Table of Content

30 November 2013, Volume 28 Issue 11

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Orginal Article

Retrospective investigation on serum lipid levels of the patients in Zhongshan Hospital, Fudan University, from 2008 to 2012

YANG Yihui,ZHANG Xilin,WU Jiong,WANG Beili, SONG Binbin, ZHANG Chunyan, GUO Wei, PAN Baishen.

2013, 28(11):  981-987.  DOI: 10.3969/j.issn.1673-8640.2013.11.005

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Objective To study the changes of serum lipid levels among the patients from 2008 to 2012,and to provide references for the diagnosis and treatment of dyslipidemia. Methods Statistical methods were used to analyze 1 810 982 samples from the patients being detected for total cholesterol (TC) or triglyceride (TG) levels for the first time during January 2008-December 2012 (TC: 904 373 cases and TG: 906 609 cases). The differences were analyzed statistically, according to the causes of treatment (inpatient group, outpatient group and healthy examination group), age and sex. Results There was an obvious increasing trend in both TC and TG levels during the 5 years. The serum lipid levels of outpatient group were higher than those ofinpatient group and healthy examination group. TC levels of outpatient group had no statistical difference in the 5 years,and TG levels decreased. TC levels in 2012 had a growth of 6.71% compared with those in 2008 in healthy examination group, and TG levels also increased significantly in the 5 years. The serum lipid levels of inpatient group were the lowest. Compared with those in 2008, TC levels of inpatient group increased in 2009, and then had no difference in the later years,while TG levels kept increasing from 2008 to 2012. The percentage of subjects with TC≥6.22 mmol/L and TG≥2.26 mmol/L was higher in the entire subjects than in healthy examination group. The percentagesof subjects with TC≥6.22 mmol/L and TG≥2.26 mmol/Lincreased in both the 2 groups during the 5 years. TC and TG levels of males and females went up in the most age groups,especially in the age group of 21- 40. TC levels were higher in males than those in females only among 21-50 age groups. TC levels in males increased with age before 50, and decreased with age after 70, while TC levels in females increased with age before 70. TG levels were higher in males than in females before 60, and were lower after 60. TG levels of males went up with age before 50, and then went down after 50,while TG levels of females went up before 70, and then went down after 70. Conclusions There is an increasing trend in serum lipid levels during 2008-2012. The prevalence of dyslipidemia among young population shows ascending trend, which should pay more attention to the management of serum lipid levels in young and middle-aged population.

Study on the correlation of cystatin C concentration with short term prognosis of acute coronary syndrome

GONG Yanfei,ZHANG Zuping,LIU Xianglin,LIU Peixiang,XIE Liyun,LIAO Wenan, LI Xiangyang.

2013, 28(11):  988-991.  DOI: 10.3969/j.issn.1673-8640.2013.07.006

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Objective　To study the relationship of cystatin C (Cys C) concentration with short term prognosis in acute coronary syndrome (ACS) patients. Methods　A total of 386 ACS patients were enrolled, including 212 patients with ST elevation ACS (STE-ACS) and 174 patients with non-ST elevation ACS (NSTE-ACS). Serum B-type natriuretic peptide (BNP), high sensitive C reactive protein (hs-CRP), Cys C and cardiac troponin I (cTnI) were determined within 24h after admission. Serum Cys C was classified according to percentile intervals. Rank-sum test was used to compare the levels of BNP, hs-CRP,age and weight in the different groups and the differences of Cys C concentrations in the STE-ACS and NSTE-ACS groups. χ² test was used to compare the distribution differences of hypertension,diabetes mellitus, high cholesterol and smoking in the different groups. The cardiovascular events of the selected patients during hospitalization and after discharge were followed up. The cumulative incidence rates of cardiovascular events were compared among the different groups, Kaplan-Meier curves of cumulative incidence rates of cardiovascular events to time were drawn, and receiver operating characteristic (ROC) curve was drawn to assess Cys C predictive adverse outcome in patients with ACS. Results　According to Cys C concentration percentile intervals, the ACS patients were classified into <0.69 mg/L group (96 patients), 0.69-<0.86 mg/L group (97 patients), 0.86-<1.03 mg/L group (98 patients) and ≥1.03 mg/L group (95 patients). The age,BNP and hs-CRP also increased in the different groups,as well as the distributions of hypertension,diabetes mellitus and high cholesterol. Weight and smoking distributions in each group had no significant difference. Cys C concentration in STE-ACS group had no statistical significance with that in NSTE-ACS (P>0.05). The cumulative incidence rates of cardiovascular events in the different groups were 6.3%, 7.2%, 9.2% and 18.9% from low-concentration Cys C to high-concentration Cys Crespectively, but there was statistical significance between ≥1.03 mg/L group and <0.69 mg/L group, according to Kaplan-Meier curves (P<0.05). The area under ROC curve predicting the risk of adverse outcome was 0.754. Conclusions　Cys C concentration is positively correlated with BNP, hs-CRP, age, hypertension, diabetes mellitus and high cholesterol, and it contributes particularly in predicting the adverse outcome in patients with ACS, with no interaction by the type of ACS.

The experimental study in erythrocyte immuno-adhering function of children patients with mesangio-proliferative glomerulonephritis

HUANG Yun, DAI Yuegang, WANG Jian, GU Lan.

2013, 28(11):  992-994.  DOI: 10.3969/j.issn.1673-8640.2013.11.007

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Objective　To investigate the mechanism of erythrocyte immuno-adhering in the pathogenesis of mesangioproliferative glomerulonephritis(MsPGN). Methods　The erythrocyte immuno-adhering function was measured in 34 children patients with MsPGN. Red blood cell C3b receptor rosette (RCR) and tumor red blood cell rosette (TRR) were determined. The complement receptor type 1(CR1)density-associated genotypes (HH type, HL type and LL type) on erythrocyte were determined by polymerase chain reaction (PCR) amplification with Hind Ⅲ restriction enzyme digestion technique. Results　RCR and TRR of the children patients with MsPGN were lower than those of healthy children (P<0.01). The most CR1 density-associated genotype on erythrocyte of the children patients with MsPGN was HH type, and HH type percentage of the children patients with MsPGN decreased significantly(P<0.05). No LL type was determined. TRR of the children patients with MsPGN was lower than that of healthy children with same genotype(P<0.01). TRR of HH typewas higher than that of HL type (P<0.01). Conclusions　The decreasing activation of erythrocyte CR1 induces low capacities of identifying,adhering,clearing immunocomplex(IC),which lead to the deposit of glomeruli and the proliferation of mesangial cells. The decrease of erythrocyte immuno-adhering function plays an important role in the pathogenesis of MsPGN. The results of CR1 density-associated genotypes are correlated with the ability of erythrocyte immuno-adhering function. There will be the secondary decrease of erythrocyte immuno-adhering function of MsPGN.

Characteristic and clinical significance of N-glycan profile in light chain multiple myeloma

CHEN Jie,FANG Meng,ZHOU Jun,SUN Quansheng,YIN Yuepeng,GAO Chunfang.

2013, 28(11):  995-1000.  DOI: 10.3969/j.issn.1673-8640.2013.11.008

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Objective To investigate the characteristic and clinical significance of serum N-glycan profile in light chain multiple myeloma(LCMM). Methods A retrospective analysis of serum N-glycan profile was performed in LCMM patients, IgG multiple myeloma(MM) patients and healthy controls with matched sex amd age by DNA sequence-assisted, fluorophore-assisted carbohydrate electrophoresis (DSA-FACE). Results Peak3 (single agalacto,core-alpha-1,6-fucosylated biantennary, NG1A2F) and Peak6(bigalacto, core-alpha-1,6-fucosylated biantennary, NA2F) in LCMM patients were significantly lower than those in healthy controls, while Peak5 (bigalacto, biantennary, NA2) was significantly higher. Using Peak 3 to verify the diagnosis efficiency, the area under the receiver operating characteristic (ROC) curve of Peak3 was 0.943. The optimum diagnosis cut-off value was 5.15% with sensitivity 88.1% and specificity 90.5%. The decrease of Peak3 and Peak6 and the increase of Peak5 were found in LCMM patients, as compared with IgG MM patients. Using Peak3 to verify the differential diagnosis efficiency, the area under the ROC curve of Peak3 was 0.895. The optimum differential diagnosis cut-off value was 6.77% with sensitivity 100.0% and specificity 78.6%. The changes of Peak3, contrary to Peak5, were positively correlated with IgG, total protein, M-spike and serum light chain ratio, and were negatively correlated with albumin, hemoglobin and platelet in the correlation analysis between serum N-glycan profile and routine laboratory parameters in the 3 groups, and the changes of Peak 6 were negatively correlated with urea and creatinine. Conclusions The characteristic change has taken place in the serum N-glycan profile of LCMM patients, especially Peak3, which is closely bound on the symptoms of hypoglobulinemia, kidney function injury and the progression of disease. Meanwhile, Peak3 may become a new biomarker for diagnosing and differentially diagnosing LCMM. During the prognosis evaluation and monitoring of LCMM, the determination of N-glycan profile avoids the hurt of drawing bone marrow and eliminates the detecting errors caused by polymers of light chain and kidney malfunction on the determination of serum and urine light chains.

Meta analysis on the positive detection rate of anti-F protein antibodies in patients with HCV infection

LIU Jie, WANG Jiashi, YU Wenhua, ZHANG Lei, KANG Hua, FAN Zhijuan, LIU Shuye.

2013, 28(11):  1001-1007.  DOI: 10.3969/j.issn.1673-8640.2013.11.009

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Objective　To investigate the production of anti-F protein antibodies in patients with hepatitis C virus (HCV) infection by Meta analysis. Methods　Relative literatures were searched from the CNKI, Wan Fang, Weipu, SinoMED, Medline, Pubmed, Splingerlink, Cochrane and Science direct from 1968 to November 2012, and hand searching investigation was as complement. The literatures were selected according to the inclusion and exclusion criteria. The final literatures were consolidated and analyzed by Revman 5.0 software. The results were evaluated by Oxman-Guyatt Overview qualityassessment questionnaire (OQAQ). Results　The results of patients with HCV infection and healthy subjects were compared, and 14 studies with 1 348 patients with HCV infection were enrolled. The positive detection rate of anti-F protein antibodies had statistical significance (P<0.000 01). The superiority of pooled rate was>1. The total odds ratio (OR) was 64.81 [95% confidence interval (CI) 29.90-140.49]. The results of patients with HCV infection and non-HCV infection were compared, and 11 studies with 923 patients with HCV infection were enrolled. The positive detection rate of anti-F protein antibodies had statistical significance (P<0.000 01). The positive detection rate of patients with HCV infection was 53.09 times for that of patients with non-HCV infection (95% CI 23.56-119.66). By comparing the positive detection rate of anti-F protein antibodies with that of anti-core protein antibodies in patients with HCV infection, and 8 studies with 770 patients with HCV infection were enrolled, and there was statistical significance (P<0.000 01). The rate difference (RD) was -0.42 (95% CI -0.59--0.25).The positive detection rate of anti-core protein antibodies was 42%, which was higher than that of anti-F protein antibodies. Conclusions　The positive detection rate of anti-F protein antibodies in patients with HCV infection is significantly higher than those in healthy subjects and patients with non-HCV infection. F protein can induce HCV infection producing anti-F protein antibodies, which is a specific protein. It provides a theoretical basis and datum support for the diagnosis of HCV infection and monitoring the interferon combination therapy.

The study of acquired resistant genes against aminoglycosides in extensively drug-resistant Acinetobacter baumannii

WANG Yuyue,SHI Weifeng,ZHOU Jun.

2013, 28(11):  1008-1011.  DOI: 10.3969/j.issn.1673-8640.2013.11.010

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Objective　To investigate the situation of acquired resistant genes against aminoglycosides in extensively drug-resistant (XDR) Acintobacter baumannii (AB) isolated from intensive care unit (ICU) patients. Methods　Bacterial identification and susceptibility tests of AB were performed by phoenix^TM-100 automatic bacterial identification and susceptibility analyzer, and the AB identification was confirmed by gyrA and parC gene amplification sequencing. For the 20 isolates of XDR-AB, 10 aminoglycoside modifying enzyme genes, 6 16S rRNA methylase genes and efflux pump adeB genes were detected by polymerase chain reaction(PCR) and verified and compared by DNA sequencing. Results　Of the 20 isolates of XDR-AB, the detection rates of aac(3)-Ⅰ,aac(6′)-Ⅰb,ant(3″)-Ⅰ and aph(3′)-Ⅰ genes were 90.0%,30.0%,95.0% and 95.0%,respectively.However, aac(3)-Ⅱ,aac(6′)-Ⅰad,aac(6′)-Ⅱ,ant(2″)-Ⅰ,ant(4′)-Ⅰand aph(3′)- Ⅵa genes were not found.In addition,the armA 16S rRNA methylase gene and efflux pump adeB genes existed in all of the 20 isolates, and the detection rates were 100%. Conclusions　All of the 20 isolates of XDR-AB carry not only armA and adeB genes but also a large amount of aac(3)-Ⅰ,ant(3″)-Ⅰand aph(3)-Ⅰgenes.It indicates that the high-level resistance to aminoglycosides in XDR-AB isolated from ICU may be associated with the resistant genes.

Study on the double-circle drug resistance to amikacin in Enterobacteriaceae

ZHOU Wanqing, SHEN Han, NING Mingzhe, ZHANG Zhifeng, XU Xuejing, ZHU Hong, CAO Xiaoli, ZHANG Kui.

2013, 28(11):  1012-1015.  DOI: 10.3969/j.issn.1673-8640.2013.11.011

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Objective　To investigate the double-circle drug resistance gene to amikacin (AMK) in Entero-bacteriaceae by disk diffusion methodand to study the influence on the expression level of resistance gene mRNA. Methods　One strain of Escherichia coli (Eco85) and one strain of Klebsiella pneumoniae (Kpn110) which showed double-circle drug resistance to AMK were collected, and the resistance phenotype change was analyzed by disk diffusion method. Polymerase chain reaction (PCR) was performed for aminoglycoside modification genes, integronsand 16S rRNA methylase gene. The armA gene expression levels among strains induced and non-induced by AMK were studied by reverse transcription PCR. Transmissibility of the resistant gene was carried out by conjugation method. Results　The double-circle resistance phenotype was changed to complete resistance at the tenth and sixteenth for Eco85 and Kpn110, respectively. The 2 strains were positive for integron geng Ⅰ, Eco85 and Kpn110 contained aadA5-dfra17 box and aadA2-dfrA12 box, respectively. The 2 strains were positive for integron gene Ⅱ and Ⅲ. Eco85 was positive for aac(6)-Ⅰ gene, and Kpn110 was positive for ant (3″)-Ⅰ gene. Eco 85 and Kpn 110 were positive for armA gene, and there was no mutation in gene sequencing and no rmt B gene. The expression level of armA gene mRNA was significantly up-regulated when the strains were induced by AMK. The conjugation test was failed. Conclusions　The double-circle drug resistance to AMK in Escherichia coli and Klebsiella pneumoniae may associate with the induction expression of 16S rRNA methylase armA gene.

The correlation study of HBoV viral load and disease severity in children with lower respiratory tract infections

ZHAO Baihui, WANG Chun, TENG Zheng, SHEN Jiaren, GAO Ye, YU Xuelian, ZHANG Hong, ZHANG Xi.

2013, 28(11):  1016-1020.  DOI: 10.3969/j.issn.1673-8640.2013.11.012

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Objective　To study the correlation of human bocavirus (HBoV) viral load and disease severity in children with lower respiratory tract infections. Methods 　Nasopharyngeal aspirates(NPAs) from 554 in-hospital children with lower respiratory tract infections under 5-year-old and swabs from 195 healthy children were collected from January 2009 to September 2012. The types of HBoV and HBoV viral load were determined by fluorescence polymerase chain reaction (PCR). The other respiratory viruses were determined by commercial kits.The results were analyzed with clinical symptoms and biochemistry parameters. Results　The positive rates of HBoV between in-hospital children and healthy children had obvious difference.The HBoV viral loads of in-hospital children (5.10×10⁶ copies/mL) were significantly higher than those of healthy children (2.70×10³ copies/mL, P<0.05). Among co-infection in-hospital children, the HBoV viral loads of mild and moderate groups (2.70×10⁵ and 3.85×10⁶ copies/mL) were lower than that in severe group (8.70×10⁶ copies/mL, P<0.05). There was 1 case ofnewborn infant with severe pneumonia, and HBoV were found in NPAs, blood and stool samples without other common respiratory trract virus and bacterium infections. Conclusions　HBoV is a pathogen for respiratory tract disease in children. HBoV viral load is correlated positively with disease severity in co-infection patients. HBoV can cause severe pneumonia in some children.

The preparation and clinical application research of self-made tacrolimus internal quality control material

ZHANG Liping, LIU Yuanming, ZHANG Jinhong, SONG Na, HAO Qinfang, YANG Xiaoli.

2013, 28(11):  1021-1025.  DOI: 10.3969/j.issn.1673-8640.2013.11.013

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Objective　To improve tacrolimus (FK506) internal quality control material, and remedy the monitoring blind of commercial ones. Methods　The results of FK506 were observed in 1 year,and the feasibility of self-made low-level quality control material was evaluated. By self-made internal quality control materialof low level (ZCON-L) and self-made internal quality control material of middle level (ZCON-M), the intra-day and inter-day relative standard deviations (RSD%) were determined. The differences between low-level and middle-level commercial internal quality control materials (Level 1 and Level 2) and self-made ones were compared. The internal quality control chart was drawn,the ZCON-M and Level 2 were analyzed statistically,and the difference of self-made internal quality control material and commercial ones was analyzed. The ZCON-L and ZCON-M were put at 4,25 and 37 ℃ and monitored for 7 d, and the influence of temperature was observed. The self-made internal quality control material were subpackaged biocleanly and stored at -30 ℃, someone was took out every week, after thawing, it was monitered following the routine works, and stored at 4 ℃. Monitoring for 10 months, the stability was observed and analyzed. Results　Among 9 975 determinations of FK506 in 1 year, there was about 28.4% in the monitoring blind. The intra-day RSD and inter-day RSD of ZCON-L and ZCON-M were 4.5％,5.3％and 7.06%, 5.37% respectively,conforming to the performance indicators of ARCHITECT i1000 automatic immunoassay analyzer and the requirement of RSD<15％ of biological sample analysis method in the Chinese Pharmacopoeia. The correlations between ZCON-L,ZCON-M and Level 1, Level 2 were good (r²=0.835 2 and 0.818 5), and their trends were consistent in the internal quality control chart. ZCON-M and Level 2 had no statistical significance by t test (P>0.05). The temperatures (4,25 and 37 ℃) in 7 d had less effect to the self-made internal quality control material. The total RSD of ZCON-L and ZCON-M in 10 months were 7.56％ and 4.97％. Conclusions　The stability of self-made FK506 internal quality control material is good,it has no difference with commercial ones,it can be used in the clinical determination, so it can remedy the monitoring blind of commercial internal quality control materials and make up the internal quality control.

Relationship between tumor metastasis and cathepsin D in serous cavity effusion

XIE Xin,CHEN Kun,HUANG Tao,LI Qian,LU Shuaijun,NIE Zhiwen,TAN Longyi.

2013, 28(11):  1026-1029.  DOI: 10.3969/j.issn.1673-8640.2013.11.014

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Objective　To study the relationship between tumor metastasis and cathepsin D(CD) in serous cavity effusion. Methods　A total of 77 patients with serous cavity effusion were enrolled in the study. According to the clinical data and pathological diagnosis,the 77 patients were classified into 2 groups,non-tumor group(22 cases) and tumor group (55 cases, including 30 cases of tumor cell positive group and 25 cases of tumor cell negative group). The concentrations of CD and carcinoembryonic antigen (CEA) in serous cavity effusion were determined by enzyme-linked immunosorbent assay (ELISA) and chemiluminescence, respectively. The concentrations of CD and CEA from different groups were compared, and the receiver operating characteristic(ROC) curve was used to evaluate the diagnosis significance of CD determination, CEA determination and the combined CD and CEA determination. Results　The concentrations of CD and CEA in the tumor group were significantly higher than those in the non-tumor group (P<0.05). The concentration of CD was positively correlated with that of CEA(Kendall correlation coefficient 0.323, Spearman correlation coefficient 0.396, P<0.001). The areas under the ROC curve of CD,CEA and CEA combined with CD for discriminating tumor were 0.763,0.723 and 0.812, respectively. The concentration of CD in the tumor cell positive group was significantly higher than that in the tumor cell negative group(P<0.05),whereas the concentrations of CEA in the 2 groups were not significantly different (P=0.051). The areas under the ROC curve of CD,CEA and CEA combined with CD for discriminating tumor metastasis were 0.677, 0.654 and 0.767, respectively. Conclusions　The concentration of CD in serous cavity effusion is related to tumor serous cavity metastasis. CD in serous cavity effusion may be a candidate indicator for discriminating tumor and tumor serous cavity metastasis. The combined CD and CEA determination is recommended.

Distribution and drug resistance of pathogenic bacteria from blood culture of children in Nanjing during 2009-2011

HOU Hong, GAO Ling, WANG Xia, CHEN Wenying.

2013, 28(11):  1030-1032.  DOI: 10.3969/j.issn.1673-8640.2013.11.015

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Objective　To investigate the distribution and drug resistance of pathogenic bacteria from blood culture of children in Nanjing during recent 3 years. Methods　The distribution and drug resistance of pathogenic bacteria from blood culture of children in Nanjing Children′s Hospital from January 2009 to December 2011 were analyzed retrospectively. Results　Totally 2 489 isolates of bacteria were collected from 14 232 blood culture samples. The isolation rate was 17.5%. A total of 2 082 isolates of Gram positive bacteria accounted for 83.6%. Gram negative bacteria and fungi accounted for 13.8% (344 isolates) and 2.6%(63 isolates), respectively. The main of Gram positive bacteria was coagulase negative Staphylococcus(CNS), and Escherichia coli was the most part of Gram negative bacteria. Gram positive bacteria were sensitive to vancomycin, ciprofloxacin and rifampicin and resistant to penicillin seriously. Gram negative bacteria were sensitive to imipenem,amikacin and cefoperazone-sulbactam. Conclusions　Gram positive bacteria are the most frequently pathogenic bacteria from blood culture of children in Nanjing. Drug resistance is serious in these isolates. We should recognize the results of drug sensitivity tests and the indication of pathogenic bacteria to use antibiotics reasonably.

The diagnosis significance of capillary electrophoresis in hemoglobin CS-H disease

LI Youqiong,HUANG Huipin,QIN Guifang,HUANG Chunli.

2013, 28(11):  1034-1037.  DOI: 10.3969/j.issn.1673-8640.2013.11.017

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Objective　To investigate the application significance of capillary electrophoresis analyzer in the diagnosis of hemoglobin(Hb) CS-H disease. Methods　A total of 34 patients with Hb CS-H disease confirmed by thalassemia genetic analysis and 70 patients with non Hb CS-H disease (including 42 cases of -^SEA/-α^3.7,19 cases of -^SEA/-α^4.2,7 cases of Hb WS-H and 2 cases of Hb QS-H) were determined for Hb with Sebia Capillarys 2 capillary electrophoresis. The thalassemia genetic analysis of the 2 groups was conducted bygap-polymerase chain reaction (Gap-PCR) and reverse dot blot hybridization. Results　The HbCS and HbH contents of Hb CS-H group were (1.89±1.33)% and (1.07±0.86)%,and the HbA₂ content was (1.17±0.68)%. However,the samples with HbCS and a part of HbH were not detected in non-Hb CS-H group,and the HbA₂ content was (1.81±1.21)%. Compared with Hb CS-H group and non-Hb CS-H group for HbA₂,there were significant significance (P<0.05). Compared with the thalassemia genetic analysis,the sensitivity of capillary electrophoresis for the diagnosis of Hb CS-H disease was 88.2%,the specificity was 100.0%,the positive predictive value was 100.0%,the negative predictive value was 94.6%,the diagnosis efficiency was 96.2%,and there was no statistical significance (P=0.134). Conclusions　The capillary electrophoresis can be used to the rapid diagnosis of Hb CS-H disease,and it will alleviate some of the economic burdens for patients.

Investigation on the range and confirmation test of hepatitis B surface antigen determination by ELISA

ZHU Yuqing,HOU Yumin.

2013, 28(11):  1038-1039.  DOI: 10.3969/j.issn.1673-8640.2013.08.018

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Objective　To investigate the retesting range of borderline results for hepatitis B surface antigen (HBsAg) negative samples determined by enzyme-linked immunosorbent assay(ELISA) and the result range of weakly positive samples for confirmation test. Methods　Serum HBsAg was detected by ELISA reagents made in China. Negative samples were retested. Positive samples were carried on confirmation test using Abbott AxSYM system and reagents. Results　There were 547 cases of HBsAg negative samples, including 510 cases of absorbance (A)≥0.073 5. After retesting, 5 cases were positive, and the results of confirmation test were positive. In 37 cases of A＜0.073 5, all retested negative. A total of 332 positive samples were carried on confirmation test, and 160 cases of A≥1.0 were all positive. In 172 cases of A＜1.0, 7 samples were negative. Conclusions　For HBsAg confirmation test using ELISA reagents made in China, it is useful to definite the retesting range of negative samples, and is necessary for weakly positive samples to identify confirmation test range.

Comparative analysis on the performance of GICA for the determination of HBV serological markers

JIAN Minhua, ZHANG Jian,CHEN Huiying, JIANG Lingli, LU Yinhua, XIAO Yanqun, SHAO Weijie, XU Chong.

2013, 28(11):  1040-1043.  DOI: 10.3969/j.issn.1673-8640.2013.11.019

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Objective　To evaluate the performance of colloidal gold immunochromatography assay (GICA) for the determination of the serological markers of hepatitis B virus (HBV-M). Methods　Abbott i1000 immunoassay system detected 653 cases of HBV-M positive samples, and the results of 103 cases of HBV-M negative samples and HBV-M standard materials by chemiluminescence immunoassay (CLIA) were as the standard. Enzyme-linked immunosorbent assay (ELISA) reagent and 5 GICA reagents were used for the detection, and the results were analyzed statistically. Results　The sensitivity for the determination of HBV-M was analyzed. ELISA and GICA detection limits for HBV-M showed that hepatitis B surface antigen (HBsAg) 0.5 IU/mL and 4-8 IU/mL,anti-hepatitis B surface antigen antibody (anti-HBs) 10 mIU/mL and 15-30 mIU/mL, hepatitis B e antigen (HBeAg) 1 NCU/mL and 2-4 NCU/mL, anti-hepatitis B e antigen antibody (anti-HBe)2 NCU/mL and 64-256 IU/mL, anti-hepatitis B core antigen antibody (anti-HBc) 2 IU/mL and 32-256 NCU/mL. The coincidence rates of HBV-M were 87.4%, 99.0%, 87.7%, 96.6% and 100.0% by ELISA and were 69.6%-71.7%, 69.0%-72.0%, 70.5%-73.9%, 42.2%-49.1% and 50.0%-60.0% by GICA. Except the specificity for the determination of anti-HBs by GICA was slightly bad, the specificities of other HBV-M were acceptable. Conclusions　GICA for the determination of HBV-M with low concentration has high missing rate.GICA can only be used for the screening HBsAg with linear range, and its results cannot be used for the clinical diagnosis and efficacy assessment of hepatitis B.