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Table of Content

    30 May 2016, Volume 31 Issue 5
    Orginal Article
    Standardization of glycated hemoglobin A1c determination and its accuracy
    FENG Renfeng
    2016, 31(5):  345-349.  DOI: 10.3969/j.issn.1673-8640.2016.05.001
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    Glycated hemoglobin A1c(HbA1c) is an important parameter for the diagnosis of diabetes mellitus and monitoring treatment efficiency. After HbA1c measurand being defined by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC),with efforts,the differences are decreasing gradually among clinical laboratories in the world. Although HbA1c manufacturers introduce their instruments' advantages and clinical significance mainly,instead of weaknesses,clinical laboratories should know instruments' characteristics and disadvantages. Instruments can be used into clinical determinations,only when the analysis performances have been verified and satisfy clinical application. Every laboratory should use 2 different methods,which can identify whether there is abnormal hemoglobin or not. Although HbA1c can be determined by immunological methods without interference from abnormal hemoglobin,the influence of abnormal hemoglobin has not been defined. In short,clinical laboratories should learn as much information as possible for patients.

    Antibacterial efficiency of cefoperazone-sulbactam combined with traditional Chinese medicine against pan-drug resistant Acinetobacter baumannii
    TAN Junqing, LI Aiwen, WANG Kangchun, HUANG Shuangwang, ZHOU Bing
    2016, 31(5):  350-354.  DOI: 10.3969/j.issn.1673-8640.2016.05.002
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    Objective To observe the antibacterial efficiency of cefoperazone-sulbactam combined with traditional Chinese medicine against pan-drug resistant Acinetobacter baumannii(PDR-AB) in vitro and in vivo. Methods Different concentrations of cefoperazone-sulbactam and traditional Chinese medicine (gallnut,coptis,scutellaria,mint,fructus forsythia,fructus mume,schisandra chinensis and rheum officinale) were used combinedly. Through calculating minimal inhibitory concentration(MIC) and fractional inhibitory concentration(FIC),the antibacterial efficiency in vitro of 36 isolates of PDR-AB was observed,and the appropriate method was chosen to evaluate the treatment for bacterial-infected mice by determining neutrophil,tumor necrosis factor-alpha (TNF-α)and procalcitonin(PCT). Results Cefoperazone-sulbactam combined with gallnut,coptis and scutellaria had synergized effect,while combined with schisandra chinensis,mint and fructus forsythia, it had additive effect. When combined with fructus mume and rheum officinale, it showed antagonised effect,and it combined with gallnut could significantly reduce the levels of neutrophil,TNF-α and PCT. Conclusions Cefoperazone-sulbactam combined with gallnut has antibacterial efficiency for PDR-AB.

    Methods for determining 3 pathogenic secreted hydrolytic enzymes of oral Candida albicans and their application
    SUN Kangde, ZHANG Jiasheng, CHEN Xu, YU Zhongmin, CHEN Fuxiang
    2016, 31(5):  355-358.  DOI: 10.3969/j.issn.1673-8640.2016.05.003
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    Objective To investigate in vitro expressions of 3 pathogenic secreted hydrolytic enzymes of oral Candida albicans. Methods The activities of secreted aspartyl proteinase(SAP),phospholipase(PL) and lipase(Lip) from 88 isolates of oral Candida albicans were determined by bovine serum albumin agar,egg yolk agar and tributyrate agar,respectively. Results In the 88 isolates,70(79.5%) isolates showed high activity of SAP ,and 64(72.7%)isolates showed high activity of PL,while only 1(1.2% ) isolate showed high activity of Lip,and 67(76.1%) isolates produced medium activity of Lip. Positive correlation was found between SAP and PL(r = 0.221,P<0.05),and no correlation was found between Lip and SAP or between Lip and PL( r = 0.085 and 0.109,P = 0.432 and 0.311). Conclusions Most of the isolates have high expressions of SAP and PL and medium expression of Lip. Secreted hydrolytic enzyme is one of the main virulence factors of oral Candida albicans.

    Significance of monitoring reticulocyte count during chemotherapy for patients with cancer
    ZHANG Yongli, LU Renquan, ZHOU Lei, GUO Lin
    2016, 31(5):  359-362.  DOI: 10.3969/j.issn.1673-8640.2016.05.004
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    Objective To monitor the change of reticulocyte(RET)count during chemotherapy for cancer patients,and evaluate RET count as an early indicator of bone marrow arrest and recovery. Methods Twenty-one d is a treatment cycle of chemotherapy for all cancer patients in this study,while the 0th day was defined as pre-chemotherapy,chemotherapy was conducted on the 1st day to 3rd day,and the 7th day to 21st day were as post-chemotherapy. RET percentages (RET%) of 48 cancer patients before and after chemotherapy were determined by SYSMEX XE-4000 automatic hematology analyzer (XE-4000),and compared with traditional manual counting for RET. Red blood cell(RBC)and white blood cell(WBC)counts were determined. These 48 cancer patients were classified into 2 groups according to RET% on the 10th day,high-elevated RET group (RET% increased≥25%)and low-elevated RET group (RET% increased <25%). The changes of RBC and WBC counts between the 2 groups were analyzed. Results RET% by XE-4000 was in accordance with that by manual counting. Since bone marrow arrest occurred after chemotherapy,RBC count,WBC count and RET% on the 7th and 10th day were lower than those before chemotherapy(P<0.05). RBC count increased with the elevation of RET%,especially on the 21st day,which was higher than that before chemotherapy(P<0.05). Although RET count increased on the 21st day,there was no statistical significance in low-elevated RET group(P>0.05). In high-elevated RET group,WBC count increased and fluctuated significantly during bone marrow recovery,and then RBC count increased. In contrast to high-elevated RET group,WBC count in low-elevated RET group increased later,along with slight change in RBC count. Conclusions RET count might act as an early indicator of bone marrow arrest and recovery after chemotherapy.

    Determination and significance of serum inflammatory factors and biochemical indices in patients with Alzheimer′s disease and vascular dementia
    DING Binbin, WU Jianmin, JIE Yong, SUN Ronglian, WANG Xiaoyan
    2016, 31(5):  363-367.  DOI: 10.3969/j.issn.1673-8640.2016.05.005
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    Objective To analyze the changes of serum inflammatory factors and biochemical indices in patients with Alzheimer′s disease(AD) and vascular dementia(VD),and to provide a reference for clinical diagnosis. Methods A total of 37 AD patients,36 VD patients and 37 healthy subjects (control group) were enrolled. Serum inflammatory factors [interleukin 1 alpha (IL-1α),interleukin 1 beta(IL-1β),interleukin 6(IL-6) and tumor necrosis factor-alpha(TNF-α)] and biochemical indices such as free fatty acid(FFA),total cholesterol(TC),triglyceride(TG),high-density lipoprotein cholesterol(HDL-C),low-density lipoprotein cholesterol(LDL-C),apolipoprotein A(apo A),apolipoprotein B(apo B),apolipoprotein E(apo E),lipoprotein(a)[Lp(a)]and homocysteine (Hcy) were determined. The changes were evaluated among the groups. Results IL-1β,IL-6,TNF-α and Hcy were increased in AD and VD groups(P<0.05),and HDL-C and apo A were decreased(P<0.05). LDL-C in VD group were increased compared with control group(P<0.05),and TG in VD group was higher than those in AD and control groups(P<0.05). The other indices had no statistical significance among AD,VD and control groups(P>0.05). Conclusions The determination of serum inflammatory factors and biochemical indices might be helpful for the diagnosis of AD and VD.

    Evaluation on measurement uncertainty of serum total bilirubin concentration by reference procedure
    DAI Huifen, WANG Huimin, WANG Jianxin, JI Huoyan, MENG Shuting
    2016, 31(5):  368-372.  DOI: 10.3969/j.issn.1673-8640.2016.05.006
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    Objective To investigate the evaluation method for measurement uncertainty of serum total bilirubin (TBil) concentration in clinical reference laboratories.Methods The International Federation of Clinical Chemistry and Laboratory Medicine(IFCC) external quality assessment scheme for reference laboratories in laboratory medicine(RELA)sample was measured by Doumas serum TBil reference procedure of the Joint Committee for Traceability in Laboratory Medicine(JCTLM),and the sources of uncertainty components were identified. The evaluation of uncertainty components was processed,and then a combined standard uncertainty was calculated. Finally,an expanded uncertainty was obtained.Results The TBil average concentration of 2013 RELA-A sample was 52.30 μmol/L,the combined standard uncertainty was 0.67 μmol/L,the 95% confidence interval was taken,and the coverage factor(k)was 2. The expanded uncertainty was 1.34 μmol/L. The TBil average concentration of 2013 RELA-B sample was 81.60 μmol/L,the combined standard uncertainty was 0.70 μmol/L,the 95% confidence interval was taken,and the k was 2. The expanded uncertainty was 1.40 μmol/L.Conclusions The established method can meet the requirements of clinical laboratories for serum TBil reference procedure.

    Relation of HMGB1 expression and cell apoptosis of synovial tissue with disease activity parameters in rheumatoid arthritis patients
    ZHU Li, WU Yu, QIN Yanghua, SHEN Qian
    2016, 31(5):  373-378.  DOI: 10.3969/j.issn.1673-8640.2016.05.007
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    Objective To investigate the relation of high mobility group box-1 protein(HMGB1)expression and cell apoptosis of synovial tissue with disease activity parameters in rheumatoid arthritis(RA)patients. Methods TUNEL apoptosis assay and immunochemistry analysis were used to determine HMGB1 expression and cell apoptosis of synovial tissue in RA patients(12 cases)and osteoarthritis(OA) patients(12 cases). Immune rate scatter nephelometry,enzyme-linked immunosorbent assay(ELISA)and infrared barrier method were performed to determine serum C-reactive protein(CRP),rheumatoid factor(RF),anti-cyclic citrullinated peptide (CCP)antibody and erythrocyte sedimentation rate(ESR)of the 2 groups. Results The differences for age and sex between RA and OA groups were not statistically significant(P>0.05). CRP,RF,anti-CCP antibody and ESR were significantly higher in RA group than those in OA group(P<0.01). HMGB1 expression in synovial tissue was significantly higher in RA group than those in OA group(P<0.01),and the cell apoptosis of synovial tissue was significantly lower in RA group than that in OA group(P<0.01). The score of cell apoptosis in RA group was negatively correlated with CRP,ESR,anti-CCP antibody and RF(r=-0.628,-0.815,-0.783 and-0.757,P<0.05),and HMGB1 expression score was positively correlated with CRP,ESR,anti-CCP antibody and RF(r=0.638,0.739,0.698 and 0.648,P<0.05). Conclusions HMGB1 expression in RA group might affect the disease activity of RA by regulating cell apoptosis.

    Serum PCT determination in the diagnosis and treatment of lower respiratory tract infection
    DUAN Xiuqun, YIN Liangqiong, GONG Guofu
    2016, 31(5):  379-382.  DOI: 10.3969/j.issn.1673-8640.2016.05.008
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    Objective To investigate the significance of serum procalcitonin(PCT) determination in the diagnosis and treatment of lower respiratory tract infection. Methods According to clinical symptoms,chest X-ray results and laboratory determination(sputum culture,serological detection,antigen detection and molecular biological detection) results,200 patients with lower respiratory tract infection were classified into bacterial infection,viral infection and mycoplasma and chlamydia infection groups,and their PCT levels were compared with those of 50 healthy subjects(healthy control group). According to the voluntary principles,the bacterial infection group was sub-classified into control group and treatment group. Control group was treated according to antibiotics usage guidelines for regular treatment,and treatment group was treated with antibiotics by monitoring PCT levels. The antibiotic usage rates,antibiotic usage days,the length of inhospital,inhospitalization expenses,and so on were compared between the 2 groups. Results PCT levels in bacterial infection group and mycoplasma and chlamydia infection group were significantly higher than those in viral infection group and healthy control group(P<0.05). PCT levels between bacterial infection group and mycoplasma and chlamydia infection group had statistical significance(P<0.05),and those between viral infection group and healthy control group had no statistical significance(P>0.05). PCT positive determination rates were 97.6% in bacterial infection group,17.1% in viral infection group and 17.9% in mycoplasma and chlamydia infection group. The antibiotic usage rates in treatment group and control group were 45.75% and 64.15%,respectively. The antibiotic usage days were 6.5±1.6 and(10.1±2.2)d. The lengths of inhospital were 9.4±2.8 and(12.8±4.5)d. Inhospitalization expenses were 5 862.5±98.6 and(7 420.5±115.4)CNY. The above statistics indices between the 2 groups had statistical significance(P<0.05). Conclusions PCT determination can assist the clinical identification of lower respiratory tract infection,and monitoring PCT level can provide a reference for antibiotic usage in lower respiratory tract bacterial infection.

    Sensitivity of carbapenem-resistant Enterobacteriaceae with different resistant genotypes against tigecycline
    LIU Lirong, LI Xiangyang, QU Lingna, TANG Yuxia, CAO Jinghong, YAN Xiaoping
    2016, 31(5):  383-386.  DOI: 10.3969/j.issn.1673-8640.2016.05.009
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    Objective To investigate the sensitivity of carbapenem-resistant Enterobacteriaceae(CRE)with different resistant genotypes against tigecycline. Methods The isolates of Enterobacteriaceae against ertapenem were screened by modified Hodge test (MHT),the diameters of tigecycline inhibition zones were determined by K-B method, and beta-lactamase gene of CRE was determined by polymerase chain reaction(PCR). Results A total of 68 isolates of CRE were screened by MHT,and there were 48 positive isolates,accounting for 70.6%. In the 48 positive isolates, there were 40 isolates (83.3%) carrying hydrolyzed carbapenem antibiotics extended-spectrum beta-lactamase gene, including KPC,NDM-1,IMP-8 and IMP-4. KPC was the most,accounting for 67.5%. In the 68 isolates of CRE,54 isolates were sensitive,12 isolates were intermediary,2 isolates were resistant,and the total sensitivity was 97%. There was no statistical significance for the sensitivity of positive and negative isolates in the 68 isolates of CRE by MHT (χ2=3.599,P>0.05). Conclusions Tigecycline for CRE exhibits excellent antibacterial activity. Antibacterial effect of tigecycline is not influenced by enzyme activity.

    Changes of CD3+,CD3+CD4+ and CD3+CD8+T lymphocytes before and after treatment in patients with leukemia and their significance
    YUAN Yongming, CHENG Li, ZHANG Shu, PENG Xianchong, QU Bin
    2016, 31(5):  387-391.  DOI: 10.3969/j.issn.1673-8640.2016.05.010
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    Objective To investigate the changes of T lymphocyte subsets (CD3+,CD3+CD4+,CD3+CD8+T cells) in peripheral blood before and after treatment in patients with leukemia and their significance. Methods SemiBio Slide assay was used to determine 100 leukemia patients [45 cases of acute lymphoblastic leukemia(ALL) and 55 cases of non-acute lymphoblastic leukemia (N-ALL)] and 90 healthy subjects(healthy control group) for peripheral blood T lymphocyte subsets as absolute value. Simultaneously,IgG,IgA and IgM were determined. According to remission after treatment,the patients with leukemia were classified into remission group(48 cases,21 cases of ALL and 27 cases of N-ALL) and non-remission group(52 cases,24 cases of ALL and 28 cases of N-ALL). Results In ALL group and N-ALL group,peripheral blood CD3+and CD3+CD4+T cell absolute values,CD3+CD4+/CD3+CD8+ratio,IgG,IgA and IgM levels were significantly lower than those in healthy control group(P<0.05). CD3+CD8+T cell absolute values were slightly higher than those in healthy control group,but there was no statistical significance(P>0.05). Whether it is ALL or N-ALL,after treatment, CD3+and CD3+CD4+T cell absolute values,CD3+CD4+/CD3+CD8+ratio,IgG,IgA and IgM in remission group was significantly higher than those before treatment (P<0.05),which were close to those in healthy control group (P>0.05). There was no statistical significance in non-remission group between before and after treatment(P>0.05). Conclusions The determination of T lymphocyte subsets (CD3+,CD3+CD4+,CD3+CD8+T cells) using absolute values has certain significance for disease monitoring and prognosis in leukemia patients.

    Establishment and performance evaluation of LC-MS/MS for the determination of plasma paclitaxel
    WANG Kouqiong, SHAO Wenqi, PENG Yingfei, HUANG Fei, CHEN Fangjun, WU Jiong, WANG Beili, ZHANG Chunyan, GUO Wei, PAN Baishen
    2016, 31(5):  394-398.  DOI: 10.3969/j.issn.1673-8640.2016.05.012
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    Objective To establish a liquid chromatography-tandem mass spectrometry(LC-MS/MS)for the quantitative determination of plasma paclitaxel,and to evaluate its performance. Methods Plasma paclitaxel was determined quantitatively by LC-MS/MS. High performance liquid chromatography was used. The flow speed was 0.3 mL/min. Multiple reaction monitoring (MRM) was used for quantitative determination. The ion pairs of paclitaxel and PTX-D5 were 876.4>308.2 and 881.5>313.2,respectively. According to U.S. Food and Drug Administration (FDA) guideline about bioanalytical method validation,the general analytical performance validation was performed for linearity,detection limit,precision and accuracy. Results The linearity was 10-1 000 ng/mL. The detection limit was 10 ng/mL. Within-run and between-run coefficients of variation (CV) were ≤4.2% and ≤8.9%,respectively. The accuracy was 88.7%-104.0%. Conclusions The performance of established LC-MS/MS meets evaluation standards,and the assay is accurate and precise for the determination of paclitaxel.

    Performance of improved uricase determination procedure and comparison with chromatography-mass spectrometry reference determination procedure
    HAN Genliang, XU Feng, XU Ling, SHEN Min, GUO Huitao, ZHANG Hong
    2016, 31(5):  399-404.  DOI: 10.3969/j.issn.1673-8640.2016.05.013
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    Objective To evaluate the performance of improved uricase determination procedure and its uncertainty. Method According to A Candidate Reference Method for Uric Acid in Serum Optimization and Evaluation which was published by American Association for Clinical Chemistry (AACC),the accuracy was improved by standard solution gravimetric method. The precision was improved by multiple centrifugation. The accuracy and precision were evaluated,and the uncertainty was evaluated according to Guide to the Expression of Uncertainty in Measurement(GUM). Results The standard curve linear equation of uric acid was Y=0.005 74X+0.003 09(R2=0.999 99). The standard bias [coefficient of variation (CV)] was < 1.0%. The recovery ranged from 98.5% to 101.5%. The results of the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC)external quality assessment scheme for reference laboratories in laboratory medicine(RELA) samples fell in the range of target value,with bias ±1.5% and relative standard uncertainty< 2.0%. Conclusions The improved uricase determination procedure is successfully established. It may provide an effective way for routine determination traceability of serum uric acid.

    Methodology verification on the performance of BD FACSCantoⅡflow cytometry analyzer
    CHEN Shuying, CHEN Jian, LIN Yong, SHI Chaohui
    2016, 31(5):  405-411.  DOI: 10.3969/j.issn.1673-8640.2016.05.014
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    Objective To verify the main performance of BD FACSCantoⅡflow cytometry analyzer. Methods According to the Clinical and Laboratory Standards Institute(CLSI)documents and projects provided from other literatures,the analytical performance of BD FACSCantoⅡflow cytometry analyzer was evaluated by precision,accuracy,linearity and reference range of common test items(peripheral blood lymphocyte subtypes:CD3+T cell,CD3+CD4+T cell,CD3+CD8+T cell,B cell and NK cell). The results were compared with the claims of manufacturers. Results The precision,accuracy,linearity and reference range of BD FACSCantoⅡflow cytometry analyzer in the determination of peripheral blood lymphocyte subtypes were in line with the performance parameters of manufacturers. Conclusions BD FACSCantoⅡflow cytometry analyzer has a good performance,accurate measurement and a high repeatability in the determination of peripheral blood lymphocyte subtypes,which can satisfy the need in clinics.

    Drug resistance of Helicobacter pylori and related gene mutations
    ZHANG Yanmei, HU Binjie, ZHAO Fuju, XIANG Ping, YANG Changqing, FANG Yi, ZHAO Hu
    2016, 31(5):  412-418.  DOI: 10.3969/j.issn.1673-8640.2016.05.015
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    Objective To study the drug resistance of Helicobacter pylori (HP) to common antibiotics and investigate the correlation of drug resistance and related gene mutations. Methods Gastric mucosa biopsy samples were collected from Huadong Hospital and Tongji Hospital, HP was isolated,and the minimal inhibitory concentrations (MIC) to clarithromycin (CLA),metronidazole (MTZ),amoxicillin (AMX) and levofloxacin (LEV)were determined by E-test. Meanwhile,the related gene mutations were determined by gene sequencing,and the correlation of drug resistance and gene mutations was analyzed. Results A total of 129 HP isolates were isolated from 514 cases of gastric mucosa biopsy samples. Among them,68.6% isolates were resistant to 1 kind of antibiotic at least,and the drug resistance rates to CLA,MTZ and LEV were 19.8%,57.0% and 29.1%,respectively,while double- and triple-drug resistance rates were 23.3% (20 isolates)and 7.0%(6 isolates). The main drug resistance gene mutation loci were 23S rRNA(A2143G),rdxA(C148T),pbp1A(A1777G) andgyrA(C261A/G),and their mutation rates were 20.9%,7.0%,9.3% and 12.8%. Conclusions The drug resistance rate of HP is high in Shanghai,and drug susceptibility test should become a standard practice during the determination of HP for eradication. Furthermore,specific gene mutations are associated with drug resistance.

    Reference intervals of clinical laboratory inter-accreditation items of Grade 3 hospitals in Fujian
    CHEN Xijun, CHEN Falin, WANG Youji
    2016, 31(5):  419-422.  DOI: 10.3969/j.issn.1673-8640.2016.05.016
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    Objective To investigate the results and sources of reference intervals in clinical laboratory inter-accreditation items among Grade 3 hospitals in Fujian,compare the difference between routine and dry chemistry in these aspects,and provide a reference to establish reference intervals of clinical laboratory inter-accreditation items for healthy subjects in Fujian. Methods A total of 1 246 data of reference intervals were collected from 29 inter-accreditation items of 27 Grade 3 hospitals in Fujian. All abnormal values and errors(lower limit was higher than upper one,or upper limit was as the same as lower one,etc.)were eliminated. The difference between routine and dry chemistry reference intervals were analyzed by SPSS 11.0.Results The differences between maximum and minimum values about the lower limits of alanine aminotransferase,aspartate aminotransferase,triglyceride and total cholesterol and the upper limits of alpha fetoprotein and carcinoembryonic antigen were big. The results of free triiodothyronine and free thyroxine were not unified. The 3 main sources of reference intervals were instructions of reagent manufacturers,the National Guide to Clinical Laboratory Procedures and the industry standards of the National Health and Family Planning Commission of the People's Republic of China. In comparison of routine and dry chemistry,the reference intervals of alanine aminotransferase and lactate dehydrogenase had significant differences(P<0.05). Conclusions The reference intervals of a part of inter-accreditation items of Grade 3 hospitals in Fujian have differences,and the sources of them are various.A few assays have statistical significance in routine and dry chemistry. In order to achieve inter-accreditation,all laboratories must share common reference intervals on the basis of standardization.

    Nonconformities during the assessment of proficiency testing provider accreditation in laboratory medicine
    JIA Rujing, ZHAO Bingnan, ZHANG Chuanbao, WANG Hualiang, HUANG Weigang, CAO Shi
    2016, 31(5):  423-425.  DOI: 10.3969/j.issn.1673-8640.2016.05.017
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    Objective To study the status of PTP system in laboratory medicine,through collecting and analyzing the nonconformities during the assessment of proficiency testing provider(PTP)accreditation in laboratory medicine. Methods The nonconformities during the assessment of PTP accreditation in laboratory medicine were collected and categorized according to the criteria of PTP accreditation (CNAS CL-03). The occurrence frequency of nonconformities was calculated and compared. Results There were 68 nonconformities in 11 on-site assessments against the criteria of PTP accreditation,involving 15 clauses of CNAS CL-03. Among them,76.0% was against technical requirements,and 24.0% was against management requirements. For technical requirements,nonconformities were most frequently reported against Clause 4.2(personnel),4.4(proficiency testing scheme),4.6(proficiency testing operation scheme) and 4.7(datum analysis and result evaluation).For management requirements,nonconformities were most frequently reported against Clause 5.1(organization). Conclusions The most frequently found nonconformities are Clause 4.2,4.4,4.6 and 4.7,which are the main directions needed to be focused to establish, develop and improve the quality management system of PTP in laboratory medicine.

    Progress of nucleic acid amplification techniques in Mycobacterium detection and drug resistance analysis
    LIU Minyan, BAI Bing, CHEN Jin
    2016, 31(5):  426-432.  DOI: 10.3969/j.issn.1673-8640.2016.05.018
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    With the rapid development of molecular biology and genome sequence decryption of Mycobacterium,especially Mycobacterium tuberculosis complex (MTBC),it is possible to detect and identify Mycobacterium and analyze drug resistance by molecular biological methods. Nucleic acid amplification (NAA) techniques are the basis of molecular biology. Recently,many kinds of Mycobacterium identification methods based on NAA techniques are established and evaluated. This paper reviews the progress of these methods and assesses their clinical application prospects in Mycobacterium detection and drug resistance analysis.