Pub Date : 2020-03-11DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.03.024
Qingxiang Liu, Weiyan Zhou, Chuanbao Zhang
Catecholamines include dopamine, norepinephrine and epinephrine. The main metabolites are 3-methoxytyramine, normetanephrine, metanephrine,homovanillic acid and vanillylmandelic acid. Detection of catecholamines and their metabolites is the cornerstone for the diagnosis of neuroendocrine tumors derived from neural crest such as pheochromocytoma, paraganglioma and neuroblastoma. Liquid chromatography tandem mass spectrometry has been widely used in the detection of catecholamines and their metabolites due to its high sensitivity and high specificity. However, the results of liquid chromatography tandem mass spectrometry in different laboratories are quite different and lack comparability. Accurate determination of catecholamines and their mtabolites in plasma and urine is currently a challenge in the field of clinical detectionbecause of their susceptibility to oxidative degradation, presence of numerous interferences and low concentration in plasma and urine samples. Key words: Catecholamines; Neuroendocrine tumor; Chromatography, liquid; Tandem mass spectrometry
{"title":"Detection and standardization of catecholamines and their metabolites","authors":"Qingxiang Liu, Weiyan Zhou, Chuanbao Zhang","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.03.024","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.03.024","url":null,"abstract":"Catecholamines include dopamine, norepinephrine and epinephrine. The main metabolites are 3-methoxytyramine, normetanephrine, metanephrine,homovanillic acid and vanillylmandelic acid. Detection of catecholamines and their metabolites is the cornerstone for the diagnosis of neuroendocrine tumors derived from neural crest such as pheochromocytoma, paraganglioma and neuroblastoma. Liquid chromatography tandem mass spectrometry has been widely used in the detection of catecholamines and their metabolites due to its high sensitivity and high specificity. However, the results of liquid chromatography tandem mass spectrometry in different laboratories are quite different and lack comparability. Accurate determination of catecholamines and their mtabolites in plasma and urine is currently a challenge in the field of clinical detectionbecause of their susceptibility to oxidative degradation, presence of numerous interferences and low concentration in plasma and urine samples. \u0000 \u0000 \u0000Key words: \u0000Catecholamines; Neuroendocrine tumor; Chromatography, liquid; Tandem mass spectrometry","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"47 1","pages":"322-327"},"PeriodicalIF":0.0,"publicationDate":"2020-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84439243","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-11DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.03.005
Jin Li, Guangming Ye, Liangjun Chen, Jiajun Wang, Yirong Li
In December 2019, a cluster of patients with pneumonia of unknown cause were linked to a seafood wholesale market in Wuhan, China. Some studies found that the virus was a new kind of virus which had never been found in the human body. Then, the virus was named 2019 novel coronavirus (2019-nCoV) by the World Health Organization (WHO). 2019-nCoV nucleic acid detection is one of the essential indicators of COVID-19. Recently, some false-negative cases in China-Japan Friendship Hospital and Hangzhou Hospital led the clinical doctors to question the value of the nucleic acid detection. In this paper, more than 3 000 results of 2019-nCoV detection in Zhongnan Hospital, Wuhan University were analyzed. Attention should be paid to the root cause of false-negative results and the related countermeasures should be taken. Key words: Coronavirus; Nucleic acids; Polymerase chain reaction; False negative reactions; Quality control
{"title":"Causes and countermeasures of false-negative results for 2019 novel coronavirus nucleic acid test","authors":"Jin Li, Guangming Ye, Liangjun Chen, Jiajun Wang, Yirong Li","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.03.005","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.03.005","url":null,"abstract":"In December 2019, a cluster of patients with pneumonia of unknown cause were linked to a seafood wholesale market in Wuhan, China. Some studies found that the virus was a new kind of virus which had never been found in the human body. Then, the virus was named 2019 novel coronavirus (2019-nCoV) by the World Health Organization (WHO). 2019-nCoV nucleic acid detection is one of the essential indicators of COVID-19. Recently, some false-negative cases in China-Japan Friendship Hospital and Hangzhou Hospital led the clinical doctors to question the value of the nucleic acid detection. In this paper, more than 3 000 results of 2019-nCoV detection in Zhongnan Hospital, Wuhan University were analyzed. Attention should be paid to the root cause of false-negative results and the related countermeasures should be taken. \u0000 \u0000 \u0000Key words: \u0000Coronavirus; Nucleic acids; Polymerase chain reaction; False negative reactions; Quality control","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"54 1","pages":"221-225"},"PeriodicalIF":0.0,"publicationDate":"2020-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"90833420","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-11DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.03.016
Yang Chen, Kang-li Xiao, Ningjie Shi, Zhen-hai Cui, Jiaoyue Zhang, Hui-qing Li
Objective To evaluate the value of plasma aldosterone concentration (PAC)/renin concentration (PRC) ratio (ARR) combined with aldosterone, renin, and sodium/potassium ratio in the diagnosis of primary aldosteronism (PA). Methods From January 2017 to October 2019, 105 patients were admitted to our hospital and diagnosed as PA and essential hypertension (EH) by clinical manifestations, laboratory examination and surgical pathological biopsy.The optimum cut-off point of ARR, PRC, PAC, plasma sodium-potassium ratio were determined by the Receiver Operating Characteristic (ROC). The sensitivity, specificity and Youden index at the optimum cut-off point were calculated in a separate test. By means of diagnostic test, the best cut-off points of ARR were tested in series with the best cut-off points of PRC, PAC and serum sodium/potassium ratio, respectively, and their specificity were calculated. Results The area under the AUC of supine ARR was greater than that of vertical ARR (0.966 vs 0.946, Z= 1.380, P= 0.168), but there was no statistical difference. The optimum cut-off point of supine ARR was 28.64(pg/ml)/(pg/ml), with a sensitivity of 92.4% and specificity of 90.5%. The sensitivity of the combined PRC test was 79.0% and the specificity was 94.3%. The sensitivity of the combined PAC test was 65.7% and the specificity was 95.2%. The sensitivity of the combined serum sodium/potassium ratio was 50.5% and the specificity was 96.2%. The optimal cut-off of vertical ARR was 22.10 (pg/ml)/(pg/ml), with 91.4% specificity and 85.7% specificity. The sensitivity of vertical ARR combined with PRC was 78.1%, specificity was 89.5%. The sensitivity of combined PAC was 74.3%, specificity was 92.4%, and the sensitivity of combined sodium/potassium ratio was 50.5%, specificity was 95.2%. Conclusions There was little difference in the diagnostic performance of PA between vertical and supine ARR values. The specificity of PA screening by ARR alone was high, and the specificity and accuracy of PA diagnosis could be improved by combining PRC, PAC and sodium/potassium ratio. Key words: Hyperaldosteronism; Aldosterone; Renin; Sodium; Potassium; Clinical laboraory techniques
{"title":"The diagnostic value of combined indexes in primary aldosteronism","authors":"Yang Chen, Kang-li Xiao, Ningjie Shi, Zhen-hai Cui, Jiaoyue Zhang, Hui-qing Li","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.03.016","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.03.016","url":null,"abstract":"Objective \u0000To evaluate the value of plasma aldosterone concentration (PAC)/renin concentration (PRC) ratio (ARR) combined with aldosterone, renin, and sodium/potassium ratio in the diagnosis of primary aldosteronism (PA). \u0000 \u0000 \u0000Methods \u0000From January 2017 to October 2019, 105 patients were admitted to our hospital and diagnosed as PA and essential hypertension (EH) by clinical manifestations, laboratory examination and surgical pathological biopsy.The optimum cut-off point of ARR, PRC, PAC, plasma sodium-potassium ratio were determined by the Receiver Operating Characteristic (ROC). The sensitivity, specificity and Youden index at the optimum cut-off point were calculated in a separate test. By means of diagnostic test, the best cut-off points of ARR were tested in series with the best cut-off points of PRC, PAC and serum sodium/potassium ratio, respectively, and their specificity were calculated. \u0000 \u0000 \u0000Results \u0000The area under the AUC of supine ARR was greater than that of vertical ARR (0.966 vs 0.946, Z= 1.380, P= 0.168), but there was no statistical difference. The optimum cut-off point of supine ARR was 28.64(pg/ml)/(pg/ml), with a sensitivity of 92.4% and specificity of 90.5%. The sensitivity of the combined PRC test was 79.0% and the specificity was 94.3%. The sensitivity of the combined PAC test was 65.7% and the specificity was 95.2%. The sensitivity of the combined serum sodium/potassium ratio was 50.5% and the specificity was 96.2%. The optimal cut-off of vertical ARR was 22.10 (pg/ml)/(pg/ml), with 91.4% specificity and 85.7% specificity. The sensitivity of vertical ARR combined with PRC was 78.1%, specificity was 89.5%. The sensitivity of combined PAC was 74.3%, specificity was 92.4%, and the sensitivity of combined sodium/potassium ratio was 50.5%, specificity was 95.2%. \u0000 \u0000 \u0000Conclusions \u0000There was little difference in the diagnostic performance of PA between vertical and supine ARR values. The specificity of PA screening by ARR alone was high, and the specificity and accuracy of PA diagnosis could be improved by combining PRC, PAC and sodium/potassium ratio. \u0000 \u0000 \u0000Key words: \u0000Hyperaldosteronism; Aldosterone; Renin; Sodium; Potassium; Clinical laboraory techniques","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"1 1","pages":"279-283"},"PeriodicalIF":0.0,"publicationDate":"2020-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78382939","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-11DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.03.020
Di Li, Y. Lyu, Huan Liu, Yan Li
Objective To explore the relationship between growth arrest-specific protein 6 (Gas6) and acute myocardial infarction (AMI). Methods Patients were included from Renmin Hospital of Wuhan University between January to June 2018. A total of 103 patients with angina pectoris aged 60.20±9.35 were included as angina pectoris group. A total of 102 patients with myocardial infarction aged 58.85±9.80 were included as AMI group. A total of 130 healthy individuals aged 63.14±10.40 were included as healthy control. Spearman analysis was performed to investigate the correlations between Gas6 and risk factors of (coronary heart disease, CHD). Logistic regression was performed to investigate the risk factor of myocardial infarction. ROC (receiver operating characteristic) curve was used to analyze the diagnostic performance of Gas6 to AMI. Results The levels of Gas6 in angina pectoris group [13.77 (10.57-17.03) ng/ ml, t=2.444, P=0.025] and AMI group[16.22 (12.70-20.09) ng/ml, t=4.965, P<0.001] was higher than control group [10.92 (8.90-14.92) ng/ml]. The levels of Gas6 in angina pectoris group was lower than AMI group (t=3.854, P<0.001). In the sensitivity analysis excluding hypertension and diabetes, the serum Gas6 level in AMI group (n=37) [15.05 (11.08-16.20) mg/L] was higher than that in control group [10.93 (8.91-14.93)mg/L, t=3.479, P=0.001] and angina group (n=42) [12.85 (9.10-16.20) mg/L, t=2.639, P=0.019]. CRP (C-reactive protein), WBC (white blood cell count), Glu (fasting glucose) and Cr (creatinine) were positively correlated with Gas6, r=0.194, 0.176, 0.180 and 0.120, P value=0.010, 0.012, 0.010 and 0.002, respectively. Logistic regression showed that Gas6 was a independent factor of myocardial infarction [OR and 95%CI were 1.080 (1.012-1.152), P=0.020]. AUC and 95%CI of ROC curve was 0.648 (0.572-0.723). Conclusion The levels of Gas6 may be positively associated with myocardial infarction risk. Key words: Acute myocardial infarction; Inflammation; Growth arrest-specific protein 6
{"title":"Study on the relationship between growth arrest-specific protein 6 and acute myocardial infarction","authors":"Di Li, Y. Lyu, Huan Liu, Yan Li","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.03.020","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.03.020","url":null,"abstract":"Objective \u0000To explore the relationship between growth arrest-specific protein 6 (Gas6) and acute myocardial infarction (AMI). \u0000 \u0000 \u0000Methods \u0000Patients were included from Renmin Hospital of Wuhan University between January to June 2018. A total of 103 patients with angina pectoris aged 60.20±9.35 were included as angina pectoris group. A total of 102 patients with myocardial infarction aged 58.85±9.80 were included as AMI group. A total of 130 healthy individuals aged 63.14±10.40 were included as healthy control. Spearman analysis was performed to investigate the correlations between Gas6 and risk factors of (coronary heart disease, CHD). Logistic regression was performed to investigate the risk factor of myocardial infarction. ROC (receiver operating characteristic) curve was used to analyze the diagnostic performance of Gas6 to AMI. \u0000 \u0000 \u0000Results \u0000The levels of Gas6 in angina pectoris group [13.77 (10.57-17.03) ng/ ml, t=2.444, P=0.025] and AMI group[16.22 (12.70-20.09) ng/ml, t=4.965, P<0.001] was higher than control group [10.92 (8.90-14.92) ng/ml]. The levels of Gas6 in angina pectoris group was lower than AMI group (t=3.854, P<0.001). In the sensitivity analysis excluding hypertension and diabetes, the serum Gas6 level in AMI group (n=37) [15.05 (11.08-16.20) mg/L] was higher than that in control group [10.93 (8.91-14.93)mg/L, t=3.479, P=0.001] and angina group (n=42) [12.85 (9.10-16.20) mg/L, t=2.639, P=0.019]. CRP (C-reactive protein), WBC (white blood cell count), Glu (fasting glucose) and Cr (creatinine) were positively correlated with Gas6, r=0.194, 0.176, 0.180 and 0.120, P value=0.010, 0.012, 0.010 and 0.002, respectively. Logistic regression showed that Gas6 was a independent factor of myocardial infarction [OR and 95%CI were 1.080 (1.012-1.152), P=0.020]. AUC and 95%CI of ROC curve was 0.648 (0.572-0.723). \u0000 \u0000 \u0000Conclusion \u0000The levels of Gas6 may be positively associated with myocardial infarction risk. \u0000 \u0000 \u0000Key words: \u0000Acute myocardial infarction; Inflammation; Growth arrest-specific protein 6","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"18 1","pages":"302-306"},"PeriodicalIF":0.0,"publicationDate":"2020-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81266250","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-11DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.03.018
R. Ma, Jing Ren, Yang Li, Z. Zhai, J. Men
Objective The anti-FⅩa assay can be used to monitor the blood concentration of Rivaroxaban. The aim is to evaluate the critical value and diagnostic performance of this test on bleeding risk assessment. Methods From September 2017 to June 2019, 368 patients were enrolled for retrospective cohort study, including 201 males and 167 females, aged (62.8±15.7) years old. They were divided into groups by age:≤60 years old group 105 cases,61-70 years old group 135 cases,≥71 years old group 128 cases. Anti-FⅩa was detected on ACL TOP 700 coagulation analyzer using chromogenic substrate method to quantitatively determine the plasma concentration of rivaroxaban. Anti-FⅩa data were expressed as M (P25-P75);Kruskal-Wallis H test was used for comparison among groups; Mann-Whitney U test was for data comparison between two groups; positive rate comparison was performed by χ2 test; the diagnostic performance of anti-FⅩa to assess bleeding risk was evaluated by ROC curve;Kaplan-Meier curve was used for the survival analysis;the risk ratio (HR) was obtained by Cox proportional hazard regression model. Results Both the peak and trough plasma concentrations were higher in patients aged 61-70 years old than ≤60 years old (U values were 5 618 and 5 725,respectively, P values were 0.006 and 0.011, respectively); higher in patients ≥71 years old than 61-70 years old (U values were 6 438 and 6 317, respectively, P values were 0.05).Both peak and trough blood concentrations were higher in patients with bleeding than without bleeding(U values were 1 429 and 2 185, respectively, P<0.001 and 0.001, respectively).ROC showed that the cut-off values of peak blood concentration in evaluation of the overall and the ≥61 year-old population′s bleeding risk were 200.8 ng/ml and 209.9 ng/ml,respectively, corresponding respectively with the sensitivity of 90.9% and 95.0%; the trough cut-off values were 35.1 ng/ml and 39.1 ng/ml, respectively, corresponding respectively with the sensitivity of 72.7% and 70.0%. However, all the above cut-off values gave a low diagnostic specificity. Survival analysis showed with 35.1 ng/ml as the trough cut-off value, the cumulative risk of bleeding significantly increased in patients above the cut-off value (Log-rank χ2=4.513,P=0.034). The Cox proportional regression model demonstrated that the hazard ratios for peak and trough blood concentration predictions of bleeding risk were 1.023 (95%CI: 0.834-1.256) and 0.948 (95%CI: 0.773-1.164). respectively. Conclusions Both the peak and trough values of blood concentration in bleeding patients are higher than non-bleeding patients. The peak blood concentration is highly sensitive to the risk of bleeding, and the elevated trough blood concentration levels indicate that the probability of bleeding risk increases in the short term. However, the specificity of both peak and trough values is relatively low in bleeding risk assessment. When used alone, the prediction of bleeding events does no
{"title":"Study on the evaluation of Rivaroxaban′s blood concentration by anti-FX activity assay","authors":"R. Ma, Jing Ren, Yang Li, Z. Zhai, J. Men","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.03.018","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.03.018","url":null,"abstract":"Objective \u0000The anti-FⅩa assay can be used to monitor the blood concentration of Rivaroxaban. The aim is to evaluate the critical value and diagnostic performance of this test on bleeding risk assessment. \u0000 \u0000 \u0000Methods \u0000From September 2017 to June 2019, 368 patients were enrolled for retrospective cohort study, including 201 males and 167 females, aged (62.8±15.7) years old. They were divided into groups by age:≤60 years old group 105 cases,61-70 years old group 135 cases,≥71 years old group 128 cases. Anti-FⅩa was detected on ACL TOP 700 coagulation analyzer using chromogenic substrate method to quantitatively determine the plasma concentration of rivaroxaban. Anti-FⅩa data were expressed as M (P25-P75);Kruskal-Wallis H test was used for comparison among groups; Mann-Whitney U test was for data comparison between two groups; positive rate comparison was performed by χ2 test; the diagnostic performance of anti-FⅩa to assess bleeding risk was evaluated by ROC curve;Kaplan-Meier curve was used for the survival analysis;the risk ratio (HR) was obtained by Cox proportional hazard regression model. \u0000 \u0000 \u0000Results \u0000Both the peak and trough plasma concentrations were higher in patients aged 61-70 years old than ≤60 years old (U values were 5 618 and 5 725,respectively, P values were 0.006 and 0.011, respectively); higher in patients ≥71 years old than 61-70 years old (U values were 6 438 and 6 317, respectively, P values were 0.05).Both peak and trough blood concentrations were higher in patients with bleeding than without bleeding(U values were 1 429 and 2 185, respectively, P<0.001 and 0.001, respectively).ROC showed that the cut-off values of peak blood concentration in evaluation of the overall and the ≥61 year-old population′s bleeding risk were 200.8 ng/ml and 209.9 ng/ml,respectively, corresponding respectively with the sensitivity of 90.9% and 95.0%; the trough cut-off values were 35.1 ng/ml and 39.1 ng/ml, respectively, corresponding respectively with the sensitivity of 72.7% and 70.0%. However, all the above cut-off values gave a low diagnostic specificity. Survival analysis showed with 35.1 ng/ml as the trough cut-off value, the cumulative risk of bleeding significantly increased in patients above the cut-off value (Log-rank χ2=4.513,P=0.034). The Cox proportional regression model demonstrated that the hazard ratios for peak and trough blood concentration predictions of bleeding risk were 1.023 (95%CI: 0.834-1.256) and 0.948 (95%CI: 0.773-1.164). respectively. \u0000 \u0000 \u0000Conclusions \u0000Both the peak and trough values of blood concentration in bleeding patients are higher than non-bleeding patients. The peak blood concentration is highly sensitive to the risk of bleeding, and the elevated trough blood concentration levels indicate that the probability of bleeding risk increases in the short term. However, the specificity of both peak and trough values is relatively low in bleeding risk assessment. When used alone, the prediction of bleeding events does no","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"22 1","pages":"291-295"},"PeriodicalIF":0.0,"publicationDate":"2020-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"78921329","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-11DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.03.019
L. You, Yuanhao Wu, Yin Zheng, Lin Lu, Jun Xue, Junfeng Liu
Objective To explore the risk factors related to hospitalization events in out patients on hemodialysis and to evaluate the effect of serum retinol-binding protein (RBP) level on hospitalization events in patients on hemodialysis. Methods Case-control study. A total of 80 patients on dialysis were recruited, including 47 men (58.8%) and 33 women (41.2%), with an average age of (60.9±11.7) years (range: 32-89 years) and a median dialysis age of 43.6 months. Dialysis-related data were collected, the serum RBP level was detected using the ELISA method. Patients were followed-up until June 30, 2019, to record the events associated with all kinds of hospitalization events. The t-test, Mann-Whitney U test and chi-square test were used to compare the differences between the hospitalized event group and the non-event group. Multivariate logistic regression was used to analyze the related risk factors of hospitalization events. The Kaplan-Meier method, Log-rank test, and Cox proportional hazards regression model were used to analyze survival data. Results During the 19-month follow-up period, 26/80 patients (32.5%) had 67 events of hospitalization. There was no difference (P>0.05) in age, sex composition, dialysis age, ratio of diabetes/hypertension, interval dialysis weight gain (IDWG), systolic/diastolic blood pressure before dialysis, kt/v and URR between the groups with or without hospitalization events. The cut-off point of serum RBP was calculated using the patient′s highest Youden index. The patients were divided into the high-RBP group (n=44) and low-RBP group (n=36) according to the level of 165.34 mg/L. The incidence of hospitalization events in the high-RBP group was higher than that in the low-RBP group (45.45%>16.67%, P=0.006). Using the multivariate logistic regression model, after adjusting for sex, age, albumin and total cholesterol (CHO), only the serum RBP level was independently correlated with hospitalization events. The high-RBP group had an odds ratio (OR) of 3.64 (95%CI, 1.14-11.58; P=0.029) compared with the low-level group in hospitalization events. The Kaplan-Meier survival analysis showed that the incidence of hospitalization events in the high-RBP group was significantly higher than that in the low-RBP group (P=0.0058). The test results of the multivariable Cox proportional hazards regression model showed that for patients on hemodialysis, an elevated serum RBP level is an independent risk factor for hospitalization events. Conclusion Elevated serum RBP level is correlated with hospitalization events in patients on hemodialysis. RBP is an independent risk factor for hospitalization events in outpatients on hemodialysis. Key words: Retinol-binding proteins; Renal dialysis; Risk factors
{"title":"Retinol-binding protein is an independent risk factor for hospitalization events in patients undergoing hemodialysis","authors":"L. You, Yuanhao Wu, Yin Zheng, Lin Lu, Jun Xue, Junfeng Liu","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.03.019","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.03.019","url":null,"abstract":"Objective \u0000To explore the risk factors related to hospitalization events in out patients on hemodialysis and to evaluate the effect of serum retinol-binding protein (RBP) level on hospitalization events in patients on hemodialysis. \u0000 \u0000 \u0000Methods \u0000Case-control study. A total of 80 patients on dialysis were recruited, including 47 men (58.8%) and 33 women (41.2%), with an average age of (60.9±11.7) years (range: 32-89 years) and a median dialysis age of 43.6 months. Dialysis-related data were collected, the serum RBP level was detected using the ELISA method. Patients were followed-up until June 30, 2019, to record the events associated with all kinds of hospitalization events. The t-test, Mann-Whitney U test and chi-square test were used to compare the differences between the hospitalized event group and the non-event group. Multivariate logistic regression was used to analyze the related risk factors of hospitalization events. The Kaplan-Meier method, Log-rank test, and Cox proportional hazards regression model were used to analyze survival data. \u0000 \u0000 \u0000Results \u0000During the 19-month follow-up period, 26/80 patients (32.5%) had 67 events of hospitalization. There was no difference (P>0.05) in age, sex composition, dialysis age, ratio of diabetes/hypertension, interval dialysis weight gain (IDWG), systolic/diastolic blood pressure before dialysis, kt/v and URR between the groups with or without hospitalization events. The cut-off point of serum RBP was calculated using the patient′s highest Youden index. The patients were divided into the high-RBP group (n=44) and low-RBP group (n=36) according to the level of 165.34 mg/L. The incidence of hospitalization events in the high-RBP group was higher than that in the low-RBP group (45.45%>16.67%, P=0.006). Using the multivariate logistic regression model, after adjusting for sex, age, albumin and total cholesterol (CHO), only the serum RBP level was independently correlated with hospitalization events. The high-RBP group had an odds ratio (OR) of 3.64 (95%CI, 1.14-11.58; P=0.029) compared with the low-level group in hospitalization events. The Kaplan-Meier survival analysis showed that the incidence of hospitalization events in the high-RBP group was significantly higher than that in the low-RBP group (P=0.0058). The test results of the multivariable Cox proportional hazards regression model showed that for patients on hemodialysis, an elevated serum RBP level is an independent risk factor for hospitalization events. \u0000 \u0000 \u0000Conclusion \u0000Elevated serum RBP level is correlated with hospitalization events in patients on hemodialysis. RBP is an independent risk factor for hospitalization events in outpatients on hemodialysis. \u0000 \u0000 \u0000Key words: \u0000Retinol-binding proteins; Renal dialysis; Risk factors","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"8 1","pages":"296-301"},"PeriodicalIF":0.0,"publicationDate":"2020-03-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"74260826","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-09DOI: 10.3760/CMA.J.CN114452-20200227-00138
Xiuzhi Duan, Xuchu Wang, Pan Yu, Weiwei Liu, Xiang Li, Lele Zhang, Gong Zhang, Huqiang Tang, Qin Chen, Xianguo Wu, Zhihua Tao
Objective To investigate the effect of virus inactivation on weak positive result of 2019 Novel Coronavirus (2019-nCoV) nucleic acid test. Method A retrospective study was conducted on the nasopharyngeal swabs of three patients with positive PCR nucleic acid test for Novel Coronavirus at different concentrations in the Second affiliated Hospital of Zhejiang University Medical College from January to February 2020.The virus in nasopharyngeal swab specimens were inactivated by water bath at 56 ℃ for 30 min, dry bath at 56 ℃ for 60 min and dry bath at 60 ℃ for 30 min respectively. After treatment, the sample RNA were extracted and then detected by three new commercial quantitative real-time polymerase chain reaction reagent kits for 2019-nCoV.Cycle threshold(Ct)value was used to evaluate the effect of virus inactivation on nucleic acid detection of 2019-nCoV. Results There was no significant difference between the groups before and after inactivation. Ct values of ORF1ab gene before inactivation were 23.28±0.28, 25.25±0.25, 28.93±0.44, 32.06±0.47, 35.20±0.38, 32.89±0.38, 36.24±0.23, 33.30±0.46, and those after inactivation were, group 1:23.60±0.20, 27.29±0.30, 31.83±0.51, 37.41±0.46, group 2:24.25±0.34, 27.18±0.42, 31.84±0.61, 34.99±1.01, 34.89±0.45,group 3:23.37±0.17, 26.89±0.52, 32.05±0.50.Ct value of N gene before inactivation were24.38±0.09, 26.64±0.11, 30.35±0.12, 33.29±0.33, 36.93±0.11, 34.50±0.12, 35.63±0.12, those after inactivation were, group 1:24.66 ±0.11, 28.52±0.14, 32.71±0.14, 37.00±0.13.group 2:25.41 ±0.10, 28.79±0.15, 33.29±0.28. group 3:23.37±0.11, 28.68±0.11, 33.54±0.13, 37.18±0.23(ORF1ab gene: t =-1.416; N gene: t=-1.379, P> 0.05). There was no significant difference amongthe three inactivation groups, the specific Ct values are shown above(ORF1ab gene: t =-0.460; N gene: t =-0.132, P>0.05). However, the Ct values of the inactivated groups (1,2,3) and the non-inactivated group at different dilution times were different (10 ×:Ct value of ORF1abwas 25.25±0.25 in the non-inactivated group, and 27.29±0.30, 27.18±0.42 and 26.89±0.52 in the inactivated group1,2 and 3.t (ORF1ab) = -7.327, P 0.05) and among the three reagents(reagent 1:7/11, 4/11, 3/11, 3/11, reagent 2:8/11, 4/11, 3/11, 3/11, reagent 3:5/11, 3/11, 3/11, 2/11)(χ2=1.199, P>0.05). Conclusion The virus inactivation can degrade the nucleic acid of the 2019nCoV, resulting in the decrease of the Ct value and the false negative results of the low-concentration specimens. Key words: Coronavirus; Virus inactivation; Nucleic acids; False negative reactions; Real-time polymerase chain reaction
{"title":"Effect of virus inactivation on weak positive results of nucleic acid test for 2019 novel coronavirus","authors":"Xiuzhi Duan, Xuchu Wang, Pan Yu, Weiwei Liu, Xiang Li, Lele Zhang, Gong Zhang, Huqiang Tang, Qin Chen, Xianguo Wu, Zhihua Tao","doi":"10.3760/CMA.J.CN114452-20200227-00138","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114452-20200227-00138","url":null,"abstract":"Objective \u0000To investigate the effect of virus inactivation on weak positive result of 2019 Novel Coronavirus (2019-nCoV) nucleic acid test. \u0000 \u0000 \u0000Method \u0000A retrospective study was conducted on the nasopharyngeal swabs of three patients with positive PCR nucleic acid test for Novel Coronavirus at different concentrations in the Second affiliated Hospital of Zhejiang University Medical College from January to February 2020.The virus in nasopharyngeal swab specimens were inactivated by water bath at 56 ℃ for 30 min, dry bath at 56 ℃ for 60 min and dry bath at 60 ℃ for 30 min respectively. After treatment, the sample RNA were extracted and then detected by three new commercial quantitative real-time polymerase chain reaction reagent kits for 2019-nCoV.Cycle threshold(Ct)value was used to evaluate the effect of virus inactivation on nucleic acid detection of 2019-nCoV. \u0000 \u0000 \u0000Results \u0000There was no significant difference between the groups before and after inactivation. Ct values of ORF1ab gene before inactivation were 23.28±0.28, 25.25±0.25, 28.93±0.44, 32.06±0.47, 35.20±0.38, 32.89±0.38, 36.24±0.23, 33.30±0.46, and those after inactivation were, group 1:23.60±0.20, 27.29±0.30, 31.83±0.51, 37.41±0.46, group 2:24.25±0.34, 27.18±0.42, 31.84±0.61, 34.99±1.01, 34.89±0.45,group 3:23.37±0.17, 26.89±0.52, 32.05±0.50.Ct value of N gene before inactivation were24.38±0.09, 26.64±0.11, 30.35±0.12, 33.29±0.33, 36.93±0.11, 34.50±0.12, 35.63±0.12, those after inactivation were, group 1:24.66 ±0.11, 28.52±0.14, 32.71±0.14, 37.00±0.13.group 2:25.41 ±0.10, 28.79±0.15, 33.29±0.28. group 3:23.37±0.11, 28.68±0.11, 33.54±0.13, 37.18±0.23(ORF1ab gene: t =-1.416; N gene: t=-1.379, P> 0.05). There was no significant difference amongthe three inactivation groups, the specific Ct values are shown above(ORF1ab gene: t =-0.460; N gene: t =-0.132, P>0.05). However, the Ct values of the inactivated groups (1,2,3) and the non-inactivated group at different dilution times were different (10 ×:Ct value of ORF1abwas 25.25±0.25 in the non-inactivated group, and 27.29±0.30, 27.18±0.42 and 26.89±0.52 in the inactivated group1,2 and 3.t (ORF1ab) = -7.327, P 0.05) and among the three reagents(reagent 1:7/11, 4/11, 3/11, 3/11, reagent 2:8/11, 4/11, 3/11, 3/11, reagent 3:5/11, 3/11, 3/11, 2/11)(χ2=1.199, P>0.05). \u0000 \u0000 \u0000Conclusion \u0000The virus inactivation can degrade the nucleic acid of the 2019nCoV, resulting in the decrease of the Ct value and the false negative results of the low-concentration specimens. \u0000 \u0000 \u0000Key words: \u0000Coronavirus; Virus inactivation; Nucleic acids; False negative reactions; Real-time polymerase chain reaction","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"106 1","pages":"358-363"},"PeriodicalIF":0.0,"publicationDate":"2020-03-09","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79553891","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-08DOI: 10.3760/CMA.J.CN114452-20200302-00155
L. Ping, Zhiyong Li, Si-ting Zhao, Qiong Li, Yan Hu, Yufeng Chen, Fan Yi, Q. Xie, Zhaoqiong Zeng, Changjuan Deng, Zhanxiang Wang, Xiaobing Xie
Objective To analyze the clinical value of serum 2019 New Coronavirus (2019-nCoV) immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies in the diagnosis of novel coronavirus pneumonia (NCP). Methods A total of 116 patients diagnosed with NCP in the First Affiliated Hospital of Hunan University of Chinese Medicine and the First Affiliated Hospital of Xiamen University were enrolled from January to February 2020 as the disease group. A total of 134 cases, including 84 non-NCP inpatients and 50 healthy individuals served as the control group. Serum samples from all subjects were collected. A fully-automated chemiluminescence immunoassay analyzer was used to detect the concentration of 2019-nCoV IgM and IgG antibodies in serum. The sensitivity and specificity of the 2019-nCoV IgM and IgG antibody single test and combined detection were compared using the χ2 test. χ2 test and Wilcoxon’s rank sum test were used to compare the positive rates and concentrations of IgM and IgG antibodies in NCP patients before and after their 2019-nCoV nucleic acid tests turning negative, respectively. The change trend of 2019-nCoV antibody concentration in the process of NCP patients was analyzed by Wilcoxon’s rank sum test. Results The sensitivity of 2019-nCoV IgG (90.5%, 105/116) was higher than that of 2019-nCoV IgM (75.9%, 88/116), the difference was statistically significant (χ2=8.91, P<0.05); The specificity of 2019-nCoV IgG (99.3%, 133/134) was higher than that of 2019-nCoV IgM (94.0%, 126/134), the difference was statistically significant (χ2=5.63, P<0.05). The sensitivity (89.7%, 87/97) of 2019-nCoV IgM combined with IgG was higher than that of 2019-nCoV IgM, the difference was statistically significant ( χ2=6.89, P<0.05). The specificity (100%, 125/125) of 2019-nCoV IgM combined with IgG was higher than that of 2019-nCoV IgM, the difference was statistically significant ( χ2=7.70, P<0.05). After 2019-nCoV nucleic acid test converted to negative, the positive rate (52.9%, 9/17) and concentration [13.0 (4.9, 24.7) AU/ml] of serum 2019-nCoV IgM antibody were significantly lower than those when the nucleic acid test was positive, positive rate (88.2%, 15/17) and concentration [29.5 (14.0, 61.3) AU/ml] , respectively (χ2=5.10, Z=-3.195, both P<0.05). In the course of NCP, patients' serum samples were collected from the first day of diagnosis to every three days, three times in total. The first 2019-nCoV IgM and IgG antibody concentrations [19.4 (12.4, 63.7) AU/ml, 105.8 (74.8, 126.1) AU/ml, respectively] were significantly higher than the second concentrations [15.8 (7.1, 40.3)AU/ml, 80.5 (66.7, 105.9) AU/ml], Z were -2.897, -3.179, both P<0.05. Conclusions 2019-nCoV IgG antibody has a good application value in the diagnosis of NCP; The concentration of 2019-nCoV IgM antibody has a certain correlation with the detection of 2019-nCoV nucleic acid; The combination of 2019-nCoV IgM and IgG antibodies with 2019-nCoV nucleic acid test may be the
{"title":"Preliminary study of serum 2019-nCoV IgM and IgG antibodies in the diagnosis of COVID-19","authors":"L. Ping, Zhiyong Li, Si-ting Zhao, Qiong Li, Yan Hu, Yufeng Chen, Fan Yi, Q. Xie, Zhaoqiong Zeng, Changjuan Deng, Zhanxiang Wang, Xiaobing Xie","doi":"10.3760/CMA.J.CN114452-20200302-00155","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114452-20200302-00155","url":null,"abstract":"Objective \u0000To analyze the clinical value of serum 2019 New Coronavirus (2019-nCoV) immunoglobulin M (IgM) and immunoglobulin G (IgG) antibodies in the diagnosis of novel coronavirus pneumonia (NCP). \u0000 \u0000 \u0000Methods \u0000A total of 116 patients diagnosed with NCP in the First Affiliated Hospital of Hunan University of Chinese Medicine and the First Affiliated Hospital of Xiamen University were enrolled from January to February 2020 as the disease group. A total of 134 cases, including 84 non-NCP inpatients and 50 healthy individuals served as the control group. Serum samples from all subjects were collected. A fully-automated chemiluminescence immunoassay analyzer was used to detect the concentration of 2019-nCoV IgM and IgG antibodies in serum. The sensitivity and specificity of the 2019-nCoV IgM and IgG antibody single test and combined detection were compared using the χ2 test. χ2 test and Wilcoxon’s rank sum test were used to compare the positive rates and concentrations of IgM and IgG antibodies in NCP patients before and after their 2019-nCoV nucleic acid tests turning negative, respectively. The change trend of 2019-nCoV antibody concentration in the process of NCP patients was analyzed by Wilcoxon’s rank sum test. \u0000 \u0000 \u0000Results \u0000The sensitivity of 2019-nCoV IgG (90.5%, 105/116) was higher than that of 2019-nCoV IgM (75.9%, 88/116), the difference was statistically significant (χ2=8.91, P<0.05); The specificity of 2019-nCoV IgG (99.3%, 133/134) was higher than that of 2019-nCoV IgM (94.0%, 126/134), the difference was statistically significant (χ2=5.63, P<0.05). The sensitivity (89.7%, 87/97) of 2019-nCoV IgM combined with IgG was higher than that of 2019-nCoV IgM, the difference was statistically significant ( χ2=6.89, P<0.05). The specificity (100%, 125/125) of 2019-nCoV IgM combined with IgG was higher than that of 2019-nCoV IgM, the difference was statistically significant ( χ2=7.70, P<0.05). After 2019-nCoV nucleic acid test converted to negative, the positive rate (52.9%, 9/17) and concentration [13.0 (4.9, 24.7) AU/ml] of serum 2019-nCoV IgM antibody were significantly lower than those when the nucleic acid test was positive, positive rate (88.2%, 15/17) and concentration [29.5 (14.0, 61.3) AU/ml] , respectively (χ2=5.10, Z=-3.195, both P<0.05). In the course of NCP, patients' serum samples were collected from the first day of diagnosis to every three days, three times in total. The first 2019-nCoV IgM and IgG antibody concentrations [19.4 (12.4, 63.7) AU/ml, 105.8 (74.8, 126.1) AU/ml, respectively] were significantly higher than the second concentrations [15.8 (7.1, 40.3)AU/ml, 80.5 (66.7, 105.9) AU/ml], Z were -2.897, -3.179, both P<0.05. \u0000 \u0000 \u0000Conclusions \u00002019-nCoV IgG antibody has a good application value in the diagnosis of NCP; The concentration of 2019-nCoV IgM antibody has a certain correlation with the detection of 2019-nCoV nucleic acid; The combination of 2019-nCoV IgM and IgG antibodies with 2019-nCoV nucleic acid test may be the","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"20 1","pages":"352-357"},"PeriodicalIF":0.0,"publicationDate":"2020-03-08","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"73613734","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-03-05DOI: 10.3760/CMA.J.CN114452-20200226-00128
Zhaogang Dong, Mingjin Zou, Yi Zhang
The prevention and control of Novel Coronavirus Pneumonia caused by Novel Coronavirus is at a critical period. Nucleic acid detection, as the definite diagnosis tool, plays an important role in rapid diagnosis, therapeutic efficacy, epidemic prevention and control. However, the disease is outbreak, and the time of nucleic acid detection in clinical application is short. So the insufficient method verification and clinical evaluation has been made. "False negative" is observed in clinical practice, and the result of nucleic acid detection is not matched with the clinical diagnosis. Therefore, it is urgent to optimize the current methods and improve detection sensitivity. Based on latest studies of Novel Coronavirus, this article reviews the current status and application prospects of nucleic acid detection. Also, this article provides references for clinicians and researchers.
{"title":"Research progress on nucleic acid detection in Novel Coronavirus Pneumonia/ 中华检验医学杂志","authors":"Zhaogang Dong, Mingjin Zou, Yi Zhang","doi":"10.3760/CMA.J.CN114452-20200226-00128","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114452-20200226-00128","url":null,"abstract":"The prevention and control of Novel Coronavirus Pneumonia caused by Novel Coronavirus is at a critical period. Nucleic acid detection, as the definite diagnosis tool, plays an important role in rapid diagnosis, therapeutic efficacy, epidemic prevention and control. However, the disease is outbreak, and the time of nucleic acid detection in clinical application is short. So the insufficient method verification and clinical evaluation has been made. \"False negative\" is observed in clinical practice, and the result of nucleic acid detection is not matched with the clinical diagnosis. Therefore, it is urgent to optimize the current methods and improve detection sensitivity. Based on latest studies of Novel Coronavirus, this article reviews the current status and application prospects of nucleic acid detection. Also, this article provides references for clinicians and researchers.","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-03-05","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"79592341","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
Pub Date : 2020-02-27DOI: 10.3760/CMA.J.CN114452-20200219-00091
Qiang Wang, Qin Du, Bin Guo, Yangliu Guo, Li Fang, Xiaolan Guo
Objective To investigate the interference factors causing false-positive result of novel coronavirus IgM antibody (SARS-CoV-2 IgM) detected by gold immunochromatography assay (GICA) and enzyme-linked immunosorbent assay (ELISA). Methods A total of 71 serum from different pathogen infections and related chronic diseases patients were collected from the Affiliated Hospital of North Sichuan Medical College from January 25, 2020 to February 15, 2020. GICA and ELISA were used to detect 2019-nCoV IgM in 71 serum, including 5 influenza A virus (Flu A) IgM positive serum, 5 influenza B virus (Flu B) IgM positive serum, 5 Mycoplasma pneumonia (MP) IgM positive serum, 5 Legionella pneumophila (LP) IgM positive serum, 29 rheumatoid factor (RF) IgM positive serum, 5 hypertension patients serum, 5 diabetes mellitus patients serum, 6 human immunodeficiency virus (HIV) infection patients serum and 6 Corona Virus Disease 2019 (COVID-19) patients serum. The interference factors causing false positive results of the two methods were analyzed, and urea dissociation test was employed to dissociate the 2019-nCoV IgM positive serum using the best dissociation concentration. Statistical analyses were performed by SPSS, version 19.0. Result s 2019-nCoV IgM was positive in 18 cases of middle-high level RF-IgM positive serum and 6 cases of 2019-nCoV-infected serum detected by two methods, and the other 47 serum were negative. When the dissociation concentration of urea was 6 mol/L, 2019-nCoV IgM was negative in 17 cases of middle-high level RF-IgM positive serum and positive in 6 cases of 2019-nCoV-infected serum detected by GICA. When the urea dissociation concentration was 4 mol/L, dissociation time was 10 min and the avidity index<0.46 was set as negative, 2019-nCoV IgM was negative in 15 cases of middle-high level RF-IgM positive serum and positive in 6 cases of 2019-nCoV-infected serum detected by ELISA. Conclusion The middle-high level of RF-IgM could cause false positive results of SARS-CoV-2 IgM detected by GICA and ELISA, and the urea dissociation test would be helpful for reducing the probability of false-positive results of SARS-CoV-2 IgM test. Key words: Coronavirus; Urea; Immunoglobulin M; False positive reactions; Immunochromatography; Enzyme-linked immunosorbent assay
目的探讨金免疫层析法(GICA)和酶联免疫吸附法(ELISA)检测新型冠状病毒IgM抗体(SARS-CoV-2 IgM)假阳性的干扰因素。方法采集川北医学院附属医院2020年1月25日至2020年2月15日不同病原菌感染及相关慢性疾病患者血清71例。采用GICA和ELISA对71例血清进行2019- ncov IgM检测，包括5例甲型流感病毒(Flu A) IgM阳性血清、5例乙型流感病毒(Flu B) IgM阳性血清、5例肺炎支原体(MP) IgM阳性血清、5例嗜肺军团菌(LP) IgM阳性血清、29例类风湿因子(RF) IgM阳性血清、5例高血压患者血清、5例糖尿病患者血清、6例人类免疫缺陷病毒(HIV)感染患者血清和6例2019冠状病毒病(COVID-19)患者血清。分析两种方法假阳性结果的干扰因素，采用尿素解离试验，利用最佳解离浓度解离2019-nCoV IgM阳性血清。采用SPSS 19.0进行统计分析。结果两种方法检测的中高水平RF-IgM阳性血清18例，2019-nCoV感染血清6例，其余47例血清阴性。尿素解离浓度为6 mol/L时，17例中高水平RF-IgM阳性血清IgM为阴性，6例GICA检测2019-nCoV感染血清IgM为阳性。当尿素解离浓度为4 mol/L、解离时间为10 min、亲和力指数<0.46为阴性时，15例中高水平RF-IgM阳性血清呈阴性，6例2019-nCoV感染血清呈阳性。结论中高水平的RF-IgM可能导致GICA和ELISA检测SARS-CoV-2 IgM结果假阳性，尿素解离试验有助于降低SARS-CoV-2 IgM检测结果假阳性的概率。关键词:冠状病毒;尿素;免疫球蛋白M;假阳性反应;免疫层析法;酶联免疫吸附试验
{"title":"Performance of urea-mediated dissociation in reducing false-positive of 2019-nCoV IgM test","authors":"Qiang Wang, Qin Du, Bin Guo, Yangliu Guo, Li Fang, Xiaolan Guo","doi":"10.3760/CMA.J.CN114452-20200219-00091","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114452-20200219-00091","url":null,"abstract":"Objective \u0000To investigate the interference factors causing false-positive result of novel coronavirus IgM antibody (SARS-CoV-2 IgM) detected by gold immunochromatography assay (GICA) and enzyme-linked immunosorbent assay (ELISA). \u0000 \u0000 \u0000Methods \u0000A total of 71 serum from different pathogen infections and related chronic diseases patients were collected from the Affiliated Hospital of North Sichuan Medical College from January 25, 2020 to February 15, 2020. GICA and ELISA were used to detect 2019-nCoV IgM in 71 serum, including 5 influenza A virus (Flu A) IgM positive serum, 5 influenza B virus (Flu B) IgM positive serum, 5 Mycoplasma pneumonia (MP) IgM positive serum, 5 Legionella pneumophila (LP) IgM positive serum, 29 rheumatoid factor (RF) IgM positive serum, 5 hypertension patients serum, 5 diabetes mellitus patients serum, 6 human immunodeficiency virus (HIV) infection patients serum and 6 Corona Virus Disease 2019 (COVID-19) patients serum. The interference factors causing false positive results of the two methods were analyzed, and urea dissociation test was employed to dissociate the 2019-nCoV IgM positive serum using the best dissociation concentration. Statistical analyses were performed by SPSS, version 19.0. \u0000 \u0000 \u0000Result \u0000s 2019-nCoV IgM was positive in 18 cases of middle-high level RF-IgM positive serum and 6 cases of 2019-nCoV-infected serum detected by two methods, and the other 47 serum were negative. When the dissociation concentration of urea was 6 mol/L, 2019-nCoV IgM was negative in 17 cases of middle-high level RF-IgM positive serum and positive in 6 cases of 2019-nCoV-infected serum detected by GICA. When the urea dissociation concentration was 4 mol/L, dissociation time was 10 min and the avidity index<0.46 was set as negative, 2019-nCoV IgM was negative in 15 cases of middle-high level RF-IgM positive serum and positive in 6 cases of 2019-nCoV-infected serum detected by ELISA. \u0000 \u0000 \u0000Conclusion \u0000The middle-high level of RF-IgM could cause false positive results of SARS-CoV-2 IgM detected by GICA and ELISA, and the urea dissociation test would be helpful for reducing the probability of false-positive results of SARS-CoV-2 IgM test. \u0000 \u0000 \u0000Key words: \u0000Coronavirus; Urea; Immunoglobulin M; False positive reactions; Immunochromatography; Enzyme-linked immunosorbent assay","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"56 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"82214768","PeriodicalName":null,"FirstCategoryId":null,"ListUrlMain":null,"RegionNum":0,"RegionCategory":"","ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":"","EPubDate":null,"PubModel":null,"JCR":null,"JCRName":null,"Score":null,"Total":0}
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