Table of Content

30 November 2015, Volume 30 Issue 11

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Orginal Article

Study on the application strategy of the Accreditation Criteria for Proficiency Testing Providers in laboratory medicine

JU Yi, LÜ Yuan

2015, 30(11):  1055-1058.  DOI: 10.3969/j.issn.1673-8640.2015.11.001

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Proficiency testing (PT) [external quality assessment (EQA)] in laboratory medicine is an important method for the quality assurance of clinical laboratories. By comparing the results with other laboratories, the laboratories can find out and correct the problems in their works, and take effective measures to prevent the recurrence of the problems. With the development of medical science and technology, in order to meet the needs of the clinical diagnosis and treatment of diseases, there are higher requirements for laboratory testing capacities. As PT providers, continuous improvement evaluation strategy will have an important impact on the quality of laboratory testing. In recent years, ISO/IEC17043:2010 the Accreditation Criteria for Proficiency Testing Providers in laboratory medicine has gradually been focused and practiced preliminarily. In this paper, we summarize the 6 papers published in this PT special topic. It is hoped that through establishing the quality system of PT providers, with the quality assurance for laboratory testing, the harmonization and standardization of laboratory results can also be promoted.

Analysis on the 3-year results of trueness-based proficiency testing for hemoglobin A_1c in Shanghai medical institutes with different levels

JU Yi, LÜ Yuan, TANG Liping, LI Qing, WANG Meijuan, LIU Wenbin, JIN Zhonggan, OU Yuanzhu, YU Xiaoxuan

2015, 30(11):  1059-1069.  DOI: 10.3969/j.issn.1673-8640.2015.11.002

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To analyze the results of proficiency testing (PT) /trueness-based proficiency testing (TPT) for hemoglobin A_1c (HbA_1c) in Shanghai from 2012 to 2014 by the use of 2011 data as baseline, in order to provide the reference for HbA_1c determination quality improvement and standardization promotion.

The results of HbA_1c PT/ TPT organized by Shanghai Center for Clinical Laboratory (SCCL) from 2011 to 2014 were collected, and the 4-year datum change trend was analyzed about hospital and determination method distributions. The pass rates of each hospital and each method were analyzed by means of comparing the assigned values (target values) by the International Federation of Clinical Chemistry and Laboratory Medicine (IFCC) HbA_1c primary reference method and the group median values. Both College of American Pathologists (CAP) criteria and Shanghai local criteria of quality assessment for HbA_1c were also used. The performance (precision and accuracy) of each survey material and each group's pass rate were analyzed and compared with CAP global quality assessment results.

The number of participants increased from 245 in 2011 to 308 in 2014. The usage of domestic brand, MQ 2000PT, and imported brands, Bio-Rad, Tosoh and Arkray [high performance liquid chromatography (HPLC)], increased rapidly, and the rate was 38.1%-360.0%. A total of 3 point-of-care testing (POCT) devices were as follows: Axis-Shield (-78.9%), Boditech (no usage since 2013) and Quo-Test (usage since 2012, 27.8%). The usage rates of 2 low pressure liquid chromatography (LPLC) devices, Drew DS5 and MQ 2000, were -80.0% and -25.0%, respectively. The whole pass rate increased annually from 83.7% in 2011 (CAP 69.8%) to 95.8% in 2014 (CAP 90.3%). In 2014, the hospitals above Grade 2A had the pass rate 98.8%, while the CAP global quality assessment data were 88.8%-96.2% in the same year. The Grade 1 and Grade 2 hospitals had low pass rate than other grades. In terms of the total pass rate of each method group, it was higher by the use of group median values than by the use of assigned values of reference method, and also higher by Shanghai criteria than by CAP criteria. By CAP annual criteria, the pass rate of HPLC group still amounted to 81.0%-100.0%, except Tosoh in 2013, and those of 2 LPLC, 3 POCT and Immuno group (except in 2014) were 0%-75.0%. The total coefficient of variance (CV) of 5 survey materials/year was 3.0%- 4.0% for HbA_1c which improved obviously compared to 4.1%-9.9% in 2011 and be close to 3.4%-3.8% in CAP survey. The total bias was -0.16% HbA_1c-0.18% HbA_1c, which was lower than 0.3% HbA_1c criteria, but was higher than CAP's 0.02% HbA_1c--0.10% HbA_1c. Compared to the CAP 2 survey data with CV<3.5% (pass rate 85.0% and 90.0%), the pass rate in Shanghai was 83.3%, and the groups of POCT and LPLC methods cannot meet the minimum criteria of CV<5.0% and bias<0.5% HbA_1c.

By the 3-year quality management and TPT, the determination quality of HbA_1c is promoted, and the pass rates of hospitals above Grade 2A reach international level. Thus, the good performance products and qualified laboratories can assure HbA_1c as the diagnosis indicator of diabetes mellitus.

Establishment and application of serum creatinine reference method in accuracy survey

JIN Zhonggan, JU Yi, TANG Liping, WANG Meijuan, LIU Wenbin, LI Qing, OU Yuanzhu, YU Xiaoxuan

2015, 30(11):  1070-1073.  DOI: 10.3969/j.issn.1673-8640.2015.11.003

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To establish the reference method for the determination of human serum creatinine based on isotope dilution liquid chromatography tandem mass spectrometry (ID-LC/MS/MS), and to use it into assigning target value to fresh frozen serum samples in clinical laboratory accuracy survey.

The reference method was established and validated according to the Joint Committee for Traceability in Laboratory Medicine (JCTLM). Accuracy and precision of the reference method were assessed by SRM 909c and RELA samples. It was then used to assign values of creatinine to fresh frozen serum samples from small molecule accuracy investigation schemes gathering with Shanghai clinical laboratories.

The relative bias of the reference method was 0.69%, and imprecision was < 2%. For the sample 201411, 201412, 201421 and 201422, the relative biases from reference method were 14.97%, -2.77%, -1.37% and -1.92% for enzymatic test results, respectively, and were 21.39%, 2.10%, 6.22% and 2.38% for the Jaffe test results, respectively. The relative bias of all the samples with different systems from reference method was less than 8% except for the sample 201411 with low concentration.

The ID-LC/MS/MS method established for serum creatinine has good precision and accuracy, and the determination of the target value is of great importance on the result analysis of laboratories. It is expected to play a role in the trueness verification of clinical laboratories in Shanghai area. Therefore, this study highlights that the clinical laboratories should attach great importance to measurement accuracy and consistency with low concentration of creatinine.

Primary investigation on the consistency of red blood cell and white blood cell counts in Shanghai, 2014

WANG Qing, SONG Ying, XU Lei, MIAO Yingbo, ZHU Peichao

2015, 30(11):  1074-1077.  DOI: 10.3969/j.issn.1673-8640.2015.11.004

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To study the consistency of red blood cell (RBC) and white blood cell (WBC) counts in Shanghai, and to provide the reference for the appropriate accuracy verification project.

A total of 2 batches of weak-fixation-treatment whole blood samples were delivered to 710 clinical laboratories in Shanghai. Every laboratory was required to finish the determination within 3 d, with 5 duplicated determination results for each batch. All the determination data were uploaded via internet for statistical analysis within scheduled time.

A total of 693 clinical laboratories, with hematology analyzers (three- and five-classification instruments) spanning 12 brands and 57 models, reported their data of RBC and WBC counts. The coefficient of variation (CV) for RBC of 2 batch samples were 2.06% and 1.99%, respectively. The CV for WBC of 2 batch samples were 4.72% and 4.84%, respectively. The CV of different analyzers for RBC and WBC of 2 batch samples were 0.76%-3.18% and 1.73%-6.32%, respectively, and the means were within 95% confidence interval.

The counting results of RBC and WBC in the clinical laboratories in Shanghai have consistency, and fresh weak-fixation-treatment whole blood sample is acceptable for substituting fresh whole blood in the application of the accuracy verification project for RBC and WBC counts.

Development and application of quality control materials for EBV nucleic acid determination

WANG Xueliang, LIU Fen, JIANG Lingli, XIAO Yanqun, WANG Hualiang

2015, 30(11):  1078-1082.  DOI: 10.3969/j.issn.1673-8640.2015.11.005

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To develop quality control materials for Epstein-Barr virus (EBV) nucleic acid determination, and to apply it into the laboratories participating Shanghai external quality assessment, in order to evaluate the performance of EBV DNA determination.

The cultured lymphocytes (NAMALWA) known to contain EBV genome were collected as internal control. The applicability of the internal control with commercial EBV kits was evaluated, and the amounts in international units by tracing the internal control to the international standard were established. The panel consisted of 5 blindly coded samples diluted with human plasma and distributed to external quality assessment participates in Shanghai. The results from the participates were summarized and analyzed.

The original NAMALWA cells were all positive with different commercial EBV PCR kits. The concentration of internal control valued by international standard was 2.13×10⁵ IU/mL. False positivity and false negativity errors were found in parts of participating laboratories. The coincidence rates were 100% for high-concentration samples (10⁵ and 10⁴ IU/mL), 92% and 40% for low-concentration samples (10³ and 10² IU/mL) and 90% for negative samples, respectively. For samples replicated in the panels, the average coefficient of variation (CV) for intra-laboratory was 4.1% (1.4%-11.3%), and that for inter-laboratory was 6%. Good overall linearity was observed for most of the laboratories (75%).

The quality control materials for EBV PCR kits have been established successfully, and the applicability in external quality assessment is proved. These results indicate that most of participating laboratories show good performance in determining EBV DNA, and it is necessary for individual laboratories to improve their operation.

Result analysis on quality control survey of bacterial vaginosis sialidase determination

GE Ping, XU Rong, CHEN Rong, WANG Jinghua, LIU Xuejie

2015, 30(11):  1083-1085.  DOI: 10.3969/j.issn.1673-8640.2015.11.006

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To investigate the result quality of bacterial vaginosis (BV) sialidase determination in Shanghai hospital clinical laboratories at different levels by a variety of survey methods.

The rapid detection of BV (sialidase method) was performed with sialidase investigation among the clinical laboratories. The quality control of the survey results from 2010 to 2014 with 15 different types were analyzed statistically, according to the different levels of hospital laboratories (a group of Level 2 and 3 hospitals and a group of private hospitals). From 2012 to 2014, 9 kinds of commonly used BV rapid test kits were used, and the results of different levels of hospital laboratories were analyzed.

Different levels of hospital laboratory results were consistent with the difference rate of 30.4%. In the case of using same kit, different levels of hospital laboratory results were consistent with BV difference rate of 50%.

BV results vary widely in different levels of clinical laboratories, and some clinical laboratory quality has serious problems. Strengthening the quality control and management of clinical laboratory determination for BV is important. Clinical laboratories should reduce the costs of kits and ensure the quality. For routine determination, strengthening internal quality control is one of the keys for quality control.

Analysis on the results of external quality assessment of lymphocyte subsets by flow cytometry

ZHU Yuqing, ZHU Jun, XU Chong

2015, 30(11):  1086-1090.  DOI: 10.3969/j.issn.1673-8640.2015.11.007

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To evaluate the assessment rationality scheme of external quality assessment (EQA) for the analysis of lymphocyte subsets by comparing the data from the lymphocyte subset EQA in the National Center for Clinical Laboratory and Shanghai Center for Clinical Laboratory and the submitted data of internal quality control from 2 laboratories in Shanghai, in order to improve the analysis quality of lymphocyte subsets.

The data of BD flow cytometry group from the National Center for Clinical Laboratory EQA in 2014 and Shanghai Center for Clinical Laboratory EQA for the first time in 2015 were analyzed statistically, and the standard deviation (s) and coefficient of variation (CV) were calculated. The internal quality control data from 2 laboratories in Shanghai were collected from September 2014 to April 2015, and the s and CV were calculated. The CD3⁺CD4⁺ percentage (CD3⁺CD4⁺%) data of Sample 201403 and Sample 201405 (target values: 42.7% and 42.1%) from the National Center for Clinical Laboratory, Sample 1521 and Sample 1525 (target values: 43.2% and 44.13%) from Shanghai Center for Clinical Laboratory and the submitted internal quality control data (monthly mean 44.39%- 46.80%) of 2 laboratories were analyzed comparatively.

The s and CV of 5 EQA samples from the National Center for Clinical Laboratory in 2014 were 1.10%-1.55% and 3.1%-5.5%, respectively, and the average CV was 3.36%. The s and CV of 5 EQA samples for Shanghai Center for Clinical Laboratory in 2015 were 0.67%-1.63% and 3.51%-8.64%, respectively, and the average CV was 4.83%. In the situation of data with approximate means, the group s (1.55% and 1.35%) and group CV (3.6% and 3.2%) from the National Center for Clinical Laboratory and the group s (1.63% and 1.55%) and group CV (3.78% and 3.51%) from Shanghai Center for Clinical Laboratory were less than those of internal quality control data from 2 laboratories (monthly s 1.06%-2.44% and 0.98%-2.03%; monthly CV 2.18%-5.28% and 2.14%-4.35%).

It is irrational that the s and CV of EQA are less than those of internal quality control since different impacts from the factors such as instrument brands and models, lysis techniques, brands and volumes of antibodies, gating strategies, experimenters and environment conditions and so on. One of the possible reasons may be that some laboratories exchanged, checked and sometime modified the EQA data before submitting the data. Other than improving the quality education for the laboratories, the solution can be the establishment of rational marking scheme.

The influence of CYP3A4, CYP3A5 and CYP2D6 single nucleotide polymorphism on tacrolimus metabolism in renal transplantation patients during stable period

ZHOU Yiwen, ZHOU Yan, WU Jiong, JU Yinghui, GUO Wei

2015, 30(11):  1091-1095.  DOI: 10.3969/j.issn.1673-8640.2015.11.008

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To investigate the influence of cytochrome P450 CYP3A4, CYP3A5 and CYP2D6 single nucleotide polymorphism on tacrolimus (FK506) metabolism, and to study the feasibility of personalized base treatment of FK506.

A total of 138 renal transplantation patients during stable period were followed up. All patients received FK506, mycophenolate mofetil and prednisolone treatment. Drug dose per body weight was recorded, the trough concentration of FK506 was calculated, and gene sequencing was used to detect single nucleotide polymorphism of CYP3A4, CYP3A4 and CYP2D6. The drug dose per body weight of FK506 and its relationship with single nucleotide polymorphism were analyzed.

Among the 138 patients genotyped for CYP3A4, 138 patients displayed wild type TT (allele frequency 0.993), heterozygous TC (0.007). There were CYP3A5 wild type AA (0.529), heterozygous AG (0.399) and homozygous GG (0.072 ). CYP2D6 showed 76 case of wild type CC (0.550) and heterozygous CT (0.449). Compared to heterozygous and homozygous alleles, CYP3A5 wild type (AA) and mutant type (AG and GG) expressed higher FK506 dose (P<0.001). CYP2D6 wild type (CC) and mutant type (CT) had no statistical significance with FK506 dose(P>0.05) .

The CYP3A4 genotype polymorphism is mainly wild type, and the significance for FK506 metabolism is minimal. CYP3A5 has a major role in FK506 metabolism, and the patients with wild type need high dose of FK506. The CYP2D6 polymorphism has no correlation with FK506 metabolism.

Clinical significance on serum NGAL,Cys C and urinary NAG combined determination in the diagnosis of diabetic nephropathy

WANG Yiyi, ZHANG Jue, LU Chuancui, LUO Yuntao

2015, 30(11):  1096-1099.  DOI: 10.3969/j.issn.1673-8640.2015.11.009

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To investigate the clinical significance of serum neutrophil gelatinase-associated lipocalin(NGAL), cystatin C(Cys C) and urinary N-acetyl-beta-D-glucosaminidase(NAG) in the diagnosis of diabetic nephropathy (DN).

According to urinary albumin excretion rate(UAER),76 type 2 diabetes mellitus(T2DM) patients were classified into 3 groups, normal albuminuria group(26 cases, UAER<30 mg/24 h), micro-albuminuria group(25 cases, UAER=30-300 mg/24 h) and clinical albuminuria group(25 cases, UAER>300 mg/24 h). Another 40 healthy subjects were enrolled as healthy control group. The relationship of NGAL, Cys C and urinary NAG with glomerular filtration rate (GFR) was analyzed. The area under receiver operating characteristic (ROC) curve was used for the diagnosis efficiency of DN .

Serum NGAL,Cys C and urinary NAG of micro-albuminuria group and clinical albuminuria group were higher than those of healthy control group(P<0.05). Serum NGAL ,Cys C and urinary NAG were negatively correlated with GFR [correlation coefficient(r)=-0.855 23, -0.760 14 and -0.701 17, P<0.05]. The area under ROC curve of serum NGAL (0.862) was biggest, and the diagnosis efficiency was highest.

Serum NGAL which has a good correlation with GFR is expected to be used in clinical diagnosis and monitor.

Correlationship between homocysteine and glomerular filtration rate in patients with chronic kidney disease

LI Pingzhu

2015, 30(11):  1100-1103.  DOI: 10.3969/j.issn.1673-8640.2015.11.010

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To investigate the correlationship between homocysteine (Hcy) and glomerular filtration rate (GFR) in patients with chronic kidney disease (CKD).

A total of 289 suspected CKD patients were enrolled. A total of 134 cases were diagnosed as CKD (CKD group), and the other 155 cases were as non-CKD group. The levels of serum Hcy, creatinine (Cr), uric acid (UA), glucose (Glu) and blood lipids [triglyceride (TG), total cholesterol (TC), low-density lipoprotein cholesterol (LDL-C) and high-density lipoprotein cholesterol (HDL-C)]were determined. The correlationship between Hcy and GFR was analyzed.

The levels of Hcy in CKD group were significantly higher than those in control group (P<0.01), while Cr, UA and GFR were significantly lower (P<0.01). According to Hcy level, compared with the group of <15 μmol/L, the groups of 15-30 μmol/L and >30 μmol/L decreased significantly for GFR and Cr (P<0.05), and UA increased slightly. Hcy was negatively correlated with GFR (r=-0.398, P<0.01). The area under the receiver operating characteristic (ROC) curve (AUC) for Hcy was 0.706 [95% confidence interval (CI): 0.643-0.745].

Hcy increases significantly in CKD patients and has a good correlation with GFR.

Research on the clinical significance of CTHRC1 for HBV

SONG Hui, LIU Xinghui, SHEN Zhenhua, CHEN Qing, XU Fengxia, XU Limin

2015, 30(11):  1104-1106.  DOI: 10.3969/j.issn.1673-8640.2015.11.011

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To investigate the influence of hepatitis B virus(HBV) on the expression of collagen triple helix repeat containing 1(CTHRC1) and its clinical significance.

The mRNA and protein levels of CTHRC1 in HepG2 and HepG2.2.15 cells were determined by real-time reverse transcription polymerase chain reaction (PCR). Serum CTHRC1 levels were measured by enzyme-linked immunosorbent assay (ELISA), and the differences of serum CTHRC1 levels among healthy subjects without HBV infection(control group), asymptomatic HBV carriers, patients with chronic hepatitis B, patients with hepatic fibrosis induced by HBV infection and patients with HBV-related hepatocellular carcinoma (HCC) were analyzed.

The expression of CTHRC1 mRNA was higher in HepG2.2.15 cells than in HepG2 cells, serum CTHRC1 levels were much higher in asymptomatic HBV carriers than in control group (P < 0.05), and CTHRC1 was detected at higher levels in patients with HBV-related group HCC than in those with hepatic fibrosis induced by HBV infection and chronic hepatitis B (P < 0.05).

HBV can upregulate the expression of CTHRC1, which is associated with the progression of HBV infection.

Research on vaccine-induced transient hepatitis B surface antigen positivity in newborn infants

LIU Hua, WANG Yingzhi, SHEN Yunyue, ZHUANG Yihui, KANG Yi, WANG Wenjing, WU Shuying, JIANG Wei, GAO Feng

2015, 30(11):  1107-1111.  DOI: 10.3969/j.issn.1673-8640.2015.11.012

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To retrospectively analyze and study the relationship of vaccination against hepatitis B virus with transient hepatitis B surface antigen(HBsAg) positivity in newborn infants.

The data of 178 newborn infants were collected and analyzed retrospectively, who were determined for HBsAg. The positive rate of HBsAg, hepatitis B 5 items, HBsAg concentration and vaccination time after vaccine inducing were determined, and the relationships were analyzed statistically. Interference testing was performed to investigate the influence of serum jaundice in HBsAg assay. The hepatitis B virus vaccine was diluted in vitro according to neonatal blood volume, and HBsAg concentration was detected.

A total of 178 newborn infants were determined for 184 times totally, and 16 newborn infants had positive HBsAg. Of these 16 newborn infants, 11 cases could be attributed to vaccination, 3 cases were due to mother-to-child transmission, and 2 cases were with unknown cause. The HBsAg positivity for newborn infants receiving vaccine 0-7d were statistically significant in comparison with those of 8-14 d and 15-31 d (P=0.046 and 0.032). After the vaccine was injected, the concentration of HBsAg was 0.12 (0.07-0.25) IU/mL, which was at low level. The concentration of HBsAg reached the highest level after 0-2d of injection, and then it decreased gradually. There were totally 11 samples which were HBsAg single positive, and 3 samples of them were both HBsAg and anti-hepatitis B surface antigen antibody (HBsAb) positive, which was obviously different from the common serum pattern of hepatitis B virus infection. HBsAg concentration was 0.13 IU/mL at 1:600 dilution of vaccine, being similar with that of vaccine-induced HBsAg positive [0.12 (0.07-0.25) IU/mL]. Jaundice interference testing showed that 383.9 μmol/L total bilirubin and 29.9 μmol/L direct bilirubin distractors did not affect HBsAg results.

Transient HBsAg positivity can occur in newborn infants within 2 weeks post-vaccination. Newborn infants may not be screened for HBsAg within 2 weeks following vaccination against hepatitis B virus.

Investigation on the significance of procalcitonin in the differential diagnosis of Gram-positive bacterium and Gram-negative bacterium infections

ZHANG Qun, HU Xiaobo

2015, 30(11):  1113-1118.  DOI: 10.3969/j.issn.1673-8640.2015.11.013

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Through the study of the different levels of procalcitonin (PCT), C reactive protein (CRP) and neutrophil CD64(CD64) in plasma and interleukin-6 (IL-6), tumor necrosis factor alpha (TNF-α) in serum for the infections of Gram-positive and Gram-negative bacteria, to discuss the significance of these indices in the differential diagnosis of 2 different bacterium infections.

A total of 204 patients were classified into Gram-positive bacterium group (25 cases), Gram-negative bacterium group (89 cases) and negative control group (90 cases). The levels of PCT, CRP, CD64, IL-6 and TNF-α among the groups were determined. The diagnosis performance of PCT and other indices was evaluated by receiver operating characteristic (ROC) curve.

The PCT levels in Gram-negative bacterium group, Gram-positive bacterium group and negative control group were 10.01, 5.80 and 1.06 μg/L, and there was statistical significance among the 3 groups(P<0.01). The differences of CRP, IL-6 and TNF-α among the 3 groups had statistical significance (P<0.05). The levels of CD64 in Gram-positive and Gram-negative bacterium groups were obviously higher than that in negative control group (P<0.01), but there was no statistical significance between Gram-positive and Gram-negative bacterium groups (P>0.05). When the cut-off value of PCT was 0.41 μg/L, the area under the ROC curve of PCT for identifying bacterium infection was 0.882. The sensitivity was 85.1%, and the specificity was 82.2%, which were higher than those of the other 4 indices. For the differential diagnosis of Gram-positive and Gram-negative bacterium groups, the cut-off values of PCT, CRP, IL-6 and TNF-α were 1.25 μg/L, 79.34 mg/L, 27.4 pg/mL and 20.5 pg/mL, and the areas under the ROC curves were 0.671, 0.625, 0.654 and 0.619. The positive predictive values were 88.6%, 83.1%, 88.5% and 90.4%. The area under the ROC curve of PCT was biggest. The sensitivity was 69.7%, and the specificity was 72%. The positive predictive value reached 88.6%.

PCT can be used to the early diagnosis bacterium infection and the differential diagnosis of Gram-positive bacterium and Gram-negative bacterium infections, but the diagnosis performance is weak.

Molecular epidemiology research of Staphylococcus aureus infection from adult and child patients

YUAN Ting, YING Chunmei

2015, 30(11):  1119-1124.  DOI: 10.3969/j.issn.1673-8640.2015.11.014

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To investigate the molecular epidemiology characteristic and antimicrobial susceptibility of Staphylococcus aureus (S. aureus) isolated from Renji Hospital affiliated to Shanghai Jiaotong University School of Medicine (Shanghai Renji Hospital) and Shanghai Children's Medical Center in order to provide reference for the rational use of clinical medication.

In 2012, 313 S. aureus isolated from Shanghai Renji Hospital and 153 S. aureus isolated from Shanghai Children's Medical Center were collected and analyzed by multilocus sequence typing (MLST) and Staphylococcus protein A spa gene typing. In addition, staphylococcal cassette chromosome mec(SCCmec) typing was performed for methicillin-resistant Staphylococcus aureus(MRSA). Antimicrobial susceptibility test was detected by Kirby-Bauer method.

There were 313 isolates of S. aureus isolated from Shanghai Renji Hospital in 2012, mainly isolated from sputum, accounting for 42.49%, 173 isolates were MRSA, and the detection rate was 55.27%. The predominant type of MLST was ST5. The predominant type of spa gene typing was t002(90 isolates, 52.02%), and next type was t030(42 isolates, 24.28%). The predominant type of SCCmec typing was Ⅱ. There were 153 isolates of S. aureus isolated from Shanghai Children's Medical Center, mainly isolated from sputum, accounting for 62.09%, 33 isolates were identified as MRSA, and the detection rate was 21.57%. The predominant type of MLST was ST59. The predominant type of spa gene typing was t437(14 isolates, 42.42%), and next type was t002(5 isolates, 15.15%) and t316(4 isolates, 12.12%). The predominant type of SCCmec typing was Ⅳ. The antimicrobial susceptibility test showed that all the S. aureus isolates were 100% sensitive to vancomycin, norvancomycin, teicoplanin, linezolid and tetracycline, and drug resistance rate was obviously lower than others. The drug resistance rates of MRSA from Shanghai Children's Medical Center to ciprofloxacin, moxifloxacin, levofloxacin, clindamycin, rifampicin and gentamicin were significantly higher than those from Shanghai Renji Hospital(P<0.01).For cefazolin and erythromycin, there was no statistical significance(P>0.01).

The type of ST5-t002-Ⅱis the major epidemic MRSA type in Shanghai Renji Hospital, and ST59-t437-Ⅳ is the major epidemic MRSA type in Shanghai Children's Medical Center in 2012.Unlike methicillin-sensitive Staphylococcus aureus (MSSA), MRSA shows clustered clonal types, suggesting a nosocomial spread in hospital. The isolation rate of MRSA in S. aureus is high. Clinic should rationally use antimicrobial agents according to the results of drug susceptibility.

Meta analysis on serum IgG4 in the diagnosis of autoimmune pancreatitis by nephelometry

LIAN Mingjian, LIU Dan, LI Dan, LIU Shuye

2015, 30(11):  1131-1137.  DOI: 10.3969/j.issn.1673-8640.2015.11.017

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Meta analysis was used to evaluate the diagnostic significance of serum IgG4 by nephelometry for autoimmune pancreatitis (AIP).

By searching Wanfang, CNKI and SinoMed, PubMed, Embase, Web of Science, Scienecdirect, Cochrane from inception to September 22, 2014, combined with additional manual tracking, both English and Chinese literatures about serum IgG4 by nephelometry for the diagnosis of AIP were reviewed. According to the inclusion and exclusion criteria, literatures were selected. Quality assessment was conducted according to Quality Assessment of Diagnostic Accuracy Studies (QUADAS). Sensitivity, specificity and diagnostic odds ratio (DOR) were pooled, and summary receiver operating characteristic (SROC) curve was drawn by the software Meta-disc 1.4. Publication bias was analyzed by Stata12.0 software.

A total of 12 studies were included. Diagnostic two-by-two table about differentially diagnosing AIP and pancreatic cancer were constructed from 8 studies of the 12 studies. Test for heterogeneity suggested no threshold effect, but there was significant heterogeneity caused by other factors group. The pooled sensitivity and specificity were 73% and 94% for AIP with control group. The pooled sensitivity and specificity were 70% and 92% for AIP with pancreatic cancer. Funnel plots (Deeks) revealed no publication bias, and sensitivity analysis revealed that the results of this meta analysis were stable.

Serum IgG4 by nephelometry is a useful parameter in diagnosing AIP as well as differentiating AIP from pancreatic cancer.

The detection of gyrA gene mutation in Escherichia coli by high-resolution melting analysis

MAO Haifeng, LIU Hongshu

2015, 30(11):  1138-1142.  DOI: 10.3969/j.issn.1673-8640.2015.11.018

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To investigate the feasibility of high-resolution melting (HRM) analysis to detect gyrA gene mutation in Escherichia coli.

A total of 70 isolates of Escherichia coli were collected, and gyrA gene was amplified with conventional polymerase chain reaction(PCR). Gene mutation was detected by sequence analysis. Specific primer was designed. The gyrA gene was amplified by fluorescence quantitation PCR. The mutation of gyrA gene was detected by amplifying product HRM curve and melting temperature (Tm) analysis. The result was compared with that of gene sequence analysis.

gyrA gene mutation sequence analysis showed that 43 of 70 isolates occurred gyrA gene mutation. In these mutations, 5 types were found. HRM analysis can accurately distinguish between wild and mutant isolates. The detection accuracy was 98.6% (69/70).The 42 of 43 mutant isolates were correctly detected, and different type gene mutations can be correctly typed. Tm analysis also showed the difference of wild and mutant isolates.

HRM analysis is accurate, simple, rapid, cheap and high-throughput, and it and would be a novel choice in analyzing drug resistance mechanism of Escherichia coli.

Comparison on the results of Mindray EH-2080B fully automatic urinary sediment analysis system made in China and manual microscopy

YAN Jiao, LI Hongjie, WANG Qianqian, , HU Suqiu, YING Xiongjiang, YING Qiaoling, WANG Ying, ZHENG Yueping, WANG Junyu, FANG Hang, ZHANG Xingxiang, SHEN Jinxiong

2015, 30(11):  1143-1146.  DOI: 10.3969/j.issn.1673-8640.2015.11.019

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To compare the results of quantitative analysis of Mindray EH-2080B fully automatic urinary sediment analysis system made in China (EH-2080B ), and to verify its function expansion.

A total of 2 243 fresh urine samples (within 1h) from outpatients and inpatients were analyzed by traditional manual microscopy as a standard method, and the system was evaluated. The qualitative comparison between EH-2080B and manual microscopy results was evaluated by false positive (negative) rate.The 100 fresh urine samples with positive red blood cell (RBC)and white blood cell (WBC)were selected to do quantitative comparison of RBC and WBC. While low power single view of liquid filling static time period and visual persistence of low power and high power photographed conversion instant view were used to observe, living sperms and trichomonas vaginalis' dynamic observation messages by the artificial screen browsing were useful to evaluate the function extension of the instrument.

The within-run and between-run precisions of EH-2080B met the requirements [WBC<10%,RBC<10%, epithelial cell (EC)<30%]. The correlation with manual microscopy was good [correlation coefficient (r) for RBC=0.973,P=0.000; r for WBC=0.990, P=0.000; r for EC=0.959, P=0.000]. WBC, RBC, fungus and so on were of a certain degree of false positive (negative) rate, but the comprehensive analysis of combinating dry chemistry information, photo information and automatic urinary sediment analysis was reliable. The coincidence rate by random sampling was more than 85%, and the RBC and WBC quantitative comparison difference from fresh urine samples with RBC and WBC positivities had no statistical significance (P>0.05).The artificial browsing could be added to capture the dynamic information or suspicious dynamic information of living sperms and Trichomonas vaginalis'dynamic observation.

The results of EH-2080B and manual microscopy are consistent. EH-2080B has some recognition analysis for urine formed elements, but for the actual work or some special specimens, manual microscopy identification is needed. The complementary effect of different detection methods can improve the work efficiency and improve the detection quality.

Influence of alpha-lipoic acid on serum adipocytokines in a rat model of dietary-induced obesity

SHAO Yun, QIN Xiaoxia, WEI Congzhen, ZHANG Qiufen, SHAO Ming, YAN Guochao

2015, 30(11):  1147-1149.  DOI: 10.3969/j.issn.1673-8640.2015.11.020

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To investigate the influence of alpha-lipoic acid (ALA)on serum adipocytokines in a rat model of dietary-induced obesity.

A total of 50 Wistar rats were randomly classified into 3 groups, a negative control (NC)group fed with normal chow (10 cases), high fat diet(HFD)group fed with a high-fat diet (16 cases) and HFD+ALA group fed with a high-fat diet with an intervention of ALA(30mg/kg, 2 weeks,16 cases).The concentrations of serum oxidative stress biomarkers and adipocytokines were determined, and the results were analyzed statistically.

The levels of serum malondialdehyde(MDA), leptin and tumor necrosis factor-alpha (TNF-α) in HFD group were (8.8±0.7)μmol/L , (9.8±0.8)ng/mL and (11.6±1.2)ng/L, which were higher than those in HFD+ALA group [(6.1±0.6)μmol/L , (7.6 ±0.7)ng/mL and (9.7±2.3)ng/L] and NC group [(7.9±0.4)μmol/L, (4.6±0.6)ng/mL and (8.8±3.5)ng/L] (P<0.05). The levels of superoxide dismutase(SOD) [(73.9±5.1)U/mL], total antioxidant capacity(T-AOC) [(18.0±3.6)U/mL] and adiponectin [(8.7±1.5) mg/L] were lower than those in HFD+ALA group [(80.9±1.8)U/mL, (25.8±5.4)U/mL and(12.6±2.1)mg/L] and NC group [(81.0±3.2)U/mL,(20.9±2.3)U/mL and (14.0±3.4)mg/L](P<0.05). Compared with NC group, the levels of serum T-AOC and leptin were much higher in HFD+ALA group (P<0.05), MDA was much lower(P<0.05), and no statistical significance between the 2 groups was observed for SOD, adiponectin and TNF-α (P>0.05). Moreover, correlation analysis showed that serum MDA , leptin and TNF- α showed a significantly positive correlation[correlation coefficients (r)=0.716 and 0.502, P<0.01]. A negative correlation of T-AOC with adiponectin (r=-0.485,P< 0.05).

ALA can improve the oxidative stress state and regulate adipocytokines in a rat model of dietary-induced obesity.

Estimation on the uncertainty of ALT catalytic activity with different manufacturers or different lot numbers

GU Wenchao, WANG Huimin, JI Huoyan, WANG Jianxin, ZHANG Weiwei, MENG Shuting, XU Lili

2015, 30(11):  1150-1156.  DOI: 10.3969/j.issn.1673-8640.2015.11.021

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To research the influence of L-alanine, alpha-ketoglutaric acid, beta-nicotinamide adenine dinucleotide reduced disodium salt hydrate(NADH) and Tris hydroxyl methyl aminomethane(Tris) coming from different manufacturers or different lot numbers on alanine aminotransferase (ALT) catalytic activity, and to evaluate the uncertainty of ALT catalytic activity with different manufacturers or different lot numbers.

The sera with 5 concentrations(S1-S5) were measured by the reference method (37 ℃) recommended by the International Federation of Clinical Chemistry and Laboratory Medicine. The consistency was analyzed by Bland-Altman method, and the uncertainties of ALT with different manufacturers or lot numbers were calculated.

The uncertainties of L-alanine, alpha-ketoglutaric acid, NADH and Tris were 0.90%, 0.65%, 0.58% and 0.23%. The expanded uncertainties of different manufacturers or lot numbers of reagents were 2.54%(k=2).

It is supposed to define every reagent manufacturer and lot number to make ALT catalytic activity measured by reference laboratories more comparable. When evaluating the uncertainty, we should consider the influence of reagents with different manufacturers or different lot numbers.

Application of oligoclonal bands in the diagnosis of central nervous system diseases

MENG Jun, PENG Yibing, ZHANG Dongqing

2015, 30(11):  1157-1160.  DOI: 10.3969/j.issn.1673-8640.2015.11.022

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The strong immune response produced by central nervous system(CNS)is the pathological basis on the occurrence and development of some autoimmune nervous diseases, characterized by immunoglobulin composition and content in cerebrospinal fluid(CSF).The CSF oligoclonal bands(OCB)are the specific antibodies produced by several B-cell strains(clone) located in CNS, which is a specific reaction for CNS.The presence of OCB in CSF often indicates that intrathecal immunoglobulin synthesis were produced in CNS.It has certain clinical significance to diagnose CNS diseases by OCB, especially for the diagnosis of CNS demyelinating diseases, like multiple sclerosis (MS).