Table of Content

30 December 2022, Volume 37 Issue 12

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Exploration and practice of regional medical laboratory center model

BAI Jianhua, ZENG Xianfei, HAO Xiaoke

2022, 37(12):  1109-1112.  DOI: 10.3969/j.issn.1673-8640.2022.12.001

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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.

Investigation and practice of smart internet inspection in regional medical laboratory center

KAN Lijuan, LI Jingli, CHEN Dayang, HAN Xinyuan, WANG Zhihong, CAI Qinquan, WEN Qilin, LIU Zhenyu, LI Ming, ZHANG Xiuming

2022, 37(12):  1113-1117.  DOI: 10.3969/j.issn.1673-8640.2022.12.002

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Objective To investigate the application efficiency of the workflow of smart internet inspection in improving regional medical laboratory center. Methods A number of internet information technologies were used to develop a smart internet inspection platform，through which the regional internet inspection items can be seamlessly connected with hospital information system（HIS）data. The regional internet inspection business volume and patient satisfaction survey results were analyzed statistically. The actual application efficiency of smart internet inspection was evaluated. Results According to the needs or disease status，customers（clinicians，patients and residents） can apply for self-service inspection，interpretation of inspection report and internet online diagnosis and treatment through different paths at the internet hospital and internet inspection platform，online real name authentication，self-service payment and sampling nearby in the area. Internet+nursing provided door-to-door sampling services. The inspection specimens were transported by special specimen transport vehicles and unmanned aircrafts. It supported mobile phone text messages，hospital and regional inspection center WeChat official accounts，Health Luohu APP and other platforms to check inspection reports online，and provided online intelligent consultation，regional internet diagnosis and treatment services. The platform had operated for 16 months from November 2020 to February 2022，and the inspection business volume had reached 469 453 person times，including 427 973 person times of severe acute respiratory syndrome coronavirus 2 nucleic acid determination，accounting for 99.2% of the total inspection business volume. In the satisfaction survey of 42 public tertiary medical institutions in Shenzhen 2021，Shenzhen Luohu People's Hospital ranked the third，and the inspection business volume，business income and patient satisfaction continued to rise steadily. Conclusions The internet inspection combined with regional medical laboratory center is an important way to reduce patients' waiting time for diagnosis and treatment，reduce costs and increase efficiency，and better carry out disease intervention and health management.

New development of regional medical laboratory centers in post-pandemic era

CHEN Hongwei, GUO Haitao, HOU Yanqiang

2022, 37(12):  1118-1121.  DOI: 10.3969/j.issn.1673-8640.2022.12.003

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Regional medical laboratory center is a new model to optimize the allocation of medical resources，and its development is in line with Chinese policy of strengthening grass-roots and grading diagnosis and treatment. In the practice of prevention and control of corona virus disease 2019，regional medical laboratory center has shown many advantages and plays a role，which has been widely recognized by government and society. In post-epidemic era，the construction of regional medical laboratory center has ushered in new development opportunities. It is mainly reflected in the further clarification and strengthening of government support，the creation of a new form of inspection by "cloud inspection" and "taobao inspection" service，the acceleration of mutual recognition of medical inspection results，the development of centralized medical inspection，the opening of a new era of unmanned artifact logistics for regional medical laboratory center and the high-quality development of regional medical laboratory center supported by intelligent inspection. Based on the in-depth progress of the new medical reform，the improvement of social demand and recognition，as well as the rapid development of internet medicine，regional medical laboratory center will advance higher，faster，stronger and more intelligent.

Analysis on the results of external quality assessment of mutual recognition quantitative items in Shanghai

YANG Xue, JU Yi, OU Yuanzhu, ZHU Yuqing, XU Chong, JIANG Lingli, WANG Qing, ZHOU Jing

2022, 37(12):  1129-1134.  DOI: 10.3969/j.issn.1673-8640.2022.12.006

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Objective To analyze the performance of mutual recognition quantitative items in Shanghai，in order to promote the mutual recognition of determination results in medical institutions. Methods The results of 58 mutual recognition quantitative items of clinical laboratories in Shanghai Center for Clinical Laboratory（SCCL） from the second External Quality Assessment（EQA） in 2020 were selected to calculate the EQA scores and the sigma（σ） metrics from allowable total error（TEa） sources. Results A total of 802 clinical laboratories of medical institutions reported the results of 58 mutual recognition quantitative items. EQA pass rates ranged from 92.59%（antithrombin） to 100.00%（18 items）. The failed rates of medical institutions were 32.54% in public hospitals and 67.46% in non-medical institution clinical laboratories. Taking the value of TEa from SCCL，39（67.24%）items had a σ metrics >3. Taking the maximum value of TEa，51（87.93%） items had a σ metrics >3，and 14（24.14%） items had a σ metrics >6. Taking the minimum value of TEa，12（20.69%）items had a σ metrics >3. Conclusions The mutual recognition quantitative items in Shanghai have good consistency among clinical laboratories. However，there are differences in determination results between clinical laboratories in different medical institutions for some items，which should be paid attention to.

Relationship between oxidative stress markers with prostatic hyperplasia and prostate cancer

WANG Linlin, XU Lili, FAN Jun, QIAN Yu

2022, 37(12):  1135-1140.  DOI: 10.3969/j.issn.1673-8640.2022.12.007

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Objective To investigate the relationship between oxidative stress markers of peripheral blood oxidative stress markers [glutathione peroxidase（GPX），superoxide dismutase（SOD），total antioxidant status（TAS），malondialdehyde（MDA） and glutathione reductase（GR）] with prostatic hyperplasia and prostate cancer. Methods A total of 222 patients with prostatic hyperplasia，136 patients with prostate cancer and 194 healthy subjects were enrolled. The levels of GPX，SOD，GR，TAS and MDA were determined. According to Gleason score，prostate cancer patients were classified into 6-7，8 and 9-10 groups. Binary Logistic regression analysis was used to evaluate the relationship between oxidative stress markers with prostatic hyperplasia and prostate cancer. Results The levels of SOD and TAS in healthy control group，prostatic hyperplasia group and prostate cancer group，were decreased successively（P<0.001），and MDA levels were increased（P<0.001）. There was no statistical significance in GPX and GR levels among the 3 groups（P>0.05）. For Gleason score 6-7，8 and 9-10 groups，SOD and TAS levels were decreased（P<0.001）. There was no statistical significance in the levels of GPX，GR and MDA among the 3 groups（P>0.05）. Binary Logistic regression analysis showed that with the healthy control group as a reference，and after adjusting for age，body mass index，smoking history，alcohol history，hypertension history and diabetes mellitus history，SOD decreasing，TAS decreasing and MDA increasing were independent risk factors for prostatic hyperplasia [odds ratios（OR）were 1.014，8.117 and 1.020] and prostate cancer （OR were 1.054，22.894 and 1.256，respectively）. With the prostatic hyperplasia group as a reference，after adjusting for age，body mass index，smoking history，alcohol history，hypertension history and diabetes mellitus history，SOD decreasing，TAS decreasing and MDA increasing were independent risk factors for prostate cancer（OR were 1.040，15.577 and 1.012，respectively）. Conclusions The decrease of SOD and TAS levels and the increase of MDA levels may be related to the occurrence of prostatic hyperplasia and prostate cancer，suggesting that oxidative stress disorder plays a role in the occurrence and development of prostatic hyperplasia and prostate cancer.

Predictive values of Lp（a） and apoB/apoA-1 ratio for the occurrence of MACE in patients with AMI after interventional therapy

ZHENG Jiahua, YAO Yanying, GAO Qingling, DONG Ye

2022, 37(12):  1141-1145.  DOI: 10.3969/j.issn.1673-8640.2022.12.008

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Objective To investigate the predictive values of lipoprotein（a） [Lp（a）] and apolipoprotein B（apo B）/apolipoprotein A-1（apo A-1） ratio for the occurrence of major adverse cardiovascular event（MACE） in patients with acute myocardial infarction（AMI） after interventional therapy. Methods A total of 200 patients with AMI undergoing interventional therapy were enrolled. According to the occurrence of MACE for 6 months after interventional therapy，they were classified into MACE group（47 cases） and non-MACE group（153 cases）. Baseline data and clinical laboratory results were collected，and Lp（a），apo B and apo A-1 were determined. Pearson correlation analysis was used to analyze the correlation between Lp（a），apo B/apo A-1 ratio and amino-terminal pro-B-type natriuretic peptide（NT-proBNP），left ventricular ejection fraction（LVEF） and low-density lipoprotein cholesterol（LDL-C）. Cox regression analysis was used to analyze the influencing factors of MACE in AMI patients after interventional therapy. Receiver operating characteristic（ROC） curve analysis was used to evaluate the predictive value of Lp（a） and apo B/apo A-1 ratio combined determination for the occurrence of MACE after interventional therapy. Results Lp（a） and apo B/apo A-1 ratio in MACE group were higher than those in non-MACE group（P<0.05）. The results of Pearson correlation analysis showed that Lp（a） and apo B/apo A-1 ratio were positively correlated with NT-proBNP and LDL-C（P<0.05），and they were negatively correlated with LVEF（P<0.05）. Cox regression analysis showed that Lp（a） and apo B/apo A-1 ratio were the influencing factors of MACE [hazard ratios（HR） were 2.347 and 2.476，95% confidence intervals（CI） were 1.459-3.774 and 1.561-3.928，respectively]. The results of ROC curve analysis showed that the areas under curves（AUC） of Lp（a），apo B/apo A-1 ratio single determinations and combined determination for the occurrence of MACE in AMI patients after interventional therapy were 0.798，0.821 and 0.898，respectively. Conclusions The high levels of Lp（a） and apo B/apo A-1 ratio are independent risk factors for MACE in AMI patients after interventional therapy. The combined determination has a high predictive value for the prognosis of interventional therapy in AMI patients.

Roles of PTH，CRP，OPG/PYR ratio in elderly patients with osteoporosis

YAO Hualong

2022, 37(12):  1146-1150.  DOI: 10.3969/j.issn.1673-8640.2022.12.009

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Objective To investigate the roles of parathyroid hormone（PTH），C-reactive protein（CRP），osteoprotegerin（OPG）/pyridinoline（PYR） ratio in elderly patients with osteoporosis（OP）. Methods Totally，137 patients with suspected OP were enrolled and classified into OP group（32 cases） and non-OP group（105 cases） according to the presence or absence of OP. The clinical data were collected，and lumbar spine and femoral neck bone mineral densities（BMD），serum PTH，CRP and OPG levels and urinary PYR levels were determined. OPG/PYR ratio was calculated. Pearson correlation analysis and partial correlation analysis were used to analyze the relationship between each index and lumbar spine and femoral neck BMD. Receiver operating characteristic（ROC） curve was used to analyze the efficiency of OP. Results The proportion of diabetes mellitus and serum PTH and CRP levels were higher in OP group than those in non-OP group（P<0.05），and lumbar spine BMD，femoral neck BMD and OPG/PYR ratio were lower than those in non-OP group（P<0.05）. Between the 2 groups，age，sex，body mass index，the proportion of alcohol consumption history，the proportion of smoking history，the proportion of hyperlipoidemia，the proportion of coronary heart disease and the proportion of hypertension had no statistical significance（P>0.05）. Pearson correlation analysis showed that PTH and CRP were negatively correlated with lumbar spine BMD and femoral neck BMD（P<0.05），and the OPG/PYR ratio was positively correlated with lumbar spine BMD and femoral neck BMD（P<0.05）. The results of partial correlation analysis showed that PTH，CRP and OPG/PYR ratio were correlated with lumbar spine BMD and femoral neck BMD after controlling for the factor of diabetes mellitus（P<0.05）. The results of ROC curve analysis showed that the areas under curves（AUC） of PTH，CRP and OPG/PYR ratio single and combined determinations to diagnose OP were 0.856，0.826，0.861 and 0.912，respectively. Conclusions PTH，CRP，OPG/PYR ratio are correlated to OP，which can be used in the auxiliary diagnosis and disease monitoring of OP.

Roles of haptoglobin and ferritin in the prognostic assessment of colon cancer patients with liver metastasis

DENG Jie, DENG Min

2022, 37(12):  1151-1156.  DOI: 10.3969/j.issn.1673-8640.2022.12.010

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Objective To investigate the roles of haptoglobin and ferritin in the prognostic assessment of colon cancer patients with liver metastasis. Methods A total of 101 colon cancer patients with liver metastasis were enrolled. The clinical and laboratory data were collected. Haptoglobin and ferritin levels were determined. The patients were followed-up with an endpoint of all-cause mortality. Receiver operating characteristic（ROC） curve was used to determine the efficiency of each indicator. Kaplan-Meier survival curve analysis was used to assess survival status. Cox proportional hazard model was used to determine the independent risk factors for all-cause mortality in colon cancer patients with liver metastasis. Results The areas under curves（AUC） of haptoglobin and ferritin was 0.77 and 0.83，respectively，which were increased to 0.87 when both indicators were used in combination. The optimal cut-off values of haptoglobin and ferritin were 1.37 g/L and 217.1 μg/L，respectively. C-reactive protein （CRP），carcinoembryonic antigen （CEA） and aspartate aminotransferase （AST）in haptoglobin>1.37 g/L group were higher than those in haptoglobin≤1.37 g/L group（P<0.05），and the other indicators had no statistical significance （P>0.05）. Age，CEA，alanine aminotransferase （ALT），AST and total bilirubin （TB） in ferritin>217.1 μg/L group were higher than those in ferritin≤217.1 μg/L group，albumin （Alb） was lower（P<0.05），and the other indicators had no statistical significance （P>0.05）. Kaplan-Meier survival curve analysis showed that the median survival in patients with haptoglobin≤1.37 g/L（19 months）was longer than that with haptoglobin >1.37 g/L（10 months，P<0.001）. The median survival in those with ferritin ≤217.1 μg/L（21 months）was longer than those with ferritin >217.1 μg/L（10 months，P<0.001）. Multivariate Cox regression model showed that the Eastern Cooperative Oncology Group（ECOG） score，CRP，albumin，haptoglobin and ferritin were independent risk factors for all-cause mortality in colon cancer patients with liver metastasis [hazard ratios（HR） were 1.99，2.12，1.38，1.76 and 1.70，95% confidence intervals（CI） were 1.38-10.64，1.20-3.72，1.08-2.03，1.14-3.29 and 1.07-2.94，respectively]. Conclusions Haptoglobin and ferritin are helpful for the prognostic assessment of colon cancer patients with liver metastasis.

Roles of serum amino acid determinations in the diagnosis of early non-small-cell lung cancer

XU Runhao, ZOU Chen, CAO Yun, CHEN Feng, LIU Yijing, ZHANG Shulin, ZHANG Jie

2022, 37(12):  1157-1163.  DOI: 10.3969/j.issn.1673-8640.2022.12.011

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Objective To investigate the roles of serum amino acid determinations in the auxiliary diagnosis of early non-small cell lung cancer（NSCLC）. Methods Totally，14 serum amino acids of 64 patients with early NSCLC（early NSCLC group），55 patients with advanced NSCLC（advanced NSCLC group），65 patients with benign pulmonary disease（benign pulmonary disease group） and 80 healthy subjects（healthy control group） were determined by liquid chromatography-tandem mass spectrometry（LC-MS/MS），and serum amino acids included alanine（Ala），glycine（Gly），leucine（Leu），proline（Pro），phenylalanine（Phe），valine（Val），methionine（Met），tyrosine（Tyr），glutamic acid（Glu），arginine（Arg），histidine（His），lysine（Lys），citrulline（Cit） and ornithine（Orn）. Carbohydrate antigen（CA） 19-9，carcinoembryonic antigen（CEA），cytokeratin 19 fragment（CYFRA 21-1） and squamous cell carcinoma antigen（SCC-Ag） were determined simultaneously. The stepwise binary Logistic regression analysis was used to fit the best diagnostic combination of various indexes. Receiver operating characteristic（ROC） curve was used to evaluate the diagnostic efficacy of single and combined determinations. Results The levels of serum His and Lys in early NSCLC group were lower than those in healthy control group（P<0.05），and the levels of serum Ala，Glu，Pro，Val，Cit，Orn，CA 19-9，CEA and CYFRA 21-1 in early NSCLC group were higher than those in healthy control group（P<0.05）. The levels of serum Ala，Glu，His，Leu，Lys，Pro，Val，Cit，Orn，CA 19-9 and CYFRA 21-1 in early NSCLC group were higher than those in benign pulmonary disease group（P<0.05）. The levels of serum Ala，Glu，Leu，Lys and Val in advanced NSCLC group were lower than those in early NSCLC group（P<0.05）. There was no statistical significance in the levels of serum SCC-Ag among all the groups（P>0.05）. Cit had the best performance in diagnosing early NSCLC，and the area under curve（AUC） was 0.709. The best combination of all the indexes in diagnosing early NSCLC was Glu+Val+Cit+CYFRA 21-1，and the AUC was 0.808. Conclusions The changes of serum aminogram are related to the occurrence and development of NSCLC. The model composed of Glu，Val，Cit and CYFRA 21-1 is potential in the auxiliary diagnosis of early NSCLC.

Predictive values of red blood cell distribution width and myocardial markers for acute myocardial infarction in patients with CAS

MA Jianguo, ZHU Xiaolin, DING Yongguang, YIN Meng, LI Hongchun

2022, 37(12):  1164-1168.  DOI: 10.3969/j.issn.1673-8640.2022.12.012

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Objective To investigate the predictive values of red blood cell distribution width（RDW） for acute myocardial infarction（AMI） in patients with coronary atherosclerosis（CAS）. Methods Totally，600 patients with CAS were enrolled. The clinical data of all the patients were collected，and RDW，cardiac troponin I（cTnI），creatine kinase MB isoenzyme（CK-MB） and lipid levels were determined. All the patients were followed up for 5 years，and the end points were AMI，death or the completion of follow-up. Receiver operating characteristic（ROC） curve was used to evaluate the value of each indicator in determining the occurrence of AMI in CAS patients. Kaplan-Meier survival curve analysis was used to analyze the differences in the occurrence of AMI among all the groups，and Cox regression analysis was used to evaluate the risk factors of AMI in CAS patients. Results Follow-up was completed in 450 of 600 CAS patients，32 of whom developed AMI. The areas under curves（AUC） of RDW，CK-MB and cTnI single and combined determination for AMI in CAS patients were 0.747，0.722，0.714 and 0.774，respectively. All the CAS patients were classified into RDW≥13.8% and RDW<13.8% according to the optimal cut-off value of RDW obtained by ROC curve. The age，CK-MB，cTnI and the occurrence of AMI in RDW≥13.8% group were higher than those in RDW<13.8% group（P<0.001）. There was no statistical significance in the other clinical data and blood lipids between the 2 groups（P>0.05）. Kaplan-Meier survival curve analysis results showed that the occurrence of AMI in RDW≥13.8% group was higher than that in RDW<13.8% group（P<0.001）. Multivariate Cox regression analysis showed that elevated RDW was an independent risk factor for AMI in CAS patients after adjusting for age，sex，body mass index，smoking history，alcohol consumption history and diabetes mellitus history [hazard ratio（HR）=1.727，95% confidence interval（CI） 1.492-1.998]. Conclusions RDW has clinical value in predicting the occurrence of AMI in patients with CAS，and the combination of CK-MB and cTnI may improve the predictive efficiency of the occurrence of AMI in patients with CAS.

Interference of high levels of bilirubin on lymphocyte subset determination in peripheral blood by flow cytometry and its elimination methods

XUE Yan, XU Li, DANG Liheng, WANG Chao, CUI Yaqiong, WANG Ping, WANG Ning, ZHANG Xinjie, LIU Yang

2022, 37(12):  1169-1173.  DOI: 10.3969/j.issn.1673-8640.2022.12.013

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Objective To investigate the interference of high levels of bilirubin on lymphocyte subset determination in peripheral blood by flow cytometry（FCM） and its elimination methods. Methods Totally，51 patients with serum total bilirubin（TB） >200 μmol/L and undergoing lymphocyte subset determination were enrolled，which included 6 cases of elevated direct bilirubin（DBil）（DBil group） and 45 cases of elevated indirect bilirubin（IBil）（IBil group）. The non-jaundiced samples from 6 healthy children（control samples）were collected，and plasmas with high DBil were added to the control samples to prepare for interference samples. Paired difference experiments were used to analyze the interference of bilirubin on lymphocyte subsets determined by FCM and to assess the dose of bilirubin interference. The effects of washing-staining-lysis method and staining-lysis-washing method on bilirubin interference elimination were assessed. Results In elevated IBil group，lymphocyte subset determination was not interfered. But in elevated DBil group，the fluorescence expressions of fluorescein isothiocyanate（FITC）-labeled CD3^- cells and CD3⁺ cells were not clearly demarcated. For interference samples treated by staining-lysis method，the fluorescence expressions of FITC-labeled CD3^- cells and CD3⁺ cells were also not clearly demarcated. When DBil≤150 μmol/L，no effect on FCM was found. When DBil≥200 μmol/L，the interference was greater. Such interference could be eliminated to the greatest extent by both washing-staining-lysis method and staining-lysis-washing method. Staining-lysis-washing method was more operable，and no significant difference was found in lymphocyte subsets between interference samples and control samples（P>0.05），and the percentages of CD3⁺，CD3⁺CD8⁺，CD3⁺CD4⁺，CD3^-CD16/56⁺，CD3^-CD19⁺ cells and CD4/CD8 ratios between the 2 samples were positively correlated（r=0.977，0.994，0.950，0.941，0.996 and 0.965，P<0.05）. Conclusions High level of DBil can interfere with the fluorescence expressions of FITC-labeled CD3^- cells and CD3⁺ cells in lymphocyte subset determination in peripheral blood by FCM. Staining-lysis-washing method can eliminate such interference to the greatest extent.

Influence of heat inactivation of blood samples at 56 ℃ for 30 min on psychiatric drug concentration monitoring

SUN Jiaqi, JIN Weifeng, LI Ping, CHEN Shuzi, LIN Ping, LI Dan, CHEN Qing, WANG Mengxia, ZHU Yuxin

2022, 37(12):  1174-1177.  DOI: 10.3969/j.issn.1673-8640.2022.12.014

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Objective To investigate the influence of heat inactivation of blood samples at 56 ℃ for 30 min on psychiatric drug concentration monitoring. Methods A total of 60 patients taking olanzapine，quetiapine，risperidone，lithium，valproic acid and clozapine were enrolled. The remaining blood samples were inactivated by heating at 56 ℃ for 30 min and then were determined again. The consistency of the results before and after heat inactivation was analyzed. Result The differences in the results of olanzapine，quetiapine，the sum of risperidone and 9-hydroxyrisperidone，valproic acid，clozapine and N-desmethylclozapine before and after heat inactivation of the samples were not statistically significant（P>0.05），which showed high consistency. The results of blood lithium after heat inactivation were higher than those before heat inactivation（P<0.05），and the consistency was poor before and after heat inactivation. After the calibration by regression equation，the differences between the calibration values and the assay results before heat inactivation were not statistically significant （Z=-0.195，P=0.845），which showed high consistency. Conclusions Heat inactivation at 56 ℃ for 30 min has no effect on the assay results of olanzapine，quetiapine，the sum of risperidone and 9-hydroxyrisperidone，valproic acid，clozapine and N-desmethylclozapine，but it affects the assay results of blood lithium. Blood lithium results still have the reference value after they are corrected by the regression equation.

Establishment and performance evaluation of peripheral blood leukocyte classification reference method by flow cytometry

SONG Ying, HAN Jiaojiao, ZHAO Qiang, XU Chong

2022, 37(12):  1190-1195.  DOI: 10.3969/j.issn.1673-8640.2022.12.018

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Objective To establish the classification reference method of peripheral blood leukocytes by flow cytometry，and to verify the feasibility of its classification. Methods An 8-colour flow cytometry leukocyte counting protocol was established using a combination of CD16-Pacific Blue，CD45-V500，SYTO16，CD7-PE，CD123-PerCP-Cy5.5，CD14-PE-Cy7，CD3+CD19-APC and CD11b-APC-Cy7 antibodies. Peripheral blood samples were collected from 50 healthy subjects with ethylenediaminetetraacetic acid dipotassium anticoagulation，and leukocyte classification was performed by full-spectrum flow cytometry（flow method），fully automated hematology analyzer（instrument method） and microscopy（manual method）. Passing & Bablok regression was used to compare the determination results of the 3 methods for paired comparison. The manual method was used as a reference method to evaluate the consistency of the 3 methods of leukocyte classification methods. Results An 8-colour flow cytometry leukocyte counting protocol was established successfully. The linear probability values（P） of regression equations for the classification results of instrument method and flow method were >0.05. The slopes of the regression equations for neutrophil（NEUT），lymphocyte（LYMPH），monocyte（MONO），eosinophil （EOS）and basophil （BASO）of the 2 methods were 1.01，0.98，0.97，1.00 and 2.33，respectively，and the intercepts were -1.53，0.90，-0.11，0.01 and -0.23，respectively. The linear probability values（P） of regression equations for the classification results of manual method and instrument method were >0.05. The slopes of the regression equations for NEUT，LYMPH，MONO，EOS，and BASO of the manual method and flow method were 0.98，0.94，0.68，0.86 and 0.50，respectively，and the intercepts were -0.96，2.64，2.74，0.29 and 0.30，respectively. The slopes of the regression equations for NEUT，LYMPH，MONO，EOS，and BASO by the manual method and instrument method were 0.99，0.94，0.76，0.93 and 0.12，with the intercepts of -1.13，1.79，2.69，0.25 and 0.26，respectively. The slopes of the regression equations for NEUT，LYMPH，MONO，EOS，and BASO by the leukocyte classification was evaluated by the manual method of leukocyte classification，and the classification results of flow method and instrument method were within the confidence interval，but the flow method and the instrument method were evaluated as superior to the flow method and the manual method from the methodological comparison for correlation. Conclusions The 8-colour flow cytometry leukocyte classification method has been established. The flow method is correlated with the reference method，and the results are within the confidence interval of the reference method. The methodological agreement between the flow method and the instrument method is better than that of the reference method，and thus can further improve the accuracy of leukocyte classification in clinical routine blood tests.

Diagnostic value of cytogenetics in acute leukemia with MLL gene abnormality

SUN Hengjuan, DU Chengkan, LI Hong, LIU Min, ZHANG Hong

2022, 37(12):  1196-1199.  DOI: 10.3969/j.issn.1673-8640.2022.12.019

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Objective To investigate the roles of conventional cytogenetics（CC） and fluorescence in situ hybridization（FISH） in the diagnosis of mixed linage leukemia（MLL） gene abnormality and chromosome 11q23 abnormality in childhood acute leukemia（AL）. Methods Totally，404 AL children were enrolled from the Children's Hospital of Shanghai from June 2016 to June 2021. The cytogenetic analysis was performed by CC and FISH. The determination rates for MLL gene abnormality were compared between the 2 methods. Results There were 404 AL children. The 57 cases of abnormal MLL gene（14.1%） were determined by FISH，which included 40 cases of acute lymphoblastic leukemia（ALL），and there were 23 cases of abnormal MLL gene signal number and 17 cases of MLL rearrangement. There were 17 cases of acute myeloid leukemia（AML），and 2 cases had abnormal MLL gene signal number and 15 cases of MLL rearrangement. Chromosomal abnormalities of MLL gene were determined in 27 cases（6.7%），there were 15 cases of ALL，and MLL rearrangement partner gene was identified in 13 cases. There were 12 cases of AML，and MLL rearrangement partner gene was identified in 11 cases. Conclusions The abnormal rate of MLL gene determined by FISH is higher than that by CC. CC can intuitively present the abnormal types of MLL rearrangement and identify its partner genes. The 2 determination methods play roles in the diagnosis of MLL gene abnormality in AL.

Performance evaluation of glycerol as stabilizer for the preparation of seminal plasma biochemical quality control products

ZHANG Chen, LI Ting, MENG Qinghao, XIE Nan, ZHANG Weimin, ZHAO Fei, LI Min, GAO Xuan, YANG Sijie

2022, 37(12):  1200-1203.  DOI: 10.3969/j.issn.1673-8640.2022.12.020

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Objective To evaluate the performance of seminal plasma biochemical quality control products prepared with glycerol as stabilizer，in order to determine a high quality seminal plasma biochemical quality control product preparation method. Methods Group A used glycerol as stabilizer to prepare seminal plasma biochemical quality control products，and group B used seminal plasma biochemical quality control products directly into seminal plasma. The 2 groups were determined for fructose and neutral alpha-glucosidase，and the homogeneity and stability were evaluated. Daily quality control test and analysis were performed to compare the precisions of the 2 biochemical quality control products. The 2 biochemical quality control products were determined daily，and the precisions of the 2 methods were compared. Results In the homogeneity evaluation test，the F values of seminal plasma fructose and neutral alpha-glucosidase of the 2 groups were <F_{critical value} [F_{0.05（9，10）}=3.02]. The homogeneity was good. In the stability evaluation test，the fructose of group A had t<t_{critical value} [t_0.05（5）=2.57] within 29 d after preparation，and the stability was good. The fructose of group B had t>2.57 at the 8th day. The stability was lower than that of group A. The neutral alpha-glucosidase of group A had t<2.57 within 85 d，and the stability was good. The neutral alpha-glucosidase of group B had t<2.57 within 29 d after preparation. The stability was lower than that of group A. The daily quality control results showed that the seminal plasma biochemical quality control results of the 2 groups（above 95%） were distributed within ±2s，and the coefficient of variation（CV） of the quality control data of the 2 items between the 2 groups was <10%. Conclusions The seminal plasma biochemical quality control product formulated with glycerol as stabilizer is more stable than seminal plasma stock solution，and it can be used as a stabilizer of seminal plasma biochemical quality control product.