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Laboratory Medicine    2021, 36 (7): 685-690.   DOI: 10.3969/j.issn.1673-8640.2021.07.001 Abstract （639）   HTML （106）    PDF （933KB）（649）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Interpretation and application of 15 quality control indicators in clinical laboratories KAN Lijuan, ZHANG Lijun, ZHANG Xiuming Laboratory Medicine    2022, 37 (10): 907-914.   DOI: 10.3969/j.issn.1673-8640.2022.010.001 Abstract （492）   HTML （83）    PDF （722KB）（499）       Knowledge map    Save The quality control indicators of clinical laboratories are essential in clinical laboratories as they enable the management to evaluate their performance objectively. As mentioned in the National Tertiary Public Hospitals Performance Evaluation Operational Manual （2022 edition），quality control indicators have been combined into performance appraisal system. Although 15 indicators from the Quality Control Indicators in Clinical Laboratory Service （2015） published by the National Health and Family Planning Commission，which are adopted in this manual，the interpretation of these indicators，the concepts of denominator and the numerator in the equations，as well as the datum acquisition methods are inconsistent，which leads to inaccurate results in performance evaluations between laboratories. This review makes the practice-based suggestions and opinions on interpreting and applying the 15 quality control indicators in clinical laboratories. Table and Figures | Reference | Related Articles | Metrics

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Expert consensus on the clinical application of AFP，AFP-L3% and DCP using GALAD and GALAD-like models in hepatocellular carcinoma Clinical Laboratory Society of Chinese Association for Rehabilitation Medicine , Molecular Diagnostics Society of Shanghai Medical Association , Tumor Immunology Branch of Shanghai Society for Immunology , Yueyang Hospital of Integrated Traditional Chinese and Western Medicine of Shanghai University of Traditional Chinese Medicine , Shanghai Center for Clinical Laboratory, Clinical Laboratory Society of Chinese Association of Integrative Medicine , Clinical Laboratory Society of Shanghai Anticancer Association , Tumor Markers Society of Shanghai Anticancer Association Laboratory Medicine    2023, 38 (7): 607-623.   DOI: 10.3969/j.issn.1673-8640.2023.07.001 Abstract （355）   HTML （114）    PDF （996KB）（446）       Knowledge map    Save Primary hepatocellular carcinoma （HCC） is a prevalent world-wide malignancy. Half of the newly developed HCC occurs in China. Optimizing the strategies for high-risk surveillance and early diagnosis is pivotal for improving 5-year survival. Constructing the scientific non-invasive determination technologies feasible for medical and healthcare institutions is a key route for elevating the efficacies in HCC diagnosis and follow-up. Based on the international and Chinese guidelines，expert consensus statements，literatures and evidence-based clinical practice experiences，this consensus published by the Clinical Laboratory Society of Chinese Association for Rehabilitation Medicine puts forward the clinical implications，application subjects，determination techniques and result interpretations for GALAD and GALAD-like models based on alpha-fetoprotein （AFP），alpha-fetoprotein heterogeneity-L3%（AFP-L3%），and des-gamma-carboxy prothrombin（DCP）. The compile of this consensus statement aims to address and push the reasonable model application of the triple-biomarker（AFP， AFP-L3%， DCP）determinations thus to maximize the clinical efficacies and help improving HCC high-risk surveillance，early diagnosis and prognosis. Table and Figures | Reference | Related Articles | Metrics

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Epidemic status and challenges of important human parasitic diseases in China CHEN Jiaxu, CAI Yuchun, AI Lin, SONG Peng, CHEN Muxin, CHEN Shaohong, LU Yan, ZHOU Xiaonong Laboratory Medicine    2021, 36 (10): 993-1000.   DOI: 10.3969/j.issn.1673-8640.2021.010.001 Abstract （920）   HTML （82）    PDF （844KB）（412）       Knowledge map    Save China has made remarkable achievements in the prevention and control of human parasitic diseases,becoming the first country in the elimination of lymphatic filariasis. Malaria has been eliminated in China,which is approved by World Health Organization in 2021. Schistosomiasis in many provinces reaches the standard of transmission interruption or elimination. The infection rate of soil-transmitted nematode drops to a new historical low. However,the population of its infection is still tens of millions. Foodborne parasitic diseases,such as clonorchiasis sinensis,still pose a great threat to food safety in China. Although the vector-borne and zoonotic parasitic diseases have been controlled to some extent,the epidemic continues and relapses. The incidence of opportunistic parasitic diseases has increased in the population with immunodeficiency,and the cases of imported parasitic diseases have also increased. The review focuses on the results of parasitic diseases' prevention and control in China,understanding the epidemic status of important human parasitic diseases,analyzing the transmission risks and challenges of human parasitic diseases' prevention and control,so as to provide a reference for the health administrative department formulating the strategies and measures of parasitic diseases' prevention and control in the new period,and to provide epidemiological datum reference for the diagnosis and treatment of clinical parasitic diseases. Reference | Related Articles | Metrics

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Consensus on androgen testing in polycystic ovary syndrome Expert Group on the Consensus on Androgen Testing in Polycystic Ovary Syndrome China Association for Promotion of Health Science and Technology-Fertility Protection and Preservation Committee Laboratory Medicine    2023, 38 (3): 203-208.   DOI: 10.3969/j.issn.1673-8640.2023.03.001 Abstract （288）   HTML （29）    PDF （916KB）（373）       Knowledge map    Save Polycystic ovary syndrome（PCOS） is one of the most common endocrine disorders in reproductive-age females，frequently leading to female infertility. Hyperandrogenemia plays a role in the pathogenesis of PCOS. Hyperandrogenemia can be evaluated by biochemical tests or clinical signs. At present，there are some limitations of immunology-based testing methods for androgen，such as cross-reaction，poor accuracy in low-concentration samples and lack of comparability among different reagent manufacturers，leading to false positivity. With the advantages of high sensitivity，high specificity，wide linear range and the capability of simultaneous determination of multiple molecules，liquid chromatography-tandem mass spectrometry（LC-MS/MS） becomes a good choice for androgen testing. On the basis of published clinical and laboratory evidence，Beijing Obstetrics and Gynecology Hospital of Capital Medical University，China Association for Promotion of Health Science and Technology-Fertility Protection and Preservation Committee，along with the experts in the clinical laboratory，gynecological endocrinology and mass spectrometry application relevant field made this consensus，in order to provide professional guidance in PCOS androgen testing in clinical laboratories. The consensus includes recommendations on types and methods of androgen testing for PCOS and challenges of androgen testing with LC-MS/MS. Table and Figures | Reference | Related Articles | Metrics

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Expert consensus on establishment of standards for the performance evaluation of systems for whole blood C-reactive protein determination of Chinese children Clinical Diagnosis and Laboratory Medicine Branch of China Maternal and Child Health Association Laboratory Medicine    2021, 36 (12): 1201-1205.   DOI: 10.3969/j.issn.1673-8640.2021.012.001 Abstract （409）   HTML （72）    PDF （939KB）（345）       Knowledge map    Save C-reactive protein（CRP）,which can be determined by serum as well as whole blood,has been traditionally utilized as a marker of infection. Many brands of whole blood CRP determination equipments have been widely used in medical institutions,especially in women's and children's hospitals. However,the standard for the performance evaluation of whole blood CRP determination system is not established. According to the data of 26 women's and children's hospitals,this consensus aims to provide the performance status of whole blood CRP determination system,and further put forward the performance evaluation requirements of whole blood CRP determination system in combination with clinical needs,biological variation and industry standards,so as to ensure the determination quality. Reference | Related Articles | Metrics

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Establishment and clinical application of multiple RT-PCR MassARRAY for the determinations of 27 respiratory pathogens LIU Hongqian, SONG Chaohui, LIANG Qiaomi Laboratory Medicine    2021, 36 (9): 939-946.   DOI: 10.3969/j.issn.1673-8640.2021.09.012 Abstract （312）   HTML （48）    PDF （1298KB）（311）       Knowledge map    Save Objective To establish a method based on multiple reverse transcription polymerase chain reaction（RT-PCR）MassARRAY for the determinations of 27 respiratory pathogens,and to investigate its clinical application value. Methods Multiple polymerase chain reaction amplification and extension primers were designed for pathogens,and the sensitivity,specificity and repeatability of multiple RT-PCR MassARRAY were evaluated with the standard plasmid of pathogens established. Totally,207 clinical specimens were determined by multiple RT-PCR MassARRAY,and the results were compared with real-time RT-PCR. Results The minimum detection limit of the established multiple RT-PCR MassARRAY for 27 respiratory pathogens was 1×101-1×103 copies/μL,with a high specificity. The 57 of 207 clinical specimens were positive,and the positive rate was 27.54%. Streptococcus pneumoniae,Moraxella catarrhalis,Mycoplasma pneumoniae and Haemophilus influenzae were the most common bacterial pathogens,and parainfluenza virus,human metapneumovirus and influenza A virus had high detection rates.”Compared with real-time RT-PCR,the total consistency rate was 99.03%,with high consistency and a kappa value of 0.98. Conclusions The detection system of 27 respiratory pathogens based on multiple RT-PCR MassARRAY has high sensitivity and specificity,simple operation and high throughput,which can provide a reference for the clinical diagnosis of respiratory pathogens. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2021, 36 (6): 642-645.   DOI: 10.3969/j.issn.1673-8640.2021.06.014 Abstract （872）   HTML （56）    PDF （786KB）（283）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Application of CLSI EP06-Ed2 in the linear verification of quantitative measurement procedures LI Xiaobo, PU Zhifei, WU Xiaoqi, LIU Yangyang, XIE Xuanbo, SHAN Hanming, YU Jiaping Laboratory Medicine    2022, 37 (3): 230-234.   DOI: 10.3969/j.issn.1673-8640.2022.03.008 Abstract （436）   HTML （54）    PDF （865KB）（277）       Knowledge map    Save Objective To investigate the application of the Clinical and Laboratory Standards Institute（CLSI） document EP06-Ed2 in the linear verification of quantitative measurement procedures,taking triiodothyronine（T3） and free triiodothyronine（FT3） as examples. Methods The samples close to the upper and lower limits of the linear interval were selected,7 samples were prepared proportionally,and each sample was repeated for determination twice. A weighted linear regression analysis was performed using dilution ratios and means（x）. The predicted value was calculated,and the 95% confidence interval（CI） of linear deviation was compared with the allowable deviation from linearity（ADL）. When the CI of all samples overlapped with ADL,the linearity of the whole interval was acceptable. Results The linear deviation 95%CI of samples No. 1-6 of T3 was within the ADL,and the linear deviation of sample No. 7 was within the ADL. The linear deviation 95%CI of samples No. 2-4 of FT3 was within the ADL,the linear deviation of samples No.1 and No.5 was within the ADL,and the linear deviation of sample No. 6 was not within the ADL,but the linear deviation 95%CI overlapped with the ADL,sample No. 7 linear deviation 95%CI was not within the ADL. Conclusions Compared with EP06-A,CLSI EP06-Ed2 has clearer and more reasonable requirements for the selection of linear sample concentration,with more effective and simple datum analysis and processing. It is a practical guide for the linear verification of quantitative measurement procedures. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2022, 37 (9): 847-849.   DOI: 10.3969/j.issn.1673-8640.2022.09.010 Abstract （766）   HTML （30）    PDF （805KB）（272）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Research progress and application of RNase H-dependent PCR technology WU Xinxin, HAN Mingyue, YU Daojun Laboratory Medicine    2021, 36 (12): 1277-1282.   DOI: 10.3969/j.issn.1673-8640.2021.012.017 Abstract （299）   HTML （17）    PDF （954KB）（265）       Knowledge map    Save Ribonuclease（RNase） H-dependent polymerase chain reaction（PCR）（rhPCR） adds RNase H2 and blocked cleavable rhPCR primers based on PCR,which eliminates the formation of primer-dimers in the reaction process,greatly reduces the occurrence of error amplification,and significantly improves the specificity,sensitivity and repeatability of the reaction. The rhPCR shows certain advantages in single nucleotide polymorphism（SNP）,genotyping,multi-target simultaneous detection,environmental nucleic acid detection and so on. This review summarizes the background,principles,key technology,technical advantages,application and development prospects of rhPCR. Reference | Related Articles | Metrics

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Research progress of non-invasive molecular biological methods for detecting Helicobacter pylori CHI Wenjing, LIU Tao, LIU Yixin, ZHAO Hu, ZHANG Yanmei Laboratory Medicine    2021, 36 (8): 880-885.   DOI: 10.3969/j.issn.1673-8640.2021.08.021 Abstract （161）   HTML （16）    PDF （811KB）（254）       Knowledge map    Save Helicobacter pylori is closely related to the occurrence of digestive system diseases,such as chronic active gastritis,peptic ulcer,gastric mucosa-associated lymphoid tissue（MALT） lymphoma and gastric cancer. It is currently the only pathogen that is classified as class Ⅰ carcinogen by World Health Organization. With the development of molecular biological technology,a variety of molecular biological methods for Helicobacter pylori identification,drug resistance and virulence analysis have emerged,which are of significance to the accurate diagnosis and treatment of Helicobacter pylori infection. The molecular biological methods of non-invasive detection of Helicobacter pylori from oral cavity or fecal samples directly have the advantages of simplicity,efficiency,economy and non-invasiveness,and have become a research hot-spot recently. This review will analyze and compare the pros and cons of various conventional methods for detecting Helicobacter pylori,focusing on the research progress of non-invasive molecular biological methods for detecting Helicobacter pylori. Reference | Related Articles | Metrics

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Clinical application of novel tumor biomarkers：prospects and challenges GAO Feng Laboratory Medicine    2023, 38 (4): 303-306.   DOI: 10.3969/j.issn.1673-8640.2023.04.001 Abstract （262）   HTML （57）    PDF （850KB）（243）       Knowledge map    Save Early diagnosis and individualized precise treatment are the keys to improve the survival rate and the quality of life and prolong the survival time of cancer patients. In the recent years，with the development of liquid biopsy technology，more and more novel tumor biomarkers have been found，showing potential in tumor diagnosis，prognostic judgment and treatment monitoring，and some indicators have been put into clinical practice. Future researches should focus on solving the problems that hinder the clinical transformation of novel tumor biomarkers，and promote more liquid biopsy indicators with clinical application prospects to optimize the diagnosis and treatment process of cancer patients，thereby reducing their disease burden. Reference | Related Articles | Metrics

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Analysis of external quality assessment of parasite morphology from 2013 to 2020 in West China Hospital of Sichuan University DENG Shanying, PEI Yuqing, ZHANG Chunying, XIE Heng, MENG Qiang, MA Ying Laboratory Medicine    2022, 37 (2): 188-193.   DOI: 10.3969/j.issn.1673-8640.2022.02.019 Abstract （392）   HTML （39）    PDF （1736KB）（224）       Knowledge map    Save Objective To improve the ability of clinical laboratory examiners to detect and identify parasites through reviewing and analyzing the results of the external quality assessment of parasite morphology. Methods A retrospective analysis of 200 samples from the external quality assessment of parasite morphology from 2013 to 2020 was conducted,of which 120 samples were from the National Center for Clinical Laboratories and the other 80 samples from the College of American Pathologists（CAP）. The accuracy of external quality assessment was calculated,the reasons for misidentification of parasites（eggs） were analyzed,and the morphological characteristics and identification points of rare and similar parasites were summarized. Results Of the 200 samples,195 samples were identified correctly（an accuracy rate of 97.5%）. Of the 80 CAP samples,77 samples were identified correctly,3 samples were identified incorrectly（an accuracy rate of 96.3%）,and 12 samples were not graded. Of the 120 samples from the National Center for Clinical Laboratories,118 samples were identified correctly,with only 2 identification errors（an accuracy rate of 98.3%）. Totally,30 parasites in 47 different life-history forms were involved in the external quality assessment of parasite morphology. The morphologically similar parasite eggs in identification included Diphyllobothrium latum eggs,Paragonimus westermani eggs,Hepatella hepatica/Fasciolopsis buski eggs,Ascaris lumbricoides eggs and hookworm eggs,hookworm eggs and Trichostrongylus orienatalis eggs,microfilaria-Brugia malayi and microfilaria-Wuchereria bancrofti. The rare parasite eggs identified were Hymenolepis nana eggs and Hymenolepis diminuta eggs. Food residue and parasite eggs in stool,as well as different kinds of cysts,were also identified. Conclusions Periodically retrospective analysis of the laboratory external quality assessment data of parasites,regular review of mixed egg samples under a microscope,review of parasite archives,and morphology review of rare and similar parasites（eggs） can improve the quality of parasite laboratory and improve the capabilities of clinical laboratory examiners. Table and Figures | Reference | Related Articles | Metrics

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Problems and solutions on autoverification of coagulation test FAN Qingkun, LI Ling, DU Jia, YANG Jun, ZHANG Zhenlu Laboratory Medicine    2022, 37 (6): 596-600.   DOI: 10.3969/j.issn.1673-8640.2022.06.018 Abstract （368）   HTML （51）    PDF （895KB）（222）       Knowledge map    Save The autoverification of reports is the future development trend of clinical laboratories,which can significantly shorten the laboratory sample turn-around time and improve work efficiency. The autoverification of coagulation tests is less used in clinical laboratories,due to many problems such as the identification of unqualified samples and the complex rules of autoverification. The basis for the implementation of autoverification is strict and standardized quality control of pre-analysis and interconnection of information systems. Based on the premise of accurate results,clinical laboratories can set appropriate autoverification rules according to its own conditions,continuously optimize the autoverification rules for coagulation test,and gradually increase the autoverification pass rate of clinical laboratory test. Table and Figures | Reference | Related Articles | Metrics

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Progress on the enrichment technology of circulating tumor cells SHEN Suya, HUANG Jianzhao, LI Xiaohuai Laboratory Medicine    2022, 37 (1): 91-96.   DOI: 10.3969/j.issn.1673-8640.2022.01.019 Abstract （215）   HTML （29）    PDF （1365KB）（221）       Knowledge map    Save Circulating tumor cells（CTC）are a few tumor cells that are shed from the site of a primary or metastatic tumor into the circulatory system. As such,the isolation of CTC from blood samples and their subsequent analysis are of importance not only for understanding cancer metastasis at the cellular level but also for clinical management of the disease. Since the content of CTC in blood is too scarce to be enriched,which has become the bottleneck restricting its clinical application. In recent years,with the development of separation and enrichment techniques,CTC as a tumor biomarker for disease prognosis evaluation has become a hot topic. This review aims to review the latest advances of CTC isolation technology in cancer diagnosis,introduces the application examples of this technology,and discusses its advantages and disadvantages,prospects and technical challenges,to provide a reference for follow-up research. Table and Figures | Reference | Related Articles | Metrics

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Research progress of new tumor molecular markers in the age of precision medicine：from accurate diagnosis to precision chemotherapy GAO Feng Laboratory Medicine    2022, 37 (4): 309-312.   DOI: 10.3969/j.issn.1673-8640.2022.04.002 Abstract （328）   HTML （38）    PDF （810KB）（219）       Knowledge map    Save Malignant tumors have evolved into a severe hazard to human health. Between China's tumor diagnosis and treatment and those of Europe,America and other developed countries,there is still a significant disparity. Early determination and accurate comprehensive diagnosis and treatment are essential for achieving the aim of a healthy China. However,there can be no proper therapy without an accurate diagnosis. Accurate diagnosis is based on a thorough understanding of tumor features and their evolution. The discovery of new tumor molecular features has changed tumor diagnostic and treatment concepts and strategies in the recent years,presenting a new opportunity and challenge in the area of tumor diagnosis and therapy. New tumor marker molecules are increasingly becoming more essential in clinical tumor diagnosis,recurrence,metastasis monitoring and prognosis. Reference | Related Articles | Metrics

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Re-understanding about the rational application of clinical laboratory determination technologies for COVID-19 diagnosis OU Tong, ZHANG Bing, ZHANG Xiuming Laboratory Medicine    2022, 37 (4): 303-308.   DOI: 10.3969/j.issn.1673-8640.2022.04.001 Abstract （443）   HTML （72）    PDF （987KB）（218）       Knowledge map    Save Corona virus disease 2019（COVID-19） epidemic has seriously endangered human health and economic and social development. Accurate etiological determination in clinical laboratories is a prerequisite for epidemic prevention and control. At present,clinical laboratory determination technologies for severe acute respiratory syndrome coronavirus-2 mainly include nucleic acid,antibody and antigen determinations. Nucleic acid determination is a gold standard for the COVID-19 diagnosis with high sensitivity and specificity,but it has high requirements for personnel technical needs and experimental conditions. Antibody determination can be used as a supplement for nucleic acid determination to reduce missed determination and monitor the disease progress,while universal vaccination will affect the interpretation of antibody determination results,like false positivity. Antigen determination is convenient and fast,which can be operated at home,but its sensitivity is greatly affected by the disease process and viral load. In order to improve the efficiency of large-scale population screening,the National Health Commission has successively issued 5-in-1,10-in-1,and 20-in-1 mixed sampling technologies. However,the multiplication of preservation solution in the mixed sampling tube will result in virus dilution and increase the missed determination probability,and mixed sampling also aggravates the workload of epidemiological investigation and subsequent confirmation of the positive specimen in primary screening. With the progress of the COVID-19 epidemic,the SARS-CoV-2 continues to mutate,and the clinical laboratory determination technologies are gradually enriched and improved. Accurate analysis and judgment of the advantages and disadvantages of existing determination technologies and their application scenarios are conducive to the scientific prevention and control of the epidemic. This review will analyzes the following key clinical laboratory determination technical issues and put forward application suggestions,including the “mixed sampling” and “mixed determination” in nucleic acid determination,the impact of virus mutation on the performance of nucleic acid determination,the advantages and disadvantages of “endogenous” and “exogenous” internal standards in nucleic acid determination,the clinical significance and application scenarios of antigen determination and the value of antibody determination after vaccination. Reference | Related Articles | Metrics

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Exploration and practice of regional medical laboratory center model BAI Jianhua, ZENG Xianfei, HAO Xiaoke Laboratory Medicine    2022, 37 (12): 1109-1112.   DOI: 10.3969/j.issn.1673-8640.2022.12.001 Abstract （230）   HTML （445）    PDF （933KB）（216）       Knowledge map    Save Regional medical laboratory center，providing clinical laboratory services for medical institutions at all levels in a certain area by using advanced information system and logistics system，is not only a medical laboratory center，but also a clinical laboratory network formed by multiple laboratories. It can realize the sharing of determination resources，the homogenization of determination quality，the standardization of determination services and the mutual recognition of determination results within the region. At present，Chinese regional medical laboratory centers are in the initial stage of development，and they have been actively explored various models. This review discusses the model，construction development and management and operation status of regional medical laboratory centers from different aspects. Table and Figures | Reference | Related Articles | Metrics

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Research progress of mitochondria in platelets ZHAO Xiaoxia Laboratory Medicine    2021, 36 (12): 1283-1286.   DOI: 10.3969/j.issn.1673-8640.2021.012.018 Abstract （191）   HTML （10）    PDF （930KB）（215）       Knowledge map    Save Platelet is nuclear-free,and mitochondria play roles in it. This review focuses on the mitochondria in energy metabolism,adenosine triphosphate（ATP） production,activation and apoptosis of platelet and the pathophysiologic role in systemic diseases,which provides a reference for further research and clinical treatment. Reference | Related Articles | Metrics

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Application of fluorescent staining in fungus detection ZHAO Lin, QIAO Yun Laboratory Medicine    2021, 36 (12): 1219-1221.   DOI: 10.3969/j.issn.1673-8640.2021.012.005 Abstract （290）   HTML （33）    PDF （1269KB）（211）       Knowledge map    Save Objective To evaluate the application of fluorescent staining in fungus detection. Methods A total of 212 clinical samples were collected. Fluorescent staining,direct smear,Gram staining,ink staining,fungal culturing and KOH wet film were used. Results In 175 deep samples,including sputum,pharyngeal swab,leucorrhea,urine and feces,the positive rates of fungi by fluorescent staining,direct smear and Gram staining were 87.43%,78.86% and 74.29%,respectively. The positive rate of fluorescent staining was higher（P<0.05）. In 27 superficial samples of dandruff and nail dandruff,the positive rates of fungi were 85.19%,59.26% and 55.56% by fluorescent staining,KOH wet film and fungal culturing,respectively（P<0.05）. The positive rates of fungi by fluorescent staining and ink staining in 30 cerebrospinal fluid samples had no statistical significance（P>0.05）. Conclusions Fluorescent staining is simple,rapid and specific,and it has certain clinical value in the diagnosis and identification of fungi. Table and Figures | Reference | Related Articles | Metrics

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Research progress in the methodology and clinical application of low-density lipoprotein receptor gene mutation and function determination ZHU Yonglin, WANG Lüya, YAN Shengkai Laboratory Medicine    2021, 36 (12): 1287-1291.   DOI: 10.3969/j.issn.1673-8640.2021.12.019 Abstract （459）   HTML （28）    PDF （999KB）（209）       Knowledge map    Save Low-density lipoprotein receptor（LDLR） is one type of cell surface glycoprotein,which plays a role in maintaining cholesterol metabolism balance in vivo. LDLR gene mutation can cause the decreasing,even the absence of LDLR on the cell surface,reduce the body's ability to metabolize cholesterol,lead to elevated plasma low-density lipoprotein cholesterol（LDL-C） level and deposition in different tissues and organs,and cause a variety of lipid metabolism disorders. Accurate and rapid determination of LDLR gene mutations and analysis of changes in LDLR function are essential for the diagnosis and differential diagnosis of familial hypercholesterolemia（FH）. This review focuses on the progress in the methodology and clinical application of LDLR gene mutation and function determination,in order to raise awareness and concern of its importance in early diagnosis and intervention of FH patients. Table and Figures | Reference | Related Articles | Metrics

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Inhibitory elimination effects of different enhancers on urea,heme and cholate in fluorescent PCR LIU Wenxia, WANG Wei, LIN Songyang, LI Zhenhong Laboratory Medicine    2022, 37 (2): 155-158.   DOI: 10.3969/j.issn.1673-8640.2022.02.012 Abstract （346）   HTML （8）    PDF （808KB）（191）       Knowledge map    Save Objective To investigate the inhibitory elimination effects of different polymerase chain reaction（PCR） enhancers on cholate,urea and heme. Methods Different concentrations of PCR enhancers [spermidine,formamide,PEG6000,NP40,Tween-20,betaine,trehalose,bovine serum albumin（BSA）,gelatin,ammonium sulfate,tetramethylammonium chloride（TMAC）,glycerol and Triton X-100] were added to the amplification system containing cholate,urea and heme. The anti inhibitory effects of different PCR enhancers were determined by fluorescent PCR and analyzed according to the cycle threshold（Ct） value. Results The 6.5 mmol/L spermidine and 20% glycerol could eliminate the inhibitory effect of 6.98 mmol/L cholate on PCR. The 6.5 mmol/L spermidine,100 mmol/L ammonium sulfate and 0.2 mol/L betaine could eliminate the inhibitory effect of 0.99 mol/L urea on PCR. The 300 mmol/L BSA,6.5 mmol/L spermidine,20% PEG6000 and 50% glycerol could eliminate the inhibitory effect of 6.98 mmol/L heme on PCR. The 40% formamide,10% NP40,40% Tween-20, 1.5 mol/L trehalose,2% gelatin,200 mmol/L TMAC and 20% Triton X-100 could not reduce the inhibitory effects of 6.98 mmol/L cholate,0.99 mol/L urea and 6.98 mmol/L heme on PCR. Conclusions Adding different types of PCR enhancers can effectively improve the determination sensitivity and accuracy of fluorescent PCR. Table and Figures | Reference | Related Articles | Metrics

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Research on performance specification of thrombelastogram MIAO Yingbo, ZHAO Qiang, SONG Ying, ZHU Peichao, ZHOU Wei, XU Chong Laboratory Medicine    2022, 37 (7): 680-683.   DOI: 10.3969/j.issn.1673-8640.2022.07.016 Abstract （353）   HTML （36）    PDF （1033KB）（187）       Knowledge map    Save Objective To investigate how to obtain the appropriate evaluation standard based on the change or constant concentration value as performance standard through thrombelastogram proficiency verification data,and to improve continuously and effectively the determination level of thrombelastogram. Methods The data reported by laboratories participating in the 2018-2020 proficiency verification of Shanghai Center for Clinical Laboratory for thrombelastogram were collected. The relation of U-scores between the reported data of coagulation reaction time,coagulation formation time,angle and maximum amplitude of thrombus and the target value was evaluated,and the evaluation standard of each index based on the change or constant concentration value was obtained. Results The constant concentration values of coagulation reaction time,angle and maximum amplitude of thrombus could be used as evaluation criteria. Coagulation formation time can adopt the evaluation standard based on the change of concentration value. Conclusions The performance specifications of each index of thrombelastogram obtained in this study can be applied to the evaluation standards of proficiency verification and the requirements of allowable imprecision of internal quality control,which can evaluate the determination level of thrombelastogram in Shanghai objectively. Table and Figures | Reference | Related Articles | Metrics

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Epidemiological characteristic analysis of Mycoplasma pneumoniae infection in children in Shanghai HU Shaohua, CHEN Li, ZHAO Meng, MA Zhan, ZHANG Hong Laboratory Medicine    2023, 38 (1): 14-17.   DOI: 10.3969/j.issn.1673-8640.2023.01.003 Abstract （297）   HTML （28）    PDF （846KB）（183）       Knowledge map    Save Objective To investigate the epidemiological characteristics of Mycoplasma pneumoniae infection in children in Shanghai，and to provide a reference for the prevention and control of Mycoplasma pneumoniae infection. Methods The serological determination（passive agglutination），colloidal gold method and real-time quantitative polymerase chain reaction（PCR） results for Mycoplasma pneumoniae IgM and DNA for 18 718 patients with Mycoplasma pneumoniae infection from January 2014 to December 2018 were collected retrospectively and analyzed statistically. Factors，such as age，sex and season，were analyzed. Results The positive rate of serological determination（passive agglutination） in 18 718 cases was 30.48%. The positive rate of girls （34.91%） was higher than that of boys （27.22%）（P<0.01）. The results of screening Mycoplasma pneumoniae IgM by colloidal gold method and real-time quantitative PCR confirmed that the positive rate of girls was higher than that of boys （P<0.01）. The positive rate of infants （<1-year-old） was the lowest，the positive rate was increasing with ages，and the positive rate of 7-14-year-old group was the highest（P<0.01）. In terms of months，July to September of each year was the seasonal peak of Mycoplasma pneumoniae infection. Conclusions The positive rate of Mycoplasma pneumoniae antibodies in children with respiratory tract diseases in Shanghai is relatively high，and the positive rates between girls and boys and with different ages are different. July to September is the peak months of Mycoplasma pneumoniae infection. Table and Figures | Reference | Related Articles | Metrics

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Clinical application value of CTC combined determination with CEA and CA125 in colorectal cancer YANG Chaomei, FENG Jie, LANG Lei, YAN Guangtao Laboratory Medicine    2021, 36 (9): 901-905.   DOI: 10.3969/j.issn.1673-8640.2021.09.003 Abstract （575）   HTML （50）    PDF （868KB）（182）       Knowledge map    Save Objective To investigate the clinical application value of the combined determination of circulating tumor cell（CTC） number,carcinoembryonic antigen（CEA）and carbohydrate antigen（CA）125 in colorectal cancer. Methods A total of 115 patients with colorectal cancer（colorectal cancer group）and 99 patients with colorectal polyps（polyp group）were enrolled. All research subjects were determined for alpha-fetoprotein（AFP）,CEA,CA125,CA19-9,CA15-3,CA72-4 and CTC number. According to CTC number,the patients with colorectal cancer were classified into group Ⅰ（CTC 0/7.5 mL）,group Ⅱ（CTC 1-4/7.5 mL） and group Ⅲ （CTC≥5/7.5 mL）. According to TNM stage of colorectal cancer,the colorectal cancer patients were classified into 0-Ⅱ stage group,Ⅲ stage group and Ⅳ stage group. Logistic regression analysis was used to evaluate the risk factors of colorectal cancer. Receiver operating characteristic（ROC）curve was used to evaluate the value of various indicators in the differential diagnosis of colorectal cancer. Results The levels of serum CEA,CA19-9 and CA72-4 in Ⅰ group were lower than those in Ⅱ group and Ⅲ group（P<0.05）,the level of serum AFP was lower than that in Ⅱ group（P<0.05）,and the level of serum CA125 was lower than that in Ⅲ group（P<0.05）. There was no statistical significance in the indicators between Ⅱ group and Ⅲ group（P>0.05）. There was statistical significance in CTC number and serum CEA,CA125,CA19-9 and CA72-4 levels between polyp group and colorectal cancer group（P<0.05）,while there was no statistical significance in serum AFP and CA15-3 levels among the groups（P>0.05）. There was statistical significance in CA19-9 and CA724 levels between TNM stage 0-Ⅱ group and stage Ⅳ group and between stage Ⅲ group and stage Ⅳ group（P<0.05）. There was statistical significance in CTC number between stage 0-Ⅱ group and stage Ⅳ group（P<0.05）. There was no statistical significance in serum CEA,AFP,CA125 and CA15-3 levels among the 3 groups（P>0.05）. Logistic regression analysis showed that the odds ratios（OR） of CEA,CA125 and CTC number were 1.368,1.135 and 5 560 619.101,respectively. 95% Confidence intervals（CI） were 1.120-1.672,1.037-1.244,0.000-2.129×10214,respectively. ROC curve analysis showed that the areas under curves（AUC） of CEA,CA125,CTC number single determinations and combined determination were 0.840,0.741,0.822 and 0.943,respectively. Conclusions The combined determination of CTC number,CEA and CA125 plays a role for patients with colorectal cancer. Table and Figures | Reference | Related Articles | Metrics

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Clinical laboratory examinations for parasitic diseases CAI Qi, WANG Jianbiao Laboratory Medicine    2021, 36 (10): 1001-1007.   DOI: 10.3969/j.issn.1673-8640.2021.010.002 Abstract （320）   HTML （28）    PDF （838KB）（180）       Knowledge map    Save Clinical laboratory examinations for parasitic diseases play an important role in the diagnosis of parasitic diseases. Clinical laboratory examinations for parasitic diseases include pathogenic examinations,immunological examinations and molecular biological examinations. Although the traditional parasitological examination is intuitive and accurate,it has some limitations. With the rapid development of medical technologies,parasite laboratory examination technology has also made great progress. Immunological examinations and molecular biological examinations have good sensitivities,specificities and repeatabilities. This review summarizes and introduces clinical laboratory examination technologies for parasitic diseases. Reference | Related Articles | Metrics

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Comparison of testing efficiency of simulated emergency biochemical samples among different instruments GE Danhong , FANG Huiling, LIN Feiran, ZHU Yuqing Laboratory Medicine    2022, 37 (8): 766-771.   DOI: 10.3969/j.issn.1673-8640.2022.08.013 Abstract （181）   HTML （17）    PDF （787KB）（176）       Knowledge map    Save Objective To compare the testing efficiency of simulated emergency biochemical samples among different instruments. Methods Single analyte and full-set analytes for single sample and a batch of samples（40 samples） were tested with 3 different instruments（A,B,C）,respectively. The testing times of different instruments were recorded. Totally,20 samples were tested in different sequences（sequence 1 and sequence 2）,and the testing time were recorded. Totally,5 instrument combinations（Ⅰ,Ⅱ,Ⅲ,Ⅳ,Ⅴ） were used to test biochemical analytes and cardiac markers for 10 samples. The combinations were determined according to various processes,and the testing times were recorded. Both split sample and unsplit sample were determined on the combinations. The samples were determined in the process of biochemical analytes first or cardiac markers first. A total of 40 samples,containing 5 hemolytic,5 icteric and 5 lipemic samples,were collected,and the 40 samples were also inspected by 4 technicians by visual. The testing time and results were recorded,and the coincidence rates of visual results were calculated. Daily maintenance for the 3 instruments was performed,and the testing time was recorded. Results It took 6,16 and 12 min to test glucose for single sample for instrument A,B and C,respectively,and 8,18 and 14 min to test full-set analytes for the above instruments,respectively. It took 12,19 and 15 min to test glucose for a batch of samples for instrument A,B and C,respectively,and 103,112 and 72 min to test full-set analytes. It took the same time to test the same analytes for 10 samples in different sequences for instrument A and C,while it took 1 more min in sequence 2 than in sequence 1 on instrument B. When 10 samples were tested for biochemical analytes and cardiac markers,it took combination Ⅰ 34 min. It took combination Ⅱ,Ⅲ,Ⅳ and Ⅴ 67,60,92 and 80 min,respectively,when testing biochemical analytes firstly. It took 69,53,72 and 71 min respectively when testing cardiac markers firstly. It took 58,48,69 and 69 min when the samples were split and start testing simultaneously on both instruments. It took the same time for the 3 instruments to test all the biochemical analytes for 40 samples. The average time for visual inspection of 40 serum samples was 122 s. The mean coincidence rates of visual inspection for hemolytic,icteric and lipemic samples were 100%,48% and 76%,respectively. It took 13,21 and 35 min to complete daily maintenance for instrument A,B and C. Conclusions The testing time is influenced by the number of samples,testing process and so on. Serum index testing needs less time and labor than visual inspection. It reflects the status of samples more objectively and helps controlling the error of pre-analysis. Laboratories can improve the testing efficiency of instrument by means of rationally configuring instruments and optimizing testing process,which may help to shorten turn-around time（TAT）. Table and Figures | Reference | Related Articles | Metrics

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Role of procalcitonin in the diagnosis of different sepsis PAN Xilong, XU Zhiyuan, XIE Feng, LI Dan Laboratory Medicine    2021, 36 (12): 1215-1218.   DOI: 10.3969/j.issn.1673-8640.2021.012.004 Abstract （235）   HTML （34）    PDF （952KB）（172）       Knowledge map    Save Objective To investigate the specific changes in the diagnostic efficacy of procalcitonin（PCT） when the diagnostic criteria for sepsis changed from Sepsis-1 to Sepsis-3,and to provide a reference for the clinical application of PCT in the diagnosis of sepsis. Methods A total of 189 patients with infection or（and） the manifestations of systemic inflammatory response syndrome（SIRS）（non-sepsis,sepsis and septic shock groups） and 30 healthy subjects（healthy control group）were enrolled. PCT was determined in all the subjects. Receiver operating characteristic（ROC） curves were used to evaluate the roles of Sepsis-1 and Sepsis-3 for the diagnosis of PCT. Results There was an increasing trend in PCT levels from healthy control,non-sepsis,sepsis to septic shock groups in each diagnostic component（P<0.05）. Based on Sepsis-1 and Sepsis-3 diagnostic criteria,the areas under curves were 0.85 and 0.73,the sensitivities were 76.85% and 57.01%,the specificities were 78.38% and 76.79%,respectively. The areas under curves,sensitivities and specificities of PCT in the diagnosis of septic shock were 0.75 and 0.76,73.91% and 64.86%,80.65% and 81.43%,respectively. Conclusions When the diagnostic criteria for sepsis change from Sepsis-1 to Sepsis-3,the diagnostic efficacy of PCT decreases in the diagnosis of sepsis,and the diagnostic efficacy of PCT does not change in the diagnosis of septic shock. Table and Figures | Reference | Related Articles | Metrics

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Research progress of miRNA in urine as a biomarker for common malignant tumors WU Yating, LI Zhuolin, LEI Yan, JIA Ruxue, ZHANG Shenghang, WANG Shuiliang Laboratory Medicine    2023, 38 (1): 94-99.   DOI: 10.3969/j.issn.1673-8640.2023.01.020 Abstract （126）   HTML （10）    PDF （842KB）（171）       Knowledge map    Save The comprehensive treatment effect of the majority of patients with advanced cancers is still desirable，so the early diagnosis of cancers is important. MicroRNAs（miRNA）are a class of non-coding small RNAs that exist widely and have various biological functions. More and more studies have shown that the dysregulated expression of specific miRNA caused by genetic or epigenetic changes plays a role in carcinogenesis，malignant progression. In view of the fact that miRNA can stably exist in blood，urine，cerebrospinal fluid，saliva and other biological fluids or secretions. Compared with blood and other fluid-based biopsies，urine-based biopsies have the advantages of easy handling and non-invasive sampling，so the research of urinary miRNA as a potential new tumor molecular marker has attracted more and more attention. This review summarizes the research progress of urinary miRNA as a non-invasive biomarker in the recent years. It makes a preliminary prospect for its possible clinical application in the future，and puts forward some urgent problems to be solved，so as to provide useful enlightenment for future related research. Table and Figures | Reference | Related Articles | Metrics

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Role of cardiac markers in children ZHANG Xin, MA Lijuan Laboratory Medicine    2023, 38 (6): 505-509.   DOI: 10.3969/j.issn.1673-8640.2023.06.001 Abstract （169）   HTML （100）    PDF （872KB）（171）       Knowledge map    Save In the recent years，an increasing number of studies have confirmed the diagnostic value and clinical application prospects of cardiac markers in different diseases，such as myocarditis，cardiomyopathy，congenital heart disease（CHD） and heart failure among children. In addition，it has made new progress in judging cardiac function，the degree of myocardial injury，the occurrence of complications and the effect of diagnosis and treatment of immune-related and other systemic diseases. Children's tissues and organs are still in growth and development stage，there are differences in the determination results of cardiac markers in children with different ages，especially in newborns，which makes the interpretation of determination reports more challenging. Therefore，future researches should focus on new analytical methods，the establishment of biological reference intervals for different ages and more evidence-based research in the diagnosis and treatment of children. Related guidelines or expert consensus should be issued to promote the clinical standard application of cardiac marker determination results in children. Reference | Related Articles | Metrics

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Mechanism and application of serum amyloid A in clinical diseases LIU Jinyan, ZHAO Juntao, XIANG Mingjie Laboratory Medicine    2021, 36 (7): 756-760.   DOI: 10.3969/j.issn.1673-8640.2021.07.017 Abstract （570）   HTML （28）    PDF （867KB）（170）       Knowledge map    Save Serum amyloid A（SAA） is an acute phase-reactive protein that rapidly increases in the acute phase of infection,inflammation and tissue damage,and rapidly declines during the recovery phase of the diseases. There are important links between SAA and infection caused by bacteria or viruses,atherosclerosis,tumors,transplant rejection,rheumatoid,amyloidosis and so on. This review focuses on the structure,function and determination method of the SAA superfamily and the development of mechanisms and applications of SAA and clinical diseases. Reference | Related Articles | Metrics

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Simultaneous determination of 5 steroid hormones in human serum by ultra-performance liquid chromatography-tandem mass spectrometry and establishment of reference intervals in healthy adults LU Youli, YANG Shuangshuang, ZHANG Meiwei, OU Meixian, DONG Chunxia, SHEN Weiwei, JIANG Fengli, LI Shuijun Laboratory Medicine    2022, 37 (2): 165-173.   DOI: 10.3969/j.issn.1673-8640.2022.02.015 Abstract （266）   HTML （40）    PDF （962KB）（170）       Knowledge map    Save Objective To establish and validate a method for the simultaneous determination of testosterone（T）,dihydrotestosterone（DHT）,androstenedione（AD）,dehydroepiandrosterone（DHEA） and 17alpha-hydroxyprogesterone（17OHP） in human serum by ultra-performance liquid chromatography-tandem mass spectrometry（UPLC-MS/MS）,and to establish the reference intervals of 5 steroid hormones in healthy adults. Methods The serum samples were purified by SOLAμ HRP solid-phase extraction,and they were separated by Poroshell 120 EC-C18 analytical column. Mobile phase was constituted of 30% acetonitrile solution and 90% acetonitrile solution containing 0.05% formic acid with gradient elution. The electrospray positive ion multi-reaction monitoring mode was used for determination,and the isotope internal standard method was used to quantify the concentration of steroid hormones. The performance of the method was verified comprehensively,and the reference intervals suitable for the local population in Shanghai were established. Results The minimum limits of quantification of the 5 steroid hormones in human serum were 0.01-0.10 ng/mL. The standard curve range covered 1 000 times （r2≥0.999 5） and showed good linearity,and the sample after dilution can be reported to cover the range of 5 000 times. The average accuracy of 5 steroid hormones ranged from 95.0% to 105.6%,with the precision of <8%. None of the 8 structural analogs interfered with the target analytes,high triglyceride blood did not affect the determination results,and hemolysis resulted in low DHEA concentration. The extraction recoveries of the analytes were 60.5%-93.3%,and there was no obvious matrix effect after calibration of internal standard. Analytes demonstrated good stability at room temperature for 4 h,at -25--15 ℃ for 30 d or at -90--70 ℃ for 100 d. The method was used and participated in a survey of endocrine accuracy verification supplied by the National Center for Clinical Laboratories in 2019. The determination deviations of T and 17OHP were -5.00%-0.38%. The results of 367 physical examination subjects were analyzed and showed that there was statistical significance in the concentration of 5 steroid hormones between females and males（P<0.05）. There was statistical significance between the 2 age subgroups（aged 16-50 years and aged>50 years） of female groups（P<0.05）. Conclusions A UPLC-MS/MS has been established for the determination of 5 steroid hormones in human serum,and the reference intervals suitable for the Central Laboratory of Shanghai Xuhui Central Hospital have been verified. Table and Figures | Reference | Related Articles | Metrics

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Role of line chart model based on peripheral blood-derived inflammation markers in early diagnosis of neonatal septicemia HE Xuelian, HE Ziyi, LIU Yueyang, YU Yanzhi, ZHANG Siying Laboratory Medicine    2022, 37 (10): 921-927.   DOI: 10.3969/j.issn.1673-8640.2022.010.003 Abstract （139）   HTML （16）    PDF （923KB）（164）       Knowledge map    Save Objective To establish and evaluate a line chart model for the early diagnosis of neonatal septicemia by using peripheral blood-derived inflammation markers. Methods Totally，137 patients with neonatal septicemia and 114 non-infected newborns were enrolled，96 cases of neonatal septicemia patients were randomly selected as septicemia group，96 cases of non-infected newborns were selected as control group，and the remaining 59 newborns（41 cases of neonatal septicemia patients and 18 cases of non-infected newborns） were included in model verification group. The clinical data of all the newborns were collected，blood routine tests were performed，and the test items included white blood cell（WBC） count，hemoglobin（Hb），platelet（PLT） count，lymphocyte percentage（LYMPH%），neutrophil percentage（NEUT%），hematocrit（HCT），C-reactive protein（CRP），procalcitonin（PCT） and interleukin-6（IL-6）. Logistic regression analysis was used to evaluate the risk factors of neonatal septicemia，and a line chart model was constructed. Receiver operating characteristic（ROC） curve，decision curve and calibration curve were used to evaluate and validate the model. Kaplan-Meier survival curve was used to evaluate the probability of neonatal septicemia in different risk groups. Results There was statistical significance in WBC count，PLT count，Hb，NEUT%，CRP，PCT and IL-6 between septicemia group and control group（P<0.05），but there was no statistical significance in LYMPH% and HCT（P>0.05）. The results of Logistic regression analysis showed that the elevated levels of CRP，PCT and IL-6 were risk factors for neonatal septicemia [odds ratios（OR） were 2.943，2.862 and 2.915，respectively，P<0.05]. The total score of risk factors in the line chart was 239.78，and the corresponding incidence of neonatal septicemia was 71.86%. The C-index value of the line chart diagnosis model for neonatal septicemia was 0.934，the area under curve was 0.831，the sensitivity was 82.1%，and the specificity was 80.4%. The ideal curve in the calibration curve was close to the actual curve，the accuracy was good，the area under decision curve was 0.792，and the clinical net benefit rate of the model was high. According to the critical value of the line chart diagnosis model score，the occurrence probability of neonatal septicemia was classified into 3 groups，low risk（≤83.65），medium risk（>83.65-≤157.89） and high risk（>157.89） groups. The probability of neonatal septicemia was 29.47%，45.57% and 83.33%，respectively. Conclusions The line chart diagnosis model based on CRP，PCT and IL-6 is of value in early diagnosis of neonatal septicemia. Table and Figures | Reference | Related Articles | Metrics

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Laboratory Medicine    2022, 37 (12): 1178-1182.   DOI: 10.3969/j.issn.1673-8640.2022.12.015 Abstract （215）   HTML （13）    PDF （966KB）（158）       Knowledge map    Save Table and Figures | Reference | Related Articles | Metrics

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Evaluation of nasopharyngeal swab bacterial culture in pathogenic diagnosis in children with bacterial respiratory tract infection XIE Yongping, HUA Chunzhen, WEI Linlin, WANG Hongjiao, WANG Gaoliang, LI Jianping Laboratory Medicine    2022, 37 (3): 201-204.   DOI: 10.3969/j.issn.1673-8640.2022.03.001 Abstract （255）   HTML （32）    PDF （808KB）（157）       Knowledge map    Save Objective To evaluate the value of nasopharyngeal swab bacterial culture in pathogenic diagnosis in children with respiratory tract infection. Methods Nasopharyngeal swab and oral aspirate samples were collected from 403 hospitalized children diagnosed as pertussis-like syndrome or pneumonia. The samples were inoculated in partitions on medium discs with semi-quantitative method. Bacteria were identified,and the isolates growing including and more than "+++" were definited as clinical isolates. The positive rates of culture between nasopharyngeal swab and sputum samples were compared and linked with clinical manifestation and treatment outcomes. Results In the 403 cases,the positive rate of nasopharyngeal swab culture was 31.5%（127/403）,and the top 4 bacteria were Bordetella pertussis（13.4%）,Haemophilus influenzae（7.9%）,Moraxella catarrhalis（4.0%） and Streptococcus pneumoniae（3.5%）. The positive rate of oral aspirate culture was 12.4%（50/403）,and the positive rates of the above 4 bacteria were 0.7%,4.5%,1.0% and 1.2%,respectively. The positive rates of nasopharyngeal swab culture was higher than that of oral aspirate culture（P<0.05）. The same bacteria were isolated from both nasopharyngeal swab and sputum samples in 31 of 50 cases（62.0%）. After treating with sensitive antibiotics,the results of nasopharyngeal swab culture swithed to negative in 98.4%（125/127） of all the patients. Conclusions Nasopharyngeal swab culture improves the determination of pathgens in respiratory tract in children,which plays a role in pathogenic diagnosis in children with respiratory tract infection. Table and Figures | Reference | Related Articles | Metrics

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Performance specification for differential blood count project in Shanghai MIAO Yingbo, SONG Ying, ZHAO Qiang, ZHU Peichao, ZHOU Wei, WANG Qing, XU Chong Laboratory Medicine    2021, 36 (12): 1274-1276.   DOI: 10.3969/j.issn.1673-8640.2021.012.016 Abstract （159）   HTML （34）    PDF （919KB）（156）       Knowledge map    Save Objective To find a performance specification for differential blood count project,and to improve the determination level of differential blood count project in Shanghai continuously and effectively. Methods The data of 60 batches of differential blood count project for 12 times from 2015 to 2020 were collected,and the passing rates of all the batches in each year were evaluated according to the performance specifications based on biological variation and the state-of-the-art. The performance specifications with passing rates ≥80% were selected as the performance specifications for differential blood count project. Results All the batches of neutrophil,eosinophil and basophil passed ≥80% when using the optimal performance specification（11.2%,18.6% and 19.2%） based on biological variation. All the batches had a passing rate of ≥80% for lymphocyte when using the minimum performance specification（24%） based on biological variation. All the batches of monocyte were counted using a performance specification based on the state-of-the-art（<1,±0.279;≥1,±27.9%）,and the passing rates were ≥80%. Conclusions The performance specifications for neutrophil,lymphocyte,eosinophil and basophil in Shanghai can be 11.2%,24.0%,18.6% and 19.2%,respectively,and those for monocyte<1 and monocyte≥1 are ±0.279 and ±27.9%,respectively. Table and Figures | Reference | Related Articles | Metrics

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Dynamic changes and clinical significance of CXCR5,sPD-1 and Hcy in AIDS patients during therapy SHI Penghui, FAN Weiguang, ZHANG Zhen, SU Miaomiao, MENG Juan, LU Xinli Laboratory Medicine    2022, 37 (2): 103-107.   DOI: 10.3969/j.issn.1673-8640.2022.02.001 Abstract （216）   HTML （31）    PDF （801KB）（151）       Knowledge map    Save Objective To investigate the changes and clinical significance of serum C-X-C chemokine receptor 5（CXCR5）,soluble programmed cell death receptor-1（sPD-1） and homocysteine（Hcy） in acquired immune deficiency syndrome（AIDS） patients during antiretroviral therapy（ART）. Methods Totally,120 AIDS patients were enrolled in AIDS group,and 45 healthy subjects were enrolled as control group. The human immunodeficiency virus（HIV）-1 load,the absolute number of CD4+T cells,CXCR5,sPD-1,Hcy,blood lipids [triglyceride（TG）,total cholesterol（TC）,low-density lipoprotein cholesterol（LDL-C） and high-density lipoprotein cholesterol（HDL-C）] were determined in AIDS patients on 1 d before therapy and 3,6 and 12 months after therapy,respectively. Pearson correlation analysis was used to evaluate the correlations between each index and the absolute number of CD4+ T cells and HIV-1 load. Results Before therapy,the levels of sPD-1 and Hcy in AIDS group were higher than those in control group（P<0.01）,and CXCR5 and the absolute number of CD4+T cells were lower than those in control group（P<0.01）. Compared with those before therapy,with the prolongation of ART time,the absolute numbers of CD4+ T cells and CXCR5 levels in AIDS patients were increased（P<0.05）. The peak was reached at 6 months after therapy. Hcy,TC,TG and LDL-C were increased after 12 months of therapy（P<0.05）. HDL-C did not change. The HIV-1 load began to decrease after 3 months of therapy（P<0.05）,and the decrease was more significant after 6 months of therapy（P<0.05）. The level of serum sPD-1 decreased after 12 months of therapy（P<0.05）. Pearson correlation analysis showed that the absolute number of CD4+ T cells was positively correlated with CXCR5 and Hcy（r=0.192 and 0.401,P<0.05）,and there was a negative correlation with sPD-1（r=-0.708,P<0.05）. The HIV-1 load was negatively correlated with CXCR5 and Hcy（r=-0.682 and -0.318,P<0.05）,and it was positively correlated with sPD-1（r=0.368,P<0.05）. Conclusions The dynamic monitoring of the absolute number of CD4+ T cells,HIV-1 load,CXCR5,sPD-1,Hcy and blood lipid changes of AIDS patients during ART can help monitor the progress of HIV infection in time. Table and Figures | Reference | Related Articles | Metrics

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Isotope dilution liquid chromatography tandem mass spectrometry candidate reference method for serum testosterone SUN Hewei, JU Yi, ZHU Lingfeng, LI Qing, JIN Zhonggan, ZHANG Sujie Laboratory Medicine    2021, 36 (10): 1064-1069.   DOI: 10.3969/j.issn.1673-8640.2021.010.016 Abstract （157）   HTML （10）    PDF （1118KB）（151）       Knowledge map    Save Objective To establish a candidate reference method for the determination of human serum testosterone based on liquid chromatography tandem mass spectrometry（LC-MS/MS）,and to use it into assessing the trueness of clinical method（microparticle chemiluminescence immunoassay）. Methods Testosterone-2,3,4-13C3 was added as internal standard. Serum samples were treated with hexane-ethyl acetate（50∶50,volume fraction）. The upper layer was dried with nitrogen flow. The residual were reconstituted with mobile phase and analyzed by LC-MS/MS. Serum testosterone concentration was calculated by 5-point bracketing method. The isotope dilution liquid chromatography tandem mass spectrometry（ID-LC-MS/MS）（carryover,specificity,linearity,imprecision,accuracy） was validated according to the Clinical and Laboratory Standards Institute（CLSI） C62-A and EP15-A3. The trueness of microparticle chemiluminescence immunoassay was evaluated according to CLSI EP9-A3. Results The ID-LC-MS/MS with 5 min total run time and without carryover was validated over a concentration range of 0.034-22.000 ng/mL,and the specificity was good. The within-run imprecision was ≤2.3%,and the between-run imprecision was ≤2.2%. The bias of analyzing the candidate reference material SRM971（Level male）was 0.2%. The relative biases of analyzing 2017 RELA-A and 2017 RELA-B were -2.9% and -3.3%,respectively. The uncertainty for 2017 RELA-A was 0.11 ng/mL. The linearity between ID-LC-MS/MS and microparticle chemiluminescence immunoassay was good（r=0.963）. However,its average relative bias was large,which total average relative bias was -24.4%,the average relative bias of low concentration group（≤1 ng/mL） was -62.4%,and the average relative bias of high concentration group（>1 ng/mL） was 6.3%. Conclusions The ID-LC-MS/MS established successfully for serum testosterone has good precision and accuracy,with simple preparation and short analysis time and may be used as a candidate reference method. Table and Figures | Reference | Related Articles | Metrics

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Application of patient-based real-time quality control using exponentially weighted moving average method on internal quality control procedures for serum ion items YANG Fan, DONG Danfeng, LU Yide Laboratory Medicine    2021, 36 (9): 962-968.   DOI: 10.3969/j.issn.1673-8640.2021.09.016 Abstract （271）   HTML （26）    PDF （1905KB）（151）       Knowledge map    Save Objective To investigate the application of patient-based real-time quality control（PBRTQC）using exponentially weighted moving average（EWMA） method on internal quality control（IQC） procedures for serum ion items. Methods The serum ion item determination results of outpatients and inpatients in Ruijin Hospital of Shanghai Jiao Tong University School of Medicine from October 2019 to May 2021 were collected. Based on PBRTQC professional intelligent software system,the normal distribution test of test data,parameter setting,procedure establishment,real-time operation and performance verification were carried out. The estimated value of EWMA for each result was included in the analysis. The cumulative coefficient of variation（CV） was calculated and was compared with the criteria of precision quality standard and the analytical IQC CV. The early-warning cases by the EWMA quality control program were recorded and analyzed for the potential reasons of analytical performace changes. Results The truncated concentration range of K（3.40-5.00 mmol/L）,Na（135-145 mmol/L）,Cl（99-110 mmol/L）,Ca（2.10-2.36 mmol/L）,Mg（0.74-0.98 mmol/L） and P（0.90-1.31 mmol/L） were shown distributed normally. The optimal weighted coefficients of K,Na and Cl were 0.02,and the optimal weighted coefficients of Ca,Mg and P were 0.05. The actual cumulative precisions（CV） of the 6 items were all smaller than the precision quality target. A total of 13 warning cases were recorded. The number of alarm cases in K,Na,Cl,Ca,Mg and P were 3,1,2,2,3 and 2,respectively. Among them,serum K,Mg and P each had 1 false positive case. Conclusions PBRTQC quality control using EWMA,as a supplementary IQC procedure,has the advantage of monitoring micro-changes in order to avoid the potential quality risks. Table and Figures | Reference | Related Articles | Metrics