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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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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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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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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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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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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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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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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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Establishment，verification and clinical application of automatic urine analysis system audit rule WANG Gangqiang, DIAO Yanjun, HE Juan, YANG Ruofan, YAN Hongbin, WANG Pei, LU Pei, LI Chenghua, XIAO Fengjing, ZHENG Shanluan, HAO Xiaoke, CHENG Xiang, LIU Jiayun Laboratory Medicine    2023, 38 (10): 957-966.   DOI: 10.3969/j.issn.1673-8640.2023.10.010 Abstract （90）   HTML （13）    PDF （970KB）（105）       Knowledge map    Save Objective To establish an automatic urine analysis system audit rule and evaluate its clinical application effects. Methods Totally，112 753 urine samples were collected at the First Affiliated Hospital of Air Force Military Medical University from April 2019 to August 2020. According to the WS/T 616—2018 "Automatic Audit of Clinical Laboratory Quantitative Inspection"，urine analysis line（2 urine dry chemical analyzers and 3 urine visible composition analyzers） operation platform was used. In combination with the self-established relevant determination system，the urine determination reference interval，hemoglobin（Hb），red blood cell（RBC），leukocyte esterase（LEU） and white blood cell（WBC） grade corresponding confirmation relationship was determined. With the results of artificial microscopy as the gold standard，the audit rules of urine analysis line operation platform were established. The validity of audit rule was verified by true negative rate，false negative rate，true positive rate，false positive rate，microscopy rate，automatic audit and manual audit agreement rate（correct rate）. The clinical effectiveness was evaluated according to audit time. Results A total of 25 automatic urine analysis system audit rules and Delta Check rules were established. Validity verification results showed that the true negative rate was 44.03%（487/1 106），the false negative rate was 4.52%（50/1 106），the true positive rate was 29.75%（329/1 106），the false positive rate was 21.70%（240/1 106），and the microscopy rate was 33.54%（371/1 106）. The agreement rate between automatic audit and manual audit was 100.00%（7 338/7 338）. The results of clinical effectiveness evaluation showed that the total pass rate during the trial operation period from May to August 2020 was 65.0%. Compared with May to August 2019，the median audit times of non-microscopy samples and microscopy samples were decreased by 10.3 and 9.3 min from 8：00 to 11：00 daily from May to August 2020，the audit effectivenesses were increased by 47.0% and 18.3%，and the number of auditors was decreased by 1，respectively. Conclusions The established automatic urine analysis audit rule can ensure the quality requirements，improve work efficiency and have good clinical applicability. Table and Figures | Reference | Related Articles | Metrics

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Research progress in influenza viruses CHEN Danyang, ZHENG Siyu, ZHENG Ruilin, SU Jingyao, ZHU Bing, LI Yinghua Laboratory Medicine    2023, 38 (7): 696-703.   DOI: 10.3969/j.issn.1673-8640.2023.07.015 Abstract （126）   HTML （38）    PDF （882KB）（104）       Knowledge map    Save Influenza is a highly infectious acute respiratory disease caused by influenza virus infection. It has severe pathogenicity and high mortality. In the recent years，the study of influenza viruses has made certain progress，but in the development of drugs and vaccines for influenza viruses it is still inadequate，and the development trend of influenza virus variation situation at present can not be predicted，so this needs scientific research workers focusing on the etiology and pathogenic mechanism of influenza viruses. In this review，the etiology，epidemiology，pathogenic mechanism，influenza-associated pneumonia and acute respiratory distress syndrome were reviewed. Table and Figures | Reference | Related Articles | Metrics

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Application progress of BNP and NT-proBNP in neonates YIN Ya, PAN Yuan, ZHOU Hongwei, SHEN Wei Laboratory Medicine    2023, 38 (6): 518-523.   DOI: 10.3969/j.issn.1673-8640.2023.06.003 Abstract （106）   HTML （9）    PDF （869KB）（104）       Knowledge map    Save B-type natriuretic peptide（BNP） and N-terminal pro-B-type natriuretic peptide（NT-proBNP） are blood markers secreted by cardiomyocytes and sensitive indicators reflecting cardiac structure and function. There is no consensus on the reference ranges of plasma levels of BNP and NT-proBNP in neonates，but many studies have explored the application in the diagnosis assessment，therapeutic monitoring and prognostic evaluation for neonatal cardiovascular diseases. This review mainly summarizes the above aspects in order to provide guidance for clinical application. Table and Figures | Reference | Related Articles | Metrics

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CK-MB/CK ratio in differentiating false positive results of CK-MB activity method in children HUANG Yihou, ZHANG Lei, YE Zhicheng, CHENG Fangying Laboratory Medicine    2023, 38 (6): 538-542.   DOI: 10.3969/j.issn.1673-8640.2023.06.006 Abstract （97）   HTML （11）    PDF （880KB）（98）       Knowledge map    Save Objective To evaluate the ratio of creatine kinase MB isoenzyme（CK-MB） to creatine kinase（CK） for differentiating false increased results of CK-MB activity method in children. Methods Totally，304 samples with positive results of CK-MB activity method （higher than reference interval）were collected and randomized into a training set and a validation set by 1∶1. All the samples were determined by CK-MB mass assay. Positivity by mass assay was the standard of true positivity by active method. The clinical disease spectrum of children with false increased results of CK-MB activity method was analyzed. Receiver operating characteristic（ROC） curve analysis was used to evaluate the efficiency of CK-MB/CK in differentiating false increased results of CK-MB activity method. Results Among the 304 samples，141 cases of false positivity were determined by CK-MB activity method. The top 3 diseases were gastroenteritis（28 cases，19.9%），cardiovascular disease（27 cases，19.1%） and tumor（25 cases，17.7%）. In training set，the area under curve（AUC） of CK-MB/CK in differentiating true positive results of CK-MB activity method was 0.921 [95% confidence interval（CI）0.866-0.958，P<0.001]. Using 0.30 as CK-MB/CK cut-off value，the sensitivity of CK-MB/CK in differentiating true positive results of CK-MB activity method was 97.56%（95%CI 91.50%-99.70%）. In validation set，the AUC was 0.919（95%CI 0.862-0.956，P<0.001），and using 0.30 as CK-MB/CK cut-off value，the sensitivity was 97.53%（95%CI 91.40%-99.70%）. Conclusions CK-MB/CK can be used to determine the false increased results of CK-MB activity method. Gastroenteritis，cardiovascular disease and tumor children are prone to false positive results of CK-MB activity method. The positive results of CK-MB activity method in children with such diseases should be objectively judged according to clinical practice. Table and Figures | Reference | Related Articles | Metrics

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Roles of lymphocyte subsets，inflammatory factors and NT-proBNP in diagnosis of Kawasaki disease LIU Yanan, XIA Min, HU Shaohua, ZHENG Yue, ZHANG Hong Laboratory Medicine    2023, 38 (6): 532-537.   DOI: 10.3969/j.issn.1673-8640.2023.06.005 Abstract （76）   HTML （11）    PDF （1120KB）（94）       Knowledge map    Save Objective To investigate the changes and roles of lymphocyte subsets，inflammatory factors and myocardial marker in children with acute Kawasaki disease（KD）. Methods From October 2016 to March 2019，222 acute KD children and 177 non-KD children with infection and fever were enrolled from Children's Hospital of Shanghai. Lymphocytes were determined by flow cytometry. The levels of 13 inflammatory factors [interleukin（IL）-8，IL-1β，IL-2，IL-6，IL-10，IL-4，IL-5，IL-12P70，IL-17A，IL-18，tumor necrosis factor-alpha（TNF-α），interferon-gamma （INF-γ）and sCD25] were determined flow cytometry and immunofluorescence technique Peripheral blood lymphocytes were determined by flow cytometry. The expressions of inflammatory cytokines and lymphocytes in peripheral blood of children with KD in acute phase and non-KD patients with fever-infected were compared. The expressions of inflammatory factors were compared before and after intravenous injection gamma globulin （IVIG） in children with KD. The changes of cardiac markers，including cardiac troponin I （cTnI），myoglobin （MYO） and N-terminal pro-B-type natriuretic peptide （NT-proBNP），in 145 children with KD in acute phase were determined，and the correlations were analyzed. Results Compared with children with infection and fever，other inflammatory factors except IL-2 were increased in children with KD（P<0.05）. Peripheral blood CD3+CD4+ T cell percentage，CD16+CD56+ natural killer cell percentage，CD4/CD8 were increased，and CD3+CD8+ T cell percentage was decreased （P<0.05）. The absolute value of CD16+CD56+ natural killer cells was increased，and the absolute value of CD3+CD8+ T cells was decreased （P<0.05）. After treatment，serum IL-8，IL-1β，IL-2，IL-6，IL-10，IL-18，TNF-α and sCD25 were decreased（P<0.05）. There was no significant increase of cTnI and MYO in peripheral blood of children with KD. There was a significant increase of NT-proBNP in peripheral blood of 62% children，which was positively correlated with IL-6，IL-10，IL-17A，IL-18，TNF-α，INF-γ，sCD25，the percentage and absolute value of CD19+ B cells，CD4/CD8，and which was negatively correlated with the percentage of CD3+CD8+ T cells. Conclusions There is up-regulation of inflammatory factors and imbalance of lymphocyte subsets in acute KD. The determination of NT-proBNP combined with immune cells and inflammatory factors can assist clinical diagnosis and treatment. Table and Figures | Reference | Related Articles | Metrics

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Role of serum albumin，interleukin-6 and ferritin combined determination in evaluating the functional prognosis of patients with spontaneous intracerebral hemorrhage ZHANG Han, LI Jun, LIU Xiaojiang, GUAN Yixiang Laboratory Medicine    2023, 38 (8): 713-718.   DOI: 10.3969/j.issn.1673-8640.2023.08.002 Abstract （112）   HTML （26）    PDF （842KB）（91）       Knowledge map    Save Objective To investigate the role of serum albumin，interleukin-6（IL-6） and ferritin combined determination in evaluating the functional prognosis of patients with spontaneous intracerebral hemorrhage（SICH）. Methods A total of 148 patients with SICH treated at Hai'an People's Hospital from January 2018 to January 2021 were enrolled. Patients' clinical，laboratory and imaging data were collected，and serum albumin，IL-6 and ferritin were determined before treatment. According modified Rankin scale（mRS） scores，the patients were classified into good prognosis group（mRS<3） and poor prognosis group（mRS≥3），and the patients were followed up for 90 d. Receiver operating characteristic（ROC） curve was used to determine the discriminative capability of various parameters for 90 d functional prognosis and death. Binary Logistic regression analysis was used to determine the factors for 90 d functional prognosis. Results Compared with good prognosis group，poor prognosis group had higher the National Institute of Health Stroke Scale（NIHSS） score，hematoma volume，perihematoma edema volume，white blood cell count，IL-6 and ferritin and lower serum albumin（P<0.05），while the difference for the other parameters were not statistically significant between the 2 groups（P>0.05）. The results of Pearson correlation analysis showed serum albumin and perihematoma edema volume was negatively correlated（r=-0.32，P<0.01），and ferritin was positively correlated with hematoma volume（r=0.27，P<0.01）. The results of binary Logistic regression analysis showed that hematoma volume，cerebral hemorrhage site，serum albumin，IL-6 and ferritin were prognostic factors for the functional prognosis of SICH patients at 90 d of onset（P<0.05）. Binary Logistic regression analysis was used to construct a combined determination model based on the above influencing factors. The results of ROC curve analysis showed that the areas under curves（AUC） of serum albumin，IL-6，ferritin alone and combined determination model for the functional prognosis of SICH patients at 90 d of onset were 0.68，0.65，0.62 and 0.94，respectively. The AUC of serum albumin，IL-6 and ferritin for judging death of SICH patients at 90 d of onset were 0.68，0.68 and 0.51，respectively. The AUC of serum albumin and IL-6 combined determination model and serum albumin，IL-6，hematoma volume and cerebral hemorrhage site combined determination model for judging death of SICH patients at 90 d of onset were 0.76 and 0.90，respectively. Conclusions Serum albumin，IL-6 and ferritin combined determination with cerebral hemorrhage site and hematoma volume help to accurately assess the functional prognosis and death at 90 d of onset in patients with SICH. Table and Figures | Reference | Related Articles | Metrics

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Correlations between the ratio of C-reactive protein to prealbumin and the prognosis of patients with acute heart failure WU Caorong, CUI Wen, TANG Binbin, HE Jingjing, LAI Zhikun Laboratory Medicine    2023, 38 (6): 579-583.   DOI: 10.3969/j.issn.1673-8640.2023.06.014 Abstract （101）   HTML （10）    PDF （904KB）（90）       Knowledge map    Save Objective To investigate the correlations between the ratio of C-reactive protein（CRP） to prealbumin（PA） and the prognosis of patients with acute heart failure（AHF）. Methods A total of 79 patients with AHF treated at the Affiliated Hospital of Traditional Chinese Medicine of Shanghai University of Traditional Chinese Medicine were enrolled retrospectively. The clinical data and laboratory determination results at admission were collected. All the patients were followed with an end date of January 2021 and a primary outcome of all-cause mortality. The optimal cut-off value of CRP/PA to predict AHF patient mortality was determined by receiver operating characteristic（ROC） curve. Pearson correlation analysis was used to determine the correlation between CRP and PA. Patient survival was evaluated by Kaplan-Meier survival curve and Log-rank χ2 test. Risk factors for all-cause mortality were identified by Cox proportional hazard ratio. Results Pearson correlation analysis showed that CRP was negatively correlated with PA（r=-0.37，P=0.001）. The results of ROC curve analysis showed that the area under curve of CRP/PA to predict AHF mortality was 0.74 with an optimal cut-off value of 0.119 9. The patients were classified into CRP/PA ≤0.119 9 group（36 cases） and CRP/PA >0.119 9 group（43 cases） according to the optimal cut-off value. Kaplan-Meier survival curve analysis showed that the survival rate of CRP/PA ≤0.119 9 group was higher than that of CRP/PA >0.119 9 group（Log-rank χ2=22.27，P<0.001）. Cox regression analysis showed that after adjusting for age，sex，left ventricular ejection fraction（LVEF），serum creatinine（SCr），B-type natriuretic peptide（BNP），history of diabetes mellitus，diastolic blood pressure，total bilirubin（TB） and albumin（Alb），patients with CRP/PA >0.119 9 had a 9.03-fold increased risk of mortality than those with CRP/PA ≤0.119 9 [hazard ratio（HR）=9.03，95% confidence interval（CI） 2.88-28.29]. Conclusions High CRP/PA is related to all-cause mortality in patients with AHF，and it is helpful for risk stratification. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2023, 38 (8): 805-806.   DOI: 10.3969/j.issn.1673-8640.2023.08.019 Abstract （107）   HTML （19）    PDF （727KB）（86）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Analysis on influencing factors of G assay FANG Wendong, WANG Youliang, CHEN Shuiping Laboratory Medicine    2023, 38 (8): 796-799.   DOI: 10.3969/j.issn.1673-8640.2023.08.017 Abstract （67）   HTML （11）    PDF （757KB）（83）       Knowledge map    Save G assay is one of the most important serological methods for the early diagnosis of invasive fungal disease（IFD）. Nowadays it is widely used in clinical practice. However，medical contamination，bacterial infection and intestinal mucosal damage can lead to false positivity of G assay results. The use of antifungal drug and breakthrough Candida infection can lead to false negativity of G assay results. In addition，as the proportion of immunosuppressed and critical patients suffering from IFD continues to increase，early diagnosis of IFD is of importance to reduce mortality and improve the prognosis of those patients. This review focuses on the factors influencing G assay to give proper guidance of the use of G assay both in clinical practice and in laboratory，as well as the corresponding countermeasures. Reference | Related Articles | Metrics

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Role of blood lipid levels in assessment of coronary artery stenosis and its treatment in patients with coronary heart disease WU Youhong, SONG Yunxiao, ZHU Yong, GE Wen, BIAN Xiaobo, YUAN Wenhua, ZHAO Zhiyun Laboratory Medicine    2023, 38 (6): 584-589.   DOI: 10.3969/j.issn.1673-8640.2023.06.015 Abstract （78）   HTML （8）    PDF （966KB）（82）       Knowledge map    Save Objective To investigate the value of blood lipid-related indexes in assessing the degree of coronary artery stenosis and treatment in patients with coronary heart disease. Methods Totally，470 patients diagnosed with coronary heart disease in Shanghai Xuhui Central Hospital were collected from January 2018 to December 2022. According to the degree of coronary artery stenosis，the patients were classified into grade Ⅰ group（80 cases），grade Ⅱ group（137 cases），grade Ⅲ group（204 cases） and grade Ⅳ group（49 cases）. The patients were classified into treatment groups（260 cases） and non-treatment groups（210 cases） according to whether they needed surgical or interventional treatment. The levels of low-density lipoprotein cholesterol（LDL-C），triglyceride（TG），high-density lipoprotein cholesterol（HDL-C），apolipoprotein（apo） A1，apo B，total cholesterol（TC） and lipoprotein（a） [Lp（a）] were determined. Logistic regression analysis was used to evaluate the risk factors for coronary artery stenosis or treatment in patients with coronary heart disease. LASSO regression analysis was used to establish a model for judging the treatment of coronary heart disease patients based on blood lipid indicators. Receiver operating characteristic（ROC） curve was used to evaluate the model's efficacy in determining the need for treatment in patients with coronary heart disease. Results The levels of TC，TG，LDL-C，apo A1 and apo B in grade Ⅰ group，grade Ⅱ group，grade Ⅲ group and grade Ⅳ group were increased successively（P<0.05），and serum HDL-C levels were decreased successively（P<0.05）. Lp（a） levels in grade Ⅲ and Ⅳ group were higher than those in grade Ⅰ and Ⅱ groups（P<0.001），and that in grade Ⅱ group was higher than that in grade Ⅰ group（P<0.001）. Logistic regression analysis showed increased TG and LDL-C levels were risk factors for grade Ⅱ and Ⅲ stenosis（P<0.05）. Decreased HDL-C level was a risk factor for grade Ⅱ and Ⅲ stenosis（P<0.05），and increased TC level was a risk factor for grade Ⅲ and Ⅳ stenosis（P<0.05）. The serum levels of TC，TG，LDL-C，apo A1，apo B and Lp（a） in treatment group were higher than those in non-treatment group（P<0.001），and HDL-C levels were lower in non-treatment group（P<0.001）. Logistic regression analysis showed that increased TC，TG，LDL-C，apo A1，apo B and Lp（a） levels and decreased HDL-C levels were risk factors for coronary heart disease needing treatment（P<0.01）. LASSO regression analysis showed that the area under curve of the combined determination model based on TC，TG and Lp（a） for predicting the need for treatment in patients with coronary heart disease was 0.939. Conclusions Blood lipid-related indexes can be used to evaluate the degree of coronary artery stenosis and can be used as potential indicators to guide clinical intervention treatment. Table and Figures | Reference | Related Articles | Metrics

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Role of serum exosomal miR-23b-3p and miR-4429 in patients with hepatocellular carcinoma CHEN Wenju, ZHOU Yong, XU Jiajia, WANG Pan Laboratory Medicine    2023, 38 (7): 624-628.   DOI: 10.3969/j.issn.1673-8640.2023.07.002 Abstract （104）   HTML （15）    PDF （1030KB）（80）       Knowledge map    Save Objective To investigate the roles of serum exosomal microRNA（miR）-23b-3p and miR-4429 expression levels in diagnosing hepatocellular carcinoma（HCC）. Methods Totally，51 HCC patients，45 chronic hepatitis B（CHB） patients and 40 healthy subjects from Taizhou Central Hospital were enrolled from November 2019 to October 2022. The exosomes in serum were extracted by size exclusion chromatography. Identification was performed by western blot. The expression levels of miR-23b-3p and miR-4429 in the exosomes were determined by real-time fluorescence quantitative polymerase chain reaction. Alpha-fetoprotein（AFP） was determined as well. Receiver operating characteristic（ROC）curve was used to evaluate the diagnostic value of miR-23b-3p，miR-4429 and AFP single and combined determinations in HCC. Results The relative expression levels of serum exosomal miR-23b-3p and miR-4429 and AFP levels in HCC group were higher than those in healthy control group and CHB group（P<0.05）. Serum AFP level in CHB group was higher than that in healthy control group（P<0.05），and there was no statistical significance in the relative expression levels of serum exosomal miR-23b-3p and miR-4429 between the 2 groups（P>0.05）. ROC curve analysis results showed that the areas under curves（AUC） of serum exosomal miR-23b-3p，miR-4429，AFP for the diagnosis of HCC were 0.911，0.876 and 0.857，respectively，and the AUC of combined determination was 0.989. The sensitivity and specificity were 92.2% and 98.0%，respectively. Conclusions Serum exosomal miR-23b-3p and miR-4429 can be used as potential biomarkers for the diagnosis of HCC，and the combined determination is helpful to improve the diagnostic efficiency. Table and Figures | Reference | Related Articles | Metrics

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Roles of fecal calprotectin and other inflammatory indicators in children with Crohn's disease ZHOU Yingqin, XIAO Yuan, MENG Jun Laboratory Medicine    2024, 39 (2): 161-165.   DOI: 10.3969/j.issn.1673-8640.2024.02.011 Abstract （55）   HTML （101）    PDF （966KB）（79）       Knowledge map    Save Objective To investigate the roles of fecal calprotectin（FC），C-reactive protein（CRP），erythrocyte sedimentation rate（ESR），interleukin-6（IL-6），tumor necrosis factor（TNF）-α and heparin-binding protein（HBP） in the diagnosis of colonic mucosal lesions in children with Crohn's disease（CD）. Methods Totally，85 children with CD at Ruijin Hospital of Shanghai Jiao Tong University School of Medicine from January 2021 to January 2023 were enrolled and classified into mucosal healing group and mucosal lesion group according to the simple endoscopic score for Crohn's disease（SES-CD），and 19 patients with functional gastrointestinal disease were enrolled as control group. FC，CRP，ESR，IL-6，TNF-α and HBP were determined. Results The levels of FC，IL-6 and TNF-α in mucosal lesion group were higher than those in control group（P<0.05）. There was statistical significance in FC，CRP，ESR，IL-6 and HBP levels between mucosal lesion group and mucosal healing group（P<0.05）. FC，CRP，ESR，IL-6 were positively correlated with SES-CD（P<0.05）. The sensitivity and specificity of FC in determining mucosal healing and mucosal lesion were 84.2% and 98.5%，respectively. Conclusions The levels of FC，CRP，ESR，IL-6 and HBP are related to mucosal healing and lesion status and prognosis of children with CD. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2023, 38 (9): 905-908.   DOI: 10.3969/j.issn.1673-8640.2023.09.019 Abstract （91）   HTML （19）    PDF （2068KB）（77）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2023, 38 (9): 901-904.   DOI: 10.3969/j.issn.1673-8640.2023.09.018 Abstract （97）   HTML （11）    PDF （808KB）（72）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Clinical application and challenges of liquid biopsy biomarkers in non-small cell lung cancer ZHOU Yunlan, SHEN Lisong Laboratory Medicine    2023, 38 (9): 807-811.   DOI: 10.3969/j.issn.1673-8640.2023.09.001 Abstract （125）   HTML （15）    PDF （839KB）（72）       Knowledge map    Save Lung cancer is a malignant tumor with the highest incidence and mortality in China. Liquid biopsy offers advantages such as speed，non-invasiveness and repeatability over traditional tissue biopsy，making it of value in precision medicine and treatment decision for non-small cell lung cancer（NSCLC）. This review provides a brief overview of liquid biopsy in screening，early diagnosis，treatment and prognosis evaluation and resistance surveillance. In the future，new technology of liquid biopsy needs to be further improved for sensitivity and specificity，and standardized processes and reference intervals need to be established. Prospective clinical trials also need to be conducted before its clinical transformation. Reference | Related Articles | Metrics

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Laboratory Medicine    2023, 38 (7): 692-695.   DOI: 10.3969/j.issn.1673-8640.2023.07.014 Abstract （71）   HTML （19）    PDF （1439KB）（71）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Analysis and progress of peptide and protein biomarker methodology for myocardial injury SUN Zepeng, WANG Hongbin, WANG Jiandong, SONG Dewei, XIAO Peng Laboratory Medicine    2023, 38 (8): 784-789.   DOI: 10.3969/j.issn.1673-8640.2023.08.015 Abstract （82）   HTML （12）    PDF （1068KB）（70）       Knowledge map    Save The prevalence of myocardial injury diseases is increasing rapidly in the world. Monitoring and accurate diagnosis of myocardial injury diseases is essential to reduce disease hazard. Currently，the biomarkers in myocardial injury mainly belong to peptides and proteins，typically expressed lower than 10-8 g/L. Immunoassay-based techniques enable a sensitive determination level for low abundant biomarkers，followed by developed as the dominant method. However，some inherent problems have also existed among current clinical immunoassays regarding testing accuracy. To illustrate testing barriers，this review proposes and summarizes some representative issues that usually interfere with the testing accuracy in B-type natriuretic peptide（BNP） and troponin. Meanwhile，some emerging technologies will be introduced in the context，and then to discuss its application that potential applied in myocardial injury clinical measurement. Table and Figures | Reference | Related Articles | Metrics

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Correlations of serum AChE and IL-17 in patients with herpes simplex encephalitis with cognitive function impairment HE Long, WANG Sha, CHENG Liping, LIAO Ziwei, WANG Donghong Laboratory Medicine    2023, 38 (8): 719-724.   DOI: 10.3969/j.issn.1673-8640.2023.08.003 Abstract （64）   HTML （85）    PDF （844KB）（69）       Knowledge map    Save Objective To investigate the correlation between serum acetylcholinesterase（AChE） and interleukin（IL）-17 levels and cognitive function impairment in patients with herpes simplex encephalitis（HSE）. Methods A total of 159 HSE patients（HSE group） in Handan Central Hospital from March 2019 to March 2021 were enrolled. The patients were classified into cognitive impairment group（69 cases） and cognitive normal group（90 cases） according to whether cognitive function impairment occurred. According to the score of the mini-mental state examination（MMSE），the patients with cognitive function impairment were classified into mild group（23 cases，MMSE score 20-25），moderate group（30 cases，MMSE score 11-19） and severe group（16 cases，MMSE score ≤10）. A total of 65 healthy subjects were enrolled as control group. Serum AChE and IL-17 levels were determined. Pearson correlation analysis was used to evaluate the correlation of AChE and IL-17 with Montreal cognitive assessment（MoCA） scores and MMSE scores. Receiver operating characteristic（ROC） curves were used to analyze the efficacy of AChE and IL-17 in diagnosing cognitive function impairment in HSE patients. Results Serum AChE and IL-17 levels in HSE group were higher than those in control group（P<0.05）. The levels of serum AChE and IL-17 in cognitive impairment group were higher than those in cognitive normal group（P<0.05）. The levels of serum AChE and IL-17 in severe group were higher than those in moderate group and mild group（P<0.05），and the levels of serum AChE and IL-17 in moderate group were higher than those in mild group（P<0.05）. The levels of serum AChE and IL-17 were negatively correlated with MoCA score in cognitive impairment group（r values were -0.311 and -0.480，P<0.01），and they were negatively correlated with MMSE score（r values were -0.349 and -0.447，P<0.01）. The areas under curves（AUC） of serum AChE and IL-17 single and combined determinations for the diagnosis of cognitive function impairment in HSE patients were 0.689，0.724 and 0.893，respectively. Conclusions Serum AChE and IL-17 levels in HSE patients are correlated with cognitive function impairment and can be used to assess the severity of cognitive function impairment. Table and Figures | Reference | Related Articles | Metrics

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Number and activity of peripheral blood eosinophils in obese people CHENG Xu, YANG Cunqing, PANG Bo, GU Chun, HOU Xueyun, FEI Jiaxin, WU Min, LI Jun, LIU Guijian Laboratory Medicine    2023, 38 (9): 855-859.   DOI: 10.3969/j.issn.1673-8640.2023.09.008 Abstract （62）   HTML （15）    PDF （1719KB）（69）       Knowledge map    Save Objective To analyze the number and activity of peripheral blood eosinophils in obese people. Methods A total of 41 subjects >40 years old at Guang' anmen Hospital from June to September 2021 were enrolled. According to body mass index（BMI），the subjects were classified into obese group（20 cases，BMI≥30 kg/m2） and control group（21 cases，18.5 kg/m2<BMI<28 kg/m2）. The general information were collected. The expressions of CD62L and CD63 in peripheral blood eosinophils were determined by flow cytometry. The level of serum eosinophil cationic protein（ECP） was determined by enzyme-linked immunosorbent assay（ELISA）. The number and percentage of peripheral blood eosinophils and the expressions of CD62L，CD63 and ECP were compared between the 2 groups. Results The number and percentage of peripheral blood eosinophils and neutrophils and serum ECP levels in obese group were higher than those in control group（P>0.05）. CD62L was lower than that in control group（P<0.05），and CD63 was higher than that in control group（P<0.01）. CD62L was negatively correlated with BMI（r=-0.332，P=0.034）. Conclusions Obesity might be related to the increase of peripheral blood eosinophil activity. Table and Figures | Reference | Related Articles | Metrics

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Relationship between soluble growth stimulating gene 2 protein and clinicopathological features and prognosis in patients with colorectal cancer ZHU Rixiang, YIN Jie Laboratory Medicine    2023, 38 (7): 629-633.   DOI: 10.3969/j.issn.1673-8640.2023.07.003 Abstract （94）   HTML （17）    PDF （877KB）（67）       Knowledge map    Save Objective To investigate the relationship between soluble growth stimulating gene 2（sST2） protein and clinicopathological features and prognosis in patients with colorectal cancer. Methods A total of 101 patients diagnosed with colorectal cancer in Hai'an Hospital of Nantong University from May 2017 to May 2020 were enrolled，and serum sST2 level was determined. Clinical data and clinical laboratory determination results were collected. The optimal cut-off value of sST2 for patient prognosis（death） was evaluated by receiver operating characteristic（ROC）curve. Patient survival state was evaluated by Kaplan-Meier survival curve and Log-rank χ2 test. Risk factors affecting overall survival（OS）were assessed using Cox proportional hazard regression analysis. Results The optimal cut-off value for sST2 was 459 pg/mL. The patients were classified into high sST2 group（>459 pg/mL）and low sST2 group（≤459 pg/mL）. Compared with low sST2 group，age，the proportion of Eastern Cooperative Oncology Group（ECOG） score ≥1 and the proportion of TNM stage Ⅲ in high sST2 group were increased（P<0.05），and the hemoglobin（Hb） level and tumor differentiation degree were decreased（P<0.05）. Kaplan-Meier survival curve indicated that the OS of high sST2 group was lower than that of low sST2 group（ Log-rank χ2=27.01，P<0.001）. Multivariate Cox proportional hazard regression analysis showed that ECOG score，TNM stage Ⅱ，TNM stage Ⅲ，moderate to poor tumor differentiation and sST2>459 pg/mL were associated with short OS [hazard ratios（HR） were 1.99，2.32，4.09，1.39，1.59，95% confidence interval（CI）1.23-3.01，1.64-4.32，2.32-8.32，1.03-2.00，1.21-2.08，P<0.05]. Conclusions High sST2 level promotes the progression of colorectal cancer and serves as an independent risk factor for poor prognosis. It can be potentially applied for the evaluation of patient prognosis. Table and Figures | Reference | Related Articles | Metrics

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Difference in identification of non-tuberculous Mycobacterium between microarray chip and multiple homologous sequence GUO Mingri, LI Yuming, LI Yan, SUN Haibai Laboratory Medicine    2023, 38 (10): 909-914.   DOI: 10.3969/j.issn.1673-8640.2023.10.001 Abstract （110）   HTML （15）    PDF （872KB）（67）       Knowledge map    Save Objective To compare microarray chip and multiple homologous sequence in the identification of non-tuberculous Mycobacterium（NTM），and to provide accurate diagnosis reference for the clinical diagnosis and treatment of NTM infection. Methods For preserved NTM from 2016 to 2019 in Tianjin Haihe Hospital，using microarray chip and multiple homologous sequence，including 16S rRNA，subunit of RNA polymerase B（rpoB），heat shock protein 65（hsp65），the 170 isolates of NTM were analyzed. The accuracy of microarray chip was analyzed for NTM using the identification results of multiple homologous sequence as reference method. The turn-around times（TAT） were compared between the 2 methods. Results Totally，8 NTM species were identified by microarray chip，and 14 NTM species were identified by multiple homologous sequence. Microarray chip failed to identify 10 isolates of slowly growing Mycobacteria（Mycobacterium simiae，Mycobacterium lentflavum and Mycobacterium parascrofulaceu） and rapidly growing Mycobacteria（Mycobacterium chelonae，Mycobacterium mageritense and Mycobacterium vaccae）. All the isolates could be identified by multiple homologous sequence. Based on the results of multiple homologous sequence，7 errors were identified by microarray chip，and the identification accuracy of complex groups was 90.0%（153/170）. The accuracies of 16S rRNA，rpoB，hsp65 and 3 homologous sequences were 93.5%，98.8%，99.4% and 100.0%，respectively. For 53 isolates of Mycobacterium chelonis/Mycobacterium abscessus complex（MABC） that could not be distinguished by microarray chip，6 isolates of Mycobacterium chelonis，25 isolates of MABC subspecies，20 isolates of MABC Masai subspecies and 2 isolates of MABC bolletii subspecies were identified by 3 homologous sequences. It took 8 h for TAT to be identified by microarray chip and 2 d for all the 170 NTM isolates to be identified. It took 3 d to identify TAT from a single sample by multiple homologous sequence and about 5 d to identify all the 170 NTM isolates. Conclusions Microarray chip could quickly provide accurate results for clinical identification of common Mycobacterium species. Multiple homologous sequence could not only identify common Mycobacterium species，but also could provide more accurate identification results and subspecies for the isolates that can not be identified by microarray chip. Table and Figures | Reference | Related Articles | Metrics

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Research progress of exosomal non-coding RNA as biomarkers for disease diagnosis ZHANG Min, WANG Binyu, CHI Weiqun, LIU Yu Laboratory Medicine    2023, 38 (6): 594-598.   DOI: 10.3969/j.issn.1673-8640.2023.06.017 Abstract （80）   HTML （7）    PDF （871KB）（66）       Knowledge map    Save Exosomes are nano-sized vesicles released by living cells and contain a variety of bioactive molecules，including proteins，DNA，mRNA and non-coding RNA（ncRNA）. The expression of exosomal ncRNA will change under different pathological or physiological states，and the differential expression of exosomal ncRNA suggests that it has potential as a biomarker for disease diagnosis. This review introduces the basic characteristics and functions of exosomes and the research progress of exosomal ncRNA for disease diagnosis. Table and Figures | Reference | Related Articles | Metrics

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Evaluation of vaginal secretion routine determination modes and review criteria analysis LU Tingyan, GU Danfeng, WANG Yahong, GE Yafang, YANG Haiou Laboratory Medicine    2023, 38 (11): 1091-1097.   DOI: 10.3969/j.issn.1673-8640.2023.11.016 Abstract （93）   HTML （12）    PDF （876KB）（64）       Knowledge map    Save Objective To evaluate the performance of vaginal secretion routine determination modes，and to establish review criteria. Methods A total of 1 334 vaginal swabs were collected from the International Peace Maternity and Child Health Hospital of Shanghai Jiao Tong University School of Medicine from February to May 2021，of which 1 064 samples were used to evaluate the sensitivities of different determination modes and establish review criteria，and 270 samples were used to verify the review criteria. Automated composition analyzer，vaginitis examination analysis，AutowoMO dry chemical enzyme instrument，automated composition analyzer combined with AutowoMO dry chemical enzyme instrument，automated composition analyzer combined with vaginitis examination analysis artificial wet smear microscopy and Gram staining microscopy were used. Totally，3 initial review criteria were designed using the results of artificial wet smear microscopy and Gram staining microscopy. The sensitivities，specificities，false positive rates，false negative rates and consistency rates of different determination modes were evaluated. The determination mode with the highest sensitivity and the lowest false negative rate was selected to further optimize the review criteria and verify it. Results Of the 1 064 samples，328（30.83%）samples were positive，and 736（69.17%） samples were negative. The results of artificial wet smear microscopy and Gram staining microscopy showed that bacterial vaginosis（BV） accounted for 18.80%（200 samples），vulvovaginal candidiasis（VVC） 14.10%（150 samples） and trichomonas vaginitis（TV） 1.03%（11 samples）. Among the 5 determination modes，automated composition analyzer combined with AutowoMO dry chemical enzyme instrument had the highest sensitivities to BV，VVC and TV [56.00%（112/200），58.00%（87/150） and 90.91%（10/11），respectively]. Through verifying the review criteria of optimal determination mode，the false negative rates of BV，VVC and TV were 5.56%，5.93% and 0，respectively，and the review rate was 24.81%. Conclusions Automated composition analyzer combined with AutowoMO dry chemical enzyme instrument is suitable for the early screening of BV，VVC and TV，and the optimized review criteria can effectively decrease the false negative rate，and the review rate is acceptable. Table and Figures | Reference | Related Articles | Metrics

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Correlation of preoperative RPR in peripheral blood with the prognosis of endometrial carcinoma patients GUO Jie, LI Haixia, LI Xiaoyun Laboratory Medicine    2023, 38 (7): 675-679.   DOI: 10.3969/j.issn.1673-8640.2023.07.011 Abstract （75）   HTML （13）    PDF （873KB）（63）       Knowledge map    Save Objective To investigate the relationship between preoperative peripheral blood red blood cell distribution width-to-platelet count ratio（RPR） and clinicopathological features and prognosis of patients with endometrial carcinoma（EC）. Methods A retrospective analysis was conducted from September 2013 to October 2016 in the First People's Hospital of Shanzhou District. The clinical data of 123 EC patients（including 5-year follow-up results）were collected. Receiver operating characteristic（ROC） curve was used to evaluate the efficacy of RPR in diagnosing EC. Taking 0.193 as the optimal cut-off value，123 EC patients were classified into high RPR group（45 cases） and low RPR group（78 cases），and the clinicopathological features and prognosis of the 2 groups were compared. Cox regression analysis was used to investigate the prognostic factors of EC patients. Results The proportion of non-adenocarcinoma，maximum tumor diameter ≥2 cm，high the Federation International of Gynecology and Obstetrics（FIGO） stage，lymphovascular space infiltration，high differentiation，lymph metastasis，low pathological grade and recurrence cases in high RPR group were higher than those in low RPR group（P<0.05），and the 5-year overall survival rate（40.0%，18/45） was lower than that in low RPR group（73.1%，57/78）（P<0.05）. The 5-year overall survival rate of EC patients with non-adenocarcinoma，maximum tumor diameter ≥2 cm，FIGO stage Ⅲ，lymphovascular space infiltration，high differentiation，lymph metastasis，recurrence and high RPR was decreased（P<0.05）. Cox regression analysis showed that non-adenocarcinoma，recurrence，FIGO stage Ⅲ and high RPR were independent prognostic risk factors for EC patients（P<0.05）. Conclusions RPR is related to clinicopathological progression in EC patients，and high RPR is an independent prognostic risk factor in EC patients. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2023, 38 (6): 599-602.   DOI: 10.3969/j.issn.1673-8640.2023.06.018 Abstract （70）   HTML （11）    PDF （1028KB）（61）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2024, 39 (1): 100-102.   DOI: 10.3969/j.issn.1673-8640.2024.01.018 Abstract （49）   HTML （6）    PDF （1589KB）（61）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Homogenization management and practice of clinical blood and body fluid determinations JIANG Haoqin, XU Qianqian, XU Liming, GUAN Ming Laboratory Medicine    2024, 39 (1): 95-99.   DOI: 10.3969/j.issn.1673-8640.2024.01.017 Abstract （44）   HTML （7）    PDF （856KB）（61）       Knowledge map    Save The homogenization management of medical determination results is a basis for achieving mutual recognition of determination results and an important initiative to promote the sharing mechanism of medical services and enhance synergy among medical institutions. Due to the complexity and timeliness of disease changes，the differences in the performance of determination equipment and quality management of determination processes，as well as the difficulties of morphological determination，a series of medical risks may be brought about during the implementation of homogenization management. By analyzing the main problems that may exist in the pre-，mid- and post-analysis phases and the impact on determination results，preventive measures are analyzed to reduce or eliminate the risk factors affecting the homogenization of blood and body fluid. Combined with the professional characteristic technology，the clinical classic case practice of homogenization management in different medical institutions and multi-hospital areas is elaborated and analyzed. Table and Figures | Reference | Related Articles | Metrics

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Changes and clinical roles of perioperative NT-proBNP and PCT in children with congenital heart disease LI Li, SUN Haiyan, LI Yuanrui, DOU Min, TANG Wen, JIANG Limin, SHEN Lisong Laboratory Medicine    2023, 38 (6): 524-531.   DOI: 10.3969/j.issn.1673-8640.2023.06.004 Abstract （75）   HTML （13）    PDF （910KB）（58）       Knowledge map    Save Objective To evaluate the changes of perioperative N-terminal pro-B-type natriuretic peptide（NT-proBNP） and procalcitonin（PCT） levels in children with simple and complex congenital heart disease（CHD）. Methods Totally，96 children with CHD（≤6 years old）（38 simple CHD patients and 58 complex CHD patients） who underwent cardiac surgery in Xinhua Hospital of Shanghai Jiao Tong University School of Medicine from January 2020 to November 2021 were enrolled. The clinical data of these CHD patients and the NT-proBNP and PCT results at 24 h before operation（T1） and 4 h after operation（T2），24 h after operation（T3） and 48 h after operation（T4）were collected. The changes of perioperative NT-proBNP and PCT were analyzed，and the correlations were evaluated. The perioperative NT-proBNP and PCT levels in predicting the prolongation of intensive care unit（ICU） stay and hospital stay were evaluated by Logistic regression analysis. Results The levels of NT-proBNP and PCT at T3 and T4 were higher than those at T1 and T2. The levels of NT-proBNP at T1，T2，T3 and T4 were negatively correlated with age and body mass（P<0.01），and that in complex CHD children was higher than that of simple CHD children. NT-proBNP levels at T3 and T4 were positively correlated with extracorporeal circulation time and aortic occlusion time（P<0.05），and NT-proBNP at T4 was positively correlated with operation time（P<0.05）. At T4，PCT was negatively correlated with age and body mass（P<0.05），and that in complex CHD children was higher than that in simple CHD children. Multivariate Logistic regression analysis showed that NT-proBNP at T3 [odds ratio（OR）=1.23] and PCT at T4（OR=1.13） were independent factors for the length of ICU stay. NT-proBNP at T3（OR=1.12） and PCT at T4（OR=1.12） were independent factors on the length of hospital stay. Conclusions Perioperative NT-proBNP and PCT levels in children with CHD are increased and then decreased after operation，and they play roles in predicting the prolongation of ICU stay and hospital stay. Table and Figures | Reference | Related Articles | Metrics

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Evaluation of 7 oscillating mixing methods for SARS-CoV-2 nucleic acid determination DU Jinghui, HE Xin, LIU Jing, LIU Ruiyan, BAO Zhijun, WANG Jun, ZHAO Yan, LEI Yaorong, LIU Min, LIU Xu Laboratory Medicine    2023, 38 (7): 680-685.   DOI: 10.3969/j.issn.1673-8640.2023.07.012 Abstract （102）   HTML （15）    PDF （1213KB）（57）       Knowledge map    Save Objective To evaluate the effect of 7 oscillating mixing methods for severe acute respiratory syndrome corona virus 2（SARS-CoV-2） nucleic acid determination and determine the optimal parameters of effective method. Methods In the first stage，30 samples（small sample） of each oscillating mixing method were used to evaluate effectiveness and determine the optimal time parameters from morphology，flow cytometry and real-time fluorescence polymerase chain reaction（PCR）. In the second stage，large sample was used to verify the effectiveness of multi-tube vortex treatment and ultrasonic shock under the optimal parameters，and the oscillation effects of multi-tube vortex treatment and ultrasonic waves were compared. Results Morphology and flow cytometry results showed that epithelial cells in preservation solution were increased by 6 oscillating mixing methods，except ultrasound（P<0.05）. Real-time fluorescence PCR showed that there was no decrease in internal reference cycle threshold（Ct） in nucleic acid amplification after reverse and cyclotron shock treatments（P>0.05）. There was no decrease in internal reference Ct in nucleic acid amplification after blowing for 6 times and reciprocating shock for 5 min. The internal reference Ct in nucleic acid amplification after single/multi-tube vortex treatment and ultrasonic shock was decreased（P<0.000 1）. Real-time fluorescence PCR results of large sample further verified the effectiveness of multi-tube vortex treatment for 2 min and ultrasonic shock for 5 min（P<0.000 1）. Conclusions For the pre-treatment of SARS-CoV-2 nucleic acid samples，2 min vortex oscillating mixing method can be adopted，which is simple and easy to use and has good oscillation effect. Table and Figures | Reference | Related Articles | Metrics

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Errors in Appendix B examples of WS/T 505—2017 and correction TAN Chunyan, ZHOU Ying, MO Zhijiang Laboratory Medicine    2023, 38 (6): 569-573.   DOI: 10.3969/j.issn.1673-8640.2023.06.012 Abstract （88）   HTML （9）    PDF （866KB）（56）       Knowledge map    Save The guideline for evaluation of qualitative test performance （WS/T 505—2017） is the authoritative guide for the performance verification or methodological comparison of qualitative determination items in domestic clinical laboratories. The example analysis in the guideline is an important basis for clinical laboratories and vendors to verify the correctness of datum analysis，but there are some errors in the Appendix B examples involving methodological comparisons that may cause confusion to users. This paper analyzes and corrects errors in the Appendix B examples using the association formula disassembled three-way comparison table，analyzes and corrects calculation errors using formulas that are identical and equivalent to WS/T 505—2017 and the Clinical and Laboratory Standards Institute EP12-A2，and complements other calculation methods for result validation，with a view to helping clinical laboratories use the guideline correctly. Table and Figures | Reference | Related Articles | Metrics

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Depolymerization effect of optical platelet count on reversible platelet aggregation after blood collection DENG Chenxia, MEI Yanping, ZHANG Xia, HUANG Baoshan, TIAN Dan, CAO Mengting, HU Yongqi, LIN Yongping, TIAN Lijun Laboratory Medicine    2023, 38 (11): 1087-1090.   DOI: 10.3969/j.issn.1673-8640.2023.11.015 Abstract （57）   HTML （9）    PDF （1312KB）（56）       Knowledge map    Save Objective To investigate whether the depolymerization effect of optical platelet（PLT） count on ethylenediaminetetraacetic acid-dependent pseudothrombocytopenia（EDTA-PTCR） applicable to reversible PLT aggregation that occurs immediately after anticoagulant blood collection. Methods A total of 201 venous blood samples collected from December 2021 to August 2022 at the outpatient and emergency departments of Tongren Hospital of Shanghai Jiao Tong University School of Medicine，Nanjing Hospital Affiliated to Nanjing Medical University，Guangzhou First Hospital Affiliated to Guangzhou Medical University and Xuzhou Children's Hospital. PLT counting was performed at 0，5，15 and 30 min after blood collection using CDR mode. Blood smear preparation and staining were performed at the above time points for partial samples. PLT aggregation was evaluated at the both sides，the tail and the edge of blood smears. Results Comparing with impedance PLT count at 30 min，the mean deviations at 0，5 and 15 min were 6.92%，3.28% and 1.65%，respectively. Comparing with optical PLT counts at 30 min，the mean deviations at 0，5 and 15 min were 0.76%，0.35% and 0.03%，respectively. PLT counts were higher in optical method compared to impedance method at 0，5 and 15 min after blood collection（P<0.001）. No statistical significance was found between the 2 methods at 30 min after blood collection（P=0.686）. Conclusions The mean deviation of impedance PLT count at 0 min after blood collection is >5% caused by reversible PLT aggregation，which could be corrected by optical method. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2023, 38 (7): 704-706.   DOI: 10.3969/j.issn.1673-8640.2023.07.016 Abstract （144）   HTML （30）    PDF （893KB）（55）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics