015.02.022
    Abstract393)   HTML1)    PDF (895KB)(1055)       Save

    Complement system, which has the characteristics of crucial immune responses and cascade reactions, not only has a crucial role in acting as a bridge between innate and adaptive immunities, but also is a part of immune regulatory network, and has important significance in the preservation of immunological homeostasis. Early studies introduced complement component deficiency. The abnormal quality and quantity of complement suggest that complement deficiency is associated with an increasing prevalence of infections and autoimmune diseases. This paper reviews the current common complement deficiencies and their associated diseases, expecting to provide new thoughts for the laboratory diagnosis of diseases.

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    Cited: Baidu(1)
    Research progress of myeloid differentiation factor 88 polymorphism
    HU Yuyi, CHEN Pu, GUO Wei, PAN Baishen
    Laboratory Medicine    2020, 35 (4): 380-386.   DOI: 10.3969/j.issn.1673-8640.2020.04.020
    Abstract970)   HTML14)    PDF (1611KB)(484)       Save

    Myeloid differentiation factor 88(MYD88)is an important adaptor protein mediating the signal transduction of Toll-like receptors(TLR),interleukin 1 receptor(IL-1R)and interleukin 18 receptor(IL-18R),which plays a key role in innate immunity. MYD88-dependent pathways play roles in the pathogenesis of multiple pathogens and have relations with tumors,infectious diseases,autoimmune diseases and so on,which are considered to be important targets for the intervention of these diseases. The L265P mutant in MYD88,an amino acid change(L265P)in the MYD88 Toll-like receptor/interleukin 1 receptor(TIR),promotes Janus kinase-signal transducer and activator of transcription 3(JAK-STAT3) signaling pathway by enhancing transcription factors such as nuclear factor kappa B(NF-κB),and mediates the production of inflammatory factors such as interleukin(IL)-6,IL-10 and interferon-beta(IFN-β). The structure and fundamental function of MYD88 and its role in signal transduction are reviewed. Furthermore,the association between MYD88 L265P and diseases are also illustrated.

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    Clinical application of human papillomavirus E6/ E7 mRNA determination
    XUAN Qiankun, GUO Jian, WU Wenjuan, LI Guangbo
    Laboratory Medicine    2018, 33 (7): 640-643.   DOI: 10.3969/j.issn.1673-8640.2018.07.015
    Abstract199)   HTML2)    PDF (813KB)(761)       Save

    Objective To evaluate the applicability of human papillomavirus(HPV) E6/E7 mRNA determination for screening HPV infection. Methods A total of 5 308 women were enrolled. Thinprep cytologic test(TCT)was performed. HPV DNA determination was performed in 4 062 cases,and HPV E6/E7 mRNA determination was performed in 1 246 cases. According to the results of TCT,the women were classified into normal group,atypical squamous cell of undetermined significance (ASCUS)group,low-grade squamous intraepithelial lesion (LSIL)group and high-grade squamous intraepithelial lesion (HSIL)group. Results The positive rate of HPV DNA determination [17.67%(718/4 062)] was higher than that of HPV E6/E7 mRNA determination [12.12%(151/1 246)] (P<0.05). The positive rates of HPV DNA determination and HPV E6/ E7 mRNA determination had no statistical significance among HSIL,LSIL and ASCUS groups (P>0.05). The positive rate of HPV DNA determination in normal group was 15.07%,which was higher than that of HPV E6/E7 mRNA determination (8.90%)(P<0.05). The positive proportions of HPV DNA and HPV E6/E7 determinations in these groups had no statistical significance (P<0.05). LSIL and HSIL were determined as cytopathological positive,and normal group and ASCUS group were determined as cytopathological negative. The proportions of LSIL and HSIL in the positive cases of HPV E6/E7 mRNA determination [15.23%(23/151)] were higher than those in HPV DNA determination positive cases [8.64%(62/718)](P<0.05). There was no statistical significance for sensitivities of LSIL+HSIL screening between HPV DNA determination (83.78%)and HPV E6/E7 mRNA determination (85.19%)(P>0.05). The specificities were 83.55% and 89.50%,respectively (P<0.05). Conclusions HPV E6/E7 mRNA determiantion is suitable for screening HPV infection. It is more specific than HPV DNA determination for screening LSIL and HSIL. It is suitable for clinical cervical cancer screening.

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    Research status and progress of influenza viruses
    MA Zhou, GUAN Ming, XING Zhifang, CAO Guojun
    Laboratory Medicine    2020, 35 (12): 1315-1319.   DOI: 10.3969/j.issn.1673-8640.2020.012.027
    Abstract581)   HTML42)    PDF (918KB)(358)       Save

    Influenza is an acute respiratory infectious disease caused by influenza viruses,which occurs frequently in spring and autumn. Because of the gene variations and unpredictable recombination of influenza viruses,it is easy to mutate to produce a new type of influenza virus variant. In addition,avian influenza viruses(AIV) frequently infect human directly from poultry cross species,even have caused a global pandemic,laying a hidden danger for human health and public health safety. In the recent years,much progress has been made in the research of influenza viruses. This review focuses on the etiology,clinical symptoms and mode of transmission,pathogenic mechanism,detection methods and treatment plan of influenza viruses.

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    Influencing factors of the determination of urinary protein by dry chemical method
    ZHANG Jun, ZHOU Fangfang, XU Wei, WANG Lei
    Laboratory Medicine    2018, 33 (10): 916-919.   DOI: 10.3969/j.issn.1673-8640.2018.10.010
    Abstract338)   HTML8)    PDF (751KB)(650)       Save

    Objective To evaluate the commonly-used methods for quantitative determination of urinary protein,and to analyze the influencing factors of false positivity in the determination of urinary protein by dry chemical method. Methods A total of 2 500 cases of random urine specimens were collected,and urinary protein was determined by dry chemical method and sulfosalicylic acid precipitation test. For those specimens with different results from the 2 methods,quantitative determination was performed using Modular P800 automatic biochemical analyzer,focusing on the main influencing factors. Aiming at the main influencing factors of occult blood and urinary pH design simulation experiments,the reason of false negativity or false positivity in dry chemical method was evaluated. Results Totally,2 500 random urine specimens were determined by dry chemical method and sulfosalicylic acid precipitation test. The results of 2 391(95.64%) specimens were identical,including one-level difference,while the results of 109(4.36%) were not identical. There was statistical significance between dry chemical method and sulfosalicylic acid precipitation test(P<0.05). Red blood cell ≥1×105 in urine specimens would cause false positivity. Urinary pH 7.0-8.5 would cause false positivity,while urinary pH ≥8.5 would cause false negativity. Conclusions Red blood cell in urine and urinary pH would cause false positivity and false negativity in dry chemical method. Clinical laboratories should pay enough concern and attention.

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    Role of human papillomavirus DNA assay combined with liquid-based cytology for screening cervical lesion
    HUANG Yan, ZHU Xiaoyun, LI Tianying
    Laboratory Medicine    2019, 34 (4): 313-317.   DOI: 10.3969/j.issn.1673-8640.2019.04.005
    Abstract201)   HTML3)    PDF (905KB)(539)       Save

    Objective To investigate the role of human papillomavirus(HPV) DNA assay combined with thin prep liquid-based cytology test(TCT) in cervical lesion screening. Methods From July 2015 to April 2018,8 498 women undergoing routine cervical lesion screening were enrolled from Peking University International Hospital. HPV DNA assay and TCT were performed. The positive rate of high-risk HPV infection and the detection rate of TCT were calculated. The sensitivities and specificities of HPV DNA assay and TCT for the diagnosis of high-grade cervical lesions were evaluated. Results The positive rate of high-risk HPV infection was 12.2%. The sensitivity of TCT for the diagnosis of cervical lesions was 56.0%,and the specificity was 77.8%. The sensitivity of HPV DNA assay was 98.4%,and the specificity was 48.9%. The sensitivities of TCT and HPV DNA assay were 55.8% and 99.0% in patients with cervical intraepithelial neoplasia(CIN)≥2,respectively. Combined TCT with HPV DNA assay,the sensitivity was 90.1%,and the negative predictive value was 91.2%. Conclusions Using HPV DNA assay as primary screening method,TCT is performed or not according to the results of HPV DNA assay. This combined screening scheme is advantageous in the diagnosis of cervical lesions.

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    Research progress in the methods for creatinine determination and the interference of common drugs on creatinine determination
    WANG Zhengyin, YIN Yuan, WANG Weiling
    Laboratory Medicine    2018, 33 (4): 370-373.   DOI: 10.3969/j.issn.1673-8640.2018.04.021
    Abstract562)   HTML14)    PDF (808KB)(971)       Save

    There are various methods for the determination of serum creatinine,and the specificities and anti-interference performance of methods are different. The determinations of serum creatinine in different clinical laboratories have biases. The interference of common drugs on creatinine determination has been drawn more and more attention. Many commonly-used drugs can lead to false results on creatinine determination. The interference directions vary from different methods of creatinine determination. The methods for creatinine determination and the interference of common drugs on creatinine determination are reviewed.

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    Standardization of glycated hemoglobin A 1c determination and its accuracy (continued)
    FENG Renfeng
    Laboratory Medicine    2016, 31 (6): 437-441.   DOI: 10.3969/j.issn.1673-8640.2016.06.001
    Abstract629)   HTML6)    PDF (855KB)(1288)       Save

    Glycated hemoglobin A1c(HbA1c) is an important parameter for the diagnosis of diabetes mellitus and monitoring treatment efficiency. After HbA1c measurand being defined by the International Federation of Clinical Chemistry and Laboratory Medicine(IFCC),with efforts,the differences are decreasing gradually among clinical laboratories in the world. Although HbA1c manufacturers introduces their instruments' advantages and clinical significance mainly,instead of weaknesses,clinical laboratories should know instruments' characteristics and disadvantages. Instruments can be used into clinical determinations,only when the analysis performances have been verified and satisfy clinical application. Every laboratory should use 2 different methods,which can identify whether there is abnormal hemoglobin or not. Although HbA1c can be determined by immunological methods without interference from abnormal hemoglobin,the influence of abnormal hemoglobin has not been defined. In short,clinical laboratories should learn as much information as possible for patients.

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    Clinical application significance of serum total bile acid detection in pediatric liver diseases
    LIU Jintao
    Laboratory Medicine    2015, 30 (1): 85-89.   DOI: 10.3969/j.issn.1673-8640.2014.06.021
    Abstract286)   HTML8)    PDF (711KB)(754)       Save

    Serum total bile acid is a highly sensitive and specific indicator for the diagnosis and treatment of hepatobiliary disorders. It has been valued highly in clinic, especially in pediatric liver diseases. Serum total bile acid has important significances in the diagnosis, treatment efficacy, disease progression and prognosis. Serum total bile acid can be used as an important reference parameter in the clinical diagnosis and treatment of pediatric liver damage and liver-related diseases.

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