Laboratory Medicine

Matrix effect on serum uric acid determination

ZHANG Jiangtao, ZENG Jie, MA Rong, ZHAO Haijian, ZHOU Weiyan, ZHANG Tianjiao, YAN Ying, HU Cuihua, WANG Jing, WANG Donghuan, ZHANG Chuanbao

2016, 31(8): 635-639. DOI: 10.3969/j.issn.1673-8640.2016.08.001

Asbtract ( 655 )

HTML ( 2)

PDF (782KB) ( 944 )

Figures and Tables | References | Related Articles | Metrics

Objective To evaluate the matrix effect of 21 samples （sera and processed materials） on 13 routine determination systems in serum uric acid determination. Methods Determinations were performed according to the health industry standard WS/T356-2011. Isotope dilution liquid chromatography tandem mass spectrometry （ID-LC/MS/MS）was used as comparison method,and 13 kinds of uric acid kits（enzymic assay） were chosen as evaluation method with HITACHI 7180 analyzer. The 21 samples included 4 calibrators,5 kinds of external quality assessment（EQA） samples,6 kinds of quality control materials,3 processed materials （1 kind of spine serum and 2 kinds of liquid solutions）,1 kind of standard reference material（SRM） 909c from the National Institute of Standards and Technology （NIST）and 2 kinds of the External Quality Assessment Scheme for Reference Laboratories in Laboratory Medicine （RELA）samples from the International Federation of Clinical Chemistry and Laboratory Medicine（IFCC）. A total of 40 fresh frozen sera and the 21 samples were analyzed by comparison method and evaluation method. The results obtained by the 2 methods were analyzed by linear regression analysis. Two-tailed 95% confidence intervals for Y predictive value were computed,and the matrix effect of sera and processed materials was evaluated. Results A total of 5 kinds of evaluation samples （2 EQA samples,1 SRM 909c and 2 RELA samples）from fresh or lyophilized sera showed no matrix effect in all routine methods. Two calibrators （Landau and Dirui） showed matrix effect in 1 routine method. Of 5 EQA samples,except for fresh sera used for trueness verification,other lyophilized sera showed matrix effect in most routine methods. The 4 of 6 quality control materials showed no matrix effect,and 2 quality control materials with high values showed negative matrix effect. Conclusions Fresh serum is a reliable sample and could be used in SRM and quality control material preparation and EQA. Some calibrators could introduce calibration bias due to matrix effect on non-matching routine methods. Thus,matrix effect evaluation and methodological verification are proposed prior to using non-matching calibrators.

Reference intervals of serum bilirubin for Han children in Changchun

LI Xin, WANG Di, YANG Chun, XU Jiancheng

2016, 31(8): 640-646. DOI: 10.3969/j.issn.1673-8640.2016.08.002

Asbtract ( 322 )

HTML ( 2)

PDF (931KB) ( 627 )

Figures and Tables | References | Related Articles | Metrics

Objective To investigate the reference intervals of serum bilirubin for Han children in Changchun. Methods According to the document C28-A3 issued by the Clinical and Laboratory Standards Institute（CLSI） and the International Federation of Clinical Chemistry and Laboratory Medicine（IFCC）,a total of 3 716 healthy children according to exclusion criteria for clinical and laboratory medicine were enrolled,and they were 1 month old-14 years old. They were classified according to age and sex. Serum total bilirubin（TBil）,conjugated bilirubin（CBil） and unconjugated bilirubin（UBil） were determined by HITACHI 7600-210 automatic biochemical analyzer. The results were analyzed by SPSS 21.0 and R language 3.0,and then the reference intervals were obtained. Results TBil,CBil and UBil were low under 2 years old,and there was an increase from 2 years old. Bilirubin was stable with no difference for sex from 2 to 5 years old. The level of TBil for boys and girls trended to peak at 12 years old,and then decreased progressively. The reference intervals of TBil,CBil and UBil for <1 year old were 1.90-11.33,0.90-3.41 and 0.60-9.31 µmol/L;for 1 year old were 2.34-12.03,0.84-3.30 and 1.17-8.70 µmol/L;for 2-5 years old and 6 years old（boys） were 2.80-12.82,1.00-3.60 and 1.60-9.72 µmol/L;for 6 years old（girls） and 7 years old were 3.25-15.37,0.95-4.46 and 1.80-11.25 µmol/L;for 8-11 years old were 3.20-16.60,1.20-4.70 and 1.80-12.20 µmol/L;for 12 years old were 2.41-19.77,1.10-5.17 and 1.16-14.95 µmol/L;for 13-14 years old were 1.80-16.33,0.90-4.60 and 0.70-12.62 µmol/L. Conclusions There are age and sex difference for the reference intervals of TBil,CBil and UBil among children. The reference intervals of serum bilirubin should be established according to age and sex in children.

Serum cathepsin K in osteoporosis diagnosis

WANG Rong, SHEN Anda, ZHU Fuying, ZHOU Yingliang, MU Xiaoqian, CHEN Guangjie

2016, 31(8): 647-651. DOI: 10.3969/j.issn.1673-8640.2016.08.003

Asbtract ( 298 )

HTML ( 0)

PDF (813KB) ( 496 )

Figures and Tables | References | Related Articles | Metrics

Objective To investigate the levels of serum cathepsin K（Cathe K） in osteoporosis diagnosis. Methods Bone mineral densities of lumbar spine and femoral neck were measured by dual energy X-ray. According to bone mineral densities,187 objects were classified into 63 cases of bone loss and 124 cases of osteoporosis. In osteoporosis group,32 cases' drug treatment efficacy was monitored. A total of 142 healthy subjects were enrolled as healthy control group. Enzyme-linked immunosorbent assay was used to determine serum Cathe K and tartrate-resistant acid phosphatase（TRAP）levels. The levels of osteocalcin（N-MID）,beta-collagen degradation product（β-crosslaps） and type Ⅰ procollagen N-terminal propeptide（PⅠNP）were determined by electrochemiluminescence immunoassay. According to ages,objects were classified into 35-45,46-55,56-65,66-70 and ≥71-year-old groups. Results For 35-45,46-55 and 56-65-year-old groups,the levels of serum Cathe K in osteoporosis group were higher than those in healthy control group（P<0.01）,but there was no statistical significance for 66-70 and ≥71-year-old groups between osteoporosis and healthy control groups （P>0.05）. For 35-45-year-old group,the level of serum Cathe K in bone loss group was higher than that in healthy control group（P<0.01）,and there was no statistical significance for the other age groups（P>0.05）. In the analysis of bone turnover markers for 45-65-year-old groups,the levels of serum Cathe K,PⅠNP,β-crosslaps,N-MID and TRAP in osteoporosis group were higher than those in bone loss and healthy control groups（P<0.05）. There was no statistical significance between bone loss and healthy control groups（P>0.05）. Serum β-crosslaps and Cathe K decreased in osteoporosis group after treatment for 3 months（P<0.05）. Conclusions Serum Cathe K can be used in the diagnosis and treatment monitoring of osteoporosis.

Establishment of the reference ranges of thyroid function determination for pregnant women

LIANG Minwen, ZHENG Youwei, CHEN Renshen, LI Jinghua, LI Zhengkang

2016, 31(8): 652-655. DOI: 10.3969/j.issn.1673-8640.2016.08.004

Asbtract ( 294 )

HTML ( 1)

PDF (831KB) ( 707 )

Figures and Tables | References | Related Articles | Metrics

Objective To establish the reference ranges of thyroid function determination for pregnant women during the 1st and 2nd trimesters in Guangdong General Hospital. Methods A total of 279 pregnant women with singleton pregnancy,including 147 women during the 1st trimester pregnancy and 132 women during the 2nd trimester pregnancy,were screened according to the National Academy of Clinical Biochemistry （NACB） recommendations and clinical criteria. The levels of free triiodothyronine（FT₃）,free thyroxine（FT₄） and thyroid stimulating hormone（TSH） were determined by chemiluminescence immunoassay. The trimester-specific reference ranges were established,according to the national health industry standard WS/T402 . Results The reference ranges of FT₃ calculated by median（M） and two-sided limits（P_2.5 and P_97.5） were 3.48-5.20 pmol/L at the 1st trimester and 3.26-5.46 pmol/L at the 2nd trimester,the reference ranges of FT₄ were 8.05-14.86 pmol/L and 7.09-12.12 pmol/L,and the reference ranges of TSH were 0.10-2.98 mIU/L and 0.05-2.48 mIU/L,respectively. The validation of these reference ranges was passed. Compared with non-pregnant control women,FT₃,FT₄ and TSH of pregnant women during the 1st and 2nd trimesters had statistical significance,except FT₄ during the 1st trimester（P<0.05）. Conclusions For the judgement and diagnosis for pregnant women's thyroid function,it is necessary for hospitals to establish the reference ranges for thyroid function determination.

The potential of 2 antigens of Mycobacterium tuberculosis for the serodiagnosis of latent tuberculosis infection

SUN Ruifeng, XIANG Zhihao, CHEN Fuzeng, RU Huanwei, MAI Juntao, YUAN Li, LIU Jun

2016, 31(8): 656-661. DOI: 10.3969/j.issn.1673-8640.2016.08.005

Asbtract ( 386 )

HTML ( 1)

PDF (1340KB) ( 736 )

Figures and Tables | References | Related Articles | Metrics

Objective To investigate the potential of 2 antigens（Rv3160c and 35kD antigens） of Mycobacterium tuberculosis（MTB） highly expressed during latent infection for the serodiagnosis of latent tuberculosis infection（LTBI）. Methods Rv3160c and 35kD antigens were purified,and the immunogenicity was evaluated by C57BL/6 mouse model. MTB antigens,early secretory antigenic target-6（ESAT-6） and 38kD antigens which were in commercial use,were included as positive controls. Serum specificity antibody reactivities of 20 active pulmonary tuberculosis patients,25 LTBI patients（contacting closely with active pulmonary tuberculosis patients for a long time） and 24 healthy subjects were determined using Rv3160c and 35kD antigens. Serum levels of anti-Rv3160c and anti-35kD antibodies were determined. Results Rv3160c and 35kD antigens induced strong humoral immunity in mice. Serum antibody titre reached 1∶256 000,which was close to that of positive control Ag85A. Serum levels of anti-Rv3160c and anti-35kD antibodies in LTBI group were higher than those in healthy control group （P<0.01）, and serum level of anti-35kD antibody in LTBI group was higher than that in active pulmonary tuberculosis group（P<0.05）. However,serum level of anti-Rv3160c antibody had no statistical significance between LTBI and active pulmonary tuberculosis groups（P>0.05）. Serum levels of anti-ESAT-6 antibody in LTBI and active pulmonary tuberculosis groups were higher than that in healthy control group（P<0.01）,and there was no statistical significance between LTBI and active pulmonary tuberculosis groups（P>0.05）. Serum level of anti-38kD antibody in LTBI group was higher than those in active pulmonary tuberculosis and healthy control groups（P<0.05）,but there was no statistical significance between active pulmonary tuberculosis and healthy control groups（P>0.05）. Both antigens reacted more strongly with sera from LTBI group than sera from healthy control group. The 35kD antigen had a weak reactivity in active pulmonary tuberculosis group,and its pattern of reactivity was similar to that of 38kD antigen. Rv3160c antigen was unable to distinguish active pulmonary tuberculosis and LTBI,and its reactivity pattern was similar to that of ESAT-6 antigen. Conclusions Rv3160c and 35kD antigens are highly specific to LTBI. It is of potential to be used in the diagnosis of LTBI.

Expression and regulation of human beta-defensin in Campylobacter jejuni infection

WU Qiong, CHEN Hongyou, TU Lihong, SONG Yuanjun, ZHANG Wenxia, CHEN Min

2016, 31(8): 662-666. DOI: 10.3969/j.issn.1673-8640.2016.08.006

Asbtract ( 242 )

HTML ( 0)

PDF (1475KB) ( 496 )

Figures and Tables | References | Related Articles | Metrics

Objective To investigate the infection status of Campylobacter jejuni isolated from diarrhea syndrome and pathogenic monitoring study in Shanghai from 2012 to 2013. To study the immune regulation of human beta-defensin （hBD） in gastrointestinal infection caused by Campylobacter jejuni. Methods Campylobacter jejuni were isolated from diarrhea syndrome and pathogenic monitoring study in Shanghai from 2012 to 2013. Minimal inhibitory concentrations（MIC） to 7 antibiotics [gentamycin（GEN）,tetracycline（TET）,azithromycin（AZI）,erythromycin（ERY）,clindamycin（CLI）,ciprofloxacin（CIP） and nalidixic acid（NAL）] were determined by agar dilution method. Sodium dodecyl sulfate-pulsed-field gel electrophoresis （SDS-PFGE） was carried out for analyzing molecular epidemic trend. Human intestinal epithelial cell line Caco-2 was infected with Campylobacter jejuni. The transcription levels of hBD-1,hBD-2,hBD-3,TLR2 and TLR4 genes were determined by fluorescence quantitation polymerase chain reaction （PCR）,and the expressions of hBD-1,hBD-2,hBD-3,TLR2 and TLR4 were determined by western blotting. Results The isolation rate of Campylobacter jejuni isolated from diarrhea syndrome and pathogenic monitoring study in Shanghai from 2012 to 2013 was 1.6%. The drug resistance rates to TET and NAL were high （95.7% and 97.8%）. There were 9 PFGE patterns. After Campylobacter jejuni infected human intestinal epithelial cell line Caco-2,the transcription levels of hBD-1,hBD-2 and hBD-3 genes reached the highest at 6 h,and the expressions of hBD-1,hBD-2 and hBD-3 reached the highest at 24 h. The transcription level of TLR2 at 24 h was higher than those at 0,6 and 10 h. However,the transcription level of TLR4 reached the highest at 6 h. The expressions of TLR2 and TLR4 were the same as their transcription levels. Conclusions hBD plays a role in defense of Campylobacter jejuni infection.

The applicability of glycated hemoglobin A_1c for patients with hemoglobin H disease

XU Anping, JI Ling, CHEN Weidong, XIA Yong, YU Jing, ZHOU Yu, LI Lu

2016, 31(8): 667-670. DOI: 10.3969/j.issn.1673-8640.2016.08.007

Asbtract ( 312 )

HTML ( 1)

PDF (960KB) ( 712 )

Figures and Tables | References | Related Articles | Metrics

Objective To investigate the influence of hemoglobin H （HbH） disease on 4 kinds of glycated hemoglobin A_1c（HbA_1c） systems and the applicability of HbA_1c for patients with HbH disease. Methods A total of 27 samples with HbH disease and 30 control samples were collected. HbA_1c determinations were performed by boronate affinity high performance liquid chromatography,capillary electrophoresis,turbidimetric immunoassay and ion exchange high performance liquid chromatography. The difference of the 4 systems was compared. Fasting glucose（FG） and glycated serum protein（GSP） were determined as well. The differences of FG,GSP,HbA_1c and average glucose were compared between control and HbH disease groups. Results Compared with boronate affinity high performance liquid chromatography（Ultra²）,P values were 0.08,0.89 and 0.64,with no statistical significance（P>0.05）. The differences of FG and GSP had no statistical significance between control and HbH disease groups（P>0.05）. The differences of HbA_1c and average glucose had statistical significance between control and HbH disease groups（P<0.01）. Conclusions HbA_1c of HbH disease group can not reflect the real level of average glucose,and it is not applicable for long-term blood glucose monitoring in patients with HbH disease.

Relationship between TGF-β1 mRNA and bcr/abl^P210 fusion gene transcription expression levels in CML patients

XU Dabing, SUN Yujie, SHEN Zuojun

2016, 31(8): 671-674. DOI: 10.3969/j.issn.1673-8640.2016.08.008

Asbtract ( 157 )

HTML ( 0)

PDF (862KB) ( 466 )

Figures and Tables | References | Related Articles | Metrics

Objective To investigate the possible pathogenesis of chronic myelogenous leukemia（CML） by analyzing the expression levels of transforming growth factor-beta 1（TGF-β1） mRNA and bcr/abl^P210 fusion gene transcription in patients with CML.Methods Real-time fluorescence quantitative polymerase chain reaction（PCR） was used to determine the expression levels of TGF-β1 mRNA and bcr/abl^P210 in peripheral blood and bone marrow of 73 patients with CML. A total of 22 healthy subjects were enrolled as healthy control group. Pearson correlation analysis was used to analyze the correlation of TGF-β1 mRNA and bcr/abl^P210. Results The expression levels of TGF-β1 mRNA and bcr/abl^P210 in peripheral blood and bone marrow of patients with CML had no statistical significance（P>0.05）. The expression levels of TGF-β1 mRNA in healthy control group were higher for 11.39 times than those in CML group（P<0.05）. The expression levels of TGF-β1 mRNA and bcr/abl^P210 had a positive correlation in CML group（r=0.53,P<0.01）. Conclusions TGF-β1 mRNA in bone marrow may be a new indicator for the diagnosis and treatment of CML.

The detection of （1,3）-beta-D-glucosan in hematological patients with invasive fungal disease

XIAO Chenlu, HAN Lizhong, NI Yuxing

2016, 31(8): 675-678. DOI: 10.3969/j.issn.1673-8640.2016.08.009

Asbtract ( 223 )

HTML ( 0)

PDF (858KB) ( 526 )

Figures and Tables | References | Related Articles | Metrics

Objective To evaluate the detection of （1,3）-beta-D-glucosan（BDG）（G test） in hematological patients with invasive fungal disease （IFD）. Methods A retrospective study was performed for 399 hematological malignancy patients,plasma G tests were performed for 2-3 times a week. The Principle and Diagnostic Criteria of the Disease of Hematopoietic System/Tumor in Patients with Invasive Fungal Infection（Revised Edition） was used as criteria. The diagnostic significance was evaluated by SPSS 11.5 software. Results The sensitivity of G test was 78.5% for the diagnosis of IFD,the specificity was 79.8%,the positive predictive value was 75.0%, and the negative predictive value was 82.7%. Conclusions Plasma BDG is correlated with IFD. Plasma G test should be taken 2-3 times per week. Combined with medical imaging,G test could improve the diagnosis of IFD and treatment efficiency and reduce the medical burden of patients.

Determination of high-concentration enzyme samples by FLEX mode-TOSHIBA TBA-120FR automatic biochemical analyzer

TIAN Honglun, YIN Ke, HE Jun, LEI Wenmei, ZHANG Ziping

2016, 31(8): 684-687. DOI: 10.3969/j.issn.1673-8640.2016.08.012

Asbtract ( 353 )

HTML ( 0)

PDF (1033KB) ( 602 )

Figures and Tables | References | Related Articles | Metrics

Objective To investigate the performance of FLEX mode-TOSHIBA TBA-120FR automatic biochemical analyzer in the determination of high-concentration enzyme samples. Methods The high-concentration alanine aminotransferase （ALT）and aspartate aminotransferase（AST）samples（ALT：2 185-5 240 U/L,AST：2 520-6 625 U/L）were determined by FLEX mode and manual dilution mode,the relative deviation of 2 modes was calculated,and the 2 modes were analyzed by linear regression analysis. Results The relative deviation was <6% between FLEX mode and manual dilution mode,which met the health industry standard WS/T403-2012 requirements. The linear regression analysis showed that the 2 modes had a good correlation [ALT：coefficient of determination（R²）=0.999,P<0.001;AST：R²=0.999,P<0.001]. The medical decision levels of high-concentration ALT and AST generated into regression equation,and the relative deviations were 1.9% and 2.2% for calculating medical decision levels. Less than half of allowable total error from the Clinical Laboratory Improvement Amendments in 1988（CLIA'88）was used as clinical acceptable level. Conclusions The reportable range of enzyme activity determination is expanded by FLEX mode,which can ensure obtaining results accurately and rapidly and improve work efficiency, and FLEX mode is of significance.

Establishment and application of real-time fluorescence LAMP for the detection of NDM-1-positive bacteria

CHEN Bin, YANG Yinmei, ZHONG Zhimin, LEI Xiuxia, LIU Dayu, XU Banglao

2016, 31(8): 688-693. DOI: 10.3969/j.issn.1673-8640.2016.08.013

Asbtract ( 292 )

HTML ( 0)

PDF (1406KB) ( 504 )

Figures and Tables | References | Related Articles | Metrics

Objective To establish a real-time fluorescence loop-mediated isothermal amplification（LAMP）for the detection of New Delhi metallo-beta-lactamase-1（NDM-1）-positive bacteria. Methods According to the sequence of NDM-1 gene,4 primers and fluorescent dye concentration of SYTO-9 were designed and optimized,and the limit of detection and specificity were also evaluated. A total of 72 isolates of multidrug-resistant Acinetobacter baumannii were detected. Results The optimal fluorescent dye concentration of the established real-time fluorescence LAMP was 4 μmol/L. The limit of detection was 10¹ copies/μL for 35 min at 63 ℃. The specificity was good. A total of 72 isolates of multidrug-resistant Acinetobacter baumannii were detected,and the positive rate was 16.7% （12/72）. The 12 isolates were further confirmed by sequencing,and the accuracy was 100%. Conclusions The established real-time fluorescence LAMP for the detection of NDM-1-positive bacteria is rapid,simple,specific,sensitive,accurate and reliable,and it could be used for the routine detection of NDM-1-positive bacteria.

Accuracy of platelet count by UniCel DxH 800 Coulter hematology analyzer

CHEN Liting, LIN Xiaoyi, WANG Jianbiao

2016, 31(8): 694-696. DOI: 10.3969/j.issn.1673-8640.2016.08.014

Asbtract ( 464 )

HTML ( 1)

PDF (1005KB) ( 569 )

Figures and Tables | References | Related Articles | Metrics

Objective To evaluate the accuracy of platelet count by UniCel DxH 800 Coulter hematology analyzer. Methods The results of platelet count by UniCel DxH 800 were compared with those of international reference method（flow cytometry）,according to the Clinical and Laboratory Standards Institute（CLSI） EP9-A2. A total of 556 ethylene diamine tetraacetic acid-K₂（EDTA-K₂） anticoagulant specimens were collected,including 113 specimens with platelet count <50.0×10⁹/L and 36 specimens with giant platelets by manual identification. All specimens were analyzed by UniCel DxH 800 and Coulter EPICS XL flow cytometry using CD41 and CD61,respectively. Results The results of platelet count by UniCel DxH 800 were in good correlation with flow cytometry （correlation coefficient was 0.994 3）,even for specimens with platelet count <50.0×10⁹/L （correlation coefficient was 0.948 0）. The biases for specimens with extremely low platelet count （<20×10⁹/L）,moderately low platelet count [（20-50）×10⁹/L],low platelet count [（50-100）×10⁹/L],normal platelet count [（100-275）×10⁹/L] and high platelet count（>275×10⁹/L） were 2.2%,2.5%,1.0%,0.6% and -1.7%,respectively,which were all lower than expected bias（12.5%）. For specimens with giant platelets,the correlation coefficient of the 2 methods was 0.986 8. Conclusions Platelet count obtained from UniCel DxH 800 is accurate at all critical levels and even in the presence of giant platelets.

S region gene epitope and gene mutation of HBsAg and HBsAb coexistence patients with genotype B and C

WANG Shan, CHEN Weiqin, WANG Lei, WANG Qihua, DONG Jingyi, WU Chunyan

2016, 31(8): 697-702. DOI: 10.3969/j.issn.1673-8640.2016.08.015

Asbtract ( 267 )

HTML ( 0)

PDF (2972KB) ( 590 )

Figures and Tables | References | Related Articles | Metrics

Objective To investigate the difference between S region gene epitope and gene mutation of hepatitis B surface antigen （HBsAg） and hepatitis B surface antibody （HBsAb） coexistence patients with genotype B and C,and to study the correlation of HBsAg and HBsAb coexistence. Methods A total of 5 HBsAg and HBsAb coexistence patients were enrolled,and 51 S region clones were collected. S regions were amplified and sequenced. Result There were 3 patients with genotype C and 2 patients with genotype B. The amino acid mutation rate in S region of 30 clones with genotype C was higher than that of 21 clones with genotype B,and differences were found in S region N-terminal,C-terminal and major hydrophilic region（MHR）. The mutation loci of clones with genotype C were mainly concentrated in locus 194,68 and 3,while the mutation loci of clones with genotype B were mainly concentrated in locus 40,200,129 and 5. Conclusions There is difference in amino acid mutation in S region among HBsAg and HBsAb coexistence patients（mutation loci and frequencies） between different genotypes,so epitopes with different genotypes are different. Amino acid mutations within epitope region could lead to the antigenicity changes of HBsAg and potential subsequent failure of neutralization by HBsAb,leading to the coexistence of HBsAg and HBsAb.

Establishment of a national grade Ⅱ reference material for HBV DNA

JIANG Lingli, WANG Hualiang, WANG Xueliang, BAO Yun, XIAO Yanqun

2016, 31(8): 703-708. DOI: 10.3969/j.issn.1673-8640.2016.08.016

Asbtract ( 242 )

HTML ( 1)

PDF (994KB) ( 624 )

Figures and Tables | References | Related Articles | Metrics

Objective To establish a national grade Ⅱ reference material for hepatitis B virus（HBV） DNA. Methods The HBV positive serum was diluted with HBV negative serum. The content was 1.00×10⁶IU/mL,packed to 1.5 mL each bottle. Roche COBAS AmpliPrep/COBAS TaqMan 48 testing system was used. Matrix interoperability was evaluated. For homogeneity evaluation,30 bottles were randomly selected,and each bottle was determined for 2 times. The prepared materials were placed at room temperature for 14 d,37 ℃ for 7 d,45 ℃ for 3 d,2-8 ℃ for 6 months and -20 ℃ for 12 months,and the stabilities were evaluated. The stabilities of the prepared materials which were repeated freezing and thawing for 15 times,7 d after the opening of bottles and simulated transportation to 2 laboratories were evaluated. The quantity of prepared materials was traced to the national standard material（GBW09150）. The uncertainties included the introduction of heterogeneity,the long-term stability and the quantity. Results Matrix interoperability test showed that the prepared materials' mean value was within the 95% confidence interval of clinical fresh samples. The between-run imprecision was 2.04%,and the within-run imprecision was 1.98%（F=1.052 4,P>0.05）. The stability test indicated the prepared materials were stable at room temperature for 14 d,37 ℃ for 7 d,45 ℃ for 3 d,2-8 ℃ for 6 months and -20 ℃ for 12 months,and the slope rates had no statistical significance compared with the 0th day/month by linear fitting test（P>0.05）. The stability was observed in prepared materials which were repeated freezing and thawing for 15 times,7 d after the opening of bottles and simulated transportation to 2 laboratories with no statistical significance compared with prepared materials which stored at -20 ℃（t=0.46,-0.35,1.53 and 0.75,P>0.05）. The quantity was（2.5±0.9）×10⁶IU/mL. Conclusions The prepared materials have reached the requirements of national grade Ⅱ reference material,which can be used as a reference material for nucleic acid amplification for HBV DNA.

Report on the morphological characteristics of peripheral blood cell smears from 1 case of mantle cell lymphoma

XU Jing, MEI Hong, GENG Chaohui, GUO Zhuying, LU Jingfeng, HU Xiaobo

2016, 31(8): 709-712. DOI: 10.3969/j.issn.1673-8640.2016.08.017

Asbtract ( 264 )

HTML ( 1)

PDF (910KB) ( 564 )

Figures and Tables | References | Related Articles | Metrics

Objective Mantle cell lymphoma（MCL） is a rare class of non-Hodgkin's lymphoma（NHL）. It is often misdiagnosed and missed diagnosis clinically. The article reports the recent findings about the morphological characteristics of peripheral blood cell smears from 1 case of MCL. Methods The clinical data and laboratory determination characteristics of the case of MCL were reviewed,retrospectively,and were analyzed with those of chronic lymphocytic leukemia. Results It was found that the morphology of lymphoma cells in the case of MCL was characterized through peripheral blood cell morphology,immunophenotype and chromosome examination. Its shape was slightly larger than those of normal small lymphocytes,and most nuclei were observed with irregularity,notch,chromatin loose,small nucleoli and cytoplasm rarely to less. Conclusions Although the diagnosis of MCL depends on lymph node biopsy,cell genetics and molecular biology,the morphology of peripheral blood cells is of significance in initial screening.

Analysis on the results of external quality assessment of cystatin C in Shanghai

TANG Liping, OU Yuanzhu, WANG Meijuan, LIU Wenbin, YU Xiaoxuan, JU Yi

2016, 31(8): 713-717. DOI: 10.3969/j.issn.1673-8640.2016.08.018

Asbtract ( 230 )

HTML ( 0)

PDF (794KB) ( 450 )

Figures and Tables | References | Related Articles | Metrics

Objective To know the status of cystatin C （Cys C） determination in Shanghai,through analyzing 4 external quality assessment and 1 flight-inspection-survey from 2014 to 2015,and to provide a reference for improving Cys C external quality assessment and the selection of quality control materials. Methods The quality control materials of external quality assessment were serum matrix quality control materials from Randox Company. The flight-inspection-survey specimens were serum samples prepared from the Clinical Chemistry Laboratory from Shanghai Center for Clinical Laboratory and from Shanghai Beijia Company. The concentration of quality control materials was 0.7-9.0 mg/L. The median of the results of external quality assessment was as target value. The flight-inspection-survey results were analyzed by primary reference material transfer target assignment value and median value. The results were classified into domestic reagent group,imported reagent group and other reagent group and analyzed statistically. The standard of qualified judgment was ±25%,and the group coefficients of variation （CV） and total CV were calculated,and group pass rates and total pass rate were also calculated. Results The total CV and group CV of 2 external quality assessment in 2014 and flight-inspection-survey in 2015 were 15%-20%,but the CV of high-concentration samples（6.3 and 8.9 mg/L） of the 2nd external quality assessment in 2014 were >25%. There was no difference for CV between domestic and imported reagent groups. The pass rate of imported reagent group（>90%） was higher than that of domestic reagent group,and the results of Sysmex was higher than those of other imported reagents. In domestic reagent group,the pass rate was the lowest when the concentration of samples was about 6.0 mg/L,which was <80%. The external quality assessment samples in 2015 had only 2 concentrations at about 0.7 mg/L and 3.4 mg/L. The total and group CV and the pass rates of external quality assessment in 2015 were better than those in 2014 and those in flight-inspection-survey in 2015,the CV were <10%,and the pass rates were >95%. However,in the 1st external quality assessment,the results using imported reagent Sekisuithe in low-concentration samples of 0.7 mg/L appeared wholly lower than lower limit,resulting in the imported reagent group at low-concentration with only 68% of pass rate. The flight-inspection-survey results were analyzed using the primary reference material transfer target assignment value and median value,and there were no differences in the results of the other 4 samples except for the low-concentration sample（0.7 mg/L）. Conclusions Though the total and group CV and the pass rates of external quality assessment in 2015 are better than those in 2014,the results of flight-inspection-survey in 2015 are consistent with the results of external quality assessment in 2014,so the status of Cys C determination may not be reflected by external quality assessment in 2015. The concentration should be in the range of 0.7-5.0 mg/L.

Research progress of vulvovaginal candidiasis

WANG Dongjiang, WU Wenjuan

2016, 31(8): 721-727. DOI: 10.3969/j.issn.1673-8640.2016.08.020

Asbtract ( 288 )

HTML ( 1)

PDF (841KB) ( 936 )

Figures and Tables | References | Related Articles | Metrics

Candida is one of normal floras. It plays a role in maintaining vaginal normal flora at ecological balance and in vaginal self-purification process. Vulvovaginal candidiasis （VVC） is a common vaginal infection caused by Candida. The incidence is related to many factors,mainly the overgrowth of Candida. This article on VVC mainly includes its epidemiological characteristics,clinical classification,etiology,pathogenic mechanism,determination,diagnosis and treatment.

Table of Content