Table of Content

30 March 2021, Volume 36 Issue 3

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Research and application of reference measurement system in laboratory medicine

JU Yi

2021, 36(3):  237-239.  DOI: 10.3969/j.issn.1673-8640.2021.03.001

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The construction of reference measurement system for laboratory medicine is an important guarantee for the metrological traceability of test results,and it is also an important basis for realizing the standardization and mutual accredit of test results. In the past half century,the reference measurement system of laboratory medicine based on reference measurement procedure,reference material and reference measurement laboratory has been basically formed and gradually improved. In recent 10 years,the development of reference measurement laboratory in China has made remarkable progress,however,the research on reference measurement procedure and reference material is relatively backward. The 6 papers published in this issue introduced the standardization of clinical chemistry,inter-accreditation evaluation of reference material,the establishment of reference measurement procedure and uncertainty evaluation,the development of reference material and matrix effect evaluation,and the application in in vitro diagnostic product（IVD）medical device and external quality assessment,hoping to further promote the research and application of reference measurement system in China.

Current situation of standardization of clinical chemistry measurement

OU Yuanzhu, CHEN Baorong, JU Yi

2021, 36(3):  240-244.  DOI: 10.3969/j.issn.1673-8640.2021.03.002

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Laboratory quality management and measurement result standardization are important foundations for the mutual accredit of clinical chemistry measurement result. Carrying out standardization work and establishing the standardization system of test items are the most effective means to realize the accuracy and comparability of test results and provide an accurate basis for regional and national laboratory quality. One of the important means to realize the comparability of test results is to establish and ensure the traceability of the results. At present,the metrological traceability of different items is achieved by establishing reference measurement procedures,reference materials and harmonization protocol in international organizations. The development of trueness verification plans and proficiency tests provides the foundations for the mutual accredit of clinical chemical test results. In this review,the current situation of clinical chemistry testing standardization is reviewed, so as to provide a reference for clinical laboratory quality management.

Application and thinking of laboratory medical reference system in IVD enterprises of China

TANG Liping, LIU Mingjin, LIU Guancai, YAN Zhonghua, CAI Hua, YANG Tao, SUN Keqi

2021, 36(3):  250-254.  DOI: 10.3969/j.issn.1673-8640.2021.03.004

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The reference system research based on metrological traceability is an important research topic in the field of laboratory medicine,and it is also an important research direction for in vitro diagnosis product（IVD） enterprises to improve product quality and influence. The accuracy and reliability of test results are important guarantees for clinical diagnosis,treatment and prevention. In this review,from the perspective of IVD enterprises,basic situation and classification of medical reference system are briefly described. The reference system applied in IVD enterprises of China were introduced from the aspects of reference measurement procedures,reference materials and uniformity. The existing problems,such as the current number of reference methods and reference materials,can not meet the demand of enterprises and clinical applications,IVD industry understanding of metrological traceability and standardization is not perfectly enough,there is a lack of laboratory network for reference measuring service,were summarized. It is expected to provide a reference for the researchers of reference system of laboratory medicine.

Production of candidate secondary reference material for catalytic activity concentration of alpha-amylase in frozen human serum

WANG Jianbing, HAN Liqiao, LIN Haibiao, ZHANG Qiaoxuan, YAN Jun, ZHUANG Junhua, HUANG Xianzhang

2021, 36(3):  255-258.  DOI: 10.3969/j.issn.1673-8640.2021.03.005

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Objective To develop a candidate secondary reference material for the catalytic activity of alpha-amylase in frozen human serum as a standard for value transmission. Methods According to JJF 1343-2012 General and Statistical Principles for Characterization of Reference Materials and JJF 1644-2017 Production of Reference Materials for Clinical Enzymology,the homogeneity,stability and commutability were evaluated. The value of the reference material was determined by 6 China National Accreditation Service（CNAS） accredited reference laboratories. The uncertainties of the certified values were calculated. Results The results of homogeneity and stability were both good. The measured values were in the 95% confidence interval in the 4 conventional detection systems for commutability. The values were （106.3±4.3）U/L（k=2）on level 1 and （268.1±7.9）U/L（k=2）on level 2. Conclusions The candidate secondary reference material of alpha-amylase has promising homogeneity,stability and commutability,and its labeled values are reliable.

Application of candidate reference method of apolipoprotein A1 and apolipoprotein B in external quality assessment

LI Qing, JU Yi, TANG Liping, JIN Zhonggan, SUN Hewei

2021, 36(3):  259-262.  DOI: 10.3969/j.issn.1673-8640.2021.03.006

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Objective To investigate the application of candidate reference method of apolipoprotein（apo） A1 and apo B in external quality assessment（EQA）. Methods Five levels of frozen human serum products were used for EQA samples. Immunoturbidimetry （ITA）was used for the detection. EQA samples were quantified by isotope dilution liquid chromatography-tandem mass spectrometry（ID-LC-MS/MS）. Samples underwent denaturing,alkalization and tryps in digestion,and were then separated by C18 column and quantified by positive ion mode and multiple reaction monitoring. Results ITA was used in 340 participants. As for apo A1,ID-LC-MS/MS gave values lower than the median of ITA for EQA2-EQA4,but not for EQA1 and EQA5. As for apo B,except EQA4,all ID-LC-MS/MS values were lower than the median of ITA. Conclusions Candidate reference method based on ID-LC-MS/MS can offer application value of assessment based on target value.

Isotope dilution mass spectrometry applied in measurement uncertainty of serum creatinine concentration

ZHANG Weiwei, JING Rongrong, JI Huoyan, WANG Jianxin, WANG Feng, WANG Huimin

2021, 36(3):  263-269.  DOI: 10.3969/j.issn.1673-8640.2021.03.007

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Objective To investigate the evaluation method for measurement uncertainties of serum creatinine concentration by isotope dilution mass spectrometry（ID-MS）. Methods We established a reference measurement procedure for the serum creatinine concentration by ID-MS. The uncertainty was evaluated according to the strict Guide to the Expression of Measurement Uncertainty（GUM） method. The strict GUM method meant that each uncertain component was analyzed and quantified in detail according to the measurement model. The calculation was based on the principle that relative values should be used in multiplication and division,and absolute values should be used in addition and subtraction. Meanwhile,traditional evaluation method and the Monte Carlo method（MCM） were used to evaluate the uncertainties of serum creatinine concentration. Results The measured specific serum creatinine concentration was 347.4 μmol/L. The combined standard uncertainty was 0.89% according to ID-MS measurement model and strict GUM principle. The uncertainty evaluated by the traditional method was 0.93%,which was 4.8% higher than that evaluated by the GUM method. The combined standard uncertainty was 0.64% by MCM,which was 27.9% lower than that evaluated by the strict GUM method. The 95% confidence interval of the measurement result by MCM was 343.1-351.8 μmol/L. Conclusions The result of uncertainty evaluated by the traditional method is higher than that of the strict GUM method,while the result of the MCM is lower than that of the strict GUM method. It is suggested that each uncertainty component should be strictly quantified and combined according to the GUM method. If possible,the MCM could be used to evaluate the uncertainty.

Primary exploration of rapid identification and drug sensitivity test of cerebrospinal fluid culture by blood culture enrichment method

QIAO Yuli, HUANG Zongshuai, TIAN Yueru, GUAN Ming, JIANG Xiaofei

2021, 36(3):  270-274.  DOI: 10.3969/j.issn.1673-8640.2021.03.008

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Objectives To explore the feasibility of rapid identification and drug sensitivity test by matrix-assisted laser desorption/ionization time-of-flight mass spectrometry（MALDI-TOF MS） after enrichment of bacteria in cerebrospinal fluid（CSF） culture with blood culture bottle. Methods A total of 1 446 CSF samples from Huashan Hospital affiliated to Fudan University from December 2018 to July 2019 were collected. Of them,345 samples were randomly cultured by blood culture bottle enrichment method,and the other 1 101 samples were cultured by conventional enrichment method. The positive rate of 2 groups were compared. The positive samples of blood culture bottle enrichment method were identified by MALDI-TOF MS and carried out drug sensitivity experiment using the rapid method（BD gel was used to separate serum tubes and enrich bacteria）and conventional method（transfer overnight to obtain pure bacteria）. The coincidence rate of identification and in vitro drug sensitivity test were analyzed. Results Compared with the routine culture,the positive rate of CSF blood culture bottle enrichment method increased significantly（χ²=60.889,P=0.000）. In 48 positive samples of CSF blood culture bottle enrichment method,the coincidence rate of rapid method and routine method was 89.80%,and there was no statistical significance between the 2 methods（χ²=0.116,P=0.990）. In the comparison of rapid and routine in vitro drug sensitivity experiment,for Gram-negative bacteria,except tigacycline with microdilution broth method had a low classification consistency,the consistent rates of other methods and antibacterial drugs were 100%;the consistent rates of erythromycin with Kirby-Bauer method,erythromycin and gentamycin with microdilution broth method,and clindamycin and gentamycin with instrument method were slightly poor,but the consistent rates of other antibacterial drugs were 100%. The consistent rates of classification and standard of cryptococcus rapid drug sensitivity were 100%. Based on pure bacteriummicrodilution broth method,the standard consistent rates of rapid microdilution broth method and rapid instrument method were 98.56% and 97.83%,respectively. Conclusions The positive rate of CSF blood culture bottle enrichment method and the detection rate of refractory bacteria can be improved without prolonging the time of positive report. The rapid identification and drug sensitivity experiment of direct centrifugation by using BD gels can greatly shorten the clinical report time and provide a rapid and accurate basis for clinical medication.

Correlation between neutrophil-to-lymphocyte ratio and short-term poor prognosis in patients with corona virus disease 2019

WANG Bin

2021, 36(3):  275-280.  DOI: 10.3969/j.issn.1673-8640.2021.03.009

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Objective To investigate the predictive value of neutrophil/lymphocyte ratio（NLR）on the short-term poor prognosis in patients with corona virus disease 2019（COVID-19）. Methods A retrospective analysis was conducted in 302 patients with COVID-19 at Tongji Hospital,Tongji Medical College,Huazhong University of Science and Technology from January 28,2020 to February 20,2020. Totally,57 healthy subjects were enrolled as control group on January 7,2020. According to the clinical manifestations on admission,the patients were classified into non-severe group（218 cases） and severe group（84 cases）. According to in-hospitalization prognosis,the patients were classified into survival group（269 cases） and non-survival group（33 cases）. Clinical data and inflammatory indicators,including white blood cell（WBC） count,the absolute value of neutrophil count（NEUT#）,the absolute value of lymphocyte count（LYMPH#）,platelet（PLT） count,high-sensitivity C-reactive protein（hs-CRP）,procalcitonin（PCT）,were collected on admission. NLR and platelet/lymphocyte ratio（PLR）were calculated. Results There were statistical differences in terms of NEUT#,LYMPH#,PLT count,NLR and PLR between COVID-19 group and healthy control group（P<0.05）. On admission in the severe group,male proportion,patient proportion of hypertension,age,WBC count,NEUT#,NLR,PLR,hs-CRP and PCT were higher than those in the non-severe group（P<0.05）,while LYMPH# and PLT count were lower than those in the non-severe group（P<0.05）. In the non-survival group,male proportion,age,WBC count,NEUT#,NLR,PLR,hs-CRP and PCT were higher than those in the survival group（P<0.05）,while the in-hospital survival time,LYMPH# and PLT count were lower than those in the survival group（P<0.05）. Multivariate Logistic regression analysis showed that male,age,NEUT# and NLR were independent risk factors for short-term prognosis in COVID-19 patients. Meanwhile,PLT count was the independent protective factor. The receiver operating characteristic（ROC）curve analysis indicated the area under curve（AUC）of NLR was 0.819 [95% confidence interval（CI） 0.756-0.882,P<0.001）. When the cut-off value was 6.18,the sensitivity,specificity,positive predictive value and negative predictive value were 79.63%,68.95%,35.88% and 93.96%,respectively. Conclusions NLR is closely related to the occurrence of short-term poor prognosis in patients with COVID-19 and is an independent predictor for in-hospital death.

Combined detection of serum NGAL and Cys C in the diagnosis of early nephropathy in patients with type 2 diabetes mellitus

ZHU Qinghua, WANG Weiwei, ZOU Guanghui, DONG Zhiwu

2021, 36(3):  281-284.  DOI: 10.3969/j.issn.1673-8640.2021.03.010

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Objective To investigate the role of combined detection of neutrophil gelatinase-associated lipocalin（NGAL） and cystatin C（Cys C） in early renal injury in patients with type 2 diabetes mellitus（T2DM）. Methods A total of 95 T2DM patients were enrolled in the study. According to 24-hour urinary albumin excretion rate（UAER）,there were 29 patients with normal urinary albumin（NA group,UAER<30 mg/24 h）,33 patients with microalbuminuria（MA group,UAER：30-300 mg/24 h）and 33 patients with clinical albuminuria（CA group,UAER>300 mg/24 h）. Seventy-eight healthy subjects were collected into control group. The levels of serum urea,creatine,uric acid,NGAL,Cys C and urine α1-microglobulin were measured. The receiver operating characteristic（ROC）curve were applied for the evaluation of the diagnostic value of the indices. Results The levels of serum urea,creatine,uric acid,NGAL,Cys C and urine α1-microglobulin in MA and CA groups were significantly higher than those in the NA and control groups（P<0.05）. However,no significant difference was found in these indices between the NA and control group,or between the MA and CA group（P>0.05）. ROC curve showed that the area under curve（AUC）of serum urea,creatine,uric acid,NGAL,Cys C and urine α₁-microglobulin were 0.649,0.713,0.632,0.795,0.869 and 0.660,respectively. The joint detection of NGAL and Cys C had a higher AUC value（0.881） than the above-mentioned single index（P<0.000 1）. Conclusions The combined detection of NGAL and Cys C can facilitate the diagnosis for early renal injury in T2DM patients and serve as an ideal index of screening.

Correlation between fasting blood glucose variability parameters and painful diabetic peripheral neuropathy

CHEN Xingyu, DONG Feifei

2021, 36(3):  285-291.  DOI: 10.3969/j.issn.1673-8640.2021.03.011

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Objective To investigate the relationship between fasting blood glucose variability parameters and painful diabetic peripheral neuropathy（PDPN）. Methods In this study,135 patients with type 2 diabetes mellitus（T2DM）and diabetic peripheral neuropathy（DPN）,including 58 patients with PDPN and 77 patients with non-painful diabetic peripheral neuropathy（NPDPN） group,63 T2DM patients and 42 healthy subjects（healthy control group）were enrolled. The general information of all subjects was collected. And glycosylated hemoglobin（HbA1c）,fasting blood glucose（FPG）,2 h postprandial blood glucose（2 h PG）,fasting insulin（FINS）,blood lipids [triglycerides（TG）,total cholesterol（TC）,high-density lipoprotein cholesterol（HDL-C）,low-density lipoprotein cholesterol（LDL-C）],brain-derived neurotrophic factor（BDNF）,high mobility group box B1（HMGB1）,blood glucose variability parameters [ within-day largest amplitude of glycemic excursion（LAGE）,mean blood glucose（MBG）throughout the day,standard deviation of blood glucose（SDBG）throughout the day,coefficient of variation of fasting blood glucose（FBG-CV）],as well as nerve conduction velocity [motor nerve conduction velocity of median nerve（MMCV）,motor nerve conduction velocity of common peroneal nerve（PMCV）,sensory nerve conduction velocity of median nerve（MSCV）,and sensory nerve conduction velocity of common peroneal nerve（PSCV）] were detected. Receiver operating characteristic（ROC）curve was used for evaluating the role of fasting blood glucose variability for the diagnosis of PDPN. Unconditional Logistic regression analysis was used to evaluate the influence factors of PDPN. The risk of cardiovascular disease and disability in patients with DPN was assessed by Kaplan-Meier curve. Spearman correlation analysis was used to evaluate the correlation between various indicators. Results Compared with healthy control group,There were significant differences in terms of body mass index（BMI）,diabetes mellitus course,FBG,2 h PG,TG,HDL-C,HbA1c,BDNF,HMGB1,MMCV,PMCV,MSCV and PSCV between healthy control group and PDPN group,between healthy control group and NDPDN group, between healthy control group and T2DM group（P<0.05,P<0.01）. FBG,TG,HbA1c,BDNF,HMGB1 and PSCV in PDNP group had statistical significance compared with those in NPDPN and T2DM groups（P<0.05,P<0.01）. ROC curve analysis showed that the area under curve（AUC） of LAGE,MBG,SDBG and FPG-CV was 0.748,0.727,0.785 and 0.837,respectively. The efficiency of FBG-CV in diagnosis of PDPN was better than those of LAGE,MBG and SDBG. Spearman correlation analysis showed that LAGE, MBG, SDBG and FBG-CV were significantly correlated with BDNF and PMCV（P<0.05）. Unconditional Logistic regression analysis showed that LAGE,MBG,SDBG and FBG-CV were risk factors for PDPN. The cumulative incidence of cardiovascular events in PDPN group was significantly higher than that in NPDPN group（P=0.017）. The cut-off value of FBG-CV for the diagnosis of PDPN was 30.00%. The cumulative incidence of cardiovascular events in patient with FBG-CV≥30.00% was significantly higher than that in patients with FBG-CV<30.00%（P=0.013）. Conclusions Fasting blood glucose variability parameters may be involved in PDPN. It is an independent risk factor for long-term cardiovascular events in PDPN patients.

Establishment of survival model for predicting prognosis of patients with acute promyelocytic leukemia

SHEN Xiaoya, LOU Yinjun, WANG Wenjuan

2021, 36(3):  292-295.  DOI: 10.3969/j.issn.1673-8640.2021.3.012

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Objective To analyze the risk factors for the prognosis of acute promyelocytic leukemia（APL）,and to establish the survival model of APL with multiple parameters. Methods A total of 218 patients with APL treated in our hospital from July 2013 to July 2017 were enrolled. The patients were divided into early death group（18 cases）and non-early death group（200 cases）. The risk factors for the prognosis of APL were analyzed,and the survival model was established. Results Patient's age >60 years old,white blood cell（WBC） count>10×10⁹/L,fibrinogen（Fib）≤1.4 g/L,serum creatinine（SCr）>105 μmol/L,lactate dehydrogenase（LDH）>250 U/L,positive PML-RARα fusion gene SG were closely related to early death（P<0.05）. Multivariate Logistic analysis showed that age [odds ratio（OR）=1.049,95% confidence interval（CI） 1.003-1.098,P=0.038] and WBC count（OR=1.030,95%CI 1.007-1.054,P=0.012） were independent risk factors for APL prognosis. The model for predicting the patient's survival was established by the indicators of age,WBC count,Fib,LDH,SCr,and PML-RARα fusion gene subtype at initial diagnosis,and evaluated by receiver operating characteristic（ROC）curve. The area under curve（AUC） was 0.797,the sensitivity was 71.4%,and the specificity was 92.6%.Conclusions Age and WBC count are independent risk factors for APL prognosis. The established model can be explored in predicting the survival status of patients.

Clinical significance of reticulocyte parameters in acute pancreatitis

LENG Deguo, YU Jinming, CAO Cheng, XU Hui

2021, 36(3):  296-299.  DOI: 10.3969/j.issn.1673-8640.2021.03.013

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Objective To investigate the levels of reticulocyte（RET） parameters in peripheral blood of acute pancreatitis（AP） patients and its clinical significance. Methods A total of 86 hospitalized AP patients,including 51 mild cases and 35 severe cases（7 deaths during hospitalization）,and 50 healthy individuals（control group） who underwent physical examination were enrolled in this study. Peripheral venous blood was collected in AP patients on day 1,5 and 10 of admission and in healthy individuals during physical examination. The levels of RET parameters including reticulocyte（RET）,reticulocyte percentage（RET%）,immature reticulocyte fraction（IRF）,low fluorescence reticulocyte（LFR）,medium fluorescence reticulocyte（MFR） and high fluorescence reticulocyte（HFR）were detected. The receiver operating characteristics（ROC） curves were used to analyze the diagnostic value of IRF,LFR and HFR for AP. Results The levels of RET,RET%,IRF,MFR and HFR in AP group on day 1,5 and 10 of admission were higher than those in the control group,while LFR level was on the contrary. In mild and severe AP patients,RET,RET%,IRF and HFR on day 5 and 10 were higher than those on day 1,while LFR level was lower than that on day 1. On the 10th day of admission,except for the increased LFR,the levels of other parameters in mild and severe patients were decreased compared with those on day 5 of admission（P<0.05）. ROC curve analysis showed that the area under curve（AUC）of the combined detection of IRF,LFR and HFR was 0.922 with sensitivity of 86% and specificity of 92%,which were higher than single detection. Conclusion The levels of RET parameters can reflect the severity of AP. Combined detection of IRF,LFR and HFR may be an effective diagnostic marker for early AP.

Clinical diagnostic value of serum allergen,IL-6 and CRP levels in patients with acute urticaria

WANG Kehui, HUANG Yun, ZHANG Zhengyin, WANG Yating, XUE Yuqin, CAI Sufang, FAN Chao, JIN Ying, ZHENG Yijing, CHANG Jinfeng

2021, 36(3):  300-303.  DOI: 10.3969/j.issn.1673-8640.2021.03.014

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Objective To investigate the diagnostic value of serum total immunoglobulin E（IgE） antibody,allergen specific immunoglobulin E（sIgE） antibody,interleukin（IL）-6 and C-reactive protein（CRP） levels in patients with acute urticaria. Methodsb From June 2018 to December 2019,75 patients with urticarial treated in our hospital were selected as study group,and 75 healthy persons were selected as control group. The diagnostic value of total IgE antibody,sIgE antibody,CRP and IL-6 in acute urticarial were compared between the two groups. Results The positive rate of serum total IgE antibody in the study group was significantly higher than that in the control group（P<0.05）. The positive rate of sIgE antibody was significantly higher than that of the total IgE antibody in the study group（P<0.05）. The serum CRP and IL-6 levels of the study group were significantly higher than those of the control group（P<0.05）. The level of serum IL-6 in the study group was correlated with the level of total IgE antibody（r=0.595,P<0.05）. Conclusion The combined detection and comprehensive evaluation of serum total IgE,sIgE,CRP and IL-6 have clinical value for early screening and diagnosis of acute urticaria.

Clinical value of combined detection of RBP,CRP and UMA in patients with chronic renal disease and ischemic cerebrovascular disease

WU Huiwen, LI Luoping, XING Xiaozhong, WAN Dayong

2021, 36(3):  304-308.  DOI: 10.3969/j.issn.1673-8640.2021.03.015

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Objective To investigate the clinical value of serum retinol binding protein（RBP）,serum C-reactive protein（CRP） and urinary microalbumin（UMA） in the diagnosis of ischemic cerebrovascular disease in patients with chronic kidney disease. Methods A total of 124 patients with chronic kidney disease and ischemic cerebrovascular disease were selected as observation group,and 124 healthy volunteers were selected as control group. The sensitivity of RBP,CRP and UMA and their combined detection to this disease were analyzed. Logistic regression analysis was used to assess the risk factors for poor prognosis. Results The RBP,CRP and UMA levels of the observation group were significantly higher than those of the control group（P<0.05）. In the observation group,the sensitivity of combined test（94.35%）was higher than that of single test of RBP,CRP and UMA（P<0.05）. Multivariate Logistic regression analysis showed that RBP,CRP and UMA were independent risk factors for poor prognosis（odds ratios were 1.417,1.851 and 1.273,all P<0.05）. Conclusion Combined detection of CRP,RBP and UMA can improve the sensitivity and accuracy of diagnosis in patients with chronic kidney disease and ischemic cerebrovascular disease. Serum CRP,RBP and UMA are independent risk factors for poor prognosis.

Application of Raman spectroscopy in the diagnosis of gestational diabetes mellitus

ZHOU Lifang, PAN Shun, TANG Zhenhua

2021, 36(3):  313-317.  DOI: 10.3969/j.issn.1673-8640.2021.03.017

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Objective To investigate the role of Raman spectroscopy in gestational diabetes mellitus（GDM）. Methods A total of 29 non-pregnant healthy subjects,29 pregnant healthy subjects and 42 GDM patients were enrolled. Meanwhile,78 GDM patients and 70 healthy subjects were enrolled for verification. Orthogonal partial least square regression（OPLS）,principal component analysis（PCA） based method support vector machine（SVM） and latent dirichlet allocation（LDA） were used to classify Raman spectra obtained. Receiver operating characteristic（ROC）curve was used to evaluate the classification ability of the 3 models,and the optimal model was selected. The new method was compared with oral glucose tolerance test（OGTT）. Results Raman peaks appeared at 1 005.86,1 034.47,1 087.64 and 1 128.39 cm^-1 in the GDM group,non-pregnant healthy group and pregnant healthy group,respectively. The Roman peaks in the GDM group at 1 005.86,1 034.47,1 128.39 and 1 343.69 cm^-1 were significantly different from that in non-pregnant healthy group and pregnant healthy group. OPLS model had a good ability to distinguish GDM,non-pregnant healthy and pregnant healthy groups. The sensitivity and accuracy of OPLS model to distinguish GDM by Raman spectroscopy were 97.43% and 95.27%,respectively,which were higher than OGTT（91.03% and 93.92%）. However,the specificity of OPLS was lower than that of OGTT（92.86% vs 97.14%）. Conclusions Raman spectroscopy combined with OPLS model has high sensitivity,specificity and accuracy,It may be used for rapid screening of GDM.

Microarray chemiluminescence immunoassay for quantitative detection of cardiac troponin I autoantibodies and preliminary clinical applications

HE Chengshan, YAO Xiaoyang, JIANG Xiudi, LU Zhicheng

2021, 36(3):  318-324.  DOI: 10.3969/j.issn.1673-8640.2021.03.018

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Objective To establish a microarray chemiluminescence immunoassay for the quantitative detection of cardiac troponin I autoantibody（cTnIAAb） based on microarray protein chip technology,and to evaluate the detection performance of this method. Methods The cardiac troponin I（cTnI）-C fusion protein was used as the detection antigen. The antigen spotting concentration,blocking solution,blocking time and secondary antibody were screened. The maximum signal-to-noise ratio of the detection results was taken as optimum condition. Taking the 95 th percentile of cTnIAAb gray value of 100 healthy subjects as the critical value,the standard curve of cTnIAAb detection was established. The detection performance（stability,precision,minimum detection limit,linear range,etc.） of microarray chemiluminescence immunoassay was evaluated. This method was used to detect cTnIAAb in 500 acute coronary syndrome（ACS）samples with serum cTnI> 0.1ng/mL. Western blotting was used to verify the specificity of microarray chemiluminescence immunoassay for cTnIAAb detection. Results The optimal experimental conditions were as follows：the concentration of antigen spot sample was 50 μg/mL,the blocking solution was 2% human milk,the optimal blocking time was 12 h,and the secondary antibody was horseradish peroxidase（HRP）-sheep anti-human IgG antibody. The precision of microarray chemiluminescence immunoassay for detecting high and low values of cTnIAb was good,with CV<15%. The limits of blank（LoB） and detection（LoD） were 0.12 and 0.23 AU/mL,respectively. The linear range was 0.23-815.00 AU/mL. Western blotting showed that specific bands were found in both cTnIAAb positive samples and positive controls with relative molecular weights of 40 000-55 000. The positive rate of cTnIAb in ACS group was 8.4%（42/500）,which was significantly higher than 2%（2/100） in normal control group（χ ²=5.023,P<0.05）. However,there was no statistical significance in serum cTnIAAb concentration between the 2 groups（P>0.05）. Spearman correlation analysis showed that there was no correlation between cTnIAAb and cTnI in ACS group（r ²=0.1,P>0.05）. Conclusions The self-developed microarray chemiluminescence immunoassay has a good performance for quantitative detection of cTnIAAb,which can provide a good methodological basis for clinical application of cTnIAAb.

Germline mutation detection in early-stage breast cancer by next-generation sequencing

YUAN Muge, WU Wenjian, HU Zhaohui, CHEN Jiachang, YU Shihui, OU Xiaohua, MAO Linlin, WU Haiyan

2021, 36(3):  325-329.  DOI: 10.3969/j.issn.1673-8640.2021.03.019

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Objective To explore germline mutations of early-stage breast cancer patients by next-generation sequencing and its correlation with clinicopathological features. Methods Ninety-nine female patients with early-stage breast cancer were selected and 21 breast cancer susceptible genes were sequenced by next-generation sequencing technology. The detected mutation sites were screened and classified,and statistical analysis was performed with clinical pathological characteristics. Results A total of 55 mutation sites in 18 genes were detected in 48 patients,including 45 missense mutations,1 nonsense mutation,8 indel mutations,and 1 splice mutation. The most mutated was the BRCA gene,and 10 mutation sites were detected. Of the 55 mutations,9（16.4%）were pathogenic mutations,4（7.3%）were harmless mutations,and 42（76.3%） were unknown mutations. The 15 newly discovered mutation sites in this study were not mentioned in the ExAC,ClinVar,dbSNP,and HGMD databases. Pathogenic germline mutations were statistically significant in different age groups（P=0.044）and different Ki67 statuses（P=0.024）. Pathogenic mutations were more likely to occur in patients aged more than 40 years and in Ki67-positive patients. Conclusions The next-generation sequencing is of great significance for screening breast cancer susceptible genes,which lays certain theoretical and experimental basis for individualized treatment.

Analysis of quality management of medical laboratory in Shanghai medical institutions

JIANG Lingli, ZHU Jun, YANG Xue, LOU Jiao, WANG Qing

2021, 36(3):  332-336.  DOI: 10.3969/j.issn.1673-8640.2021.03.021

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Objective To analyze the current situation of laboratory quality management according to the on-site supervision of laboratories in different types of medical institutions in Shanghai in 2019. Methods According to the quality management standard of clinical laboratory in Shanghai medical institutions,the quality management of laboratory was evaluated by on-site inspection in 289 laboratories and the results were summarized. Results The median score was 89 in the 289 laboratories,and 98 in 37 laboratories approved by ISO 15189. The excellent rate of the laboratory of the third level hospital,second level hospital,first level hospital,medical laboratory and nongovernmental hospital were 70.0%（35/50）,23.4%（18/77）,0%（0/80）,47.8%（22/46） and 16.7%（6/36）;the unqualified rate was 0%（0/50）,7.8%（6/77）,17.5%（14/80）,2.2%（1/46） and 19.4%（7/36）,respectively. “5.6 ensuring quality of examination results” was listed in the top three terms of the frequency of non-conformity in different types of medical institutions. The other non-conformity terms are not identical,including “4.2 quality management system”“4.5 examination by referral laboratories”“4.14 evaluation and audits”“5.1 personnel”“5.3 laboratory equipments,reagents and consumables”. Conclusions The quality management of laboratories approved by ISO 15189 is better than that of non-accredited laboratories. The overall quality management of laboratories in the third level hospitals is better than that in other medical institutions. There is different frequency of noncompliance in varied medical institutions.

Research progress of antibody-dependent enhancement of human coronaviruses

YUAN Mengjiao, YU Qian, WANG Beili, PAN Baishen, GUO Wei

2021, 36(3):  341-346.  DOI: 10.3969/j.issn.1673-8640.2021.03.023

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Antibody-dependent enhancement（ADE） of viral entry has been a major concern for epidemiology,vaccine development and antibody-based drug therapy. ADE of coronavirus replication is believed to occur when antibodies mediate coronavirus to bind to its viral receptor or Fc receptor（FcR） to enhance viral infection in some certain cases. ADE is regulated by a series of complex factors of the virus and the host,such as the structure of spike protein,the affinity with receptor and the titer of antibody of coronavirus. In this review,the present advances of ADE in human coronaviruses were discussed to provide reference for the subsequent vaccine design,antibody-related drugs,and immunotherapy.

Role of lipids in membrane fusion of human coronavirus

ZHANG Huijie, DONG Hairong

2021, 36(3):  347-351.  DOI: 10.3969/j.issn.1673-8640.2021.03.024

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Coronavirus is a kind of positive single stranded RNA virus. It is proven that 7 coronaviruses can infect human beings,including human coronavirus 229E（HCoV-229E）,middle east respiratory syndrome-related coronavirus（MERSr-CoV）,severe acute respiratory syndrome-related coronavirus（SARSr-CoV）,human coronavirus OC43,human coronavirus HKU1,human coronavirus NL63 and severe acute respiratory syndrome coronavirus 2（SARS-CoV-2）. Lipids are closely related to human pathogenic coronavirus infection,such as phospholipids,fatty acids and cholesterol. This article reviews the role of lipids and lipid related regulatory enzymes in coronavirus infection.

Key points for the nucleic acid detection of SARS-CoV-2

DIAO Yanjun, YANG Liu, SU Mingquan, HAO Xiaoke, LIU Jiayun

2021, 36(3):  352-356.  DOI: 10.3969/j.issn.1673-8640.2021.03.025

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Severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) can cause corona virus disease 2019（COVID-19）and has become a global pandemic. As direct diagnostic evidence of COVID-19,nucleic acid detection based on reverse transcription-polymerase chain reaction（RT-PCR）has become a hot technique and has been pushed to the forefront of virus prevention and control. However,problems such as high false-negative rate and retest positive rate gradually appear along with the cognition of nucleic acid detection. This review focuses on the biological characteristics of SARS-CoV-2 and the principle,significance,condition,protection and result interpretation of the nucleic acid detection. Furthermore,it also supplies explanations for the false-negative and retest positive problems.