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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 Abstract （492）   HTML （83）    PDF （722KB）（499）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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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 Abstract （355）   HTML （114）    PDF （996KB）（446）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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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 Abstract （288）   HTML （29）    PDF （916KB）（373）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2022, 37 (9): 847-849.   DOI: 10.3969/j.issn.1673-8640.2022.09.010 Abstract （766）   HTML （30）    PDF （805KB）（272）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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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 Abstract （262）   HTML （57）    PDF （850KB）（243）       Knowledge map    Save 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. Reference | Related Articles | Metrics

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Problems and solutions on autoverification of coagulation test FAN Qingkun, LI Ling, DU Jia, YANG Jun, ZHANG Zhenlu Laboratory Medicine    2022, 37 (6): 596-600.   DOI: 10.3969/j.issn.1673-8640.2022.06.018 Abstract （368）   HTML （51）    PDF （895KB）（222）       Knowledge map    Save The autoverification of reports is the future development trend of clinical laboratories,which can significantly shorten the laboratory sample turn-around time and improve work efficiency. The autoverification of coagulation tests is less used in clinical laboratories,due to many problems such as the identification of unqualified samples and the complex rules of autoverification. The basis for the implementation of autoverification is strict and standardized quality control of pre-analysis and interconnection of information systems. Based on the premise of accurate results,clinical laboratories can set appropriate autoverification rules according to its own conditions,continuously optimize the autoverification rules for coagulation test,and gradually increase the autoverification pass rate of clinical laboratory test. Table and Figures | Reference | Related Articles | Metrics

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Exploration and practice of regional medical laboratory center model BAI Jianhua, ZENG Xianfei, HAO Xiaoke Laboratory Medicine    2022, 37 (12): 1109-1112.   DOI: 10.3969/j.issn.1673-8640.2022.12.001 Abstract （230）   HTML （445）    PDF （933KB）（216）       Knowledge map    Save Regional medical laboratory center，providing clinical laboratory services for medical institutions at all levels in a certain area by using advanced information system and logistics system，is not only a medical laboratory center，but also a clinical laboratory network formed by multiple laboratories. It can realize the sharing of determination resources，the homogenization of determination quality，the standardization of determination services and the mutual recognition of determination results within the region. At present，Chinese regional medical laboratory centers are in the initial stage of development，and they have been actively explored various models. This review discusses the model，construction development and management and operation status of regional medical laboratory centers from different aspects. Table and Figures | Reference | Related Articles | Metrics

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Research on performance specification of thrombelastogram MIAO Yingbo, ZHAO Qiang, SONG Ying, ZHU Peichao, ZHOU Wei, XU Chong Laboratory Medicine    2022, 37 (7): 680-683.   DOI: 10.3969/j.issn.1673-8640.2022.07.016 Abstract （353）   HTML （36）    PDF （1033KB）（187）       Knowledge map    Save Objective To investigate how to obtain the appropriate evaluation standard based on the change or constant concentration value as performance standard through thrombelastogram proficiency verification data,and to improve continuously and effectively the determination level of thrombelastogram. Methods The data reported by laboratories participating in the 2018-2020 proficiency verification of Shanghai Center for Clinical Laboratory for thrombelastogram were collected. The relation of U-scores between the reported data of coagulation reaction time,coagulation formation time,angle and maximum amplitude of thrombus and the target value was evaluated,and the evaluation standard of each index based on the change or constant concentration value was obtained. Results The constant concentration values of coagulation reaction time,angle and maximum amplitude of thrombus could be used as evaluation criteria. Coagulation formation time can adopt the evaluation standard based on the change of concentration value. Conclusions The performance specifications of each index of thrombelastogram obtained in this study can be applied to the evaluation standards of proficiency verification and the requirements of allowable imprecision of internal quality control,which can evaluate the determination level of thrombelastogram in Shanghai objectively. Table and Figures | Reference | Related Articles | Metrics

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Epidemiological characteristic analysis of Mycoplasma pneumoniae infection in children in Shanghai HU Shaohua, CHEN Li, ZHAO Meng, MA Zhan, ZHANG Hong Laboratory Medicine    2023, 38 (1): 14-17.   DOI: 10.3969/j.issn.1673-8640.2023.01.003 Abstract （297）   HTML （28）    PDF （846KB）（183）       Knowledge map    Save Objective To investigate the epidemiological characteristics of Mycoplasma pneumoniae infection in children in Shanghai，and to provide a reference for the prevention and control of Mycoplasma pneumoniae infection. Methods The serological determination（passive agglutination），colloidal gold method and real-time quantitative polymerase chain reaction（PCR） results for Mycoplasma pneumoniae IgM and DNA for 18 718 patients with Mycoplasma pneumoniae infection from January 2014 to December 2018 were collected retrospectively and analyzed statistically. Factors，such as age，sex and season，were analyzed. Results The positive rate of serological determination（passive agglutination） in 18 718 cases was 30.48%. The positive rate of girls （34.91%） was higher than that of boys （27.22%）（P<0.01）. The results of screening Mycoplasma pneumoniae IgM by colloidal gold method and real-time quantitative PCR confirmed that the positive rate of girls was higher than that of boys （P<0.01）. The positive rate of infants （<1-year-old） was the lowest，the positive rate was increasing with ages，and the positive rate of 7-14-year-old group was the highest（P<0.01）. In terms of months，July to September of each year was the seasonal peak of Mycoplasma pneumoniae infection. Conclusions The positive rate of Mycoplasma pneumoniae antibodies in children with respiratory tract diseases in Shanghai is relatively high，and the positive rates between girls and boys and with different ages are different. July to September is the peak months of Mycoplasma pneumoniae infection. Table and Figures | Reference | Related Articles | Metrics

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Comparison of testing efficiency of simulated emergency biochemical samples among different instruments GE Danhong , FANG Huiling, LIN Feiran, ZHU Yuqing Laboratory Medicine    2022, 37 (8): 766-771.   DOI: 10.3969/j.issn.1673-8640.2022.08.013 Abstract （181）   HTML （17）    PDF （787KB）（176）       Knowledge map    Save Objective To compare the testing efficiency of simulated emergency biochemical samples among different instruments. Methods Single analyte and full-set analytes for single sample and a batch of samples（40 samples） were tested with 3 different instruments（A,B,C）,respectively. The testing times of different instruments were recorded. Totally,20 samples were tested in different sequences（sequence 1 and sequence 2）,and the testing time were recorded. Totally,5 instrument combinations（Ⅰ,Ⅱ,Ⅲ,Ⅳ,Ⅴ） were used to test biochemical analytes and cardiac markers for 10 samples. The combinations were determined according to various processes,and the testing times were recorded. Both split sample and unsplit sample were determined on the combinations. The samples were determined in the process of biochemical analytes first or cardiac markers first. A total of 40 samples,containing 5 hemolytic,5 icteric and 5 lipemic samples,were collected,and the 40 samples were also inspected by 4 technicians by visual. The testing time and results were recorded,and the coincidence rates of visual results were calculated. Daily maintenance for the 3 instruments was performed,and the testing time was recorded. Results It took 6,16 and 12 min to test glucose for single sample for instrument A,B and C,respectively,and 8,18 and 14 min to test full-set analytes for the above instruments,respectively. It took 12,19 and 15 min to test glucose for a batch of samples for instrument A,B and C,respectively,and 103,112 and 72 min to test full-set analytes. It took the same time to test the same analytes for 10 samples in different sequences for instrument A and C,while it took 1 more min in sequence 2 than in sequence 1 on instrument B. When 10 samples were tested for biochemical analytes and cardiac markers,it took combination Ⅰ 34 min. It took combination Ⅱ,Ⅲ,Ⅳ and Ⅴ 67,60,92 and 80 min,respectively,when testing biochemical analytes firstly. It took 69,53,72 and 71 min respectively when testing cardiac markers firstly. It took 58,48,69 and 69 min when the samples were split and start testing simultaneously on both instruments. It took the same time for the 3 instruments to test all the biochemical analytes for 40 samples. The average time for visual inspection of 40 serum samples was 122 s. The mean coincidence rates of visual inspection for hemolytic,icteric and lipemic samples were 100%,48% and 76%,respectively. It took 13,21 and 35 min to complete daily maintenance for instrument A,B and C. Conclusions The testing time is influenced by the number of samples,testing process and so on. Serum index testing needs less time and labor than visual inspection. It reflects the status of samples more objectively and helps controlling the error of pre-analysis. Laboratories can improve the testing efficiency of instrument by means of rationally configuring instruments and optimizing testing process,which may help to shorten turn-around time（TAT）. Table and Figures | Reference | Related Articles | Metrics

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Research progress of miRNA in urine as a biomarker for common malignant tumors WU Yating, LI Zhuolin, LEI Yan, JIA Ruxue, ZHANG Shenghang, WANG Shuiliang Laboratory Medicine    2023, 38 (1): 94-99.   DOI: 10.3969/j.issn.1673-8640.2023.01.020 Abstract （126）   HTML （10）    PDF （842KB）（171）       Knowledge map    Save The comprehensive treatment effect of the majority of patients with advanced cancers is still desirable，so the early diagnosis of cancers is important. MicroRNAs（miRNA）are a class of non-coding small RNAs that exist widely and have various biological functions. More and more studies have shown that the dysregulated expression of specific miRNA caused by genetic or epigenetic changes plays a role in carcinogenesis，malignant progression. In view of the fact that miRNA can stably exist in blood，urine，cerebrospinal fluid，saliva and other biological fluids or secretions. Compared with blood and other fluid-based biopsies，urine-based biopsies have the advantages of easy handling and non-invasive sampling，so the research of urinary miRNA as a potential new tumor molecular marker has attracted more and more attention. This review summarizes the research progress of urinary miRNA as a non-invasive biomarker in the recent years. It makes a preliminary prospect for its possible clinical application in the future，and puts forward some urgent problems to be solved，so as to provide useful enlightenment for future related research. Table and Figures | Reference | Related Articles | Metrics

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Role of cardiac markers in children ZHANG Xin, MA Lijuan Laboratory Medicine    2023, 38 (6): 505-509.   DOI: 10.3969/j.issn.1673-8640.2023.06.001 Abstract （169）   HTML （100）    PDF （872KB）（171）       Knowledge map    Save In the recent years，an increasing number of studies have confirmed the diagnostic value and clinical application prospects of cardiac markers in different diseases，such as myocarditis，cardiomyopathy，congenital heart disease（CHD） and heart failure among children. In addition，it has made new progress in judging cardiac function，the degree of myocardial injury，the occurrence of complications and the effect of diagnosis and treatment of immune-related and other systemic diseases. Children's tissues and organs are still in growth and development stage，there are differences in the determination results of cardiac markers in children with different ages，especially in newborns，which makes the interpretation of determination reports more challenging. Therefore，future researches should focus on new analytical methods，the establishment of biological reference intervals for different ages and more evidence-based research in the diagnosis and treatment of children. Related guidelines or expert consensus should be issued to promote the clinical standard application of cardiac marker determination results in children. Reference | Related Articles | Metrics

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Role of line chart model based on peripheral blood-derived inflammation markers in early diagnosis of neonatal septicemia HE Xuelian, HE Ziyi, LIU Yueyang, YU Yanzhi, ZHANG Siying Laboratory Medicine    2022, 37 (10): 921-927.   DOI: 10.3969/j.issn.1673-8640.2022.010.003 Abstract （139）   HTML （16）    PDF （923KB）（164）       Knowledge map    Save Objective To establish and evaluate a line chart model for the early diagnosis of neonatal septicemia by using peripheral blood-derived inflammation markers. Methods Totally，137 patients with neonatal septicemia and 114 non-infected newborns were enrolled，96 cases of neonatal septicemia patients were randomly selected as septicemia group，96 cases of non-infected newborns were selected as control group，and the remaining 59 newborns（41 cases of neonatal septicemia patients and 18 cases of non-infected newborns） were included in model verification group. The clinical data of all the newborns were collected，blood routine tests were performed，and the test items included white blood cell（WBC） count，hemoglobin（Hb），platelet（PLT） count，lymphocyte percentage（LYMPH%），neutrophil percentage（NEUT%），hematocrit（HCT），C-reactive protein（CRP），procalcitonin（PCT） and interleukin-6（IL-6）. Logistic regression analysis was used to evaluate the risk factors of neonatal septicemia，and a line chart model was constructed. Receiver operating characteristic（ROC） curve，decision curve and calibration curve were used to evaluate and validate the model. Kaplan-Meier survival curve was used to evaluate the probability of neonatal septicemia in different risk groups. Results There was statistical significance in WBC count，PLT count，Hb，NEUT%，CRP，PCT and IL-6 between septicemia group and control group（P<0.05），but there was no statistical significance in LYMPH% and HCT（P>0.05）. The results of Logistic regression analysis showed that the elevated levels of CRP，PCT and IL-6 were risk factors for neonatal septicemia [odds ratios（OR） were 2.943，2.862 and 2.915，respectively，P<0.05]. The total score of risk factors in the line chart was 239.78，and the corresponding incidence of neonatal septicemia was 71.86%. The C-index value of the line chart diagnosis model for neonatal septicemia was 0.934，the area under curve was 0.831，the sensitivity was 82.1%，and the specificity was 80.4%. The ideal curve in the calibration curve was close to the actual curve，the accuracy was good，the area under decision curve was 0.792，and the clinical net benefit rate of the model was high. According to the critical value of the line chart diagnosis model score，the occurrence probability of neonatal septicemia was classified into 3 groups，low risk（≤83.65），medium risk（>83.65-≤157.89） and high risk（>157.89） groups. The probability of neonatal septicemia was 29.47%，45.57% and 83.33%，respectively. Conclusions The line chart diagnosis model based on CRP，PCT and IL-6 is of value in early diagnosis of neonatal septicemia. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2022, 37 (12): 1178-1182.   DOI: 10.3969/j.issn.1673-8640.2022.12.015 Abstract （215）   HTML （13）    PDF （966KB）（158）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Establishment of allowable total error，allowable imprecision and allowable bias for 22 endocrine analytes WANG Wei, ZHANG Zhixin, ZHANG Chuanbao, ZHOU Weiyan, WANG Zhiguo Laboratory Medicine    2023, 38 (8): 707-712.   DOI: 10.3969/j.issn.1673-8640.2023.08.001 Abstract （140）   HTML （30）    PDF （796KB）（148）       Knowledge map    Save Objective To set the allowable total error（TEa），allowable imprecision [coefficient of variation（CV）] and allowable bias（Bias） for 22 endocrine analytes，and to recommend performance specifications for related items. Methods The data，including external quality assessment（EQA） data and internal quality control（IQC） data，of the National Center for Clinical Laboratories from 2020 to 2022 were collected. According to the performance specification setting mode newly determined at the Milan conference in Italy，the performance specification was derived based on biological variation（BV）and current technology level. For the analytes with BV data，the percentage difference of EQA data and the in-control CV of month IQC data were compared with the 3-level evaluation criteria derived based on BV，and the percentage difference passing rate and CV passing rate of all-batch quality control materials were calculated. When the passing rate reached 80%，the performance specifications of this level met the requirements of the recommended performance specifications of the analyte. For the analytes without BV data or the analytes whose performance specifications at 3-level evaluation criteria derived based on BV could not be used as recommended performance specifications，the recommended TEa and allowable CV may be derived based on the current technology level. Based on the current technology level，the recommended TEa and allowable CV were derived，and then the allowable Bias was derived. Results TEa/allowable CV recommended for 22 endocrine analytes were as follows：free triiodothyronine 18.9%/6.5%，triiodothyronine 17.4%/7.1%，free thyroxine 25.0%/6.2%，thyroxine 20.0%/7.0%，thyroid-stimulating hormone 24.6%/8.9%，cortisol 26.3%/8.2%，estradiol 26.0%/7.5%，follicle-stimulating hormone 21.2%/6.2%，luteinizing hormone 25.0%/6.8%，progesterone 26.2%/9.3%，prolactin 18.7%/7.4%，testosterone 16.5%/6.3%，C-peptide 20.8%/8.3%，folate 29.5%/8.9%，insulin 25.0%/6.4%，thyroglobulin 28.2%/8.0%，parathyroid hormone 30.0%/11.8%，aldosterone 21.4%/9.2%，dehydroepiandrosterone sulfate 25.0%/7.5%，vitamin B12 25.0%/7.5%，growth hormone 25.0%/7.0% and adrenocorticotropic hormone 27.4%/9.1%. Conclusions For 22 endocrine analytes，the TEa，allowable CV and allowable Bias that meet the current technology level of Chinese clinical laboratories are recommended. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2022, 37 (9): 892-893.   DOI: 10.3969/j.issn.1673-8640.2022.09.020 Abstract （523）   HTML （33）    PDF （816KB）（144）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Preliminary research for the determination of HPV E6/ E7 mRNA by nucleic acid molecular hybridization-flow cytometry ZHANG Yaxu, CUI Yanwei, LIU Ziyan Laboratory Medicine    2023, 38 (1): 46-50.   DOI: 10.3969/j.issn.1673-8640.2023.01.009 Abstract （139）   HTML （48）    PDF （1206KB）（144）       Knowledge map    Save Objective To investigate the reliability and application value of determining human papillomavirus（HPV） E6/E7 mRNA by nucleic acid molecular hybridization-flow cytometry. Methods Totally，361 samples of cervical epithelial exfoliated cells collected from gynecological departments of Guangdong Maternal and Child Health Hospital and the First Affiliated Hospital of Sun Yat-sen University from October 2018 to October 2019 were collected，and thinprep cytologic test（TCT），HPV DNA，biopsy histopathology and HPV E6/E7 mRNA determinations were performed. Results The proportion of positive HPV E6/E7 mRNA results was increased with the severity of pathological biopsy results. Compared with HPV DNA，HPV E6/E7 mRNA had higher specificity（72.73%）and positive predictive value（47.06%）. According to HPV E6/E7 mRNA results，the accuracy of colposcopy shunt of atypical squamous cell of undetermined significance（ASCUS） in abnormal TCT results was 66%. Conclusions HPV E6/E7 mRNA has high consistency with histopathological examination，and the accuracy of colposcopy shunt，specificity and positive predictive value for high-grade lesions are high. Table and Figures | Reference | Related Articles | Metrics

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Clinical application of cardiac troponin determination in pediatric cardiac involvement related diseases YANG Qiong, XU Fen, LIN Yahui Laboratory Medicine    2023, 38 (6): 510-517.   DOI: 10.3969/j.issn.1673-8640.2023.06.002 Abstract （90）   HTML （86）    PDF （905KB）（143）       Knowledge map    Save Cardiac troponin （cTn） is a sensitive and specific marker of myocardial injury. In adults，cTn is widely used in the diagnosis of acute and chronic myocardial injury and risk stratification. Being different from adults，the prevalence of myocardial infarction and coronary heart diseases in children is low，and myocarditis，pericarditis and congenital heart disease（CHD） are common in children. Cardiac injury can occurred secondary to infection，trauma and cancer drug therapy in children. The indicator，cTn，is useful in all these clinical conditions with proper interpretations based on the pediatric patients. This review focuses on the clinical application of cTn determination in children. Reference | Related Articles | Metrics

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Analysis on the difference of lipoprotein（a） particle concentration and mass concentration in certain disease states WANG Yang, MO Huifang, SHEN Ruojian, SHEN Yifeng, WANG Beili, PAN Baishen, GUO Wei Laboratory Medicine    2023, 38 (5): 405-412.   DOI: 10.3969/j.issn.1673-8640.2023.05.001 Abstract （127）   HTML （15）    PDF （1991KB）（135）       Knowledge map    Save Objective To analyze the results of lipoprotein（a）[Lp（a）] mass concentration and particle concentration in certain disease states. Methods A total of 581 inpatients from September 2018 to August 2019 in Zhongshan Hospital of Fudan University were enrolled，which included 406 males and 175 females，aged （63.59±14.52） years old. There were 133 cases in coronary heart disease group，76 cases in hepatocarcinoma group，192 cases in diabetes group and 180 cases in chronic kidney disease group. Totally，200 healthy subjects were enrolled as well，which included 125 males and 75 females，aged （61.84±5.50） years old. The particle concentration and mass concentration of Lp（a） were determined，and the correlation and positive rate difference between particle and mass concentration in disease groups and healthy control group were analyzed by Spearman correlation analysis. Passing-Bablok regression analysis and Bland-Altman bias evaluation were used to analyze the consistency between the mass concentration calculated by particle concentration and the mass concentration determined directly. Results The correlation between Lp（a） particle concentration and mass concentration was good（r=0.948 7，P<0.05），the highest in coronary heart disease group（r=0.976 3，P<0.05），and the lowest in hepatocarcinoma group（r=0.863 2，P<0.05）. The positive rates of particle concentration and mass concentration in chronic kidney disease group and diabetes group had statistical significance（P<0.05）. There was no statistical significance in the positive rates of particle concentration and mass concentration among coronary heart disease group，hepatocarcinoma group and healthy control group（P>0.05）. The 95% agreement margin between mass concentration calculated by particle concentration and mass concentration determined directly exceeded 1/2 of the allowable total error. Conclusions There is a certain correlation between the particle concentration of Lp（a） and its mass concentration. In different disease groups（coronary heart disease，hepatocarcinoma，diabetes and chronic kidney disease） and healthy control group，the positive rates between Lp（a） particle and mass concentrations are different. The difference between the mass concentration calculated by particle concentration and mass concentration determined directly exceeds the clinically acceptable range，and it is not recommended to convert the Lp（a） particle concentration and mass concentration in clinical practice. Table and Figures | Reference | Related Articles | Metrics

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Analysis on the results of external quality assessment of mutual recognition quantitative items in Shanghai YANG Xue, JU Yi, OU Yuanzhu, ZHU Yuqing, XU Chong, JIANG Lingli, WANG Qing, ZHOU Jing Laboratory Medicine    2022, 37 (12): 1129-1134.   DOI: 10.3969/j.issn.1673-8640.2022.12.006 Abstract （149）   HTML （20）    PDF （1046KB）（135）       Knowledge map    Save Objective To analyze the performance of mutual recognition quantitative items in Shanghai，in order to promote the mutual recognition of determination results in medical institutions. Methods The results of 58 mutual recognition quantitative items of clinical laboratories in Shanghai Center for Clinical Laboratory（SCCL） from the second External Quality Assessment（EQA） in 2020 were selected to calculate the EQA scores and the sigma（σ） metrics from allowable total error（TEa） sources. Results A total of 802 clinical laboratories of medical institutions reported the results of 58 mutual recognition quantitative items. EQA pass rates ranged from 92.59%（antithrombin） to 100.00%（18 items）. The failed rates of medical institutions were 32.54% in public hospitals and 67.46% in non-medical institution clinical laboratories. Taking the value of TEa from SCCL，39（67.24%）items had a σ metrics >3. Taking the maximum value of TEa，51（87.93%） items had a σ metrics >3，and 14（24.14%） items had a σ metrics >6. Taking the minimum value of TEa，12（20.69%）items had a σ metrics >3. Conclusions The mutual recognition quantitative items in Shanghai have good consistency among clinical laboratories. However，there are differences in determination results between clinical laboratories in different medical institutions for some items，which should be paid attention to. Table and Figures | Reference | Related Articles | Metrics

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Feasibility study of automated hematology analyzer on routine cell counts of serous cavity effusion WANG Chong, ZHU Jie, YANG Shuo, GU Meixiu, PAN Baishen, WANG Beili, GUO Wei Laboratory Medicine    2022, 37 (6): 551-556.   DOI: 10.3969/j.issn.1673-8640.2022.06.011 Abstract （338）   HTML （39）    PDF （1022KB）（133）       Knowledge map    Save Objective To investigate the feasibility of replacing manual counting method with microscope in cell counts and white blood cell classification by automated hematology analyzer in body fluid mode. Methods A total of 287 serous cavity effusion specimens from inpatients were collected,and the manual counting method with microscope（manual method） and the instrumental determination method with automated hematology analyzer（instrumental method） were used for red blood cell and white blood cell counts and white blood cell classification. The manual method was used as the gold standard. The accuracy of instrumental method was evaluated. Results For the specimens whose white blood cell count 201-15 000 cells/μL or the red blood cell count ≥200 cells/μL,the instrumental method and manual method had good correlation in cell counts,and the 2 methods had a good correlation in white blood cell classification（P<0.01）. Conclusions The automated hematology analyzer has the advantages of rapidity,accuracy and reproducibility in cell counts and white blood cell classification of serous cavity effusion specimens. When the red blood cell and white blood cell counts are within certain linear ranges,instrumental method can replace the manual counting method with microscope. Table and Figures | Reference | Related Articles | Metrics

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Research progress of biomarkers of prostate cancer WU Jiong, HU Jiahua, SHI Meifang, LIU Tao, DAI Jie, LU Xinyi, ZOU Zheng Laboratory Medicine    2023, 38 (2): 190-195.   DOI: 10.3969/j.issn.1673-8640.2023.02.018 Abstract （162）   HTML （13）    PDF （895KB）（133）       Knowledge map    Save Prostate cancer is one of the most common cancers in males，and it has high incidence rate and mortality rate. Prostate-specific antigen（PSA） plays a role in prostate cancer screening. With the research progress of prostate cancer diagnosis and treatment，various biomarkers have emerged，which play a role in the whole process of prostate cancer diagnosis and treatment. Prostate health index（PHI），4K score，PCA3，selected MDx and exocrine intelligence scores，can effectively assist in the screening and diagnosis of prostate cancer. Blood circulating tumor cells（CTC） and circulating tumor DNA（ctDNA） can be used for the risk stratification of prostate cancer and the selection of therapeutic drugs，therapeutic responses and alternative endpoints of clinical trials. Genomic prostate score and Prolaris score of prostate cancer tissue samples can be used for prostate risk stratification. This review focuses on various biomarkers of prostate cancer in blood，urine and other specimen types. Table and Figures | Reference | Related Articles | Metrics

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Predictive values of red blood cell distribution width and myocardial markers for acute myocardial infarction in patients with CAS MA Jianguo, ZHU Xiaolin, DING Yongguang, YIN Meng, LI Hongchun Laboratory Medicine    2022, 37 (12): 1164-1168.   DOI: 10.3969/j.issn.1673-8640.2022.12.012 Abstract （220）   HTML （26）    PDF （1073KB）（131）       Knowledge map    Save Objective To investigate the predictive values of red blood cell distribution width（RDW） for acute myocardial infarction（AMI） in patients with coronary atherosclerosis（CAS）. Methods Totally，600 patients with CAS were enrolled. The clinical data of all the patients were collected，and RDW，cardiac troponin I（cTnI），creatine kinase MB isoenzyme（CK-MB） and lipid levels were determined. All the patients were followed up for 5 years，and the end points were AMI，death or the completion of follow-up. Receiver operating characteristic（ROC） curve was used to evaluate the value of each indicator in determining the occurrence of AMI in CAS patients. Kaplan-Meier survival curve analysis was used to analyze the differences in the occurrence of AMI among all the groups，and Cox regression analysis was used to evaluate the risk factors of AMI in CAS patients. Results Follow-up was completed in 450 of 600 CAS patients，32 of whom developed AMI. The areas under curves（AUC） of RDW，CK-MB and cTnI single and combined determination for AMI in CAS patients were 0.747，0.722，0.714 and 0.774，respectively. All the CAS patients were classified into RDW≥13.8% and RDW<13.8% according to the optimal cut-off value of RDW obtained by ROC curve. The age，CK-MB，cTnI and the occurrence of AMI in RDW≥13.8% group were higher than those in RDW<13.8% group（P<0.001）. There was no statistical significance in the other clinical data and blood lipids between the 2 groups（P>0.05）. Kaplan-Meier survival curve analysis results showed that the occurrence of AMI in RDW≥13.8% group was higher than that in RDW<13.8% group（P<0.001）. Multivariate Cox regression analysis showed that elevated RDW was an independent risk factor for AMI in CAS patients after adjusting for age，sex，body mass index，smoking history，alcohol consumption history and diabetes mellitus history [hazard ratio（HR）=1.727，95% confidence interval（CI） 1.492-1.998]. Conclusions RDW has clinical value in predicting the occurrence of AMI in patients with CAS，and the combination of CK-MB and cTnI may improve the predictive efficiency of the occurrence of AMI in patients with CAS. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2022, 37 (10): 948-951.   DOI: 10.3969/j.issn.1673-8640.2022.010.008 Abstract （168）   HTML （10）    PDF （750KB）（130）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Roles of PTH，CRP，OPG/PYR ratio in elderly patients with osteoporosis YAO Hualong Laboratory Medicine    2022, 37 (12): 1146-1150.   DOI: 10.3969/j.issn.1673-8640.2022.12.009 Abstract （163）   HTML （20）    PDF （979KB）（129）       Knowledge map    Save Objective To investigate the roles of parathyroid hormone（PTH），C-reactive protein（CRP），osteoprotegerin（OPG）/pyridinoline（PYR） ratio in elderly patients with osteoporosis（OP）. Methods Totally，137 patients with suspected OP were enrolled and classified into OP group（32 cases） and non-OP group（105 cases） according to the presence or absence of OP. The clinical data were collected，and lumbar spine and femoral neck bone mineral densities（BMD），serum PTH，CRP and OPG levels and urinary PYR levels were determined. OPG/PYR ratio was calculated. Pearson correlation analysis and partial correlation analysis were used to analyze the relationship between each index and lumbar spine and femoral neck BMD. Receiver operating characteristic（ROC） curve was used to analyze the efficiency of OP. Results The proportion of diabetes mellitus and serum PTH and CRP levels were higher in OP group than those in non-OP group（P<0.05），and lumbar spine BMD，femoral neck BMD and OPG/PYR ratio were lower than those in non-OP group（P<0.05）. Between the 2 groups，age，sex，body mass index，the proportion of alcohol consumption history，the proportion of smoking history，the proportion of hyperlipoidemia，the proportion of coronary heart disease and the proportion of hypertension had no statistical significance（P>0.05）. Pearson correlation analysis showed that PTH and CRP were negatively correlated with lumbar spine BMD and femoral neck BMD（P<0.05），and the OPG/PYR ratio was positively correlated with lumbar spine BMD and femoral neck BMD（P<0.05）. The results of partial correlation analysis showed that PTH，CRP and OPG/PYR ratio were correlated with lumbar spine BMD and femoral neck BMD after controlling for the factor of diabetes mellitus（P<0.05）. The results of ROC curve analysis showed that the areas under curves（AUC） of PTH，CRP and OPG/PYR ratio single and combined determinations to diagnose OP were 0.856，0.826，0.861 and 0.912，respectively. Conclusions PTH，CRP，OPG/PYR ratio are correlated to OP，which can be used in the auxiliary diagnosis and disease monitoring of OP. Table and Figures | Reference | Related Articles | Metrics

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Application of serum peptidomics based on MALDI-TOF MS in the differential diagnosis of benign and malignant pancreatic diseases HUANG Yuan, CHEN Feng, MAO Leili, ZHANG Linglin, LÜ Qian, YAN Jun, CUI Wei Laboratory Medicine    2023, 38 (1): 1-7.   DOI: 10.3969/j.issn.1673-8640.2023.01.001 Abstract （145）   HTML （28）    PDF （1096KB）（128）       Knowledge map    Save Objective To investigate the role of serum peptidomics based on matrix-assisted laser desorption/ionization time-of-flight mass spectrometry（MALDI-TOF MS） in the differential diagnosis of benign and malignant pancreatic diseases. Methods A total of 176 patients with pancreatic ductal adenocarcinoma（PDAC） and 148 patients with chronic pancreatitis（CP） were enrolled and randomly classified into training set（122 cases of PDAC，103 cases of CP） and validation set（54 cases of PDAC，45 cases of CP） at a ratio of 7 to 3. Serum peptides were extracted by weak positive ion exchange method combined with magnetic bead adsorption，and peptide profiles were determined by MALDI-TOF MS. In the training set，binary Logistic regression analysis was used to establish a differential diagnosis model for distinguishing PDAC from CP based on differentially expressed peptides，and in the validation set，the model was verified. The amino acid sequences of differentially expressed peptides were determined by nano-liquid chromatography-electrospray ionization-tandem mass spectrometry（nano-LC/ESI-MS/MS），and the proteins to which they belonged to were identified. Receiver operating characteristic（ROC） curve was used to evaluate the efficacy of the differential diagnosis model in distinguishing PDAC from CP，which was compared with the differential diagnosis efficacy of serum carbohydrate antigen 19-9（CA19-9）. Results A total of 20 peptides were found to be different between PDAC and CP patients. The area under curve（AUC） of the differential diagnosis model established based on these 20 peptides was 0.988，the optimal cut-off value was 0.469，the sensitivity was 94.26%，and the specificity was 97.09%. In the validation set，the sensitivity of the model was 94.44%，and the specificity was 97.78%. The performance of differential diagnosis model was better than that of serum CA19-9（the sensitivity of 67.90% and the specificity of 91.30%）. The AUC of the differential diagnosis model combined with CA19-9 to distinguish PDAC and CP was 0.996，the sensitivity was 97.60%，and the specificity was 100.00%. The proteins to which the 3 peptides belonged to were successfully identified by nano-LC/ESI-MS/MS，m/z 1 758 was the fragment of zyxin，and m/z 4 053 and m/z 5 351 were both the fragments of fibrinogen. Conclusions A model for the differential diagnosis of PDAC and CP has been established based on serum peptidomics，which can distinguish PDAC from CP and malignant pancreatic diseases accurately，and it provides an idea for the further development of a non-invasive cancer diagnosis method. Table and Figures | Reference | Related Articles | Metrics

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Establishment and application of automatic review rules for clinical biochemical quantitative detection items CAI Yongmei, WANG Haiying, MEI Yanfang, WANG Zhiwei Laboratory Medicine    2022, 37 (6): 590-595.   DOI: 10.3969/j.issn.1673-8640.2022.06.017 Abstract （224）   HTML （15）    PDF （784KB）（127）       Knowledge map    Save Objective Based on the characteristics of patient population into clinical laboratories,to establish the automatic review rules of clinical biochemical items,and to ensure effective and stable passing rate of automatic review. Methods According to accreditation criteria for quality and competence of medical laboratories and autoverification of medical laboratory results for specific disciplines,personalized automatic review rules for clinical biochemical quantitative detection items were established and verified. Statistical analysis was used for the rate of automatic review without outdated normal range severity（NS） and delta check severity（DS） rules. Results Totally,40 clinical biochemical quantitative detection items had been established,and more than 400 effective rules were set. The failure to pass the automatic examination results of each item was mainly DS and NS rules,accounting for about 95%. After optimizing DS and NS rules,the pass rate of automatic examination were increased from 56.33% to 66.13%. Conclusions Totally,40 clinical biochemical quantitative detection items have been established. The NS and DS rules are the main rules for the stability of the automatic review and the accuracy and reliability of the automatic review results,which should be scientific,feasible and appropriate. Table and Figures | Reference | Related Articles | Metrics

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Clinical value of MTHFR gene C677T polymorphism determination in patients with H-type hypertension WANG Shan, XU Minyi, WANG Wei, JIANG Mingming, LU Pei, XIONG Zhongbo, WANG Lei Laboratory Medicine    2022, 37 (11): 1012-1016.   DOI: 10.3969/j.issn.1673-8640.2022.011.002 Abstract （220）   HTML （22）    PDF （830KB）（125）       Knowledge map    Save Objective To investigate the clinical value of methylenetetrahydrofolate reductase（MTHFR） gene C677T polymorphism determination in H-type hypertension. Methods The MTHFR gene C677T polymorphism was determined by digital fluorescence molecular hybridization in 215 patients with hypertension and 113 healthy subjects，and the levels of serum homocysteine（Hcy） were determined. The patients with hypertension were classified into H-type group（143 cases） and non-H-type hypertension group（72 cases） according to Hcy levels. According to the severity of hypertension，they were classified into Grade Ⅰ，Ⅱ and Ⅲ groups（48，77 and 90 cases，respectively）. Serum Hcy levels were determined in patients with H-type hypertension before and after folic acid treatment for 6 months. Results Serum Hcy level in H-type hypertension group was higher than those in non-H-type hypertension group and healthy control group（P<0.01）. Serum Hcy level in Grade Ⅲ hypertension group was higher than those in Grade Ⅱ and Grade Ⅰ hypertension groups（P<0.05）. The frequencies of CC，TT genotype and C，T allele in H-type hypertension group were higher than those in non-H-type hypertension group and healthy control group（P<0.05）. The frequencies of TT genotype and T allele in Grade Ⅱ and Grade Ⅲ hypertension group were higher than those in Grade Ⅰ hypertension group（P<0.05）. In patients with H-type hypertension，serum Hcy level in TT genotype group was higher than those in CT genotype group and CC genotype group before and after folic acid treatment（P<0.01）. After folic acid treatment，serum Hcy levels of the 3 genotypes were lower than those before treatment（P<0.05）. Serum Hcy levels of TT genotype patients with H-type hypertension before and after folic acid treatment were higher than those of CT genotype patients and CC genotype patients（P<0.01）. Conclusions The MTHFR gene C677T polymorphism is related to the severity of hypertension，and its determination has clinical value for individualized treatment efficacy of H-type hypertension. Table and Figures | Reference | Related Articles | Metrics

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Role of Mycoplasma pneumoniae RNA determination in diagnosis and efficacy monitoring of pneumonia in children WANG Huiying, TANG Yu, DONG Lili, WANG Jing Laboratory Medicine    2023, 38 (9): 865-869.   DOI: 10.3969/j.issn.1673-8640.2023.09.010 Abstract （100）   HTML （5）    PDF （910KB）（125）       Knowledge map    Save Objective To analyze the role of Mycoplasma pneumoniae（MP） RNA determination in the diagnosis and efficacy monitoring of pneumonia in children. Methods Totally，167 children with pneumonia in Zhengzhou Children's Hospital from May 2019 to January 2021 were enrolled. Sputum samples were collected for MP-RNA，MP-DNA，MP-IgG antibody and MP-IgM antibody determinations. The specificities and sensitivities of MP-DNA，MP-RNA，MP-IgM antibody and MP-IgG antibody for diagnosing MP were evaluated. The positive rate of MP-RNA and MP-DNA and the incidence of clinical symptoms after 1，2，3 and 4 weeks of treatment were analyzed. The duration of clinical symptoms and serum C-reactive protein（CRP），interleukin-8（IL-8） and white blood cell（WBC） count of children with different MP-RNA turn-negative time were compared. Results MP culture proved that 95 of 167 children were infected with MP. The specificities for diagnosing MP pneumonia in children were MP-RNA>MP-DNA>MP-IgM antibody>MP-IgG antibody. The sensitivities were MP-RNA>MP-IgM antibody>MP-DNA>MP-IgG antibody. The positive rates of MP-RNA and MP-DNA were negatively correlated with the duration of treatment（r=-0.901，P=0.017；r=-0.601，P=0.031）. For 2，3 and 4 weeks of treatment，the positive rate of MP-RNA was lower than that of MP-DNA（P<0.000 1）. Compared with MP-DNA，the incidence of cough after MP-RNA turn-negative was higher（P<0.05）. After 1，2，3 and 4 weeks of treatment，the duration of fever，cough，wheezing and pulmonary rales in MP-RNA turn-negative children were successively prolonged（P<0.000 1），and serum CRP，IL-8 and WBC count were successively increased on admission（P<0.000 1）. Conclusions MP-RNA and MP-DNA have certain diagnostic value in children with MP pneumonia. In contrast，MP-DNA is more suitable for the diagnosis of children with MP，and MP-RNA is suitable for monitoring the efficacy of children with MP. Table and Figures | Reference | Related Articles | Metrics

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Investigation and practice of smart internet inspection in regional medical laboratory center KAN Lijuan, LI Jingli, CHEN Dayang, HAN Xinyuan, WANG Zhihong, CAI Qinquan, WEN Qilin, LIU Zhenyu, LI Ming, ZHANG Xiuming Laboratory Medicine    2022, 37 (12): 1113-1117.   DOI: 10.3969/j.issn.1673-8640.2022.12.002 Abstract （156）   HTML （20）    PDF （1207KB）（123）       Knowledge map    Save Objective To investigate the application efficiency of the workflow of smart internet inspection in improving regional medical laboratory center. Methods A number of internet information technologies were used to develop a smart internet inspection platform，through which the regional internet inspection items can be seamlessly connected with hospital information system（HIS）data. The regional internet inspection business volume and patient satisfaction survey results were analyzed statistically. The actual application efficiency of smart internet inspection was evaluated. Results According to the needs or disease status，customers（clinicians，patients and residents） can apply for self-service inspection，interpretation of inspection report and internet online diagnosis and treatment through different paths at the internet hospital and internet inspection platform，online real name authentication，self-service payment and sampling nearby in the area. Internet+nursing provided door-to-door sampling services. The inspection specimens were transported by special specimen transport vehicles and unmanned aircrafts. It supported mobile phone text messages，hospital and regional inspection center WeChat official accounts，Health Luohu APP and other platforms to check inspection reports online，and provided online intelligent consultation，regional internet diagnosis and treatment services. The platform had operated for 16 months from November 2020 to February 2022，and the inspection business volume had reached 469 453 person times，including 427 973 person times of severe acute respiratory syndrome coronavirus 2 nucleic acid determination，accounting for 99.2% of the total inspection business volume. In the satisfaction survey of 42 public tertiary medical institutions in Shenzhen 2021，Shenzhen Luohu People's Hospital ranked the third，and the inspection business volume，business income and patient satisfaction continued to rise steadily. Conclusions The internet inspection combined with regional medical laboratory center is an important way to reduce patients' waiting time for diagnosis and treatment，reduce costs and increase efficiency，and better carry out disease intervention and health management. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2022, 37 (8): 754-756.   DOI: 10.3969/j.issn.1673-8640.2022.08.010 Abstract （283）   HTML （28）    PDF （752KB）（121）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2023, 38 (10): 980-982.   DOI: 10.3969/j.issn.1673-8640.2023.10.014 Abstract （123）   HTML （11）    PDF （809KB）（119）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Candidate biomarkers in metabolic syndrome based on GEO database CHEN Xuewei, LI Yirong Laboratory Medicine    2023, 38 (1): 32-38.   DOI: 10.3969/j.issn.1673-8640.2023.01.007 Abstract （173）   HTML （14）    PDF （2895KB）（117）       Knowledge map    Save Objective By analyzing the Gene Expression Omnibus （GEO） database （GSE98895 and GSE23561） of peripheral blood mononuclear cells （PBMC） from patients with metabolic syndrome，and to identify the key genes for metabolic syndrome. Methods The differentially expressed genes of PBMC in metabolic syndrome patients and healthy subjects in the GSE98895 dataset were analyzed. Gene Ontology （GO） and Kyoto Encyclopedia of Genes and Genomes （KEGG） pathway analysis of differentially expressed genes were carried out. Protein-protein interaction （PPI） network analysis was also performed. The top 10 hub genes with a high degree of connectivity were selected in the PPI network. The hub gene expression in PBMC of metabolic syndrome patients had been illustrated in the GSE98895 and GSE23561 datasets and human protein atlas （HPA） dataset. A circular RNA（circRNA）-microRNA（miRNA）-mRNA network for the pathogenesis of metabolic syndrome was constructed. Results A total of 155 differentially expressed genes between metabolic syndrome patients and healthy subjects were identified，among which 62 genes were up-regulated，and 93 genes were down-regulated. The results of the GO and the KEGG enrichment pathway analysis indicated that the differentially expressed genes were mainly involved in the regulation of transcription，immune response，cAMP signaling pathway and T cell receptor signaling pathway. Totally，10 genes （JUN，IFNG，MMP9，PIK3R1，LCK，NGF，PDGFRB，CD79B，CX3CR1 and ABCA1） with the highest degree scores were identified. The expressions of IFNG and LCK in PBMC of patients with metabolic syndrome were higher than those of healthy subjects （P<0.05）. HPA dataset analysis showed that IFNG and LCK were mainly expressed in T cells and natural killer（NK） cells. A circRNA-miRNA-mRNA network had been constructed for metabolic syndrome. Totally，7 miRNA and 43 circRNA associated with IFNG were identified，and 16 miRNA and 62 circRNA associated with LCK were identified. Conclusions IFNG and LCK have up-regulated expressions in PBMC of metabolic syndrome patients. An in-depth study of the circRNA-miRNA-mRNA network for IFNG and LCK may help to discover the molecular mechanism of occurrence and development and the biomarkers of metabolic syndrome. Table and Figures | Reference | Related Articles | Metrics

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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 Abstract （126）   HTML （203）    PDF （1474KB）（114）       Knowledge map    Save 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. Table and Figures | Reference | Related Articles | Metrics

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Relationship between neutrophil/lymphocyte ratio，fibrinogen and carotid intima-media thickness in type 2 diabetes mellitus patients DENG Xu, ZHUANG Wenlong, XUE Hui, ZHU Shuqin, LI Ying Laboratory Medicine    2023, 38 (4): 368-372.   DOI: 10.3969/j.issn.1673-8640.2023.04.013 Abstract （99）   HTML （22）    PDF （878KB）（113）       Knowledge map    Save Objective To evaluate the relationship between neutrophil/lymphocyte ratio（NLR），fibrinogen（Fib） and carotid intima-media thickness（CIMT） in patients with type 2 diabetes mellitus. Methods Totally，327 patients with type 2 diabetes mellitus from Suqian First People's Hospital of Nanjing Medical University from January 2019 to April 2020 were enrolled and classified into normal CIMT group（116 cases），thickened CIMT group（38 cases） and plaque group（173 cases），according to CIMT. The differences of general data，blood routine test results and biochemical indicator determination results among the 3 groups were compared. Logistic regression analysis was used to analyze the risk factors for CIMT abnormalities in type 2 diabetes mellitus，and receiver operating characteristic（ROC） curves were used for the diagnosis efficiency of CIMT abnormalities. Results There was no statistical significance in sex，body mass index，diastolic blood pressure，renal function，blood lipid，white blood cell count，prothrombin time and international normalized ratio（INR） among normal CIMT，thickened CIMT and plaque 3 groups（P>0.05）. Compared with normal CIMT group，there was statistical significance in age，NLR and Fib in thickened CIMT group and plaque group（P<0.05）. Compared with normal CIMT group，diabetes mellitus disease course，systolic blood pressure and lymphocyte count in plaque group had statistical significance（P<0.05），and neutrophil count and glycated hemoglobin in thickened CIMT group had statistical significance（P<0.05）. Age，systolic blood pressure，NLR and Fib were risk factors for CIMT abnormality in type 2 diabetes mellitus patients [odds ratios（OR） were 1.062，1.041，1.285 and 1.477，P<0.05]. The areas under curves of NLR and Fib for diagnosing CIMT abnormality were 0.588 and 0.604，respectively（P<0.05）. Conclusions NLR and Fib play roles in screening and the diagnosis of CIMT abnormality. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2023, 38 (4): 378-381.   DOI: 10.3969/j.issn.1673-8640.2023.04.015 Abstract （191）   HTML （12）    PDF （884KB）（112）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Correlation between blood lipid levels and cardiac function indexes in patients with coronary heart disease MA Jianguo, LI Hongchun Laboratory Medicine    2023, 38 (7): 659-664.   DOI: 10.3969/j.issn.1673-8640.2023.07.008 Abstract （115）   HTML （19）    PDF （861KB）（112）       Knowledge map    Save Objective To investigate the correlation between blood lipid levels and cardiac function indexes in patients with coronary heart disease（CHD）. Methods A total of 200 CHD patients（CHD group） and 200 healthy subjects（control group） in Jiangsu Shuyang Zhongxing Hospital from January 2021 to January 2022 were enrolled. Serum total cholesterol（TC），triglyceride（TG），low-density lipoprotein cholesterol（LDL-C），high-density lipoprotein cholesterol（HDL-C），small and dense low-density lipoprotein cholesterol（sd-LDL-C），apolipoprotein（apo）A and apo B，apo E，lipoprotein（a） [Lp（a）] and lipoprotein-associated phospholipase A2（Lp-PLA2） levels were determined. Cardiac function indexes [end-diastolic volume（EDV），end-systolic volume（ESV），left ventricular ejection fraction（LVEF）] were determined. Pearson correlation analysis，multiple linear correlation analysis and Logistic regression analysis were used to evaluate the relationship between blood lipid levels and cardiac function indexes. Results The levels of apo B，apo E，Lp（a），Lp-PLA2，LDL-C，TG and TC levels and EDV and ESV in CHD group were higher than those in control group（P<0.001），and serum HDL-C and apo A levels and LVEF were lower than those in control group（P<0.001）. There was no statistical significance in serum sd-LDL-C levels between the 2 groups（P>0.05）. Pearson correlation analysis showed that apo B，apo E，Lp（a），Lp-PLA2，LDL-C，TG and TC were positively correlated with EDV and ESV（P<0.001），and they were negatively correlated with LVEF（P<0.001）. HDL-C and apo A were negatively correlated with EDV and ESV（P<0.001），and they were positively correlated with LVEF（P<0.05）. EDV and ESV increased by 0.130 and 0.110 mm for each 1 mmol/L increase of LDL-C（β=0.130 and 0.110）. EDV and ESV increased by 0.220 and 0.189 mm for each 1 mmol/L increase of TC（β= 0.220 and 0.189）. For each 1 mmol/L increase of TC，LVEF decreased by 0.310%（β=-0.310）. EDV and ESV of LDL-C>3.40 mmol/L group and TC>5.17 mmol/L group were higher than those of LDL-C≤3.40 mmol/L group and TC≤5.17 mmol/L group，respectively（P<0.001），and LVEF was lower than LDL-C≤3.40 mmol/L group and TC≤5.17 mmol/L group，respectively（P<0.001）. Logistic regression analysis showed that after adjusting for age，sex，body mass index and diabetes mellitus history，LDL-C>3.40 mmol/L and TC>5.17 mmol/L were risk factors for increasing EDV and ESV and decreasing LVEF（P<0.001）. Conclusions TC and LDL-C are correlated with cardiac function in patients with CHD. Abnormal lipid metabolism may be involved in the pathological process of heart failure in patients with CHD. Table and Figures | Reference | Related Articles | Metrics

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Roles of MxA，CRP and WBC count in the differential diagnosis of acute respiratory tract viral and bacterial infections LIU Chunxiao, YI Changlin, WANG Xiaoshan, ZHU Yongzhen, LUO Aner, CHEN Changqiang Laboratory Medicine    2022, 37 (10): 944-947.   DOI: 10.3969/j.issn.1673-8640.2022.010.007 Abstract （181）   HTML （14）    PDF （803KB）（111）       Knowledge map    Save Objective To investigate the clinical application values of myxovirus resistance protein A（MxA），C-reactive protein（CRP） and white blood cell（WBC） count in the differential diagnosis of acute respiratory tract viral infection and bacterial infection. Methods The viral infection group（350 cases），bacterial infection group（244 cases） and healthy control group（100 cases） were enrolled for determining MxA，CRP and WBC count. The diagnostic efficacy of the 3 indexes in each group was analyzed by receiver operating characteristic（ROC） curve. Results The MxA level in viral infection group was higher than those in bacterial infection group and healthy control group（P<0.05，P<0.01），and that in bacterial infection group was higher than that in healthy control group（P<0.05）. The CRP level and WBC count were higher in bacterial infection group than those in viral infection group and healthy control group（P<0.05，P<0.01），and that in viral infection group was higher than that in healthy control group（P<0.05）. ROC curve analysis showed that the areas under curves（AUC） of MxA，CRP，WBC count single determinations and combined determination were 0.829，0.703，0.665 and 0.850 for the differential diagnosis of viral infection and bacterial infection，respectively. The differential diagnostic performance of combined determination was better than those of single determinations（P<0.01）. Conclusions MxA，CRP and WBC count have good clinical application value in acute respiratory tract infectious diseases. MxA is superior to CRP and WBC count in distinguishing viral infection and bacterial infection，and the differential diagnostic performance of combined determination is better. Table and Figures | Reference | Related Articles | Metrics

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Microecological characteristics of vaginitis patients in Xi'an LI Jiao, ZHANG Qian, GAO Juanjuan, LI Na, GAO Li, PEI Meili, GOU Wenli Laboratory Medicine    2023, 38 (3): 272-275.   DOI: 10.3969/j.issn.1673-8640.2023.03.013 Abstract （106）   HTML （9）    PDF （940KB）（110）       Knowledge map    Save Objective To study the pathogenic characteristics of female vaginal microecology and mixed vaginitis in Xi'an，and to provide a reference for clinical diagnosis and treatment. Methods A total of 20 218 outpatients in the Department of Obstetrics and Gynecology of the First Affiliated Hospital of Xi'an Jiao Tong University from January 2021 to May 2022 were enrolled. The bacterial morphology and function of vaginal secretions were determined. The results of vaginal microecological tests of these patients were analyzed. Results The 50.6% females were with vaginal dysbiosis. The main diseases were bacterial vaginitis（BV）（28.3%），vulvovaginal candidiasis（VVC）（20.0%） and aerobic vaginitis（AV）（15.2%）. In the 10 222 vaginal dysbiosis females，61.6% cases were simple vaginitis（6 293 cases），and 38.4% cases were mixed vaginitis（3 929 cases）. The proportions of mixed infection BV+AV，BV+VVC，AV+BV+VVC and AV+BV+trichomonal vaginitis（TV） were 54.98%，16.14%，13.01% and 8.00%，respectively. Vaginitis recurred in 1 119 cases，with simple vaginitis accounting for 47.6%（533 cases） and mixed vaginitis accounting for 52.4%（586 cases）. Conclusions Mixed vaginitis has a high incidence of clinical infection. Using vaginal microecological tests for the identification of vaginal infection may provide a reference for the diagnosis and treatment of refractory vaginal infection. Table and Figures | Reference | Related Articles | Metrics

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New development of regional medical laboratory centers in post-pandemic era CHEN Hongwei, GUO Haitao, HOU Yanqiang Laboratory Medicine    2022, 37 (12): 1118-1121.   DOI: 10.3969/j.issn.1673-8640.2022.12.003 Abstract （177）   HTML （20）    PDF （932KB）（109）       Knowledge map    Save Regional medical laboratory center is a new model to optimize the allocation of medical resources，and its development is in line with Chinese policy of strengthening grass-roots and grading diagnosis and treatment. In the practice of prevention and control of corona virus disease 2019，regional medical laboratory center has shown many advantages and plays a role，which has been widely recognized by government and society. In post-epidemic era，the construction of regional medical laboratory center has ushered in new development opportunities. It is mainly reflected in the further clarification and strengthening of government support，the creation of a new form of inspection by "cloud inspection" and "taobao inspection" service，the acceleration of mutual recognition of medical inspection results，the development of centralized medical inspection，the opening of a new era of unmanned artifact logistics for regional medical laboratory center and the high-quality development of regional medical laboratory center supported by intelligent inspection. Based on the in-depth progress of the new medical reform，the improvement of social demand and recognition，as well as the rapid development of internet medicine，regional medical laboratory center will advance higher，faster，stronger and more intelligent. Reference | Related Articles | Metrics