Table of Content

30 August 2021, Volume 36 Issue 8

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Role of secondary results from non-invasive prenatal testing using cell-free DNA for fetal Klinefelter syndrome

CHEN Liyuan, XU Yong, WANG Hui, XU Xiaoxin, XIE Jiansheng

2021, 36(8):  785-789.  DOI: 10.3969/j.issn.1673-8640.2021.08.001

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Objective To investigate the accuracy of secondary results from non-invasive prenatal testing（NIPT） using cell-free DNA for fetal Klinefelter syndrome（KS）,and to analyze parents' decisions in cases with high risk of KS,pregnancy outcomes and factors for parental decision-making. Methods Totally,50 760 singleton pregnant women accepted NIPT using cell-free DNA were enrolled. Pregnancy outcomes and health for the newborns at 3 months of cases with high risk of KS were followed up by telephone. NIPT indications,the results of invasive prenatal diagnosis,pregnancy and neonatal outcomes,factors for parental decisions on invasive prenatal diagnosis and KS acceptance（continue the pregnancy ） were analyzed. Results NIPT detected 0.09%（44/50 760） of high risk KS fetuses. A total of 33 of 44 cases（75.00%） received invasive prenatal diagnosis,and 29 of 33 KS fetuses were determined,giving a positive predictive value of 88.00%（29/33）. Pregnant women at 12⁺⁰-22⁺⁶ gestational weeks were more likely to accept invasive prenatal diagnosis than those at ≥23 gestational weeks（84.00% and 28.57%,P<0.05）. Among the 29 confirmed KS cases,26（90.00%） cases were terminated,and 3（10.00%） cases chose to continue their pregnancies,while all of the 11 cases who refused invasive prenatal diagnosis chose to continue their pregnancies. In view of acceptance of KS fetuses（continue the pregnancy）,there were more women at ≥23 gestational weeks than those at 12 ⁺⁰-22⁺⁶ gestational weeks（71.43% and 27.00%,P<0.05）,more the first pregnancy than the second and the third pregnancy or more times（53.33%,12.50% and 44.44%,P<0.05）,more primiparae than multiparae（52.00% and 15.79%,P<0.05）,more with college degree or below than with university degree or above（57.14% and 23.00%,P<0.05）,and more without fetal karyotype than with fetal KS karyotype（100.00% and 10.34%,P<0.05）. Totally,11 high-risk KS and 3 with fetal KS karyotype cases who continued the pregnancy gave birth to alive babies,but none of the fetuses received postnatal karyotyping. Conclusions The accuracy of NIPT in screening KS is relatively high,so it might be considered as a preferred prenatal screening method for KS and is included into prenatal management.

Clinical values of IL-1β,IL-6 and TNF-α in different clinical courses of chronic HBV infection

LI Caidong, ZHANG Xuqiang, LEI Zhiping, CHEN Qiaoli, CHEN Lu, TIAN Pengfei, DUAN Zhengjun

2021, 36(8):  790-794.  DOI: 10.3969/j.issn.1673-8640.2021.08.002

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Objective To investigate the clinical values of interleukin（IL）-1β,IL-6 and tumor necrosis factor-alpha（TNF-α） in patients with different clinical courses of chronic hepatitis B virus（HBV） infection. Methods Totally,240 patients with chronic HBV infection were enrolled and classified into 60 patients with asymptomatic carriers（ASC）（ASC group）,60 patients with chronic hepatitis B（CHB）（CHB group）,60 patients with liver cirrhosis（LC）（LC group） and 60 patients with hepatocellular carcinoma（HCC）（HCC group）. Sixty healthy subjects were enrolled as healthy control group. Serum IL-1β,IL-6,TNF-α,alanine aminotransferase（ALT）,aspartate aminotransferase（AST）,total bilirubin（TB）,albumin（Alb） and HBV DNA load were determined. Results The levels of IL-1β,IL-6 and TNF-α in ASC group,CHB group,LC group and HCC group were higher than those in healthy control group（P<0.01）. The levels of IL-1β and IL-6 in HCC group were lower than those in ASC group,CHB group and LC group（P<0.01）,and the TNF-α levels in ASC group were lower than those in LC group（P<0.01）. There was no statistical significance for the other indicators among the groups（P>0.05）. There was no correlation between IL-1β,IL-6,TNF-α and HBV DNA load,ALT,AST,TB and Alb in ASC group and CHB group（P>0.05）. Except for the negative correlation between IL-6 and ALT in LC group（r=-0.314,P<0.05）,there was no correlation among the other indicators（P>0.05）. Except for the negative correlation between TNF-α and HBV DNA load in HCC group（r=-0.348,P<0.05）,there was no correlation among the other indicators（P>0.05）. Conclusions Serum IL-1β,IL-6 and TNF-α levels may be used to assess the severity of patients with chronic HBV infection.

Correlation of gestational diabetes mellitus with plasma TMAO

LE Jiangman, LI Tianyuan, TAN Meiyu, WANG Yajie, ZHOU Lida, SHU Jie, WU Jiaoxiang, SUN Hanxiao, XUAN Binbin, CAI Xushan, SHENG Huiming

2021, 36(8):  795-799.  DOI: 10.3969/j.issn.1673-8640.2021.08.003

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Objective To investigate the correlation between plasma trimethylamine oxide（TMAO）and gestational diabetes mellitus（GDM）. Methods Totally,272 singleton pregnant women were enrolled and determined for oral glucose tolerance test（OGTT） from 24 to 28 gestational weeks. There were 178 cases of GDM and 94 cases of healthy pregnant women（control group）. The general data of all pregnant women were recorded. Serum triglyceride（TG）,total cholesterol（TC）,high-density lipoprotein cholesterol（HDL-C）,low-density lipoprotein cholesterol（LDL-C）,apolipoprotein（apo）A1,apo B100,alanine aminotransferase（ALT） and fasting blood glucose （FBG） levels were determined during early pregnancy（gestational week≤13）,and TMAO levels in the second and third trimesters of pregnancy were determined as well. Multiple Logistic regression analysis was used to assess the risk factors of GDM. Results The levels of TG and FBG in the early pregnancy in GDM group were higher than those in control group（P<0.05）,and the levels of ALT,TC,HDL-C,LDL-C,apo A1 and apo B100 in GDM group had no statistical significance from those in control group（P>0.05）. The level of TMAO in GDM group was higher than that in control group（P<0.05）. There was no statistical significance in TMAO level between the second and third trimesters of pregnancy in GDM group（P>0.05）. Multiple Logistic regression analysis showed that the increase of FBG [odds ratio（OR）=3.883,95% confidence interval（CI） 1.805-8.353],TG（OR=2.146,95%CI 1.245-3.702） and TMAO（OR=1.514,95%CI 1.079-2.125） were independent risk factors for GDM. Conclusions Plasma TMAO levels in the second trimester are positively associated with the risk of GDM.

Analysis for distribution and drug resistance of fungemia pathogen from 2014 to 2020 in a Tianjin hospital

LI Yanchun, TIAN Bin, YUE Na, HU Zhidong

2021, 36(8):  800-804.  DOI: 10.3969/j.issn.1673-8640.2021.08.004

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Objective To analyze the distribution and drug resistance of fungemia pathogen from 2014 to 2020 in Tianjin Medical University General Hospital,and to provide a reference for clinical diagnosis and antibiotic usage of fungemia. Methods The clinical data of fungemia patients from 2014 to 2020 were analyzed retrospectively. The distribution and antimicrobial sensitivity results were analyzed statistically by WHONET 5.6 software. Results A total of 401 isolates of yeast-like fungi were isolated from blood culture during the 7 years,and the main isolates were Candida parapsilosis（199 isolates,49.63%）,Candida albicans（62 isolates,15.46%）,Candida tropicalis（37 isolates,9.23%） and Candida glabrata（37 isolates,9.23%）. The majority of fungemia patients were males（63.34%）and were aged ≥65-year-old（56.11%）. All the isolates were highly sensitive to 5-flucytosine and amphotericin B,and different genera presented various degrees of resistance to azoles. Conclusions Candida parapsilosis is the most common pathogen of fungemia in Tianjin Medical University General Hospital. The sensitivity rates of Candida glabrata,Candida tropicalis and Rhodotorula to azoles are relatively low. Analyzing the distribution and drug resistance of fungemia pathogen is of significance in the diagnosis,treatment and prognosis of patients with fungemia.

Influence of different inactivating conditions on nucleic acid determination for respiratory pathogens

WANG Bowen, ZENG Xiaohua, PENG Kaige, LIU Chang, WU Yingchao, HUANG Yingmei, MA Panpan, Lamuciren , LI Guokai, YANG Li

2021, 36(8):  805-808.  DOI: 10.3969/j.issn.1673-8640.2021.08.005

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Objective To investigate the influence of different inactivating conditions on nucleic acid determination for respiratory pathogens. Methods A total of 12 patients who were positive of adenovirus,Mycoplasma,influenza A virus or influenza B virus in nasopharyngeal swabs were enrolled. Different inactivating temperatures and times were designed as follows：the samples were inactivated for 30 min in 56,66,76 and 86 ℃,as well as they were inactivated in 56 ℃ for 30,60,120,240,480 and 960 min. The real-time fluorescence quantitative polymerase chain reaction（qPCR） results were compared between the groups before and after inactivation. Results For adenovirus and Mycoplasma,no statistical significance was found in cycling threshold（Ct） values among the groups that were inactivated for 30 min in 56 and 66 ℃ and non-inactivation（P>0.05）. An increase was determined in the groups that were inactivated for 30 min in 76 and 86 ℃（P<0.05）. Inactivation in 56 ℃ for 30,60,120 and 240 min did not result in changes in Ct values of samples（P>0.05）. Inactivation in 56 ℃ for 480 and 960 min would reduce the Ct values of samples（P<0.05）. For influenza A virus and influenza B virus,no statistical significance was found in Ct values between the groups that were inactivated for 30 min in 56 ℃ and non-inactivation（P>0.05）. An increase was determined in the groups that were inactivated for 30 min in 66,76 and 86 ℃（P<0.05）. Inactivation in 56 ℃ for 30,60 and 120 min did not result in changes in Ct values of samples（P>0.05）. Inactivation in 56 ℃ for 240,480 and 960 min would reduce the Ct values of samples（P<0.05）. Conclusions The samples inactivated in 56 ℃ no more than 120 min would not influence the Ct values in qPCR. Inactivation for severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） does not have effect on nucleic acid determination in other respiratory pathogens.

Correlation analysis of drug resistance and antibiotic usage in a Grade 3 traditional Chinese medicine hospital

XIN Ran, GAO Xiang, AN Haiying, XIN Guangqin, DAI Weili, GONG Jingshu

2021, 36(8):  809-813.  DOI: 10.3969/j.issn.1673-8640.2021.08.006

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Objective To investigate the correlation of drug resistance and antibiotic usage in a Grade 3 traditional Chinese medicine hospital. Methods The determination status and antibiotic usage data from 2013 to 2020 were collected,and the correlation between the determination rate of multiple drug resistant organisms（MDRO）and antibiotic defined daily doses was analyzed by Pearson or Spearman correlation analysis. Results In 2013-2020,the determination rate of methicillin-resistant Staphylococcus aureus（MRSA） showed an increased trend. The determination rate of CRE showed a positive correlation with the defined daily dose of carbapenems （P=0.022 5）,and the determination rate of vancomycin-resistant Enterococcus showed positive correlations with the defined daily doses of polypeptides（P=0.001 2）,macrolides（P=0.006 3） and penicillin（P=0.008 1）.Conclusions The determination rate of MDRO is correlated with the antibiotic defined daily dose,and it is important for MDRO prevention and control to use antibiotic reasonably and scientifically.

Efficacy of imipenem,meropenem,biapenem combined with cefoperazone-sulbactam against hospital-acquired multidrug-resistant Acinetobacter baumannii

XUE Nali, HE Yanpei, FAN Deping, HUANG Qiulan

2021, 36(8):  814-817.  DOI: 10.3969/j.issn.1673-8640.2021.08.007

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Objective To evaluate the optimal treatment plan of cefoperazone-sulbactam combined with imipenem,meropenem or biapenem by Monte Carlo simulation（MCS） in the treatment of multidrug-resistant Acinetobacter baumannii（MRAB）. Methods The minimum inhibitory concentrations（MIC） of imipenem,meropenem,biapenem and cefoperazone-sulbactam alone and in combination against 36 isolates of MRAB were determined,and the fractional inhibitory concentration（FIC） was identified. The probability of achieving target and cumulative response score（CFR） of different anti-infective regimens were calculated by MCS to evaluate the optimal treatment plan. Results MIC₉₀ and MIC₅₀ were both decreased in the evaluation of combined medication. Totally,3 kinds of carbapenems combined with cefoperazone-sulbactam mainly showed that the synergistic effect accounted for >50%,the additive effect accounted for ≥25%,and the irrelevant effect and antagonism accounted for <12%. Conclusions MCS can guide MRAB anti-infective drug treatment. The CFR values of imipenem,meropenem,biapenem and cefoperazone-sulbactam alone are all less than the effective target value,and the effective target value could be obtained by increasing the dose or prolonging the infusion time of combined medication.

Retrospective clinical analysis of κ light chain multiple myeloma with cytoplasmic granules

WANG Hongling, LI Li, ZHANG Chunling, LIN Lihui, DING Jing, LI Huidan, WEI Daolin, BAI Ping

2021, 36(8):  818-822.  DOI: 10.3969/j.issn.1673-8640.2021.08.008

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Objective To analyze cytoplasmic inclusions in plasma cells of multiple myeloma,that will be useful for the morphological diagnosis of multiple myeloma with abnormal plasma cells. Methods A rare kind of plasma cells was found in the bone marrow smear of κ light chain multiple myeloma using Wright-Giemsa staining. The case was analyzed retrospectively,and the relevant literatures in Pubmed were searched. Results Abnormal plasma cell cytoplasma in this case showed obvious,different-sized,irregular and purple-red granules. The granules in this case may be azurophilic granules. Russell bodies,Mott cells,Dutcher bodies and Auer rod-like inclusions were common intra-cytoplasmic inclusions in plasma cells. These inclusions may play roles in clinic. Conclusions The morphological diagnosis of multiple myeloma with abnormal plasma cells plays a role in the diagnosis of light chain multiple myeloma or multiple myeloma with abnormal plasma cell inclusions.

Correlation of serum magnesium level with body composition and survival in hemodialysis patients

QIAN Xiangbei, WU Zhiming

2021, 36(8):  823-827.  DOI: 10.3969/j.issn.1673-8640.2021.08.009

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Objective To investigate the relationship between serum magnesium level and body composition （somatic cell mass index,over-hydration,over-hydration/extracellular water ratio,non-adipose tissue index and adipose tissue index）and 3-year cumulative survival rate in hemodialysis patients. The baseline（initial examination） clinical data of patients were collected,and serum magnesium,beta₂-microglobulin（β₂-MG）,hemoglobin（Hb）,albumin（Alb）,C-reactive protein（CRP）,serum calcium,parathyroid hormone,phosphate and body composition were determined. All the patients were classified into 3 groups according to serum magnesium levels（low-level magnesium group,middle-level magnesium group and high-level magnesium group）. Logistic regression analysis was used to evaluate the risk factors of hypomagnesemia（serum magnesium <0.73 mmol/L） in hemodialysis patients. Kaplan-Meier analysis was used to compare the 3-year cumulative all-cause survival. Cox regression analysis was used to determine the risk factors of 3-year all-cause mortality in hemodialysis patients. Results Compared with the middle-level magnesium group and the high-level magnesium group,the low-level magnesium group was elder（P<0.05）,the dialysis time was shorter（P<0.05）,the serum CRP level and over-hydration/extracellular water ratio were higher（P<0.05）,serum Alb level and somatic cell mass index were lower（P<0.05）,and the over-hydration was higher（P<0.05）. There was no statistical significance in the other items among the 3 groups（P>0.05）. Logistic regression analysis showed that dialysis time and over-hydration/extracellular water ratio were risk factors for hypomagnesemia in hemodialysis patients [odds ratios（OR） were 1.04 and 1.02,95% confidence intervals（CI） were 1.01-1.08 and 1.00-1.04,respectively]. When adjusted for age,sex,body mass index（BMI）,the history of diabetes mellitus and blood pressure,hypomagnesemia [hazard ratio（HR）=1.71,95%CI 1.04-2.52] and Alb（HR=1.79,95%CI 1.71-1.98） were risk factors for increased mortality in hemodialysis patients. Conclusions Hypomagnesemia is correlated with dialysis time and over-hydration/extracellular water ratio,which is an independent risk factor for 3-year cumulative survival of hemodialysis patients.

Relationship between AFP,free-βHCG,uE3 and GDM in the second trimester of pregnancy

WANG Yu, ZHANG Wenwen, LIU Meiling, LIU Xiaojuan

2021, 36(8):  828-832.  DOI: 10.3969/j.issn.1673-8640.2021.08.010

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Objective To investigate the relationship between serum alpha fetoprotein（AFP）,free beta human chorionic gonadotrophin（free-βHCG）,unconjugated estriol（uE3） and gestational diabetes mellitus（GDM） in the second trimester of pregnancy. Methods A total of 17 005 pregnant women who underwent Down's screening in the second trimester of pregnancy and delivered were enrolled,and they were classified into GDM patients（GDM group,378 cases） and healthy pregnant women（control group,16 627 cases）. Serum AFP,free-βHCG and uE3 were determined by time-resolved fluorescence immunoassay. The multiple of median（MoM） of each index was calculated. Multivariate Logistic regression analysis was used to analyze the influencing factors of GDM,and receptor operating characteristic（ROC） curve was drawn to evaluate the diagnostic values of AFP MoM,free-βHCG MoM and uE3 MoM for GDM. Results The age,body mass index（BMI）,fasting blood glucose（FBG）,postprandial 1 h blood glucose,postprandial 2 h blood glucose,AFP MoM,free-βHCG MoM in GDM group were higher than those in control group（P<0.05）,and the uE3 MoM was lower than that in control group（P<0.05）. Gestational week,systolic blood pressure,diastolic blood pressure and blood lipid in the 2 groups had no statistical significance （P>0.05）. Age,BMI,FBG,postprandial 1 h blood glucose,postprandial 2 h blood glucose,AFP MoM and free-βHCG MoM were independent risk factors of GDM [odds ratios（OR） were 1.093,1.107,1.359,1.587,1.520,1.254,1.242,95% confidence interval（CI） were 1.021-1.135,1.058-1.249,1.167-1.560,1.224-1.813,1.372-1.796,1.103-1.458,1.076-1.412],and uE3 MoM was an independent protective factor for GDM（OR=0.901,95%CI 0.864-0.956）. The areas under curves（AUC） of AFP MoM,free-βHCG MoM,uE3 MoM and the combined determination for diagnosing GDM were 0.904,0.852,0.854 and 0.931,respectively. Conclusions AFP,free-βHCG and uE3 play roles in the diagnosis of GDM,which can predict GDM.

Roles of serum GM-CSF,sTREM-1 combined with T-SPOT.TB in the differential diagnosis of pulmonary tuberculosis

LI Dian, ZHENG Zheng, JIANG Yezhou

2021, 36(8):  833-836.  DOI: 10.3969/j.issn.1673-8640.2021.08.011

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Objective To investigate the roles of serum granulocyte macrophage colony stimulating factor（GM-CSF）,soluble triggering receptor expressed on myeloid cell-1（sTREM-1） combined with T-cell spot test for tuberculosis infection（T-SPOT.TB） in the differential diagnosis of pulmonary tuberculosis. Methods A total of 94 patients with pulmonary tuberculosis were enrolled as observation group,and 94 patients with other lung diseases were enrolled as control group. Serum GM-CSF and sTREM-1 levels were determined,and T-SPOT.TB was performed simultaneously. Logistic regression analysis was used to establish the equation of GM-CSF,sTREM-1 and T-SPOT.TB combined determination for the diagnosis of pulmonary tuberculosis. The diagnostic efficiency of GM-CSF,sTREM-1 and T-SPOT.TB in the diagnosis of pulmonary tuberculosis was evaluated by receiver operating characteristic（ROC） curve. Results The levels of GM-CSF and sTREM-1 in observation group were higher than those in control group（P=0.000）. Taking sputum smear or culture test results as standard,the areas under curves（AUC） of GM-CSF,sTREM-1,T-SPOT.TB single determinations and combined determination for the diagnosis of pulmonary tuberculosis were 0.674,0.687,0.758 and 0.832,respectively. The combined determination of the 3 indicators was more effective than single determinations in diagnosing pulmonary tuberculosis（P<0.05）. Conclusions GM-CSF,sTREM-1 combined determination with T-SPOT.TB can effectively improve the diagnostic efficiency of pulmonary tuberculosis.

Roles of FK506,renal function indexes and mononuclear cell count in the judgment of renal transplant recipients with positive urinary BKV DNA

HUANG Sicong, SHI Yongjie, JIA Hongyun

2021, 36(8):  837-842.  DOI: 10.3969/j.issn.1673-8640.2021.08.012

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Objective To investigate the roles of FK506,urea,creatinine（Cr） and mononuclear cell count in the judgment of renal transplant recipients with positive urinary BK virus（BKV） DNA. Methods Urinary BKV DNA were determined in 197 renal transplant recipients,which the cases ≥2.0×10³ copies/mL were enrolled in positive group,and which the cases <2.0×10³ copies/mL were enrolled in negative group. The differences of FK506,urea,Cr,the percentage of lymphocyte（LYMPH%） and the absolute value of lymphocyte（LYMPH#）,the percentage of monocyte（MO%） and the absolute value of monocyte（MO#） between the 2 groups were evaluated. A total of 21 patients with negative to positive urinary BKV DNA within 3 to 6 months after transplantation were enrolled for matching comparison. The efficiency of determining positive urinary BKV DNA by each indicator was evaluated by receiver operating characteristic（ROC） curve,and the correlation between each indicator and urinary BKV DNA load was evaluated by Pearson or Spearman analysis. The indicators with significant difference were compared in 21 recipients with the first change of urinary BKV DNA from negative to positive. Results The levels of FK506,urea and Cr in BKV positive group were higher than those in BKV negative group（P<0.05）. LYMPH%,LYMPH#,MO% and MO# showed no statistical significance between the 2 groups（P>0.05）. Urinary BKV DNA load was positively correlated with FK506（r=0.466,P<0.001）,and there was no correlation with urea（r=0.157） and Cr（r=0.156）（P>0.05）. ROC curve analysis showed that the areas under curves（AUC）of FK506,urea and Cr for the positive determination of urinary BKV DNA were 0.685,0.581 and 0.606,respectively. The optimal cut-off values were 7.05 ng/mL,7.20 mmol/L and 100.5 μmol/L,respectively. The sensitivities were 58.3%,71.4% and 83.3%,and the specificities were 74.3%,46.0% and 38.1%,respectively. FK506 was increased in the 21 recipients when they firstly experienced urinary BKV DNA conversion from negative to positive（P<0.001）,and urea and Cr had no statistical significance（P>0.05）. Conclusions FK506 is valuable in the judgment of renal transplant recipients with positive urinary BKV DNA.

Consistency of abnormal results before and after re-determinations based on K⁺,Na⁺ and total calcium determinations

LÜ Xianmin, YU Guoqi, CHEN Zhengzheng, JIANG Lihua, YAN Luwei, FEI Xianming

2021, 36(8):  843-846.  DOI: 10.3969/j.issn.1673-8640.2021.08.013

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Objective To investigate the consistency and acceptability of abnormal results before and afterre-determinations in clinical laboratory based on K⁺,Na⁺ and total calcium determinations. Methods The samples of abnormal K⁺,Na⁺ and total calcium concentrations close to clinically significant and critical levels were collected to evaluate the within-run and between-run coefficient of variation（CV）. According to the Clinical and Laboratory Standards Institute（CLSI） EP9-A3,the correlation between abnormal results before and after re-determinations was evaluated,and the deviation of results in clinically significant and critical levels was subsequently analyzed. Based on the methods aforementioned,the differences of abnormal K⁺,Na⁺ and total calcium levels before and after re-determinations were further assessed from January to June 2019. Results The CV of K ⁺,Na⁺ and total calcium concentrations close to clinically significant and critical levels were less than the allowable CV in WS/T 403—2012,the health industry standard of the People's Republic of China. The medically determined levels and critical values of K ⁺,Na⁺ and total calcium were respectively substituted into the linear equations obtained from the results before and after re-determinations to calculate the deviation,and the acceptable deviation was less than 1/3 of the allowable total error（TEa） of the Clinical Laboratory Improvement Amendment of 1988（CLIA'88）. In all the samples with abnormal results,the percentages of <1/3TEa-deviations were 99.6%,85.7% and 84.1% for K⁺,Na⁺ and total calcium concentrations,respectively. The percentages of >1/3TEa-deviations were 0.4%,14.3% and 15.9%,respectively. Conclusions Although the performance of the modern determination system is excellent,there is always some inevitably unacceptable results with high deviations. Therefore,the abnormal results in clinical determinations should be re-determined to ensure the accuracy of results before reporting,and to avoid unnecessary troubles caused by abnormal results affecting clinical decisions.

Application of self-made drying device in the preparation of dried blood filter paper samples

CHEN Yujia, SUN Zhiyong, WANG Shaojing, YANG Jiangtao, WU Benqing

2021, 36(8):  857-863.  DOI: 10.3969/j.issn.1673-8640.2021.08.017

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Objective To investigate the value of self-made drying device in the preparation of dried blood filter paper samples. Methods Totally,50 μL of whole blood were dropped onto the filter papers to make blood spots（the diameter was 12 mm）,and fresh blood spots were dried by natural air drying or by self-made drying device. The changes of drying state of blood spots with time under different experimental conditions were recorded. Liquid chromatography-tandem mass spectrometry（LC-MS/MS）was recruited to determine the contents of 8 kinds of amino acids and 15 kinds of carnitines in the dried blood spots. The results were compared between different punching parts [center and peripheral parts（upper left,upper right,lower left and lower right）] and between different drying methods,and the precision and accuracy were evaluated. Results At room temperature of （23±2）℃ and humidity of （60±5）%,it took 95 and 40 min to dry the blood filter paper samples by natural air drying and by the self-made drying device,respectively. However,at room temperature of （23±2）℃ and humidity of （80±5）%,it took 115 min for both methods to dry the blood filter paper samples completely. Except for octanoyl carnitine（C8）and 3-hydroxypalmitoyl carnitine（C16-OH）in the natural air drying with a difference of -15.51% and -19.23%,respectively,and C16-OH in the self-made drying device with a difference of -16.67%,the difference of results between peripheral and center punching sampling was -14.81%-14.61%. The coefficient of variation（CV）（2.85%-21.98%）and accuracy（97.08%-118.18%）of amino acid and carnitine by different drying methods meet the requirements. Conclusions The self-made drying device can improve the drying efficiency of blood filter paper,and it will not affect the results of amino acid and carnitine,suggesting that it can be used for the preparation of dried blood filter paper.

MALDI-TOF MS combined with SDS and SAP pretreatment for rapid identification of positive blood culture

YU Jiajia, LI Yuanrui, LIU Ying

2021, 36(8):  864-868.  DOI: 10.3969/j.issn.1673-8640.2021.08.018

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Objective To evaluate the role of matrix-assisted laser desorption/ionization time-of-flight mass spectrometry（MALDI-TOF MS） combined with sodium dodecyl sulfate（SDS） and saponin（SAP） pretreatment for rapid identification of positive blood culture. Methods A total of 296 positive blood cultures were collected in Xinhua Hospital,Shanghai Jiao Tong University School of Medicine from April 2018 to April 2019. The positive blood cultures were pretreated with SDS and SAP,and the pellets of bacteria were acquired and determined by MALDI-TOF MS. The traditional identification of inoculated culture from positive blood cultures were regarded as golden standard. The identification accuracies of the 2 methods were compared and analyzed. Results The identification accuracies of 272 positive monomicrobial blood cultures using MALDI-TOF MS combined with SDS and SAP pretreatment were 77.2% and 70.6% for species level,respectively（P=0.079）. The identification accuracies were 83.1% and 75.7% for genus level,respectively（P=0.034）. The identification accuracies of 24 positive polymicrobial blood cultures using MALDI-TOF MS combined with SDS and SAP pretreatment were 62.5% and 58.3% for 1 species of bacteria which was identified to species level,respectively（P=0.551）. Conclusions The high identification accuracy of MALDI-TOF MS combined with SDS and SAP pretreatment can help us with reporting the bacterium species that cause bloodstream infection to clinicians rapidly and accurately and provide a reference for clinical empirical anti-infection treatment. SDS is slightly better than SAP as a cell lysis agent.

Establishment of clinical laboratory risk control system based on the ISO 15189 quality system

CHEN Ping, CHEN Tingting

2021, 36(8):  869-874.  DOI: 10.3969/j.issn.1673-8640.2021.08.019

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Objective To establish an informationization-based risk control model for clinical laboratories according to ISO 15189 quality system. Methods Based on ISO 15189 quality system,the whole process closed-loop management of risk setting,information collection,identification,warning,disposal,regular assessment and risk plan adjustment was established by means of informationization according to the 42 automatic identification indicators and 147 risk points. The difference was compared between before and after using the risk control system. Results Since the operation of the risk control system,the system had identified a total of 497 risk events. The risk events were mainly distributed in personnel,environment,reagents,information system,specimens,analytical equipment,quality control,testing process and reports and clinical laboratory management. After 5 risk assessments,the overall risk assessment value decreased by 27.7% compared with that before using the risk control management system. Conclusions The clinical laboratory can select suitable risk points and risk indicators for management,monitoring and regular assessment according to the specific situation of the clinical laboratory,so as to identify the risk factors that are easy to cause harm to patients,and effectively reduce the occurrence of medical errors. Finally,the sharing of information resources of each business module of clinical laboratory is realized,and the effect of clinical laboratory improvement is evaluated and tracked from the perspective of risk management.

External quality assessment of irinotecan-related metabolism genotyping in Shanghai

ZHANG Pengyin, QUAN Jing, WANG Xueliang, XIAO Yanqun, BAO Yun

2021, 36(8):  875-879.  DOI: 10.3969/j.issn.1673-8640.2021.08.020

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Objective To use human genome DNA as quality control samples to evaluate the performance of irinotecan-related metabolism genotyping in external quality assessment（EQA） program,and to discuss the problems found in clinical laboratories enrolled. Methods The samples of various combination of Urdine Diphosphate glucuronosyltransferase 1 family polypeptide A1 (UGT1A1)*6 and UGT1A1*28 genotyped by human genome DNA sequencing were obtained. Each sample panel contained 5 different samples of the genomic DNA above. Participating clinical laboratories were asked to test these samples using their routine methods and report the results before deadline. The score of each laboratory and the overall compliance rate of different samples as well as the sensitivity and specificity of different methods were calculated based on their results. Results The 88.00%（22/25） and 86.36%（19/22） of the clinical laboratories submitted correct results for all the samples in 2 EQA schemes. The overall compliance rates were 96.33%（236/245） and 96.74%（208/215）,respectively. All the clinical laboratories using digital fluorescence hybridization got full credits in 2 EQA schemes. The compliance rates for Sanger sequencing were 91.82%（101/110） and 93.00%（93/100）,respectively. Conclusions The overall accuracy rate of clinical laboratories enrolled is high,while the performance capability of some clinical laboratories needs to be improved,especially the whole process quality control of clinical laboratory developed Sanger sequencing.

Research progress of non-invasive molecular biological methods for detecting Helicobacter pylori

CHI Wenjing, LIU Tao, LIU Yixin, ZHAO Hu, ZHANG Yanmei

2021, 36(8):  880-885.  DOI: 10.3969/j.issn.1673-8640.2021.08.021

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Helicobacter pylori is closely related to the occurrence of digestive system diseases,such as chronic active gastritis,peptic ulcer,gastric mucosa-associated lymphoid tissue（MALT） lymphoma and gastric cancer. It is currently the only pathogen that is classified as class Ⅰ carcinogen by World Health Organization. With the development of molecular biological technology,a variety of molecular biological methods for Helicobacter pylori identification,drug resistance and virulence analysis have emerged,which are of significance to the accurate diagnosis and treatment of Helicobacter pylori infection. The molecular biological methods of non-invasive detection of Helicobacter pylori from oral cavity or fecal samples directly have the advantages of simplicity,efficiency,economy and non-invasiveness,and have become a research hot-spot recently. This review will analyze and compare the pros and cons of various conventional methods for detecting Helicobacter pylori,focusing on the research progress of non-invasive molecular biological methods for detecting Helicobacter pylori.