Table of Content

30 April 2021, Volume 36 Issue 4

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Influence of pre-analysis factors on clinical biochemical test results

WANG Wei, WANG Lei

2021, 36(4):  357-361.  DOI: 10.3969/j.issn.1673-8640.2021.04.001

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At present,clinical test items keep increasing,determination methods are constantly updated,and routine biochemical test items account for a large proportion in clinical laboratories. In the process of clinical biochemical test,various factors might influence on the test results,especially pre-analysis factors. The topic of "pre-analysis influencing factors of clinical biochemical test" includes 1 article,2 case reports and 2 reviews,which elaborates the influence of sample characteristics,determination methods,sample turn-around time（TAT） and drugs on clinical biochemical test results. Laboratory personnels should pay attention to thses problems,as well as patient status and clinical communication,continuously improving the accuracy of test results.

Detection and prevention of common interference in turbidimetric immunoassay

JIA Keke, SUN Wenyuan, NIE Rui, CUI Liyan

2021, 36(4):  362-368.  DOI: 10.3969/j.issn.1673-8640.2021.04.002

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The accuracy of turbidimetric immunoassay is affected by a few interference factors,such as sample appearance,endogenous interference,hook effect and carry-over contamination. These interference factors may cause the results increasing or decreasing falsely and further affect clinical diagnosis and treatment monitoring. The laboratory staff should be familiar with common interference factors and mechanisms,communicate with doctors in time and identify,confirm and prevent possible interference,in order to reduce the occurrence of adverse events.

Influence of pre-analysis factors on the determination of serum renal function items

LIU Fei, HU Yanwei

2021, 36(4):  369-373.  DOI: 10.3969/j.issn.1673-8640.2021.04.003

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Uric acid,creatinine,urea and cystatin C（Cys C） are the most commonly used serum renal function items. However,due to the influence of pre-analysis factors,including physiological factors,sample appearance and drugs,the determination results may not be consistent with the clinical manifestations of patients,or even the false results may affect clinical judgement,resulting in misdiagnosis and wrong intervention,and increasing the risk of patients. Clinicians,nurses and laboratorians should pay attention to the above pre-analysis factors,be aware of the influence,and timely find the wrong results caused by the interference of the pre-analysis factors on the determination methods,so as to correctly guide sample collection,and interpret and communicate the results with doctors and patients. This review focuses on the pre-analysis factors affecting the determination of 4 serum renal function items.

Process optimization for determining blood lactic acid and ammonia in inpatients and its quality improvement

JI Xiaoyi, LI Dong, DAI Yan

2021, 36(4):  374-377.  DOI: 10.3969/j.issn.1673-8640.2021.04.004

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Objective To find out the reasons for high positive rate of blood lactic acid and ammonia determination results among the inpatients in Tongji Hospital affiliated to Tongji University,and to take measures to improve the accuracy of blood lactic acid and ammonia determination results. Methods With blood lactic acid >2.2 mmol/L and blood ammonia >30 μmol/L indicating positive results,the total number and positive rate of blood lactic acid and ammonia determinations and the time used for each link in the determination process in the outpatient,emergency,inpatient and inpatient emergency departments were calculated from January to June 2019. Totally,40 clinical samples were collected randomly,and blood lactic acid and ammonia were determined at 15,30,45,60,90,120 and 180 min after sample collection. With the results at 15 min as the baseline values,the deviation between the means of the results at the subsequent time points and the baseline values was calculated. After improvement measures were formulated and implemented,the positive rate of blood lactic acid and ammonia determination results was calculated,and the changes in the time used for each link in the determination process were compared. Results The positive rates of blood lactic acid determinations were 36.87%,50.73%,58.28% and 84.44%,and those of blood ammonia determinations were 14.68%,13.48%,34.04% and 72.67% in the outpatient,emergency,inpatient and inpatient emergency departments from January to June 2019,respectively. The median times from sample collection to determination on machines were 35,32,130 and 83 min in the outpatient,emergency,inpatient and inpatient emergency departments,respectively. The deviations between the results and the baseline values of blood lactic acid and ammonia determination increased gradually over time in the 40 clinical samples. After the improvement of determination process,the positive rates decreased to 32.59% and 22.65% for blood lactic acid and ammonia determination results,respectively. The time used from sample collection to determination on machines was shortened to 43 min. Conclusions Through the optimization of pre-determination process,the time used from sample collection to determination on machines can be reduced effectively,so that the positive rates of blood lactic acid and ammonia determination results are decreased with improved accuracy.

Correlations of mean platelet volume,D-dimer and fibrinogen degradation product levels with cerebral infarction and its pathological degree

DING Ning, ZHANG Weifeng, CHEN Xiaoyong, ZHAO Kewen

2021, 36(4):  384-387.  DOI: 10.3969/j.issn.1673-8640.2021.04.007

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Objective To investigate the correlations of mean platelet volume（MPV）,D-dimer（DD） and fibrinogen degradation product（FDP） with cerebral infarction（CI）,its infarct volume and the National Institute of Health stroke scale（NIHSS） score. Methods From January 2016 to December 2018,303 CI patients from the North Campus of Ruijin Hospital of Shanghai Jiao Tong University School of Medicine were enrolled as CI group,and 70 healthy subjects were enrolled as control group. MPV,DD and FDP levels were determined. The difference of MPV,DD and FPD with different infarct volumes was analyzed. The correlations of MPV,DD and FPD with NIHSS score were analyzed. The correlations of MPV with DD and FPD were evaluated. Results Compared with control group,MPV,DD and FDP levels of CI group were increased（P<0.05）. In CI group,MPV was positively correlated with DD and FDP（P<0.05）. The MPV,DD and FDP levels in patients with small infarct size,medium infarct size and large infarct size were increased in turn（P<0.05）. The MPV,DD and FDP levels were positively correlated with NIHSS score（r=0.871 0,P<0.05;r=0.483 2,P<0.05;r=0.478 1,P<0.05）. A linear correlation was found between MPV level and DD and FDP levels（r=0.426 1,P<0.05;r=0.438 9,P<0.05）. Conclusions MPV,DD and FDP are correlated with CI and its pathological degree,they may be used as independent predictors of CI severity and play roles in prognosis assessment.

Role of thrombophilia related marker screening in patients with unexplained recurrent spontaneous abortion

CAI Mei, SHEN Qiongdan, LIN Yiyu, HE Jialiang, TANG Zhenhua

2021, 36(4):  388-391.  DOI: 10.3969/j.issn.1673-8640.2021.04.008

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Objective To investigate the correlations of thrombophilia related markers and unexplained recurrent spontaneous abortion（URSA）,and to provide a reference for etiological investigation and treatment. Methods The URSA group enrolled 104 patients diagnosed with URSA（abortion ≥ 2 times） from November 2016 to March 2018 in the International Peace Maternity and Child Health Hospital. Totally,45 healthy women who had given birth were enrolled as control group. The lupus anticoagulant（LA） positive rate,anticardioliolipin antibody（ACA） positive rate,protein C（PC） activity,protein S（PS） activity,antithrombin（AT） activity,coagulation factor Ⅻ（FⅫ） activity and D-dimer（DD） level were determined. Results There was statistical significance in LA positive rate,PC activity,PS activity,AT activity,FⅫ activity and DD level between URSA and control groups（P<0.05）. Conclusions LA positive,PS deficiency and FⅫ deficiency are related to URSA. LA,PS,FⅫ and DD are good screening indicators for determining hypercoagulability in URSA patients,supplemented by AT and PC as reference indicators,which can predict the risk of thrombosis events in URSA.

NIPT and NIPT-plus in detecting fetal chromosomal abnormalities among IVF pregnant women

LU Loukaiyi, ZHANG Ying, CHEN Yisheng, WANG Feifei, YING Chunmei

2021, 36(4):  392-395.  DOI: 10.3969/j.issn.1673-8640.2021.04.009

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Objective To evaluate the roles of non-invasive prenatal testing（NIPT） and NIPT-plus in screening fetal chromosomal abnormalities among in vitro fertilization-embryo transfer（IVF） pregnant women through peripheral blood. Methods Pregnant women undergoing NIPT and NIPT-plus at Obstetrics and Gynecology Hospital of Fudan University from May 2017 to October 2019 were enrolled and classified into 2 groups,IVF group and natural conception（control） group. Through retrospective analysis,the roles of NIPT and NIPT-plus in IVF fetal chromosomal abnormalities,including chromosome aneuploidy and copy number variation（CNV）,were evaluated. Results A total of 1 312 pregnant women were enrolled as IVF group,and the age was （32.83±4.02） years at gestational （15.59±2.16） weeks when received NIPT and NIPT-plus,with singleton pregnancy 925 cases and twin pregnancy 387 cases. The age of control group was （30.62±4.77） years at gestational （16.44±2.73） weeks when received NIPT and NIPT-plus,with singleton pregnancy 22 444 cases and twin pregnancy 587 cases. In IVF group,4 cases（3.05‰）were screened out trisomy 21（T21）,and the positive predictive value（PPV） was 100%;3 cases（2.29‰）were screened out trisomy 13（T13）;17 cases（12.96‰）were screened out sex chromosome abnormality,and the PPV was 55.56%;3 cases（2.29‰）were screened out CNV;6 cases（4.57‰）were screened out other chromosomal abnormalities,and the PPV was 33.33%. Conclusions NIPT and NIPT-plus are valuable in chromosomal aneuploidy screening in IVF group. NIPT and NIPT-plus are effective in detecting autosomal and sex chromosome trisomy. When being applied to screening out chromosomal monomer and CNV,NIPT and NIPT-plus have certain value.

Comparison of 4 commercial kits for detecting SARS-CoV-2 nucleic acid

CHEN Jianbo, YANG Yong, LI Huiyuan, REN Chanjun, DU Juan, LI Genshi, TAO Ran, CHEN Jingxian, ZHANG Ling, LI Miao

2021, 36(4):  396-399.  DOI: 10.3969/j.issn.1673-8640.2021.04.010

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Objective To compare the performance of 4 commercial kits for the detection of severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） nucleic acid. Methods Totally,318 pharyngeal swab samples were collected. After nucleic acid extraction,these samples were detected by the 4 commercial kits. Results Kappa values were 0.741（Kit A vs Kit B）,0.653（Kit A vs Kit C）,0.510（Kit A vs Kit D）,0.669（Kit B vs Kit C）,0.633（Kit B vs Kit D） and 0.565（Kit C vs Kit D）（P<0.01）. The positive rates of Kit A,Kit B,Kit C and Kit D were 39.94%,30.50%,31.45% and 18.55%,respectively. There was statistical significance（P<0.05） except for that between Kit B and Kit C（P>0.05）. The sensitivity and specificity were 98.2% and 90.4% for Kit A,87.1% and 99.0% for Kit B,82.6% and 95.2% for Kit C,54.1% and 100.0% for Kit D,respectively,and the accuracy of Kit D was lower than those of the other kits（P<0.05）. Conclusions The performance of Kit A is consistent with that of Kit B,and Kit A has good sensitivity and accuracy for the detection of SARS-CoV-2 nucleic acid. Kit D is not appropriate for screening corona virus disease 2019（COVID-19） due to its low sensitivity.

Role of blood glucose variability in the prognosis of severe corona virus disease 2019 patients

HU Senan, TAN Junfeng, PENG Chang, AI Honghong, LI Dan

2021, 36(4):  400-403.  DOI: 10.3969/j.issn.1673-8640.2021.04.011

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Objective To investigate the role of blood glucose variability in the prognosis of patients with severe and critical（collectively referred to as severe） corona virus disease 2019（COVID-19） patients. Methods The general data of 83 patients with severe COVID-19 were collected,and acute physiological and chronic health evaluation Ⅱ（APACHEⅡ） score when transferred to intensive care unit（ICU）,dynamic glucose variability data within 72 h [mean glucose fluctuation amplitude（Glu-MAGE）,glucose-coefficient of variation（Glu-CV）,glucose instability index（Glu-GLI） and 72 h mean glucose] were recorded. According to the prognosis of 28 d,the patients were classified into survival group and death group. According to the patients' average 72 h blood glucose,the cut-off values of 11.1 and 7.8 mmol/L,the patients were classified into >11.1 mmol/L ,7.8-11.1 mmol/L and <7.8 mmol/L groups. Based on the results 72 h Glu-CV,the patients were classified into 4 groups by quartiles（Q₁-Q₄）. According to the history of diabetes,the patients were classified into non-diabetic group and diabetic group. Blood glucose variability and mortality were compared in each group. Results The age,APACHEⅡ score,72 h mean glucose,Glu-MAGE,Glu-GLI,Glu-CV of death group were higher than those of survival group（P<0.05）. In the >11.1 mmol/L group,Glu-MAGE,Glu-CV were higher than those in 7.8-11.1 mmol/L and <7.8 mmol/L groups（P<0.05）. There was no statistical significance between 7.8-11.1 mmol/L group and <7.8 mmol/L group（P>0.05）. The other items were not statistically significant among the 3 groups（P>0.05）. The 28 d mortality increased with the increase of blood glucose,and the difference among the 3 groups had statistical significance（P<0.05）. In Q₁-Q₄ groups,the 28 d mortality rate of 28 d of diabetic patients was higher than that of non-diabetic patients（P<0.05）. With or without diabetes,the 28 d mortality rate increased with the increase of Glu-CV（P<0.05）. Conclusions Death risk in patients with severe COVID-19 increases with the increasing of blood glucose variability.

Correlation between exercise blood pressure and VCAM-1,sICAM-1 and FMD in patients with essential hypertension

FAN Taohong, SONG Zhiming, AN Yuanyuan, LIU Luyang, DONG Fengjuan

2021, 36(4):  404-407.  DOI: 10.3969/j.issn.1673-8640.2021.04.012

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Objective To investigate the relationship between exercise blood pressure and vascular cell adhesion molecule-1（VCAM-1）,soluble intercellular cell adhesion molecule-1（sICAM-1） and flow mediated dilation（FMD） in patients with essential hypertension. Methods Serum levels of VCAM-1 and sICAM-1 were determined in 80 patients with essential hypertension and 80 healthy subjects（healthy control group）. The diastolic blood pressure of hypertensive patients（rest group）,healthy control group at rest and hypertensive patients after moderate exercise（exercise group） were measured. According to the diastolic blood pressure after exercise,the exercise group was classified into diastolic blood pressure >11.97 kPa（90 mmHg） and diastolic blood pressure≤11.97 kPa（90 mmHg） groups. Pearson correlation analysis was used to evaluate the correlation between various indicators. Results The levels of serum VCAM-1 and sICAM-1 in rest group were higher than those in healthy control group（P<0.05）. Serum VCAM-1 level in exercise group was higher than that in rest group（P<0.01）. Serum VCAM-1 and sICAM-1 in exercise group with diastolic blood pressure >11.97 kPa were higher than those with diastolic blood pressure ≤11.97 kPa（P<0.01）. The diastolic blood pressure represented FMD. The healthy control group,rest group and exercise group had negative correlations between VCAM-1 level and FMD for diastolic blood pressure≤11.97 kPa（r values were -0.24,-0.63 and -0.52,respectively,P<0.05）. In exercise group,there was no correlation between VCAM-1 level and FMD in patients >11.97 kPa（r=-0.34,P>0.05）. The level of sICAM-1 in healthy control group was positively correlated with FMD（r=0.41,P<0.01）. There was no correlation between the level of sICAM-1 and FMD in the other groups（P>0.05）. Conclusions Exercise blood pressure in patients with hypertension is closely related to VCAM-1,sICAM-1 and FMD.

Virus spectrum of children's upper respiratory tract viral infection in Zhenjiang

WANG Yanan, ZHANG Wen

2021, 36(4):  408-411.  DOI: 10.3969/j.issn.1673-8640.2021.04.013

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Objective Viral macrogenomics was used to study the composition of viral communities in nasal cavity of children with upper respiratory tract viral infection in Zhenjiang. Methods A total of 100 nasal mucosal secretion samples were collected from children with upper respiratory tract viral infection. Nucleic acid was extracted and sequenced by Miseque high-throughput sequencing. The viral community was analyzed by viral macrogenomics analysis platform. Results The viral community in the microenvironment of children's nasal mucosal secretion samples in Zhenjiang was mainly composed of adenoviridae (30.13%), picornaviridae (24.04%), coronaviridae (11.22%) and actinoviridae (10.58%), polyomaviridae (10.58%), paramyxoviridae (7.37%) and so on. The detected library viruses were mainly adenoviridae (30.13%) and picornaviridae (24.04%). Conclusions The virus spectrum of children's upper respiratory tract viral infection in Zhenjiang is various,which are mainly adenoviridae and picornaviridae. It provides a reference for the prevention and clinical treatment of children with upper respiratory tract viral infection.

Performance evaluation of Vitek 2 Compact AST-N334,AST-N335,AST-P639 Chinese antimicrobial susceptibility test cards

TIAN Yueru, WANG Jingjing, AI Fuqi, MA Yimin, WANG Bei, JIANG Xiaofei

2021, 36(4):  417-423.  DOI: 10.3969/j.issn.1673-8640.2021.04.015

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Objective To evaluate the performance of Vitek 2 Compact AST-N334,AST-N335,AST-P639 Chinese antimicrobial susceptibility test（AST） cards. Methods Totally,73 strains of quality control bacteria were collected from authoritative institutions and 112 strains of clinical bacteria were randomly collected from hospitalized patients in Huashan Hospital from January to June 2018. The reliability of AST cards was evaluated,the accuracy of AST cards and broth microdilution method（BMM） was evaluated by quality control bacteria and AST results provided by authoritative institutions. The accuracy of AST cards in the detection of antibiotic resistance diversity was evaluated,and the accuracy of AST cards was evaluated by the clinical bacteria using BMM results as the reference standard. Results With the results of AST provided by the authoritative institutions as the reference standard,the percentages of AST-N334,AST-N335 and AST-P639 categorical agreement（CA） were 95.5%（126/132）,96.8%（179/185） and 99.5%（182/183）. With the results of BMM as the reference standard,the percentage of AST-N334 essential agreement（EA） was 88.4% （961/1 087）,CA was 94.6%（903/955）,very major error（VME） accounted for 0.3%（3/955）,major error（ME） accounted for 1.9%（18/955）,and minor error（MIE）accounted for 3.2%（31/955）. AST-N335 EA was 89.9%（1 388/1 544）,CA was 95.1%（1 414/1 487）,VME accounted for 0.3%（5/1 487）,ME accounted for 0.8%（12/1 487）,and MIE accounted for 3.8%（56/1 487）. AST-P639 EA was 95.4%（541/567）,CA was 98.7%（389/394）,ME accounted for 0.5%（2/394）,and MIE accounted for 0.8%（3/394）. Conclusions Vitek 2 Compact AST-N334,AST-N335,AST-P639 Chinese AST cards have high accuracy and reliability in clinical application. However,there are some error rates and limitations,which should be paid attention.

Clinical application of matrix-assisted laser desorption ionization time-of-flight mass spectrometry in the direct detection of blood culture positive specimens

HOU Weiwei, JIANG Lian, LI Dong

2021, 36(4):  424-429.  DOI: 10.3969/j.issn.1673-8640.2021.04.016

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Objective To investigate the feasibility of matrix-assisted laser desorption ionization time-of-flight mass spectrometry（MALDI-TOF MS） in the direct and rapid detection of blood culture positive specimens. Methods Totally,682 positive blood culture specimens were collected from Tongji Hospital. Blood was directly extracted from blood culture bottle and centrifuged in separated gel collecting tube. The centrifugally enriched bacteria were identified by MALDI-TOF MS. They were examined by slide review for the transmitted inoculation culture simultaneously. The culture colonies were identified by Vitek 2 Compact automatic microbial identification system and MALDI-TOF MS. The consistency of the identification results was compared. The strains with different results were verified by 16S rDNA gene sequencing. Results Among 682 blood culture positive specimens,664 cases were infected by single bacterium,and 539 strains（81.2%） were identified by MALDI-TOF MS,122 strains（18.4%） were not identified（species/genus）,but only 3 strains（0.5%） were identified incorrectly（species/genus）,including 1 case of Pantoea,1 case of Klebsiella pneumoniae and 1 case of Staphylococcus capitis. The 664 strains were infected by single bacterium,including 367 strains of Gram-negative bacteria,286 strains of Gram-positive bacteria and 11 strains of Candidia albicans. Compared with the results of traditional colony identification,the accuracies（species/genus） of MALDI-TOF MS were 85.8%/6%,65%/3.1% and 63.6%/0%,respectively. The accuracy of Gram-negative bacteria was higher than those of Gram-positive bacteria and fungi（χ²=57.967,P<0.01;χ²=7.21,P<0.05）. Among Gram-negative bacteria,the accuracies（species/genus） of Enterobacteriaceae,non-fermentative bacteria and other Gram-negative bacteria were 89.0%/5.0%,65.0%/10.0% and 66.7%/22.2%,respectively. Among Gram-positive bacteria,the accuracies（species/genus） of Staphylococcus,Enterococcus,Streptococcus and other Gram-positive bacteria were 70.9%/1.1%,71.4%/2.4%,40.5%/10.8% and 50%/7.1%,respectively. There were 18 cases of complex bacterium infection,of which the accuracy（species/genus） of one or two kinds of bacteria was 77.8% / 0%. Conclusions It is feasible to apply MALDI-TOF MS in direct and rapid detection of positive blood samples,and the accuracy（species/genus） identified monotypic bacteria is high. The accuracy identified common clinical pathogenic bacteria was >70%. The results identified complex bacteria are not good. The rational identification ways should be chosen according to actual situation.

Influence of E3 ubiquitin protein ligase 1 on SOX2 stability

GUO Ping, SUN Xiaozhi, LIU Yujie, LI Ziyi, YANG Jing, GUAN Hengyu, LIAO Bing

2021, 36(4):  430-436.  DOI: 10.3969/j.issn.1673-8640.2021.04.017

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Objective To investigate whether WW domain containing E3 ubiquitin protein ligase 1（WWP1） and WW domain containing E3 ubiquitin protein ligase 2（WWP2） modulate the protein levels of octamer-binding transcription factor 4（OCT4）,sex-determining region Y-box protein 2（SOX2） and NANOG. Methods Exogenous WWP1 or WWP2 was enforced to expression in HEK 293FT cells along with OCT4,SOX2 and NANOG respectively by plasmid transfection. The influence of WWP1 or WWP2 overexpression on the protein levels of OCT4,SOX2 and NANOG was determined by western blotting. GST pull-down and immunoprecipitation experiments were carried out to verified the protein interaction between WWP1 and SOX2. In vitro ubiquitination assay was conducted to demonstrate that WWP1 was a new E3 ubiquitin ligase of SOX2. Results In the co-expression systems of WWP1 and OCT4,WWP1 and SOX2,and WWP2 and OCT4,both WWP1 and WWP2 showed dose-dependent down-regulation of the corresponding co-expression protein OCT4 or SOX2,and the down-regulation of SOX2 protein was the most obvious in the co-expression system of WWP1 and SOX2. In the other co-expression systems,WWP1 or WWP2 had no significant down-regulation effect on the corresponding co-expressed proteins. The lysosome inhibitor chloroquine partially prevented the decrease in SOX2 protein levels. After 24 h treatment with cyclohexmide（CHX）,the SOX2 protein level in WWP1 and SOX2 co-expression system decreased faster than that of SOX2 overexpression alone（P<0.05）. WWP1 protein interacted with SOX2 protein directly and catalyzed ubiquitin modification on SOX2 in vitro. Conclusions WWP1 is a new specific E3 ubiquitin ligase of SOX2,and WWP1 may promote SOX2 protein turnover through ubiquitin-lysosome pathway,resulting in attenuation of protein stability and abundance of SOX2.

Internal quality control of HBV DNA determination in blood center nucleic acid laboratory

WEN Liangxue, ZHANG Lanyi, SU Li, WANG Mingfen, LIU Yongsheng

2021, 36(4):  437-440.  DOI: 10.3969/j.issn.1673-8640.2021.04.018

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Objective To investigate the internal quality control（IQC） of hepatitis B virus（HBV） DNA determination in blood center nucleic acid laboratory. Methods The experiment was effective when quality control（QC） and positive control（PC） were positive,and negative control（NC） was negative. The average value,standard deviation and coefficient of variation of QC cycle threshold（Ct）,PC Ct,VIC Ct and VIC Ct SD were calculated. Draw Levey-Jenning QC chart was drawed. Westgard multi-rules were used. The total number of samples,mixed reactivity and split reactivity were evaluated. The general monitoring was performed（minipool nucleic acid test positive ratio,positive split ratio and effective split ratio）. Results Every experiment was effective in 3 months. QC Ct in day 32,VIC Ct in day 30 and 58 was out of control by rule 1_3s. VIC Ct SD was out of control in day 27 by 2_2s and day 58 by R_4s. Total number of samples,mixed reactivity and split reactivity were 14 172,13 and 8,respectively. Minipool nucleic acid test positive ratio,positive split ratio and effective split ratio were 0.092%,0.056% and 61.54%,respectively. Conclusions It could be applied effectively for blood center to use QC as IQC and Levey-Jenning QC chart of QC Ct,PC Ct,VIC Ct and VIC Ct SD combined with general monitoring indicators.

External quality assessment of fungal culture identification and in vitro drug sensitivity test in Shanghai

CHEN Rong, ZHANG Minmin, XIA Qihang, QIAN Chengkai, CUI Lin, LIU Xuejie, XU Rong, WANG Qingzhong, GE Ping, HUANG Weigang, WANG Jinghua

2021, 36(4):  441-443.  DOI: 10.3969/j.issn.1673-8640.2021.04.019

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Objective To study the development and determination quality of fungal culture identification and in vitro drug sensitivity test in Shanghai through external quality assessment（EQA）. Methods In 2019,EQA issued a total of 10 samples for culture and identification,of which 4 samples required further drug sensitivity test. According to the feedback results,the coincidence rate of fungal identification and the development of in vitro drug sensitivity test were analyzed. Results A total of 75 effective returns were received,45 of which were tested for fungal drug sensitivity. The 4 of 10 strains（including 2 genera and 9 species） were identified with 100% coincidence rate,and the strains with wrong identification results were Candida lusitaniae,Candida guilliermondii,Candida parapsilosis,Candida albicans,Cryptococcus laurentii and Cryptococcus neoformans. In the first EQA in 2019,93.3%（70/75） of the laboratory results were completely correct,6.7%（5/75） of the laboratories had wrong results,but the total score was qualified. In the second EQA,94.7%（71/75） of the laboratory results were completely correct,4.0%（3/75） of the laboratories had wrong results,but the total scores were qualified,and 1.3%（1/75） of the laboratories were unqualified. Conclusions The overall determination ability and accuracy rate of fungal culture and identification in clinical laboratories in Shanghai are relatively high. The number of clinical laboratories carrying out fungal drug sensitivity test is limited. Quality control in clinical laboratories is essential to assure the accuracy of results.

Arteriosclerotic cardiovascular disease risk markers research progress

WANG Qian, ZHU Shiyao, LU Di, ZHU Kun, WU Jiong, QUAN Jiali

2021, 36(4):  447-452.  DOI: 10.3969/j.issn.1673-8640.2021.04.021

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The incidence of cardiovascular diseases is high,the rate of disability is high,and the mortality is high. At present,cardiovascular diseases have become one of the major diseases that seriously endanger human health. Arteriosclerotic cardiovascular disease（ASCVD）risk markers have emerged one after another,and some have become potential targets for intervention. It is helpful for accurate clinical evaluation of patients,which can improve the prevention and treatment of cardiovascular diseases. This review focuses on lipid,hormone,inflammation and nutrition-related ASCVD risk markers.

Progress of IPAI experimental diagnosis

GAO Dongtian, LIU Lihua, SHEN Aihua, SUN Yin

2021, 36(4):  453-461.  DOI: 10.3969/j.issn.1673-8640.2021.04.022

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The diagnostic performance of invasive pulmonary Aspergillus infection（IPAI） determinations were evaluated in terms of etiology（smear microscopy,culture）,immunohistochemistry,molecular biology,13 kinds biomarkers of Aspergillus and combined determination. The positive rate of immunohistochemistry was 87.5%. The sensitivity of smear microscopy was 87.7%,and the specificity was 72.1%. The positive rate of culture was <61%. Among these specimens,sputum accounted for 12%,bronchoalveolar lavage fluid（BALF） accounted for 40%-50%,and blood accounted for <5%. The sensitivity and the specificity of molecular biology were 50%-100% and 75%-89%,respectively. The sensitivity of biomarkers was 61%-100%,and the specificity was 77%-95%. The sensitivity of combined determination was 73%-94%,and the specificity was 0.81%-99.4%. The sensitivities and specificities of these technologies are different,the determations of biomarkers have the characteristics of rapidity,high sensitivity and high specificity,and the combined determination is of great significance.

Advance in the technologies of molecular assays for SARS-CoV-2

HUANG Fei, ZHANG Chunyan, PAN Baishen, WANG Beili, GUO Wei

2021, 36(4):  462-466.  DOI: 10.3969/j.issn.1673-8640.2021.04.023

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The ongoing outbreak of severe acute respiratory syndrome coronavirus 2（SARS-CoV-2） infection has posed a challenge for worldwide public health. Molecular assays for SARS-CoV-2,a gold standard for the diagnosis of pathogen infection,play roles in the diagnosis,therapy,prevention and control of corona virus disease 2019（COVID-19）. This review focuses on the advance in the technologies of molecular assays and patterns of sample pooling of SARS-CoV-2,so as to provide a reference for selecting molecular assays and screening strategies for SARS-CoV-2 in clinical laboratories.