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2001, 16 (01): 48-48.   Abstract （289）      PDF （32KB）（9385）       Knowledge map    Save Related Articles | Metrics

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2000, 15 (04): 255-255.   Abstract （281）      PDF （32KB）（5838）       Knowledge map    Save Related Articles | Metrics

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2003, 18 (02): 119-121.   Abstract （375）      PDF （99KB）（3301）       Knowledge map    Save Related Articles | Metrics

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A study on the resistance mechanism of Morganella morganii to carbapenems    2012, 27 (4): 266-270.   Abstract （1102）   HTML    PDF （788KB）（2428）       Knowledge map    Save Objective  To investigate resistance mechanisms to carbapenems and transmission modes of 3 Morganella morganii isolates (M1， M2 and M3) isolated from patients in surgical intensive care unit (SICU).  Methods  The susceptibility of antimicrobial agents was detected by agar dilution method. The molecular epidemiological characteristics of the isolates were analyzed by enterobacterial repetitive intergenic consensus (ERIC)-polymerase chain reaction (PCR). The encoding genes of beta-lactamases were analyzed by specific PCR amplification. The transitivity and homology of plasmids were detected by plasmid conjugation and restriction endonuclease analysis. Genetic environments around bla KPC were analyzed by sequencing. The changes of outer membrane permeability were analyzed by the electrophoresis of outer membrane protein.  Results The bla KPC-2 was detected by PCR in all 3 isolates and their transconjugants. M1 and M2 were the same clonal type. Carbapenem-resistance was successfully transfered by conjugation experiments. The bla KPC-2 was located on dissimilar plasmids with quite different restriction profiles. The genetic environments around bla KPC-2 were the same. The 3 original Morganella morganii isolates showed a loss of 38 000 outer membrane proteins, and additional 36 000 outer membrane proteins appeared compared with the Morganella morganii isolates susceptible to carbapenems. Conclusions  The bla KPC-2is detected in the 3 Morganella morganii isolates belonging to 2 clonal types . This gene encoded by dissimilar plasmids is likely located on the same mobile genetic elements by which bla KPC-2 is possibly transferred between different plasmids. The KPC-2-producing and lack of outer membrane proteins together cause these 3 Morganella morganii isolates resistant to carbapenems possibly. Reference | Related Articles | Metrics Cited: Baidu(2)

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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 Abstract （408）   HTML （16）    PDF （1050KB）（1996）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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2012, 27 (9): 776-779.   Abstract （1022）   HTML    PDF （667KB）（1897）       Knowledge map    Save Reference | Related Articles | Metrics

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The significance of comprehensive analysis in the diagnosis of leukemia HUANG Jingqin, XU Shanshan, LI Zhi, ZHENG Te, WENG Wenhao, WANG Jiayi    2014, 29 (11): 1158-1163.   DOI: 10.3969/j.issn.1673-8640.2014.11.019 Abstract （447）   HTML    PDF （22385KB）（1892）       Knowledge map    Save Objective To testify the significance of comprehensive analysis in the diagnosis of leukemia. Methods A total of 6 cases of leukemia， including acute promyelocytic leukemia M3a， large granular lymphocyte leukemia， hairy cell leukemia（HCL）， acute myeloblastic leukemia with significant maturation M2a， chronic lymphocyte leukemia（CLL） and acute myeloblastic leukemia without cytologic maturation M0 were diagnosed by routine blood testing， bone marrow morphology， cellular chemical dyeing， flow cytometry， cellular genetics， molecular biology analysis and bone marrow pathological diagnosis. Results Acute promyelocytic leukemia was confirmed through bone marrow morphology and cellular chemical dyeing. Large granular lymphocyte leukemia was confirmed through bone marrow morphology，cellular chemical dyeing and flow cytometry. HCL was confirmed through bone marrow morphology， cellular chemical dyeing， flow cytometry and bone marrow pathological diagnosis. However， the diagnosis of acute myeloblastic leukemia with significant maturation manifested that it was still hard to make the decision through bone marrow morphology， cellular chemical dyeing and flow cytometry. The confirmation was made in aid of chromosome examination and molecular biology analysis. CLL was confirmed through bone marrow morphology and flow cytometry. Acute myeloblastic leukemia without cytologic maturation was confirmed through bone marrow morphology， cellular chemical dyeing， flow cytometry and chromosome examination. Conclusions The comprehensive analysis of multiple laboratory items makes critical clinical importance in the confirmation of untypical leukemia as the results of environmental changes，aging of population and so on. Reference | Related Articles | Metrics Cited: Baidu(1)

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Value and risk of next generation sequencing in the diagnosis and treatment of cancer FAN Qishi, WU Beiying Laboratory Medicine    2017, 32 (4): 245-249.   DOI: 10.3969/j.issn.1673-8640.2017.04.001 Abstract （321）   HTML （16）    PDF （839KB）（1872）       Knowledge map    Save Sequencing technology has been developed from the 1st generation to the 4th one,and the length of reads is from long to short and from short to long again. Its progress has promoted the development of life science and clinical medical research. Next generation sequencing （NGS） technology has high flux,high accuracy and huge quantity of information. Different sequencing platforms have their own advantages in flux,length of reads,accuracy,speed and cost. They play important roles in de novo genome sequencing,resequencing,transcriptome and apparent genetics. In recent years,the datum output of NGS shows the trend of exponential growth,and has been gradually applied to clinical services,such as personalized medicine and genetic diagnosis. NGS in clinical oncology research and determination also shows a huge market value,but at the same time it hides certain degree of risk,which should be paid great attention and vigilance. Reference | Related Articles | Metrics

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Roles of SARS-CoV-2 N protein and S protein antibody determinations in the diagnosis of COVID-19 TIAN Yaling, LU Junyan Laboratory Medicine    2020, 35 (11): 1136-1139.   DOI: 10.3969/j.issn.1673-8640.2020.11.012 Abstract （4144）   HTML （95）    PDF （820KB）（1858）       Knowledge map    Save Objective To compare the roles of serum severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） nucleocapsid（N） protein antibody and spike（S） protein antibody determinations in the diagnosis of corona virus disease 2019（COVID-19）. Methods Enzyme-linked immunosorbent assay（ELISA） was used to determine SARS-CoV-2 N protein immunoglobulin（Ig） M and IgG antibodies and SARS-CoV-2 receptor binding domain（RBD） IgM and IgG antibodies in sera of 39 COVID-19 patients（COVID-19 group）,40 suspected COVID-19 patients（disease control group） and 225 healthy subjects（healthy control group）. Receiver operating characteristic（ROC） curve was used to evaluate the roles of various indicators in diagnosing COVID-19. Results The S/CO values of SARS-CoV-2 N protein IgM antibody and IgG antibody and SARS-CoV-2 RBD IgM antibody and IgG antibody in COVID-19 group were higher than those in disease control group（P<0.05） and healthy control group（P<0.05）. ROC curve analysis results showed that the areas under curves（AUC） of SARS-CoV-2 N protein IgM antibody,IgG antibody,IgM+IgG antibodies and SARS-CoV-2 RBD IgM antibody,IgG antibody,IgM+IgG antibodies for the diagnosis of COVID-19 were 0.949,0.991,0.992,0.994,0.999 and 0.999,respectively. Conclusions SARS-CoV-2 RBD antibodies have better diagnostic performance for the diagnosis of COVID-19 than that of SARS-CoV-2 N protein antibodies. Table and Figures | Reference | Related Articles | Metrics

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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 Abstract （550）   HTML （17）    PDF （839KB）（1801）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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Progress of vitamin D assay standardization ZHOU Yan, PAN Baishen Laboratory Medicine    2016, 31 (1): 71-75.   DOI: 10.3969/j.issn.1673-8640.2016.01.016 Abstract （415）   HTML （15）    PDF （994KB）（1774）       Knowledge map    Save The assay of serum 25-hydroxyvitamin D [25（OH）D] concentration is the best approach to assess human vitamin D status. However,it has also been recognized that there is substantial between-assay variability which clearly confounds the diagnosis and treatment of hypovitaminosis D. Therefore,to develop and implement evidence-based clinical guidelines,it is essential that 25（OH）D determination should be standardized in both clinical and research laboratories. In 2010,the Vitamin D Standardization Program was organized by the Office of Dietary Supplements of the National Institutes of Health （NIH-ODS）. In this review,we outline a way toward achieving the Vitamin D Standardization Program. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    1990, 5 (1): 62-64.   Abstract （165）      PDF （125KB）（1638）       Knowledge map    Save Related Articles | Metrics

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Influence of sample hemolysis on electrochemiluminescence immunoassay results CHEN Haibin;LIANG Yebin;HUANG Huichang;ZHENG Muyang;MENG Xiujian    2012, 27 (8): 651-653.   Abstract （1142）   HTML    PDF （640KB）（1612）       Knowledge map    Save Objective To study the influence of different degrees of sample hemolysis on electrochemiluminescence immunoassay（ECLIA） results.  Methods The blood samples were manually intervened into different degrees of hemolysis, and were used for detecting and analyzing the concentrations of 28 indices such as thyroid function, tumor markers, endocrine hormones and so on in various groups of samples. Results Sample hemolysis can reduce the concentration of insulin（INS），and the concentration of folic acid （FA） and neuron-specific enolase （NSE） were increased. Severe hemolysis can make the results to have a higher trend on determination of ferritin，however, it was not statistically significant, and the determination results of other indices was not affected by hemolysis.  Conclusions The results of most hemolytic samples except certain indices are not affected. The determinations of INS, FA and NSE should absolutely avoid hemolytic samples to ensure the accuracy of results. Reference | Related Articles | Metrics Cited: Baidu(2)

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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 Abstract （643）   HTML （16）    PDF （1177KB）（1450）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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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 Abstract （671）   HTML （6）    PDF （1131KB）（1444）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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The primary report on neonatal screening for congenital adrenal hyperplasia TIAN Guoli;ZHU Weiming;WANG Yanmin;XU Hongping;YAO Jing    2010, 25 (02): 86-88.   Abstract （345）   HTML    PDF （203KB）（1428）       Knowledge map    Save Related Articles | Metrics Cited: Baidu(8)

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2013, 28 (3): 252-256.   DOI: 10.3969/j.issn.1673-8640.2013.03.023 Abstract （737）   HTML    PDF （655KB）（1402）       Knowledge map    Save Reference | Related Articles | Metrics

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Application and prospect of high-throughput sequencing in clinical molecular diagnosis JIANG Xiaofeng Laboratory Medicine    2017, 32 (4): 250-254.   DOI: 10.3969/j.issn.1673-8640.2017.04.002 Abstract （609）   HTML （17）    PDF （840KB）（1401）       Knowledge map    Save ：High-throughput sequencing,next generation sequencing（NGS）,is a new type of genetic screening technology. Its innovation accelerates the understanding of genetic markers and molecular mechanism,and also promotes clinical gene diagnosis from single gene to multi-genes,especially for complex genetic diseases. As the new sequencing technology used in clinic,doctors will change the management of genetic diseases,and patients will be placed into different groups eventually based on genetic diagnosis. In addition,with the improvement of bioinformatics and package,the application of NGS in clinic will be more routine. This review discusses the major platform and performance of NGS and its application in clinic and the process of NGS analysis of sequence variations. Table and Figures | Reference | Related Articles | Metrics

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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 Abstract （456）   HTML （23）    PDF （837KB）（1397）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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Clinical significance of serum pepsinogen determination in the diagnosis of various gastric diseases FEI Fengying;WANG Jinjin;ZHU Xinhua;GONG Qian;LIN Jianmin    2012, 27 (1): 57-59.   Abstract （1857）   HTML    PDF （595KB）（1383）       Knowledge map    Save Objective To study the relationship between serum pepsinogen (PG) Ⅰ/PGⅡ ratio with various gastric diseases, and provide the reference for screening in the early diagnosis of gastric cancer.   Methods Chemiluminesent microparticle immunoassay was used to determine the levels of PGⅠ and PGⅡ and the ratio of PGⅠ/PGⅡ in 145 patients with various gastric diseases. The results were analyzed statistically.  Results Compared with patients with chronic nonatrophic gastritis,the serum PGⅠ/PGⅡ ratios in patients with gastric ulcer and atrophic gastritis were lower ( P<0.05), and that in patients with gastric cancer was significantly lower ( P<0.001). There was no statistical significance of PGⅠ/PGⅡ ratio among atrophic gastritis, gastric cancer and gastric ulcer ( P> 0.05).  Conclusions The changes of serum PGⅠ/PGⅡ ratio are related with gastric pathological changes, and the PGⅠ/PGⅡ ratio has a clinical significance for the early screening of gastric cancer and gastric precancerosis. Reference | Related Articles | Metrics Cited: Baidu(14)

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null    2012, 27 (10): 871-876.   Abstract （488）   HTML    PDF （671KB）（1368）       Knowledge map    Save Reference | Related Articles | Metrics

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Clinical significance of peripheral blood CD3 +, CD4 + and CD8 + T lymphocyte subset determination in patients with tumor YAN Jian, YUAN Yongming, ZHANG Shu, PENG Xiancong    2013, 28 (10): 901-903.   DOI: 10.3969/j.issn.1673-8640.2013.10.009 Abstract （324）   HTML    PDF （615KB）（1365）       Knowledge map    Save Objective To investigate the changes of peripheral blood T lymphocyte subsets (CD3+, CD4+, CD8+ and CD4+/CD8+) in patients with tumor and the clinical significance. Methods A total of 100 patients with tumor (including 40 patients with lung cancer, 40 patients with gastrointestinal cancer and 20 patients with other tumors) and 90 healthy controls were enrolled. Peripheral blood T lymphocyte subsets′ absolute counts and immunoglobulin (IgG, IgA and IgM) were determined. The differences between the 2 groups were analyzed statistically. Results T lymphocyte subsets′ absolute counts were CD3+ [(1 041±358)/μL], CD4+[(689±263)/μL], CD4+/CD8+ ratio (1.15±0.40) in tumor group, which were significantly lower than those in control group (P<0.05), and CD8+[(602±223)/μL] increased slightly compared with that in control group (P>0.05). IgG, IgA and IgM were higher in tumor group than in control group. Conclusions Tumor patients have immune dysfunction, and the changes of T lymphocyte subsets′ counts have significance on the monitoring and prognosis in patients with tumor. Reference | Related Articles | Metrics

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Clinical application significance of serum amyloid A and C-reactive protein combined determination FEI Fengying, YI Ping, LIN Jianmin.    2014, 29 (10): 1031-1033.   DOI: 10.3969/j.issn.1673-8640.2014.10.011 Abstract （351）   HTML    PDF （729KB）（1358）       Knowledge map    Save Objective To evaluate the clinical application significance of the combined determination of serum amyloid A (SAA) and C-reactive protein (CRP). Methods The levels of serum SAA and CRP in 82 inflammatory disease patients (15 cases of pneumonia, 23 cases of acute bronchitis, 17 cases of acute appendicitis, 16 cases of acute cholecystitis and 11 cases of pancreatitis) and 92 healthy controls were determined by colloidal gold method and immunoturbidimetry, respectively. Their concentration median and positive determination rate were analyzed comparatively between the 2 groups. Resutls The serum SAA and CRP medians in inflammatory disease group were 149.50 mg/L and 34.20 mg/L, respectively, which were obviously higher than those in healthy control group (4.60 mg/L and 3.82 mg/L). There was a statistical significance between the 2 groups ( P<0.05). The positive determination rates of serum SAA and CRP in inflammatory disease group were 87.80% and 79.26%, respectively. Conclusions SAA has the same trend with CRP when inflammatory disease happens, and shows a more sensitive performance than CRP. SAA and CRP can be used as meaningful markers for monitoring inflammation. The combined determination of SAA and CRP could improve the determination rate of inflammatory disease, which provides a more sensitive reference for diagnosis. Reference | Related Articles | Metrics Cited: Baidu(12)

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The application of mass spectrometry in clinical biochemistry ZHANG Ziqiang, LI Yan Laboratory Medicine    2015, 30 (5): 407-409.   DOI: 10.3969/j.issn.1673-8640.2015.05.001 Abstract （371）   HTML （14）    PDF （800KB）（1348）       Knowledge map    Save Recently, mass spectrometry has been playing more and more important roles in clinical laboratory medicine. The development of gas or high-performance liquid chromatography and tandem mass spectrometry technologies has expanded the application of mass spectrometry, and it becomes an efficient tool for clinical biochemical determination. This article introduces the technical principle of mass spectrometry and presents the utilization in clinical biochemistry, such as newborn screening for genetic diseases and so on. Mass spectrometry has shown great potential with the advantages of high specificity, high sensitivity and low limit of determination in clinical biochemistry. Reference | Related Articles | Metrics

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Standardization of glycated hemoglobin A 1c determination and its accuracy FENG Renfeng Laboratory Medicine    2016, 31 (5): 345-349.   DOI: 10.3969/j.issn.1673-8640.2016.05.001 Abstract （404）   HTML （6）    PDF （774KB）（1338）       Knowledge map    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 introduce 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. Reference | Related Articles | Metrics

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Contrast observation of ITS-PCR identification and phenotypic identification for nontuberculous Mycobacterium GUI Jing，WANG Feng，LI Jinli    2012, 27 (11): 908-912.   Abstract （502）   HTML    PDF （645KB）（1326）       Knowledge map    Save Objective To evaluate the clinical significance of 16S-23S rRNA intergenic transcribed spacer-polymerase chain reaction（ITS-PCR）identification for nontuberculous Mycobacterium（NTM）. Methods A total of 80 NTM identified by ITS-PCR were randomly selected. Phenotypic characteristics of NTM were identified by growth characterization test and drug sensitivity test.The results for the 3 identification methods were analyzed contrastively. Results The proportion of Mycobacterium avium complex（MAC） and Mycobacterium abscessus was 85%.Mycobacterium abscessus，Mycobacterium kansasii， Mycobacterium fortuitum and Mycobacterium szulgai were identified accurately by ITS-PCR.The results were consistent among the results of growth characterization test，drug sensitivity test and ITS-PCR except that of MAC. Conclusions The combination of ITS-PCR with the phenotypic identification for NTM is suitable to the clinical application. Reference | Related Articles | Metrics

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2012, 27 (4): 252-256.   Abstract （1029）   HTML    PDF （668KB）（1305）       Knowledge map    Save Reference | Related Articles | Metrics

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Application of CLSI EP12-A2 document in the performance evaluation of qualitative test of HBeAb HUANG Wujiao1，HUANG Xianzhang1，ZHUANG Junhua1，LI Qiang1，HUANG Hui1，ZHANG Qiang2    2012, 27 (11): 900-903.   Abstract （3296）   HTML    PDF （694KB）（1303）       Knowledge map    Save Objective To evaluate A and B ELISA kits for detecting qualitatively anti-hepatitis B e antigen antibody（HBeAb），and to provide useful reference for choosing suitable HBeAb kits. Methods According to Clinical and Laboratory Standards Institute（CLSI） EP12-A2 document，the bias and imprecision of A and B HBeAb kits were analyzed，and their C50，C5-C95 intervals and imprecision curves were compared.The HBeAb of 910 specimens were simultaneously determined by both A and B kits.The 95% confidence interval（ CI）for concordance was calculated.The Kappa value was calculated to evaluate their concordance. Results C50 for A kit was less than that for B kit.C5-C95 interval of A kit was narrower than that of B kit.The imprecision curve of A kit was steeper than that of B kit.The 95% CI for concordance was calculated as 93.2%-96.1%，and the Kappa value was 0.87. Conclusions EP12-A2 is a useful protocol for the evaluation of qualitative test performance. Reference | Related Articles | Metrics Cited: Baidu(6)

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The laboratory characteristics of multiple myeloma WANG Wei. Laboratory Medicine    2015, 30 (8): 847-851.   DOI: 10.3969/j.issn.1673-8640.2015.08.018 Abstract （355）   HTML （6）    PDF （664KB）（1300）       Knowledge map    Save Multiple myeloma(MM) is a plasma cell monoclonal malignant proliferative disease. The myeloma cells infiltrate bone and soft tissue, produce M protein and cause bone destruction, anemia, renal insufficiency, repeated infection and so on. Through the statistics, the incidence of MM in all malignant tumors accounts for about 1%, and its incidence in blood system of malignant tumor is more than 10%.The pathogenesis of MM is not fully clear, the complex and various clinical symptoms lead to misdiagnosis or missed diagnosis easily. The difference of laboratory examination may lead to difficult disease diagnosis and differential diagnosis. Therefore, investigating the clinical and laboratory diagnosis characteristics of MM has clinical significance for the early detection, early diagnosis and early treatment of MM. In this paper, the clinical and laboratory diagnosis characteristics of MM are reviewed in detail. Reference | Related Articles | Metrics

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2002, 17 (03): 133-136.   Abstract （382）      PDF （143KB）（1283）       Knowledge map    Save Related Articles | Metrics

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Study on the diagnostic significance of T cells spot test in Mycobacterium tuberculosis infected patients with pleural effusion XU Xuecheng, MAO Liming Laboratory Medicine    2015, 30 (3): 254-257.   DOI: 10.3969/j.issn.1673-8640.2015.03.013 Abstract （228）   HTML （0）    PDF （716KB）（1270）       Knowledge map    Save To investigate the application significance of Mycobacterium tuberculosis (MTB) T cells spot test (T-SPOT) in the rapid diagnosis for suspected MTB infected patients with pleural effusion. The 124 patients with pleural effusion which were suspected as having suspected MTB infection were enrolled. T-SPOT was used to detect the immune response of peripheral blood lymphocyte against MTB special secreted protein EAST-6 and CFP-10. The MTB DNA method was used to detect MTB in pleural effusion, meanwhile serum anti-MTB antibody was detected by immuno-gold filtration assay, and the results were analyzed statistically. The 44 of 124 cases were diagnosed as tuberculosis by sputum, pleural effusion and ascites smear test, sputum, pleural effusion and ascites MTB culture, tuberculin test, MTB DNA method and anti-MTB antibody test, and the positive rate was 35.5%. The positive rate of T-SPOT in the 124 patients with pleural effusion was 33.06%(41/124). The positive rate of MTB DNA method was 14.52%(18/124), and that of anti-MTB antibody test was 9.68%(12/124). Among the 44 confirmed tuberculosis patients, T-SPOT had the consistency rate of 86.36%(38/44), while the consistency rates of MTB DNA method and anti-MTB antibody test were 27.27%(12/44) and 18.18%(8/44), respectively. The positive rate and consistency rate of T-SPOT were significantly higher than those of the others (P<0.05). The positive and negative predictive values of T-SPOT in suspected MTB infected patients with pleural effusion were 92.68% and 92.77%, respectively. T-SPOT is fast, sensitive and specific to diagnose the suspected MTB infected patients with pleural effusion. T-SPOT is better than MTB DNA method and anti-MTB antibody test. T-SPOT can become a new diagnostic method to be applied in the diagnosis of MTB infection. Table and Figures | Reference | Related Articles | Metrics

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2012, 27 (3): 155-158.   Abstract （1149）   HTML    PDF （736KB）（1265）       Knowledge map    Save Reference | Related Articles | Metrics

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Establishment of reference intervals for renal function parameters in middle and late pregnancy XU Liyuan, YING Chunmei Laboratory Medicine    2017, 32 (8): 682-685.   DOI: 10.3969/j.issn.1673-8640.2017.08.005 Abstract （340）   HTML （1）    PDF （763KB）（1263）       Knowledge map    Save Objective To investigate the renal function parameters [urea,creatinine（Cr）,uric acid（UA）,urea/Cr ratio and UA/Cr ratio] during healthy pregnancy,and to establish the reference intervals for renal function parameters in middle and late pregnancy. Methods The levels of urea,Cr and UA were determined in 4 000 healthy pregnant women（pregnancy group）and 4 000 healthy women of childbearing age（healthy control group）. For pregnancy group,urea,Cr and UA levels were determined at 14-20,24-28 and 37-40 gestational weeks．The reference intervals in middle and late pregnancy were defined as the 2.5th percentile （P2.5）- the 97.5th percentile （P97.5）. Results The levels of urea and Cr in pregnancy group were lower than those in healthy control group（P<0.05）,and the levels of UA at 14-20 and 24-28 gestational weeks were lower than those in healthy control group（P<0.05）. The levels of UA in 37-40 gestational weeks were higher than those in healthy control group（P<0.05）.Compared with healthy control group,serum urea/Cr ratio in pregnancy group decreased to various degrees at 14-20 and 24-28 gestational weeks（P<0.05）,and then increased at 37-40 gestational weeks（P>0.05）．Serum UA/Cr ratio in pregnancy group decreased at 14-20 gestational weeks,and then increased with the progression of gestational weeks（P<0.05）．The reference intervals of renal function parameters at 14-20,24-28 and 37-40 gestational weeks were 1.8-3.9,1.7-3.8,1.7-5.0 mmol/L for urea,33-53,32-54,31-60 μmol/L for Cr,141-269,127-352,161-457 μmol/L for UA,43.66-92.71,39.97-97.37,36.44-124.04 for urea/Cr ratio,and 3.15-6.25,3.17-8.55,3.18-11.20 for UA/Cr ratio. Conclusions There are different degrees of physiological changes of renal function in pregnant women with the progression of pregnancy,so it should establish the reference intervals of renal function parameters in middle and late pregnancy. Table and Figures | Reference | Related Articles | Metrics

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2012, 27 (1): 71-74.   Abstract （1749）   HTML    PDF （678KB）（1257）       Knowledge map    Save Reference | Related Articles | Metrics

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Comparative study on alpha-fetoprotein and carbohydrate antigen 125 determination by three chemiluminescence immunoassay systems XU Ke;CHI Shengying;ZHANG Dongchu;GUO Junfeng    2009, 24 (02): 120-123.   Abstract （390）   HTML    PDF （240KB）（1254）       Knowledge map    Save Related Articles | Metrics Cited: Baidu(3)

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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 Abstract （626）   HTML （6）    PDF （855KB）（1249）       Knowledge map    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. Reference | Related Articles | Metrics

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Establishment and performance evaluation of liquid-chromatography tandem-mass spectrometry for determining serum cortisone ZHU Yuqing, ZHU Lingfeng, ZHAO Xiaojun, XU Chong, SHAO Weijie, CAO Danru, LU Yinhua Laboratory Medicine    2017, 32 (6): 524-530.   DOI: 10.3969/j.issn.1673-8640.2017.06.018 Abstract （372）   HTML （6）    PDF （962KB）（1244）       Knowledge map    Save Objective To establish isotope-dilution liquid-chromatography tandem-mass spectrometry（ID-LC-MS/MS） for determining serum cortisone,and to evaluate its performance. Methods ABSCIEX TRIPLE QUAD 5500 liquid-chromatography tandem-mass spectrometry was used to determine serum cortisone quantitatively. According to the Clinical and Laboratory Standards Institute（CLSI） document,the performance,including linearity,precision,extraction and recycling rates and accuracy,was verified. Results Cortisone-d4 was added to analytes, and they were equilibrated at room temperature for 1 h. ID-LC-MS/MS for determining serum cortisone had linear regression equation Y=0.018 7X+0.043 4 （r=0.999 8）. The linear range was 25-500 ng/mL. The determination limit was 0.05 ng/mL for serum cortisone. The within-run and between-run coefficients of variation（CV） were <4% and <6%. The extraction and recycling rates were 84.5%-90.4%. The biases of the International Federation of Clinical Chemistry and Laboratory Medicine External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine（RELA）-A and RELA-B were 3.19% and 2.84%. Conclusions The established ID-LC-MS/MS has good precision,accuracy and repeatability,which is suitable for determining serum cortisone. Table and Figures | Reference | Related Articles | Metrics

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Establishment and verification of blood cell analysis review criteria in women and children specialized hospital WANG Yuefang，JIANG Yongmei，ZHANG Ge，DU Zeli，CHEN Lan，YE Lei，CHEN Qi    2013, 28 (4): 296-300.   DOI: 10.3969/j.issn.1673-8640.2013.04.011 Abstract （575）   HTML    PDF （658KB）（1237）       Knowledge map    Save Objective To establish proper review criteria for blood cell analysis in women and children specialized hospital.  Methods Based on the review criteria from the cooperation group of formulation for blood cell analysis by Sysmex XE-2100 hematology analyzer，as the women and children specialized hospital with the own unique disease characteristics and children white blood cell (WBC) physiological characteristics，the review criteria was optimized. The total 1 120 samples were detected by Sysmex XE-2100 hematology analyzer， blood smear determination was as the golden standard，and the new review criteria was evaluated and optimized.  Results The review rate of initial review criteria was 65.98%. According to the women and children specialized hospital characteristics，by adjusting the WBC，platelet (PLT) count and WBC differential percentage for the first time after optimization，the false positive rate was 40.71%. By combining immature granulocyte (IG) and WBC≥10×109/L，combining blast cell (Blast) and WBC≤4×10 9/L or ≥10×10 9/L，and combining atypical/variant lymphocyte (Lymph) (Atypical/Variant) and Lymph%＞50% for the second time after optimization，the false positive and false negative rates were 17.53% and 4.49%. The main items were Atypical/Variant Lymph （<5%）and PLT＞70×10 9/L，which were verified. The proper review criteria in women and children specialized hospital was established.  Conclusions The review criteria for women and children specialized hospital should be established in clinical application，improve the review criteria timely，and improve the analysis quality and efficiency of blood cell analysis. Reference | Related Articles | Metrics

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The comparative study on the testing results between 2 analyzers for determining C reactive protein SONG Na;ZHANG Jiayun;YU Xiaohong;GUO Xia    2012, 27 (4): 257-260.   Abstract （1461）   HTML    PDF （615KB）（1217）       Knowledge map    Save Objective  To evaluate the analysis performance of testing results between speed scattering turbidimetric method and transmitted immunoturbidimetric method for determining C reactive protein(CRP). Methods  The speed scattering turbidimetric method (Siemens Healthcare Diagnostica BN-Ⅱ specific protein analyzer) and transmitted immunoturbidimetric method (Finland Orion Diagnostica QuikRead CRP analyzer) were used to determine CRP, and the precision, linearity, interference, correlation and bias were evaluated methodologically. Results  The total coefficient of variation (CV) of the BN-Ⅱ specific protein analyzer was <6%, when the concentration of CRP was 2.0-80.0 mg/L. The total CV of the QuikRead CRP analyzer was <7%, when the concentration of CRP was 8.0-80.0 mg/L. The linearity range was 8.0-70.0 mg/L. Haemoglobin (Hb) <10 g/L and bilirubin (Bil) <300 mg/L had no significant interference (<10%) for the assay. The interference (<10%) was not significant to the BN-Ⅱ specific protein analyzer when triglyceride (TG) <20 mmoL/L. When TG >15 mmol/L, the interference of low-value CRP samples was >10%, and there was no interference in high-value CRP samples for QuikRead CRP analyzer. The correlation analysis of 50 blood samples showed that both analyzers were correlated well (r=0.98，P<0.01). There was no significant bias from linearity regression through Cusum between the 2 analyzers（P>0.05）. The values of BN-Ⅱ specific protein analyzer were slightly lower than those of QuikRead CRP analyzer. Bland-Altman curve showed that the average bias of the 2 analyzers was -2.1. 〖WTHZ〗 Conclusions  The precision, interference and linearity tests are suitable for routine CRP determination on the 2 analyzers. Although the results have bias, they meet the clinical requirements. Reference | Related Articles | Metrics Cited: Baidu(6)

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2013, 28 (9): 739-744.   DOI: 10.3969/j.issn.1673-8640.2013.09.002 Abstract （418）   HTML    PDF （708KB）（1214）       Knowledge map    Save Reference | Related Articles | Metrics