Table of Content

30 December 2014, Volume 29 Issue 12

Previous Issue    Next Issue

Introduction of the ICSH guidelines for the evaluation of blood cell analyzers, 2014 edition (Ⅰ)

HU Xiaobo, SONG Ying, WANG Qing, JIN Daming, XIONG Lifan

2014, 29(12):  1201-1206.  DOI: 10.3969/j.issn.1673-8640.2014.12.001

Asbtract ( 554 )   HTML   PDF (753KB) ( 836 )  

Related Articles | Metrics

This article introduces the International Council for Standardization in Haematology (ICSH) guideline for the evaluation of blood cell analyzers, 2014 edition. In this guideline, the performance evaluation, including sampling mode, within-run precision, between-run precision, carry-over, linearity, sample stability, reference interval, accuracy and comparability of haematology analyzers, should be conducted through validation and verification by manufacturers. The assessment of flow cytometry-based or digital imaging-based leukocyte differential count, nucleated red blood cell count and immature granulocyte count is recommended by flow cytometry immune-phenotypic counting as a reference method. A part of validation or transference of instrument should be performed by each clinical laboratory before reporting patient results.

Significance of routine urinalysis in the diagnosis of urinary tract infection

FAN Hongjia, TANG Jin, WANG Jianqiang, CHEN Weibin, CHEN Yu, GAO Feng

2014, 29(12):  1207-1211. 

Asbtract ( 452 )   HTML   PDF (966KB) ( 957 )  

References | Related Articles | Metrics

Objective　To evaluate the significance of routine urinalysis in the diagnosis of urinary tract infection. Methods　A total of 586 patients undergoing routine urinalysis and with mid-stream urine culturing as positive and 500 healthy subjects were enrolled. The areas under receiver operating characteristic（ROC） curves（AUC） of white blood cell（WBC）， leukocyte esterase（LEU） and nitrate（NIT） were analyzed. The sensitivities， specificities， positive predictive values and negative redictive values of WBC， LEU and NIT serial and parallel detections were calculated. Results　The AUC of WBC， LEU and NIT were 0.852， 0.822 and 0.706. The sensitivities of WBC， LEU and NIT serial and parallel detections were 82.6%， 83.6%， 43.8%， 41.4% and 87.2%， the specificities were 74.0%， 73.0%， 96.8%， 98.0% and 67.2%， the positive predictive values were 78.9%， 78.4%， 94.1%， 96.0% and 75.7%， and the negative predictive values were 78.4%， 79.2%， 59.5%， 58.8% and 81.8%. Conclusions　Routine urinalysis is a rapid and simple test with good sensitivity and specificity， and is applicable for the early diagnosis and fast screening of urinary tract infection， especially for male patients.

Analysis on chromosome karyotypes and Y chromosome microdeletions in patients with azoospermia or severe oligozoospermia

TENG Xianlin, SHI Jinqiao, GUO Hui, ZHOU Yanxia

2014, 29(12):  1212-1214. 

Asbtract ( 160 )   HTML   PDF (660KB) ( 545 )  

References | Related Articles | Metrics

Objective 　To investigate chromosome karyotypes and Y chromosome microdeletions and their distribution characteristics in patients with azoospermia or severe oligozoospermia， in order to provide thev reference for genetic screening of intracytoplasmic sperm injection（ICSI） before pregnancy. Methods　A total of 150 patients with azoospermia or severe oligozoospermia were enrolled. Chromosome karyotype analysis was performed on peripheral blood lymphocytes with G-banding. Y chromosome microdeletions were detected by multiplex polymerase chain reaction（PCR） combined with agarose gel electrophoresis. Results　There were 14 cases of abnormal chromosome karyotypes and 16 cases of Y chromosome microdeletions in 150 patients with azoospermia or severe oligozoospermia， and the abnormal rates were 9.3% and 10.7%， respectively. Conclusions　For patients with azoospermia or severe oligozoospermia， the chromosome karyotype analysis and Y chromosome microdeletion determinations could provide genetic screening reference before performing ICSI treatments， avoiding the genetic deficiency being passed to offspring and reducing the patients' mental and economic burdens.

Significance on the combined detection of human epididymis protein 4 and CYFRA21-1 in the diagnosis of non-small cell lung cancer

ZHANG Ping, ZHOU Hongxing, BAI Yang, HU Yujing, SUN Yingxin, ZHANG Hong

2014, 29(12):  1215-1217. 

Asbtract ( 169 )   HTML   PDF (777KB) ( 569 )  

References | Related Articles | Metrics

Objective　To investigate the significance on the combined detection of human epididymis protein 4（HE4） and cytokeratin 19 fragment（CYFRA21-1） in the diagnosis of non-small cell lung cancer（NSCLC）. Methods　The levels of serum HE4 and CYFRA21-1 were detected in 50 NSCLC patients， 40 patients with pneumonia and 50 healthy subjects. The diagnosis significance of the combined detection of serum HE4 and CYFRA21-1 for NSCLC was analyzed by receiver operating characteristic（ROC） curve. Results　The levels of serum CYFRA21-1 and HE4 in all the NSCLC patients and the level of HE4 in patients with Ⅰ-Ⅱ stages of NSCLC were significantly higher than those in pneumonia patients and healthy subjects（P＜0.05）. The levels of serum HE4 and CYFRA21-1 in patients with Ⅲ-Ⅳ stages of NSCLC were significantly higher than those in patients with Ⅰ-Ⅱ stages of NSCLC（P＜0.05）. The sensitivity of the combined detection was high than that of any single detection. Conclusions　The detection of serum HE4 has a high significance for the early diagnosis of NSCLC compared with CYFRA21-1 detection. The combined detection of HE4 and CYFRA21-1 for the diagnosis of NSCLC has a high sensitivity， and is suitable for the clinical screening of lung cancer.

Relationship on mRNA of lysyl oxidase and elastin with pelvic organ prolapse

WU Huiheng, LI Huaifang, TONG Xiaowen, CHEN Xinliang

2014, 29(12):  1218-1221. 

Asbtract ( 140 )   HTML   PDF (767KB) ( 464 )  

References | Related Articles | Metrics

Objective　To investigate the expression of lysyl oxidase（LOX） and elastin in anterior vaginal wall of women with pelvic organ prolapse（POP） and the relationships with POP. Methods　The anterior vaginal wall samples were obtained from 39 POP patients undergoing anterior colporrhaphy or total hysterectomy， including 12 premenopausal cases due to vaginocele or uterine prolapse and 27 postmenopausal cases. The other anterior vaginal wall samples were obtained from 40 non-POP women（control group） undergoing total hysterectomy due to benign gynecological diseases， non-stress urinary incontinence or POP. Real-time fluorescence quantitation polymerase chain reaction（PCR） was used to verify the mRNA level of LOX and elastin. Results　The premenopausal and postmenopausal POP groups demonstrated significantly decreasing expressions of LOX， lysyl oxidase like 1（LOXL1） and elastin in anterior vaginal wall compared with control group（P＜0.05）.In POP group， the mRNA expressions of LOX， LOXL1 and elastin in postmenopausal patients were significantly lower than those in premenopausal patients（P＜0.05）. There was a positive correlation between LOX and LOXL1 mRNA with elastin mRNA in POP group（r=0.936 1 and 0.689 8， P＜0.05）. Conclusions　The decreasing expressions of LOX and LOXL1 in the anterior vaginal wall may contribute to POP.

The significance of the combined detection of AFP and ferritin with serum hepatic fibrosis indices in Child-Pugh classification among patients with liver cirrhosis

WANG Fengyuan, ZHANG Linhua, LAI Weiqiang

2014, 29(12):  1222-1225. 

Asbtract ( 325 )   HTML   PDF (1224KB) ( 447 )  

References | Related Articles | Metrics

Objective　To investigate the correlations of serum hepatic fibrosis indices， alpha fetoprotein（AFP） and ferritin with Child-Pugh classification among patients with liver cirrhosis and their significance. Methods　A total of 128 patients with liver cirrhosis were enrolled， including viral hepatitis B（67 cases）， alcoholic liver cirrhosis（48 cases） and viral hepatitis C（13 cases）. Child-Pugh classification of these patients were A（45 cases）， B（49 cases） and C（34 cases）. A total of 50 healthy subjects were enrolled as control group. Venous blood was extracted for serum fibrosis indices， AFP and ferritin determinations. Results　With the severity of liver cirrhosis， Child-Pugh classification increased from A to C， and serum fibrosis， AFP as well as ferritin also gradually increased. There was a significant correlation with Child-Pugh classification. Conclusions　Serum fibrosis indices， AFP and ferritin are all related with the severity of liver cirrhosis. The combined detection has high reference significance for evaluating the severity and prognosis of liver cirrhosis.

Evaluation of an improved immuno-chromatographic assay to detect chlamydia trachomatis in genitourinary tract infection

WU Lei, YANG Yang, TANG Zhenhua, ZHANG Qiangqiang, LU Tingyan, JIN Yuelan, HU Weizhong, XU Ming, GU Weiming

2014, 29(12):  1226-1229. 

Asbtract ( 195 )   HTML   PDF (725KB) ( 464 )  

References | Related Articles | Metrics

Objective　To evaluate the performance of an improved immuno-chromatographic assay for the detection of chlamydia trachomatis（CT） in genitourinary tract infection， and then to assess the significance of clinical application. Methods　A total of 261 patients from sexually transmited infection clinics and healthy subjects in 3 hospitals of Shanghai were enrolled and determined by an improved immuno-chromatographic assay kit（chemtrue-CT）. The polymerase chain reaction（PCR） kit（PCR-CT） as a reference standard was used to analyze the performance of chemtrue-CT. Results　The total positive rate of PCR-CT（28.4%） was higher than that of chemtrue-CT（21.8%， P＜0.01）. The sensitivity and specificity of chemtrue-CT were 75.7% and 99.5%， respectively. The overall coincidence rate between
the 2 assays was 92.7% with male group's coincidence rate 88.8%（P＜0.01） and female group's coincidence rate 97.4%（P＞0.05）. The 2 assay resultswere similar with an overall coincidence rate of 96.8% and 98.2% in female group. Conclusions　The performance difference between chemtrue-CT and PCR-CT is narrowing. Particularly for female group， chemtrue-CT shows acceptable performance in comparison with PCR-CT.

Methodology evaluation on the determination of blood lead by screen printing electrode method

YU Xiaogang, YAN Chonghuai, SHENG Qingsong

2014, 29(12):  1230-1233. 

Asbtract ( 170 )   HTML   PDF (1344KB) ( 457 )  

References | Related Articles | Metrics

Objective　To compare the applications of screen printing electrode（SPE） method and graphite furnace atomic absorption spectrophotometry（GFAAS） for blood lead determination， and to evaluate the practicability and reliability of SPE method. Methods　The SPE method was used to detect the quality control sample of the
National Center for Clinical Laboratory and whole blood samples in order to evaluate methodologically， and the results were compared with those of GFAAS. Results　　The SPE method was used to determine high， medium and low levels of blood lead， and the relative standard deviation（RSD） were 14.80%， 4.03% and 2.11%， respectively. The average recovery rate of SPE method was 103.7%. When SPE method was used to the determination of whole blood samples， there was no statistical significance compared with GFAAS（P＞0.05）. The linear regression correlation coefficient（r2） was 0.964. There was a high correlation between the 2 methods. The Bland-Altman analysis showed that the 2 methodshad consistency. With GFAAS as gold standard， the false positive rate of SPE method was 4.4%， and the false negative rate was 0.0%. Conclusions　The SPE method shows a marked performance in stability and ease of operation， and it is highly correlated with GFAAS， which is suitable for clinical bulk samples' rapid determination.

Analysis on the molecular characteristics and drug resistance of Staphylococcus aureus isolated from Haian,Jiangsu

DONG Deping, GU Feifei, CHEN Xu, XIAO Shuzhen, HAN Lizhong, NI Yuxing

2014, 29(12):  1234-1237. 

Asbtract ( 163 )   HTML   PDF (714KB) ( 511 )  

References | Related Articles | Metrics

Objective　To analyze the molecular characteristics and drug resistance of Staphylococcus aureus isolated from Haian， Jiangsu. Methods　A total of 43 isolates of Staphylococcus aureus were collected in Haian from July 2011 to July 2012， and the isolates were identified by biochemical phenotypic test and plasma coagulase test. Antimicrobial susceptibility test to 12 kinds of antibiotics was performed by disk diffusion and broth dilution methods. Panton-Valentine leukocidin（PVL） gene was detected by polymerase chain reaction（PCR）， Staphylococcal cassette chromosome mec（SCCmec） typing was conducted according to multiplex PCR， and Staphylococcus protein A（SPA） genotyping was performed by PCR and sequencing. Results　A total of 21 isolates of methicillin-resistant Staphylococcus aureus（MRSA） were detected. t030-Ⅲ was the major MRSA clone， including 2 resistant profiles， P-CX-CN-TOB-E-CC-RA and P-CX-CN-TOB-RA. Conclusions　The isolation rate of MRSA is high， and clone spread is the main reason of resistance prevalence.

The performance evaluation of thyroid hormone testing

XIAO Yaling, ZHANG Chuanbao, ZHAO Haijian, WANG Wei, WANG Zhiguo

2014, 29(12):  1238-1242. 

Asbtract ( 256 )   HTML   PDF (1028KB) ( 849 )  

References | Related Articles | Metrics

Objective　To evaluate the performance of thyroid hormone testing all over the country. Methods　The difference percentage between resultsand target values was estimated according to external quality assessment（EQA） data， and the imprecision was obtained according to internal quality control（IQC） data [coefficient of variation（CV）]. The EQA evaluation criterion in our country and biological variation quality specification were used to analyze the acceptabilities of difference percentage and imprecision in each group. The sigma（σ） value was calculated with the formula of σ=[total allowable error（TEa）- bias]/CV. The scatter diagram was drawn， and the distribution of σ value was analyzed. Results　The mean of CV and the median of difference percentage for thyroid stimulating hormone（TSH） were the lowest of all， while those for triiodothyronine（T3） were the highest. Regardless of quality specifications， the acceptabilities of imprecision and difference
percentage for TSH were the highest， and those for thyroxine（T4） were the lowest. The scatter of T4 in the scatter diagram of σ value was entirely low， 63.0% and 98.2% σ＜3. However， that of TSH was entirely high， 75.6% and 72.9% σ≥3. Conclusions　σ value is a simple and visible method to evaluate the testing performance. The performance of TSH is better than the others， but T4 is worst of all.

Application of quality supervision in the quality management and recognition of medical laboratory

CHEN Yanzhi

2014, 29(12):  1254-1259. 

Asbtract ( 122 )   HTML   PDF (669KB) ( 477 )  

References | Related Articles | Metrics

By comparing and analyzing the terms of quality supervision in International Organization for Standardization (ISO)15189 standard, combined with the practical application of medical laboratory quality supervision and the problems needed to be solved, the proportion of unqualified blood specimens in laboratory from January 2012 to June 2014 is analyzed. In the yield of pre-examination process quality control assessment, the effectiveness of supervision work is evaluated. How to make rational use of laboratory resources to meet the standard requirements, how to improve the quality of laboratory medicine, how to meet the clinical needs to practice, and how to provide a good reference for the connotation of intends to apply for approval or approved medical laboratory quality supervision are considered.

Problems in the calibration of automatic biochemistry analyzers

WANG Zhiwei, NI Lan, WEI Jun

2014, 29(12):  1260-1262. 

Asbtract ( 207 )   HTML   PDF (655KB) ( 646 )  

References | Related Articles | Metrics

The problems in the calibration of automatic biochemistry analyzers are investigated. Clinical laboratories should attach the importance to the calibration of automatic biochemistry analyzers and standardize the process of calibration. The review mainly discusses the questions in the plan of calibration and verification, the purpose of calibration, the selection of calibration methods, calibration performers and the process and content of calibration. We provide feasible solutions to these problems through discussion and analysis. Consumables and parts for automatic biochemistry analyzers should be checked up, cared, maintained and replaced periodically. It is necessary to insure automatic biochemistry analyzers working in best state by preventive maintenance. The measurements for instrument maintenance and inspection can be established, including calibration and verification to improve the quality of clinical laboratory determinations.

Research advance on mechanisms of hyperhomocysteinemia neurotoxicity

WANG Xiaoyan, WANG Weiling

2014, 29(12):  1263-1267. 

Asbtract ( 184 )   HTML   PDF (751KB) ( 1028 )  

References | Related Articles | Metrics

Hyperhomocysteinemia (HHcy) is caused by abnormal metabolism of homocysteine (Hcy). HHcy is not only an independent risk factor for cardiovascular and cerebrovascular diseases,but also closely correlated with a variety of neurodegenerative and mental diseases.HHcy mainly plays a pathogenic role by vascular and neuron neurotoxicity. In this article, we review the mechanisms of HHcy neurotoxicity in recent years.