Table of Content

06 June 2012, Volume 27 Issue 6

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Analysis on the immunophenotype and positive cell percentages of acute leukemia

MO Yang;LI Zhishan

2012, 27(6):  431-435. 

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Objective　To investigate the immunophenotype characteristics of acute leukemia(AL) . Methods　CD45/ side scatter (SSC) gating strategy and multiparametric flow cytometry were used to determine immunophenotype of 89 patients with AL. Results　In acute myeloid leukemia (AML)， the cluster of antigen total percentages and positive cell percentages in patients with positive expression were CD13（96.7%,68.6%±22.7%）,CD33（95.0%,72.6%±23.5%）,myeloperoxidase (cMPO)（90.0%,57.5%±26.9%） and CD117（73.3%,33.7%±14.4%）. In acute B lymphoblastic leukemia (B-ALL)， the cluster of antigen total percentages and positive cell percentages in patients with positive expression were cCD79a（96.2%,69.8%±22.1%）,CD19(96.2%,67.4%±23.2%) and CD10(53.8%,66.7%±15.4%). In acute T lymphoblastic leukemia (T-ALL)，the cluster of antigen total percentages and positive cell percentages in patients with positive expression were cCD3(100.0%,53.6%±18.9%) and CD7(66.7%,92.0%±0.5%). Conclusions　There are differences of the cluster of antigen total percentages and positive cell percentages in patients with positive expression in all subtypes of AL， which can be used for the reference of the immunophenotype diagnosis by flow cytometry.

The analytical performance assessment and clinical practice of three Assays for the Measurement of anti-cyclic citrullinated peptide antibodies

ZHAO Ying;SONG Binbin;GUO Wei;ZHANG Chunyan;TAN Qiwen;PENG Yingfei;PAN Baishen

2012, 27(6):  436-441. 

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Objective　To evaluate the analytical performance of 3 assays for the measurement of anti-cyclic citrullinated peptide（CCP）antibodies, and compare the clinical application. Methods　Serum samples from 93 patients with rheumatoid arthritis（RA），118 non-RA patients (82 patients with autoimmune diseases and 36 patients with osteo arthritis) and 20 healthy subjects were collected. The analytical performance of 3 reagents from Elecsys，Euroimmun and Fuchun was compared. The correlation was compared among the different reagents. The preliminary clinical application value for different reagents was evaluated. Results　No statistical significance was found in precision of the 3 reagents.The within-run and interday coefficients of variation（CV）were <10 %. Both of Elecsys and Euroimmun could be evaluated as linearity in detection range，and the real linearity range of Fuchun was 25.0-1 027.9 RU/mL. The correlation of anti-CCP assays by the 3 reagents was good. The correlations (r) of Elecsys with Euroimmun and Elecsys with Fuchun were 0.90 and 0.87 respectively，and the r of Euroimmun with Fuchun was 0.97. According to the cut-off values proposed by the manufacturers，the diagnostic sensitivities were 83.9 % - 86.0 %, and the specificities were 92.0 % - 97.1 %.The areas under receiver operating characteristic (ROC) curve（AUC）of the anti-CCP assays by Elecsys, Euroimmun and Fuchun were 0.91, 0.92 and 0.89，respectively.There was no statistical difference between the AUC of any 2 assays（Z=0.27, 0.89 and 0.63，P>0.05）. Conclusions　Overall, the analytical performance of anti-CCP assays is comparable among the different assays，and their diagnostic characteristics are not significantly different.However, the standardization still has problems.

Evaluation on the diagnostic value of CEA，CA72-4 and pepsinogen combined determination for gastric cancer

LU Canrong;ZHANG Shiwu;ZHANG Yong;WEI Bo

2012, 27(6):  442-444. 

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Objective　To investigate the diagnostic value of serum carcinoembryonic antigen (CEA)， carbohydrate antigen 72-4 (CA72-4) and pepsinogen (PG) combined determination for gastric cancer.  Methods　Serum CEA，CA72-4，PGⅠ，PGⅡ and PGⅠ/Ⅱ were detected in 96 healthy controls，37 gastric hyperplasia patients and 107 gastric cancer patients. Results　When the CA72-4，CEA，PGⅠ，PGⅡand PGⅠ/Ⅱ were used to diagnose gastric hyperplasia and gastric cancer individually，CA72-4 had the best diagnostic capability. Its sensitivity and specificity were 72.00% and 59.50%. Binary logistic regression was used to evaluate the diagnostic value of combining CEA and CA72-4 to diagnose the gastric hyperplasia and gastric cancer. The area under the curve was 0.715， and the sensitivity and specificity were 70.10% and 67.60%. Compared to the sensitivity and specificity of each marker， the sensitivity and specificity of combined determination with 3 markers were better. Multilayer perceptron neural network analysis was also used to analyze the diagnostic value of CEA and CA72-4 combined determination. The area under the curve was 0.711. Conclusions　The diagnostic value of the combined determination is superior， and it also provides reference for the clinical diagnosis of gastric cancer.

Change on CD3⁺，CD4⁺ and CD8⁺T lymphocyte levels in peripheral blood of patients with gastric cancer

TONG Minghong;SHAO Jun;CHEN Yanhong;XING Ying

2012, 27(6):  445-447. 

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Objective　To investigate the clinical significance and expression of peripheral blood T lymphocyte subset CD3⁺,CD4⁺, CD8⁺and CD4⁺／CD8⁺ratio in patients with gastric cancer. Methods　Peripheral blood T lymphocyte subset CD3⁺, CD4⁺, CD8⁺and CD4⁺/CD8⁺ratio were determined by automatic blood cell analyzer in 40 patients with gastric cancer ［according to the clinical stages:Ⅰ-Ⅱ stage group (18 cases) and Ⅲ-Ⅳ stage group (22 cases)］ and 25 healthy subjects. Results　The peripheral blood T lymphocyte subset CD3⁺, CD4⁺ and CD4⁺／CD8⁺ratio in the gastric cancer group were 0.78%±0.35%，0.37%±0.21% and 0.61%±0.42%, respectively, which were significantly lower than those in the healthy control group (P<0.05). The T lymphocyte subset CD3⁺, CD4⁺ and CD4⁺／CD8⁺ratio in Ⅲ-Ⅳ stage group were 0.42%±0.27%，0.21%±0.17% and 0.29%±0.25%, which were significantly lower than those in Ⅰ-Ⅱ stage group（0.95%±0.35%，0.45%±0.19% and 0.76%±0.30%，P<0.05）. Conclusions　The determinations of T lymphocyte subset CD3⁺, CD4⁺, CD8⁺and CD4⁺／CD8⁺ratio in peripheral blood of patients with gastric cancer are helpful to study and assess the immune status of patients，but also provide a theoretical reference to improve tumor immune therapy .

Studies on quantum dot labeling rapid immunoassay

WU Weihua;TANG Haiying;ZHANG Pengfei

2012, 27(6):  448-450. 

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Objective Based on prepared and modified quantum dots, conjugated with anti Hepatitis B antibodies under EDC activation to obtain quantum dot-antibody bioconjugates. To certify its usage in immune assay. Methods High temperature decomposition are used to prepare CdSe quantum dots, and modified with GSH and PEG separately for water solubility and stability. Conjugate quantum dots and goat-anti-HBsAg polyclone antibodies with ethyl-(dimethylaminopropyl) carbodiimide (EDC). Routine immune dot blot protocol was done for the test of HbsAg antigen. Results quantum dots were produced with uniformity and stability. The HBsAg antibody can be covalently linked with quantum dots and the bioconjugates were confirmed by various characterization. The bioconjugates can be used to detect 1.6 ng HBsAg proteins by dot blot immunoassay. Conclusion The new bioconjugates of conjugation of antibodies onto quantum dots for detection of the corresponding antigens provide better amplified signal immunoassays.

Detection and its clinical significance of IL-2, IL-10 and TNF-α in the sera of patients with early symptomatic syphilis

HU Xiaoyan;NIE Fang

2012, 27(6):  451-453. 

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Objective　To investigate the role of interleukin-2 （IL-2），interleukin-10（IL-10） and tumor necrosis factor-alpha（TNF-α）in the pathogenesis of early symptomatic syphilis. Methods　Double-antibody sandwich enzyme-linked immunosorbent assay（DAbS-ELISA） was used to detect the serum levels of IL-2，IL-10 and TNF-α in 53 patients with early symptomatic syphilis （25 cases with primary syphilis and 28 cases with secondary syphilis） and 65 healthy subjects. Results　Serum levels of IL-2，IL-10 and TNF-α in early symptomatic syphilis group were significantly higher than those in control group （P<0.01）. Serum levels of IL-2 and TNF-α in primary syphilis group were significantly higher than those in secondary syphilis group （P<0.01）. Serum level of IL-10 in secondary syphilis group was significantly higher than that in primary syphilis group （P<0.01）. IL-2 and IL-10 were negatively correlated in early symptomatic syphilis group （r＝－0.760，P＝0.000）. IL-2 and TNF-α were positively correlated（r＝0.633，P＝0.000），and IL-10 and TNF-α were not correlated（r＝－0.063，P＝0.575）. Conclusions　IL-2， IL-10 and TNF-α are involved in the pathogenesis of syphilis. Up-expression of IL-10 may contribute to the helper T cell （Th）1/Th2 immune response imbalance during the development of early symptomatic syphilis.

Clinical application significance of serum soluble transferrin receptor in diagnosis of iron deficiency anemia

BAI Xiaosong;JIN Ligang;LIU Yun

2012, 27(6):  454-456. 

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Objective　To investigate the clinical application significance of serum soluble transferrin receptor （sTfR） in diagnosis of iron deficiency anemia （IDA）. Methods　A total of 58 controls and 58 patients with IDA were enrolled in the study. Iron metabolism related indices such as sTfR， serum iron（Fe）， total iron binding capacity （TIBC）， transferrin saturation （TS）， transferrin （TF）， serum ferritin （SF）， hemoglobin （Hb）， mean corpuscular volume （MCV）， mean corpuscular hemoglobin （MCH）， mean corpuscular hemoglobin concentration （MCHC） and red blood cell volume distribution width （RDW） were detected quantitatively. The data were analyzed by t test between groups and receiver operating characteristic （ROC） curve. Results　The levels of sTfR were （46.40±9.43） nmol/L in IDA group and （15.45±2.95） nmol/L in control group. There were statistical significances between the sTfR levels of IDA and control groups （P<0.01）. The area under the ROC curve of sTfR was 0.971（P<0.01）. Conclusions　Serum sTfR can reflect iron storage in body correctly. The sTfR has a clinical application significance in the diagnosis of IDA.

The application of Mycobacterium tuberculosis direct test in the diagnosis of AIDS co-infection with tuberculosis

YANG Shao-Min;FAN Yi-Shan;LI Hui-Qin;GAO Li;YANG Bi-Hui;ZHANG Mi;LI Zheng-Lun;ZHOU Zeng-Quan

2012, 27(6):  457-460. 

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Objective　To investigate the clinical application of Mycobacterium tuberculosis direct（MTD） test in the diagnosis of acquired immune deficiency syndrome（AIDS） co-infection with tuberculosis. Methods　The sputum samples of 127 AIDS patients suspected of tuberculosis co-infection were determined by MTD test， Mycobacterium tuberculosis culturing and acid-fast stain test. Sputum samples of 25 inpatients suspected of tuberculosis without human immunodeficiency virus（HIV） infection were analyzed as controls. Results　The sputum positive rates of the 127 AIDS patients were 29.1%， 25.2% and 18.9% by MTD test，Mycobacterium tuberculosis culturing and acid-fast stain test， respectively. The positive rates of the controls were 44.0%， 44.0% and 40.0% by MTD test， Mycobacterium tuberculosis culturing and acid-fast stain test，respectively. Conclusions　MTD test has application value in AIDS patients suspected of tuberculosis co-infection. It can improve the positive rate and provide the laboratory results within 1 d.

Epidemiology and drug-resistance analysis of nosocomial infection of Candida glabrata

ZHENG Bing;YAO Dong-Ting;YING Chun-Mei;WANG Ya-Ping;ZHANG Hao-Min;YANG Jun

2012, 27(6):  461-466. 

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Objective　To investigate genotypes and drug susceptibility of Candida glabrata isolated from Renji Hospital in order to study its drug-resistance and epidemic situation， and investigate their correlation. Methods　Multilocus sequence typing （MLST）technique was introduced to identify sequences of 6 housekeeping genes from 34 isolates of Candida glabrata. The results were compared with sequence information in MLST databases by Clustalx software to determine a strain allelic profile and sequence type（ST）. By drawing the phylogenetic tree by Clustalx software， the isolates were classified into various clonal complexes by eBURST program to compare the genetic relationship. ATB FUNGUS semi-automatic system was used to test the drug susceptibility. Ridit analysis method was used to analyze the correlation between the genotypes and drug susceptibility. Results　The 34 isolates belonged to 6 clone sequences. ST-7 had the most proportion of 79.4%（27/34）. There were 3 isolates belonged to ST-10，accounting for 8.8%（3/34）， and the remaining 4 isolates belonged to ST-3，ST-15， ST-43 and ST-55，respectively. A total of 34 isolates of Candida glabrata were 100.0% sensitive to fluorocytosine and amphotericin，while the sensitive rates of voriconazole and fluconazole were 97.1% and 91.2%，respectively.The effect of itraconazole was poor with the sensitive rate of 11.8% As ST-7 for the standard group，the Ridit values in the group of ST-10 and other types of ST were included the mean Ridit value of the standard group in fluconazole，voriconazole and itraconazole. Conclusions　ST-7 is the dominant genotype in Renji Hospital. No correlation between the Candida glabrata genotype and its drug susceptibility is found.

Distribution and antibiotic resistance of isolates from 7 688 blood culture samples of children

HUANG Wei-Chun;SHEN Hui-Ying;XIANG Ying;FU Qi-Hua

2012, 27(6):  467-470. 

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Objective　To analyze the distribution and antibiotic resistance of isolates from blood culture samples of children， and provide the reference for rational use of antibiotic.  Methods　A total of 7 688 blood culture samples of children were detected by BD BACTEC 9240 automatic blood culture system with pedsplus/f bottles.The positive blood culture samples were identified by VITEK-32 automatic microbiology system， and bacterial susceptibility testings were conducted on all isolates by E-test and disk diffusion method.  Results　There were 741 isolates identified from 7 688 blood culture samples， and the total positive rate was 9.64%. The positive rates of gram-positive cocci， gram-negative bacilli and fungi were 85.0%（630 isolates）， 14.0%（104 isolates） and 1.0%（7 isolates）， respectively. The top 5 isolates with high detection frequency were coagulase-negative Staphylococcus， Enterococcus， Streptococcus， Escherichia coli and Klebsiella pneumoniae.Coagulase-negative Staphylococcus to penicillin，oxacillin， erythromycin and oxacillin / sulbactam had low sensitivity. Vancomycin-resistant Staphylococcus  and Enterococcus were not found. The sensitivity of Enterococcus to nitrofurantoin was high. The sensitivity of alpha-hemolytic Streptococcus was lower than that of beta-hemolytic Streptococcus. Escherichia coli and Klebsiella pneumoniae to 3，4-generation cephalosporin resistance rates were 33.3% and 42.9%.  Conclusions　Coagulase-negative Staphylococcus mainly causing children bacteremia and （or） septicemia was highly resistant to commonly used antibiotics，and more attention should be paid to the detection and rational use of antibiotic.

Pathogenic bacterium distribution of elderly patients with nosocomial infection and drug resistance analysis

LI Shanmei;MIAO Jin;HUANG Yaping;XU Yinping;SU Jin;WANG Rong;YU Ping;XU Huijin;ZHENG Guomin

2012, 27(6):  471-474. 

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Objective　To analyze the pathogenic bacterium distribution of elderly patients with nosocomial infection and drug resistance，and provide the reference for reasonable clinical use of antibacterial drugs.  Methods　In Huangpu District 3 secondary general hospitals from January 2009 to December 2010，the specimens were collected from elderly patients with nosocomial infection，and determined for the analysis of pathogenic bacterium identification and drug resistance.  Results　In 369 cases of elderly patients with nosocomial infection， a total of 179 strains of pathogenic bacterium were detected， including 120 gram-negative bacteria （67.0%），38 gram-positive bacteria （21.2%） and 21 fungi （11.8%）. The drug resistant rates of Escherichia coli and Acinetobacter baumannii to carbapenems were 11.1% and 14.2% respectively. The resistance of gram-positive bacteria to penicillins and third generation cephalosporin increased gradually.  Conclusions　Pathogens of elderly patients with nosocomial infection are opportunistic，mainly as gram-negative bacilli. The resistance is high， and the proportion of fungal infection rapidly rises. Therefore，etiological examination and medicine sensitive monitoring should be paid attention，and they will contribute to the clinical rational selection and use of antibacterial drugs.

Research on virulence gene of multi-source methicillin-resistant Staphylococcus aureus

ZHU Jin;LU Jun;YU Xu-Liang;BAI Yong-Feng

2012, 27(6):  475-478. 

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Objective　To investigate the infection status of clinical methicillin-resistant Staphylococcus aureus（MRSA），and analyze the distribution of Staphylococcus aureus（SA） virulence gene in clinical detection of MRSA and methicillin-sensitive Staphylococcus aureus（MSSA）.  Methods　A total of 60 clinical MRSA isolates and 54 clinical MSSA isolates were collected from January 2009 to June 2011 in Quzhou People′s Hospital. Polymerase chain reaction（PCR） was used to detect virulence gene panton-valentine leukocidin（pvl），staphylococcal enterotoxin C（sec），staphylococcal enterotoxin H（seh），hemolysin A （Hla），hemolysin B（Hlb），clumping factor A（clfA），clumping factor B（clfB），fibronection-binding protein A（fnb A） and fibronection-binding protein protein B（fnbB）of these clinical SA isolates.  Results　A majority of 60 MRSA isolates distributed in Neurosurgery，General Surgery， Paediatrics and Orthopaedics Departments. The 17 isolates of 60 MRSA were considered as community-associated MRSA（CA-MRSA）， and 43 isolates of 60 MRSA were hospital-associated MRSA（HA-MRSA）. In contrast to MSSA， the positive detection rate of pvl in MRSA was higher， but the positive detection rates of clfA，fnbA，sec and seh were lower. The positive rates of pvl and fnbA in CA-MRSA were higher than those in HA-MRSA.  Conclusions　The virulence of MSSA isolates is probably higher than that of MRSA. The virulence of CA-MRSA isolates is higher than that of HA-MRSA.The different distribution of the virulence genes of these clinical SA isolates may be associated with the site of infection.

Detection of Y chromosome AZF gene microdeletion in idiopathic infertile males from Shanghai

YANG Huimin;CHEN Guowu

2012, 27(6):  479-481. 

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Objective　To investigate the azoospermia factor（AZF） gene microdeletion and its characteristic in idiopathic infertile males from Shanghai.  Methods　Polymerase chain reaction and agarose electrophoresis were used to detect microdeletion in AZFa，AZFb and AZFc in 38 patients with idiopathic azoospermia， 231 patients with oligozoospermia and 10 healthy controls.  Results　AZF gene STS point microdeletion was found in 18 of 269 infertile patients. There were 14 cases in AZFc，2 cases in AZFb+c， 1 case in AZFa+b+c and 1 case in AZFa. The total prevalence rate of microdeletion was 6.7% .  Conclusions　AZFc is a major gene for AZF gene screening in idiopathic infertile patients.Screening of AZF gene microdeletion for idiopathic infertile patients is essential.

The evaluation of the interference of variant hemoglobin and carbamino hemoglobin to the detection of glycosylated hemoglobin

KANG Jianhua;YANG Lishun;YUAN Haisheng

2012, 27(6):  482-485. 

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Objective　To evaluate the influence of variant hemoglobin and hemoglobin derivative carbamino hemoglobin on the detection of glycosylated hemoglobin （HbA1c） by ion exchange-high performance liquid chromatography（HPLC） and enzymatic method.  Methods　The normal hemoglobin structure diabetes mellitus patients′ samples without uremia，the fetal hemoglobin（HbF） samples and the concentration of HbA1c in patients with uremia were detected by the 2 Methods simultaneously.  Results　There was no significant difference between the 2 Methods for the HbA1c concentration in the normal hemoglobin structure diabetes mellitus samples without uremia（P>0.05）. For the ion exchange-HPLC， when HbF < 8.75%， there was no significant difference between the measured results and the expected value. When HbF was 8.8%-23.0%， the results were significantly lower than the theoretical concentration of HbA1c. When HbF was 35.0%-70.0%， the concentration of HbA1c can not be detected. For the carbamino hemoglobin， the HbA1c concentration in patients with uremia by ion exchange-HPLC was significantly higher than that by enzymatic method. Enzymatic method of HbA1c could not be interfered by HbF and carbamino hemoglobin.  Conclusions　The determination of HbA1c is influenced by HbF and carbamino hemoglobin by ion exchange-HPLC. There is no interference by enzymatic method.

Establishment of saliva glucose detection system for healthy subjects

LUO Man;XUAN Wenyang;CHEN Wenxi

2012, 27(6):  486-490. 

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Objective　To establish a high sensitive detection system to detect the glucose level in saliva in order to realize the daily noninvasively blood glucose monitoring for healthy subjects.  Methods　The method of glucose oxidase-peroxidase with 2，4，6-tribromo-3-hydroxybenzoic acid（TBHBA） as chromogen was modified， in which pH value and the consistency of ion were optimized， and citral was added to adjust the activity of the enzyme.  Results　The reaction of the new detection system could be completed in 30 min， and the maximal absorbing wavelength of detecting absorbance（A） value was 510 nm. The optimization of the new detection system parameters was pH: 5.8，0.3 mol/L NaCl and 1 220 μg/mL citral. The low limit value of glucose level detection was 0.006 mmol/L. Conclusions　The sensitivity of the optimized detection system is about 7 times more than that of the original system. The low limit value is 1/10 of fasting saliva glucose mean level in healthy subjects. It is sensitive enough to detect the glucose level in saliva of healthy subjects.

Diagnosis significance of serum lipase for acute pancreatitis

HANG Yonglun;HUANG Yuanshuai

2012, 27(6):  491-494. 

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Objective　To investigate the differential diagnosis significance of serum lipase （LPS） for acute pancreatitis （AP） in patients with acute abdominal pain. Methods　A total of 598 patients with acute abdominal pain were classified into AP group （192 cases） and non-AP （NAP）group （406 cases），including cholecystolithiasis （30 cases），intestinal obstruction （15 cases），acute cholecystitis （10 cases），abdominal trauma （9 cases），pancreas malignancy （6 cases），special abdominal pain （299 cases），diabetes mellitus （6 cases），upper digestive tract disease （11 cases），pulmonary disease （9 cases） and acute renal failure （11 cases）. Receiver operating characteristic（ROC） curve was set up， and the sensitivity， specificity， positive and negative predictive values were analyzed for LPS and serum amylase （AMY）. Results　Serum AMY and LPS levels in AP group were significantly higher than those in NAP group（P<0.01）. When the cut-off values of LPS and AMY were both set to 3 times of upper limit of normal reference range （180 and 300 U/L）， the sensitivities were 87.5% and 62.5%， the specificities were 89.4% and 95.3%， the positive predictive values were 80.0% and 86.3%， the negative predictive values were 94.7% and 88.2%， respectively. The areas under ROC curve for LPS and AMY were 0.959 and 0.921. There was positive correlation between serum AMY and LPS levels（r＝0.90）. Conclusions　Serum LPS has clinical significance in AP diagnosis， and is a better marker than AMY.

The diagnosis significance of urine alpha-L-fucosidase for diabetes mellitus early renal injury

CHANG Liangang;WANG Lei

2012, 27(6):  495-499. 

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Objective　To investigate the clinical application significance of urine alpha-L-fucosidase （AFU） for screening early renal injury of diabetes mellitus （DM）. Methods　The 178 type 2 DM patients were classified into DM without nephropathy group（79 cases），DM with nephropathy in early stage group（54 cases） and clinical DM with nephropathy group （45 cases）， according to the 24 h urine microalbumin（mAlb） excretion rate. A total of 178 type 2 DM patients and 320 healthy subjects were enrolled in this study. By the continuous monitoring method established by our laboratory，the urine AFU，urine mAlb，urine beta₂-microglobulin（β₂-MG） and N-acetyl-beta-D-glucosaminidase（NAG） contents were detected. The results between the 2 groups were analyzed comparatively. Results　The linearity of the AFU determination was up to 300 U/L.The within-run coefficients of variation（CV） of high and low AFU concentration samples were 1.69％ and 1.26％ respectively.The between-run CV of high and low AFU concentration samples were 4.51％ and 3.52％ respectively.There was no interference for urine AFU when vitamin C， bilirubin and hemoglobin were 50 mg/L，136.8 μmol /L and 1 g/L.Compared with the control group［（0.82±0.45）U/ g·Cr，（11.54±8.81）mg/ g·Cr，（0.11±0.07）mg/ g·Cr and （9.08±5.21）U/ g·Cr］，the urine AFU， mAlb，β₂-MG and NAG significantly increased ［（2.87±0.91）U/ g·Cr，（67.62±21.27） mg/ g·Cr， （0.48±0.32） mg/ g·Cr and （29.23±8.29） U/ g·Cr］ in DM group （P<0.01）. The urine AFU，mAlb，β₂-MG and NAG among the 3 groups of patients with DM were statistically significant （P<0.01）， and the urine AFU was positively correlated with NAG in patients with DM（r＝0.859，P<0.01）. In the DM without nephropathy group， the positive rate of urine AFU was 19.0%，with specificity 85.7%，sensitivity 91.8%，Youden index 0.77 and diagnostic efficiency 89.9％.The level of urine AFU after the treatment in the DM with nephropathy group （99 cases）［（2.7±1.26）U/ g·Cr］ was significantly lower than that before the treatment［（4.6±1.72）U/ g·Cr］（P<0.01）. Conclusions　The determination of urine AFU is a valuable indicator for screening early renal injury of DM.

Application on the combined detection of serum iron，ferritin， transferrin，haptoglobin，alpha 2-macroglobulin in liver diseases

2012, 27(6):  500-502. 

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To investigate the relationships of the levels of serum iron（Fe）， ferritin（Ferr）， transferrin（TRF）， haptoglobin（Hp） and alpha2-macroglobulin（α2-MG） with common liver diseases. Methods　The Fe levels of 98 hepatitis B patients（chronic hepatitis group）， 80 patients with liver cirrhosis （liver cirrhosis group） and 60 healthy subjects （control group） were determined by Hitachi 7170A automatic biochemical analyzer. The serum Fe， TRF， Hp and α2-MG levels in the 3 groups were detected by Siemens automatic specific protein instrument （BNP）. Results　In chronic hepatitis group， the Fe level （30.40±4.80）μmol/L and Ferr level （256.00±48.00）μg/L were higher than those in the control group （P<0.05）. The TRF level （2.18±0.20）g/L and Hp level （0.66±0.32）g/L were significantly lower than those in the control group（P<0.05）. The α2-MG level （2.28±0.39） g/L was slightly higher than that in the control group， but without statistical significance （P>0.05）. In liver cirrhosis group， the Fe level （33.60±5.00）μmol/L and Ferr level （287.00±51.00）μg/L were higher than those in the control group （P<0.05）. The TRF level （2.00±0.18）g/L and Hp level （0.52±0.30）g/L were lower than those in the control group （P<0.05）.The α2-MG level （2.30±0.40）g/L was slightly higher than that in the control group， but with no statistical significance （P>0.05）. Conclusions　Serum Fe，Ferr，TRF，Hp and α2-MG levels can be important indices for predicting the degree of liver diseases， and have significance for disease diagnosis and treatment.

Investigation on acceptable range of external quality assessment of quantitative PCR for HBV DNA detection

2012, 27(6):  503-505. 

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Objective　To investigate the reasonable acceptable range of external quality assessment of quantitative polymerase chain reaction（PCR） for hepatitis B virus（HBV） DNA detection， and make the external quality assessment more truly reflect and monitor the detection capabilities of clinical laboratories. Methods　Shanghai Center for Clinical Laboratory arranged a flight check for HBV DNA with 5 quality control samples，which were distributed to 51 participating clinical laboratories. After 3 hours，the test results of all participants were brought back and analyzed by investigator. The reagents were classified into A， B and C groups， according to the number of hospital using ≥10. The results，group mean values， sample standard deviations（s） ith different concentrations and coefficients of variatio（CV） among various reagent groups were compared， respectively. The value of logarithm±0.4 calculated from group mean value±3s， group mean value±0.5log10 and test values traceable to national standards was used to evaluate the detection results of clinical laboratory. Results　The detection results of clinical laboratories among various reagent groups had significant difference. Compared with the B reagent group，the A reagent group detection results of sample 1142，1144 and 1145 were statistically significant（P<0.05）. Compared with the C reagent group， the A reagent group detection results of sample 1144 and 1145 were statistically significant（P<0.05）. When comparing the A reagent group mean value with the B and C reagent group mean values，or the test values traceable to national standards （the results indicated as logarithm value， and the unit was IU/mL）， the difference of sample 1144 and 1145 exceeded 0.4，and the sample s and s and CV of 4 different concentration samples all exceeded the sample s and CV with an allowable total errors of 0.4. The pass rates of participating laboratories which were evaluated by the 3 kinds of Methods were 100%，88.2% and 64.7%， respectively. Conclusions　The mean value±3s used for acceptable range of external quality assessment of the quantitative PCR for HBV DNA detection is more reasonable， and can truly reflect and monitor the detection capabilities of clinical laboratories.