Table of Content

30 November 2019, Volume 34 Issue 11

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Orginal Article

Intelligence of clinical microbiological laboratories

JIANG Yanqun, LI Xin

2019, 34(11):  965-966.  DOI: 10.3969/j.issn.1673-8640.2019.11.001

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Because of the complexity of microbiological determination workflows,the automation and intelligence of microbiological laboratories are currently the main challenges for microbiologists. This special topic focuses on microbiological laboratory information system（MLIS） developed independently by Tongji University Tongji Hospital clinical microbiological laboratory. The MLIS system covers 5 points of classic workflows,including smear and inoculation,identification and drug susceptibility,report review,specimen check and warning and critical value report. The MLIS system realizes the application of 2 modes of personal computer（PC）terminal and mobile terminal. Intelligent MLIS standardizes the microbiological operation process and realizes intelligent quality control in the process,which reduces the error rate and improves the work efficiency.

Reengineering intelligent clinical microbiological laboratory operation process

HOU Weiwei, JIANG Lian, WAN Haiying

2019, 34(11):  967-972.  DOI: 10.3969/j.issn.1673-8640.2019.11.002

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Objective To establish on intelligent microbiological laboratory information system（MLIS）,improve work efficiency and reduce error rate by reengineering the operation process and information system of clinical microbiological laboratory. Methods Based on traditional clinical microbiological operation process,an intelligent MLIS was established using Microsoft Visual Studio 2012. Results The association between specimen and patient information was established by bar-code,and the whole process of paperless and process monitoring was realized. New clinical microbiological operation process was established. The time consumed from specimen collection to culture medium matching（before inoculation） was reduced by 66.3%,the reporting time of blood culturing was reduced by 80.5%,the error rate of information manual input was 0.5‰,the error rate of report check was 0.1‰,and the report check error rate was 0 in the 3 years after using the new process. Conclusions Optimizing the microbiological operation process and developing an intelligent MLIS could achieve clear and standardized operation process,realizing intelligent information control,which reduces the error rate and improves work efficiency.

Design of intelligent clinical microbiological testing quality control management system

HOU Weiwei, JIANG Lian, WAN Haiying

2019, 34(11):  973-977.  DOI: 10.3969/j.issn.1673-8640.2019.11.003

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Objective To achieve intelligent control of clinical microbiological workflow and important operational points using information technology,ultimately to unify judgment rules and avoid manual errors in operation process. Methods According to the quality control requirements,the quality control points in operation process was analyzed,the microbiological operation process was reseted,and the program of information control was written. Results The contents of internal quality control（IQC） in the operation process were summarized as quality control of new reagents and batches after changing the reagent batch number/article number. The control points of the microbiological operation process included smear and inoculation,the identification of drug susceptibility,report review,specimen check and warning and blood culture critical value management. Through the management and control of key technical elements in the processes,the quality control in microbiological operation process was improved,and the intelligent management system was realized. Conclusions The intelligent microbiological laboratory information system（MLIS） has standardized the clinical microbiological operation process and quality control,enhances the process control ability and realizes the monitoring and management of the whole process of microbiological testing.

Design and application of mobile terminal and PC terminal of intelligent microbiological laboratory information system

GUO Jian, QIAO Dan, DONG Zhenghua, WANG Dongjiang, HE Lihua, NI Lijun, LÜ Li, WU Wenjuan

2019, 34(11):  978-983.  DOI: 10.3969/j.issn.1673-8640.2019.11.004

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Objective To investigate the design and application of intelligent microbiological laboratory information system（MLIS） with mobile terminal and personal computer（PC） terminal in paperless and whole process management of microbiological testing. Methods Based on the classic microbiological testing mode,2 modes of MLIS with PC terminal and mobile terminal were established to realize the record storage,transmission and monitoring of inspection information,such as professional group signing,allocation unit,inoculation and culture,rapid detection,isolation and identification,drug susceptibility test,report issuance and quality control,as well as the application,signing and receiving of nosocomial infection monitoring. Results On the basis of classic microbiological testing process,the optimization of testing process under PC terminal and mobile terminal was realized. The standardization and paperless of whole process of microbiological testing were realized. Conclusions The combination of PC terminal and mobile terminal of MLIS effectively improves the efficiency of microbiological testing,ensures the quality of testing and standardization of operators and realizes the standardization and paperless of whole process which is potential.

Clinical characteristics and drug resistance of Corynebacterium striatum in Henan

CHEN Wanzhen, LI Gefei, YAO Zonghui, MA Bing, XU Junhong, MA Qiong, YAN Wenjuan, YUAN Youhua, ZHANG Jiangfeng, WANG Shanmei, LI Yi

2019, 34(11):  984-986.  DOI: 10.3969/j.issn.1673-8640.2019.11.005

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Objective To analyze the clinical characteristics and drug resistance of Corynebacterium striatum in Henan,and to provide a reference for rational usage of antibiotics. Methods A total of 74 isolates of Corynebacterium striatum were collected in Henan Provincial People's Hospital from 2016 to 2018,and the sample type,department distribution and drug susceptibility test results were analyzed. Results The incidence rate of Corynebacterium striatum infection in Henan showed an increasing trend from 2016 to 2018（χ²=4.196,P=0.041）. The main sample source was sputum（44.6%）. The main department was intensive care unit（31.1%）. There were 60 cases（81.1%） with underlying diseases,while 65 cases（87.7%） underwent invasive manipulation. Drug susceptibility test showed that these isolates had high resistance rates to penicillin,ciprofloxacin and clindamycin（the drug resistance rates >90%）,but they had low resistance rates to vancomycin and linezolid（the drug resistance rates were 0% and 2.7%,respectively）. Conclusions The infection rate of Corynebacterium striatum in Henan is increased with a relatively high detection rate of non-respiratory samples. The drug susceptibility is regionally specific,so that it should pay more attention on them.

Antibacterial activities of 8 kinds of Chinese herbal medicines to clinical common isolates in vitro

ZHAO Yingmei, QIAO Yun

2019, 34(11):  987-990.  DOI: 10.3969/j.issn.1673-8640.2019.11.006

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Objective To study the antibacterial activities of 8 kinds of Chinese herbal medicines to clinical common resistant and non-resistant isolates in vitro. Methods Totally,8 kinds of Chinese herbal medicines,including Rhizoma coptidis,Honeysuckle,Chrysanthemum indicum,Forsythia,Rhubarb,Cordate houttuynia,Rhizoma phragmitis and Andrographis paniculata,were selected and extracted with pure water concentrated with1 g/mL. Staphylococcus aureus ATCC 29213,methicillin-sensitive Staphylococcus aureus（MSSA）,methicillin-resistant Staphylococcus aureus（MRSA）,Escherichia coli ATCC 25922,Escherichia coli ATCC 35218 which produced extended-spectrum beta-lactamase（ESBL）,ESBL（-） Escherichia coli and ESBL（+） Escherichia coli were used to determine the minimum inhibitory concentration（MIC） and minimum bactericidal concentration（MBC） in vitro by liquid dilution method. Results The MIC of Rhizoma coptidis,Honeysuckle,Chrysanthemum indicum,Forsythia and Rhubarb to Staphylococcus aureus ATCC 29213,MSSA and MRSA were 7.81-125.00 mg/mL.The MIC of Rhizoma coptidis and Honeysuckle to Escherichia coli ATCC 25922,Escherichia coli ATCC 35218 produced ESBL,ESBL（-） Escherichia coli and ESBL（+） Escherichia coli were 62.5-250.0 mg/mL. The MBC of Rhizoma coptidis to Staphylococcus aureus ATCC 29213,MSSA and MRSA were 15.62-62.50 mg/mL,and the MBC of Rhizoma coptidis to Escherichia coli ATCC 25922 and Escherichia coli ATCC 35218 produced ESBL,ESBL（-） Escherichia coli and ESBL（+） Escherichia coli were 250-500 mg/mL. The bacteriostatic action of the same kind of Chinese herbal medicine to resistant and non-resistant isolates had no statistical significance. Conclusions Rhizoma coptidis,Honeysuckle,Chrysanthemum indicum,Forsythia and Rhubarb have strong bacteriostatic action to Staphylococcus aureus ATCC 29213,MSSA and MRSA. Rhizoma coptidis and Honeysuckle also have certain bacteriostatic action to Escherichia coli ATCC 25922,Escherichia coli ATCC 35218 produced ESBL,ESBL（-）Escherichia coli and ESBL（+） Escherichia coli.

Comparative study on reference change values and reference change factors of tumor markers

ZHANG Li, HE Yao

2019, 34(11):  991-993.  DOI: 10.3969/j.issn.1673-8640.2019.11.007

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Objective To calculate the reference change values（RCV） and reference change factors（RCF） of 7 tumor markers [alpha-fetoprotein（AFP）,carcinoembryonic antigen（CEA）,carbohydrate antigen（CA）125,CA15-3,CA19-9,free prostate-specific antigen（f-PSA） and total prostate-specific antigen （t-PSA）]. Methods The unidirectional ranges and bidirectional ranges of RCV and RCF reference change upper limit factor（RCF_up） and reference change lower limit factor（RCF_down） were calculated. Results The RCV and RCF of AFP,CEA,CA125,CA15-3,CA19-9,f-PSA and t-PSA were calculated according to the formulas. Conclusions It is recommended that clinical laboratories use both RCV and RCF as reference intervals for healthy subjects. RCF is used as a method for clinical dynamic interpretation when continuously monitoring related indicators of tumor patients.

Analysis of genotyping and 6 nucleosides' resistance of HBV in patients with chronic hepatitis B

GAO Wanqin, ZHANG Qin, ZHU Lin, WU Bin, HE Wentao, ZHANG Tinglu, ZHAO Changxin

2019, 34(11):  994-997.  DOI: 10.3969/j.issn.1673-8640.2019.11.008

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Objective To investigate the distribution characteristics of hepatitis B virus（HBV） genotypes,the variation of drug resistance genes and the drug resistance of 6 nucleosides in patients with chronic hepatitis B（CHB）. Methods The HBV DNA of 82 CHB patients was determined by real-time fluorescence quantitative polymerase chain reaction（PCR）. The detection of HBV drug resistance gene was carried out by nested PCR to amplify the gene fragment of HBV P region. The Sanger sequencing method was used to detect the gene drug resistance site of HBV P region. Alanine aminotransferase（ALT）,aspartate aminotransferase（AST）,hepatitis B e antigen（HBeAg） and hepatitis B e antibody（HBeAb） were determined. Results Totally,25 cases（30.5%） of HBV type B,51 cases（62.2%） of HBV type C,5 cases（6.1%） of HBV B+C mixed type and 1 case（1.2%） of other type were detected in 82 CHB patients. There was no statistical significance in ALT,AST,HBV DNA load,HBeAg and HBeAb between type B and type C CHB patients（P>0.05）. The sensitivities of adefovir dipivoxil and tenofovir dipivoxil were 64.63%,and the decreased sensitivity of entecavir accounted for 34.15%. The resistance rate of telbivudine was 53.66%,those of emtricitabine and lamivudine were 50.0%. Conclusions The main HBV genotypes of 82 patients with CHB are type C and type B. Adefovir dipivoxil and tenofovir dipivoxil have high sensitivities.

Role of laboratory parameters in incomplete Kawasaki disease with coronary artery lesions

CHEN Jie, ZHOU Yujie, ZHAO Menghua, YUAN Yonghua, TAN Chaochao, CAO Youde

2019, 34(11):  998-1001.  DOI: 10.3969/j.issn.1673-8640.2019.11.009

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Objective To investigate the role of laboratory parameters in the diagnosis and prognosis of incomplete Kawasaki disease（KD） with coronary artery lesions. Methods The clinical data of 295 patients with KD in Hunan Provincial People's Hospital from January 2014 to December 2016 were collected and analyzed retrospectively,and the laboratory parameter results of 86（29.2%） patients with incomplete KD were compared and analyzed. The investigated patients were followed up for 1 year. Results A total of 28 of 86 patients with incomplete KD had coronary artery lesions. The levels of C-reactive protein（CRP） and D-dimer（DD） in patients with coronary artery lesions were higher than those without coronary artery lesions（P<0.01）. Multivariate Logistic regression analysis showed that CRP and DD were independent risk factors for coronary artery lesions（P<0.05）. The levels of CRP and DD were not related to the prognosis of coronary artery lesions（P>0.05）. The areas under receiver operating characteristic（ROC） curves（AUC） of CRP and DD determinations were 0.965 and 0.759,respectively,and the AUC of the combination determination of CRP and DD were 0.989. Conclusions CRP and DD can be used as the markers for the diagnosis and differential diagnosis of coronary artery lesions in incomplete KD.

Role of serum soluble transferrin receptor in the diagnosis of adult iron deficiency anemia

ZHOU Chunlei, CHEN Ruping, WANG Kai, GAO Qiang, MU Hong

2019, 34(11):  1002-1006.  DOI: 10.3969/j.issn.1673-8640.2019.11.010

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Objective To investigate the role of serum soluble transferrin receptor（sTfR） in the diagnosis of adult iron deficiency anemia（IDA）,to observe the correlations between serum iron（SI）,total iron binding capacity（TIBC） and sTfR,and to analyze the diagnostic efficiency of sTfR and sTfR/SI ratio. Methods A total of 79 patients with IDA and 50 patients with other types of anemia,including 35 cases of renal anemia,7 cases of megaloblastic anemia and 8 cases of aplastic anemia,were enrolled. Totally,60 healthy adults were enrolled as control group. Their serum samples were collected. Serum sTfR was determined by immunoturbidimetry assay. SI and TIBC were determined by colorimetry method. The diagnostic efficiency of sTfR and sTfR/SI ratio were analyzed by receiver operating characteristic（ROC） curve analysis. The correlations between SI,TIBC and sTfR were analyzed by regression analysis. Results In healthy adults,there was no statistical significance of sTfR between males and females（P=0.389）. The level of sTfR in IDA group was higher than those in other anemia group and control group（P<0.01）. In the diagnosis of IDA,the area under curve（AUC） of sTfR was 0.985（P<0.01）. The optimal cut-off value of sTfR was 77.42 nmol/L,and the sensitivity and specificity were 93.67% and 96.08%,respectively. There was a negative correlation between sTfR and SI（r=-0.796,P<0.01）,and sTfR was positively correlated with TIBC（r=0.668,P<0.01）. The sTfR/SI ratio in IDA group was higher than those in other anemia group and control group（P<0.01）. In the diagnosis of IDA,the AUC of sTfR/SI ratio was 0.998（P<0.01）. The optimal cut-off value was 11.84. The sensitivity and specificity were 93.70% was 100.00%,respectively. Conclusions The indicator, sTfR, is of significance in the diagnosis and differential diagnosis of IDA,sTfR/SI ratio can be used as a diagnostic indicator of IDA,and its diagnostic efficiency is better than that of sTfR.

Influence of plasma homocysteine level change on atherosclerosis in H-type hypertension patients

CAO Ming, WANG Qijun

2019, 34(11):  1007-1010.  DOI: 10.3969/j.issn.1673-8640.2019.11.011

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Objective To investigate the influence of plasma homocysteine（Hcy） levels on atherosclerosis in patients with H-type hypertension,and to investigate the related risk factors of atherosclerosis,in order to provide a reference for clinical treatment. Methods A total of 207 H-type hypertension patients,200 non-H-type hypertension patients and 200 healthy subjects（healthy control group） were enrolled. The blood pressure,serum Hcy level,total cholesterol（TC）,triglyceride（TG）,lipoprotein（a）[Lp（a）],uric acid（UA）and creatinine（Cr） were determined. Carotid ultrasound examination was performed. The patients were subclassified into 4 groups（H₁,H₂,H₃ and H₄） according to their serum Hcy levels. Results Serum levels of Lp（a） and Cr in H-type hypertension group were higher than those in non-H-type hypertension group and healthy control group（P<0.05）. Compared with healthy control group,the levels of TG and UA were higher in hypertension groups（P<0.05）. There was no statistical significance for the other 3 indicators among the 3 groups（P>0.05）. The proportion of severe hypertension in H-type hypertension group was higher than that in non-H-type hypertension group（P=0.02）,the intima-media thickness（IMT） was greater than that in non-H-type hypertension group（P=0.011）,and the incidence of atherosclerosis in H-type hypertension group was also higher（P=0.032）. The prevalence of atherosclerotic plaque and ITM showed statistical significance among H₁,H₂,H₃ and H₄ groups（P<0.05）. The high Hcy level [odds ratio（OR）=2.515,P=0.036],severe hypertension （OR=2.216,P=0.038） and high Lp（a） level（OR=2.189,P=0.041） were risk factors for atherosclerosis in patients with H-type hypertension. Conclusions H-type hypertension patients have high risk of atherosclerosis. While treating hypertension,regular monitoring of Hcy level is of significance for the treatment and prognosis of H-type hypertension.

Performance evaluation and clinical application of 1,5-anhydrous sorbitol determination by enzymatic method

ZHOU Mi, SHEN Ruojian, WU Weiyun, YAN Hongmei, GUO Wei, PAN Baishen, WANG Beili

2019, 34(11):  1015-1020.  DOI: 10.3969/j.issn.1673-8640.2019.11.013

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Objective To evaluate the performance of 1,5-anhydrous sorbitol（1,5-AG） determination by enzymatic method,and to analyze its role in diabetes mellitus（DM） and acute myocardial infarction（AMI）. Methods A total of 70 patients with DM（DM group）,56 patients with AMI（non-DM group）,78 patients with DM and AMI（DM+AMI group） and 120 healthy subjects were enrolled. The performance of 1,5-AG determination（correctness,precision,lower limit of detection,linear range and reference interval） by enzymatic method was verified. The determinations of 1,5-AG,aspartate aminotransferase（AST）,alanine aminotransferase（ALT）,gamma-glutamyltransferase（GGT）,alkaline phosphatase（ALP）,blood urea nitrogen（BUN）,creatinine（Cr）,uric acid（UA）,total cholesterol（TC）,triglyceride（TG）,high-density lipoprotein cholesterol（HDL-C）,low-density lipoprotein cholesterol（LDL-C）,blood glucose（Glu）,glycated albumin（GA）,glycated hemoglobin A_1c（HbA_1c） and beta-hydroxybutyrate（β-HB） were performed. Pearson correlation analysis was used to evaluate the correlation between 1,5-AG and Glu,GA and HbA_1c. Results By enzymatic method,the 1,5-AG calibrator had a relative bias of 4.05%,which was below the manufacturer's stated bias（<10.0%）. The within-run coefficient of variation（CV） was 0.60%-3.43%,and the between-run CV was 1.02%-3.14%,which met the manufacturer's stated requirements（<5%）. After repeating determination for 20 times,1,5-AG level was close to the manufacturer's stated detection limit（0.25 μmol/L） of the sample（0.28 μmol/L）,and those of 20 times were all determined. The linear range was 24.5-147.5 μmol/L. Of the 120 healthy subjects,the 1,5-AG determination results of 115 cases were fell within the reference range（>85.29 μmol/L）declared by the manufacturer,and the reference interval was validated. 1,5-AG was negatively correlated with Glu,GA and HbA_1c（r =-0.342,-0.591 and -0.685,P<0.001）. The levels of 1,5-AG,ALT,AST,Glu,GA,HbA_1c,β-HB and HDL-C in DM group had statistical significance compared with those in non-DM group（P<0.01,P<0.001）. There was statistical significance in the determinations of 1,5-AG,GA,HbA_1c,AST and ALT between DM and DM+AMI groups（P<0.01,P<0.001）. Conclusions 1,5-AG plays a role in the early diagnosis of DM,and it can be used as a diagnostic indicator for DM.

Role of anti-chromatin antibody determined by automatic multiplex bead immunoassay in the diagnosis of connective tissue diseases

WANG Juan, SHEN Qingying, WANG Kaiwen, ZHAO Jiangfeng

2019, 34(11):  1021-1025.  DOI: 10.3969/j.issn.1673-8640.2019.11.014

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Objective To investigate the role of anti-chromatin antibody determined by automatic multiplex bead immunoassay in the diagnosis of connective tissue diseases. Methods The expressions of anti-chromatin antibody in 384 patients with connective tissue diseases [243 cases of systemic lupus erythematosus（SLE）,39 cases of polymyositis（PM）,15 cases of mixed connective tissue disease（MCTD）,51 cases of Sjögen's syndrome（SS）,7 cases of systemic sclerosis（SSc） and 29 cases of rheumatoid arthritis（RA）],200 non-rheumatic disease patients（disease control group） and 200 healthy subjects（healthy control group） were determined. Anti-double-stranded DNA（dsDNA） antibodies,anti-histone antibodies and anti-nucleosome antibodies were determined by enzyme-linked immunosorbent assay（ELISA）. Anti-nuclear antibodies（ANA） were determined by indirect immunofluorescence. The correlation between systemic lupus erythematosus disease activity index（SLEDAI） score and anti-chromatin antibody was evaluated. Receiver operating characteristic（ROC） curve was used to analyze the roles of these indicators for the diagnosis of SLE. Results The positive rates of anti-chromatin antibodies in healthy control,disease control,SLE,MCTD,PM,SS,SSc and RA groups were 0.00%,1.00%,70.78%,73.33%,23.08%,17.65%,28.57% and 10.34%,respectively. The positive rate of anti-chromatin antibodies increased with the increase of ANA titer. MCTD,PM,SS,SSc and RA groups were merged into non-SLE group. Serum anti-chromatin antibody level in SLE group was higher than that in non-SLE group（P<0.000 1）. For anti-chromatin antibody,anti-dsDNA antibody,anti-nucleosome antibody and anti-histone antibody in SLE group,the rates of single-antibody positive and the other 3-antibody negative was 45.39%,32.34%,13.42% and 7.37%,respectively. There were some cross-positive rates among the 4 antibodies. The areas under curves（AUC） of anti-nucleosome antibody,anti-chromatin antibody,anti-dsDNA antibody and anti-histone antibody for the diagnosis of SLE were 0.813,0.779,0.777 and 0.613,respectively. There was no correlation between anti-chromatin antibodies and SLEDAI score （r= 0.124 6,P=0.177 0）. There was no statistical significance in serum anti-chromatin antibodies between SLE patients without nephritis and those with nephritis（P>0.05）. Conclusions Automatic multiplex bead immunoassay for the determination of anti-chromatin antibody plays a role in the diagnosis of connective tissue diseases.

BRCA1 and BRCA2 gene determinations in breast cancer patients by next-generation sequencing

LI Jinjie, DIAO Yanjun, LI Rui, SU Mingquan, MA Yueyun, HAO Xiaoke, YANG Liu

2019, 34(11):  1026-1031.  DOI: 10.3969/j.issn.1673-8640.2019.11.015

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Objective To determine the breast cancer susceptibility protien（BRCA）1 and BRCA2 genes by next-generation sequencing,and to investigate the roles of BRCA1 and BRCA2 in screening familial bresst cancer. Methods Totally,7 female breast cancer patients and 12 healthy females without the family history of breast cancer were enrolled. All participants received BRCA1 and BRCA2 gene determinations using next-generation sequencing,and all mutations in the probands were confirmed with Sanger sequencing. The family mumbers of the patient who carried BRCA1 mutation had been determined for the same gene site. Results Of the 7 patients,there was 1 case of BRCA2（c.5073dupA） pathogenic mutation,1 case of BRCA1（c.3343G>T） likely pathogenic mutation and 1 case of BRCA2（c.1211A>T） variant of uncertain significance mutation. None of suspicious mutation was found in healthy females. In the family carrying BRCA1（c.3343G>T）,2 cases of breast cancer were found. Conclusions BRCA1（c.3343G>T） has firstly been reported. The family carrying this site shows a high incidence of breast cancer. Therefore,close follow-ups and surgical and drug intervention are recommended for the first-degree relatives of breast cancer patients.

Evaluation on the uncertainty of TB reference measurement procedure by GUF

ZHOU Weiping, DAI Huifen, TAO Yun, WANG Huimin, WANG Jianxin, JI Huoyan, CHEN Feng

2019, 34(11):  1032-1037.  DOI: 10.3969/j.issn.1673-8640.2019.11.016

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Objective To evaluate the uncertainty of Doumas total bilirubin（TB） reference measurement procedure by Guide to the Expression of Uncertainty in Measurement（GUM）uncertainty framework（GUF）. Methods The sample of the International Federation of Clinical Chemistry and Laboratory Medicine（IFCC） External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine（RELA） was determined by Doumas TB reference measurement procedure of the Joint Committee for Traceability in Laboratory Medicine（JCTLM）. The sources of each uncertainty component in the whole procedure were identified. The evaluation of uncertainty components was processed,and a relative combined uncertainty was calculated. Finally,standard uncertainty and expanded uncertainty were given. Results The concentrations of TB of 2014 RELA-A and RELA-B samples were 67.33 and 31.99 μmol/L. The relative combined standard uncertainties were 1.57% and 1.61%. The standard uncertainties were 1.06 and 0.52 μmol/L. The 95% confidence interval was taken,the coverage factor（k）was 1.96,so the expanded uncertainties were 2.07 and 1.01 μmol/L. Conclusions The uncertainty of TB by reference measurement procedure by GUF can meet the requirements of clinical laboratory.

Influence of common drugs on clinical test results

ZHU Yuqing, ZHAO Xiaojun, CHEN Ziqi, WANG Hualiang

2019, 34(11):  1038-1044.  DOI: 10.3969/j.issn.1673-8640.2019.11.017

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This review focuses on the influence mechanism of common drugs on clinical test results,including the in vivo effect of drugs and metabolites,for example,pharmacological effects,bio-affinity effects,drug metabolism and the influence of metabolites. The influence of common drugs,including antibiotics,cardiovascular drugs,antipyretic analgesics,vitamins,hormone drugs,anti-cancer drugs,diabetes drugs,antithyroid drugs,psychotropic drugs,on clinical test results were introduced. This review finally summarizes the ways on reducing the effect of drugs on clinical test results,including timely and effective communication with clinicians and continuous improvement of clinical test methods.