Pub Date : 2020-02-27DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.03.007
Wan-zhou Xu, Juan Li, Xiaoyun He, Cai-xia Zhang, Si-qing Mei, Congrong Li, Yan Li, Shao-hui Cheng, Pingan Zhang
Objective To investigate the diagnostic value of immunoglobulin M (IgM) and immunoglobulin G(IgG) antibodies to 2019 Novel Coronavirus (2019-nCoV) in 2019-nCoV infection. Method This is a retrospective study. Serum samples were collected from 284 patients including outpatients and inpatients in the Renmin Hospital of Wuhan University from January 20, 2020 to February 17, 2020. Among them 205 cases were 2019-nCoV infected patients, including 186 cases confirmed with nucleic acid test and 19 cases diagnosed by clinical symptoms and CT characteristics according to "the New Coronavirus Pneumonia Control Protocol (5th edition)" . A total of 79 subjects with other diseases but negative to 2019-nCoV infection were recruited as control group. Serum IgM and IgG antibodies to 2019-nCoV were measured with fully automated immunoassay technology for all subjects. Statistical significance between 2019-nCoV antibodies test and 2019-nCoV nucleic acid test was determined using the χ2 tests. Result The sensitivity of serum IgM and IgG antibodies to 2019-nCoV were 70.24%(144/205) and 96.10%(197/205) respectively and the specificity were 96.20%(76/79) and 92.41%(73/79) respectively. The positive and negative predictive values of 2019-nCoV antibodies were 95.63%(197/206) and 91.03% (71/78) respectively, and the positive and negative predictive values of 2019-nCoV nucleic acid test were 100%(186/186) and 80.61%(79/98) respectively. The total coincidence rate of diagnosing 2019-nCoV infection between antibody tests and nucleic acid test for 2019-nCoV were 88.03%(250/284). Conclusion Joint detection of serum IgM and IgG antibodies to 2019-nCoV is an effective screening and diagnostic indicators for 2019-nCoV infection, and an effective complement to the false negative results to nucleic acid test. Key words: Coronavirus; Pneumonia, viral; Immunoglobulin M; Immunoglobulin G; Coronavirus infections; Serologic tests
{"title":"The diagnostic value of joint detection of serum IgM and IgG antibodies to 2019-nCoV in 2019-nCoV infection","authors":"Wan-zhou Xu, Juan Li, Xiaoyun He, Cai-xia Zhang, Si-qing Mei, Congrong Li, Yan Li, Shao-hui Cheng, Pingan Zhang","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.03.007","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.03.007","url":null,"abstract":"Objective \u0000To investigate the diagnostic value of immunoglobulin M (IgM) and immunoglobulin G(IgG) antibodies to 2019 Novel Coronavirus (2019-nCoV) in 2019-nCoV infection. \u0000 \u0000 \u0000Method \u0000This is a retrospective study. Serum samples were collected from 284 patients including outpatients and inpatients in the Renmin Hospital of Wuhan University from January 20, 2020 to February 17, 2020. Among them 205 cases were 2019-nCoV infected patients, including 186 cases confirmed with nucleic acid test and 19 cases diagnosed by clinical symptoms and CT characteristics according to \"the New Coronavirus Pneumonia Control Protocol (5th edition)\" . A total of 79 subjects with other diseases but negative to 2019-nCoV infection were recruited as control group. Serum IgM and IgG antibodies to 2019-nCoV were measured with fully automated immunoassay technology for all subjects. Statistical significance between 2019-nCoV antibodies test and 2019-nCoV nucleic acid test was determined using the χ2 tests. \u0000 \u0000 \u0000Result \u0000The sensitivity of serum IgM and IgG antibodies to 2019-nCoV were 70.24%(144/205) and 96.10%(197/205) respectively and the specificity were 96.20%(76/79) and 92.41%(73/79) respectively. The positive and negative predictive values of 2019-nCoV antibodies were 95.63%(197/206) and 91.03% (71/78) respectively, and the positive and negative predictive values of 2019-nCoV nucleic acid test were 100%(186/186) and 80.61%(79/98) respectively. The total coincidence rate of diagnosing 2019-nCoV infection between antibody tests and nucleic acid test for 2019-nCoV were 88.03%(250/284). \u0000 \u0000 \u0000Conclusion \u0000Joint detection of serum IgM and IgG antibodies to 2019-nCoV is an effective screening and diagnostic indicators for 2019-nCoV infection, and an effective complement to the false negative results to nucleic acid test. \u0000 \u0000 \u0000Key words: \u0000Coronavirus; Pneumonia, viral; Immunoglobulin M; Immunoglobulin G; Coronavirus infections; Serologic tests","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"3 1","pages":"230-233"},"PeriodicalIF":0.0,"publicationDate":"2020-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89130302","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.CN114452-20200214-00073
Yaling Shi, Jingyi Ou, Xing Chen, M. Tan, Fang Li, Yanxia Liu
Objective To explore the Expressions of multiple inflammation markers in the patients with 2019 novel coronavirus pneumonia (COVID-19) and their clinical values, and to provide theoretical basis for clinical diagnosis and treatment. Methods A total of 164 patients, diagnosed with COVID-19 and admitted to Guangzhou Eighth People's Hospital from January to February 2020, were selected as the research group and divided into three groups (ordinary, severe, and critically severe pneumonia) according to the disease severity. Meandwhile 66 non-infected patients during the same period were selected as negative control group. The expressions of WBC, LYM, CRP, SAA, and PCT were retrospective studied and compared between groups. The diagnostic values of WBC, CRP, SAA and the combination of these three markers in all patients with COVID-19 and in different severity groups were analyzed by ROC curve. Results Compared with control group (WBC count :8.13(6.51,9.42)×109/L, LYM count:2.00(1.28,2.43)×109/L), WBC count [4.94(4.05, 6.67) ×109/L] and LYM count [1.33(0.94, 1.96) ×109/L] of COVID-19 patients were significantly reduced (Z=-7.435, P<0.01; Z=-4.906, P<0.01) . Compared with the control group [CRP: 1.36 (0.57~5.67) mg/ml; SAA:[4.98 (4.80~15.75) mg/mL], CRP [7.93 (2.45~23.98) mg/ml] and SAA [34.13 (4.83~198.40) mg/ml] were increased in research group (Z=-5.72, P<0.01; Z=-4.166, P<0.01) . PCT in the control group and the research group were 0.100 0(0.030 6~0.100 0)ng/ml and 0.044 5(0.031 6~0.077 0)ng/ml, respectively. There was no statistical difference between two groups (Z=-1.451, P=0.147) . The areas under the ROC curve (AUC) of WBC, CRP and SAA in patients with COVID-19 were 0.814, 0.742, 0.673, respectively (P<0.01), while the AUC of the combination of three indexes for COVID-19 diagnosis was 0.882, with 83.33%(55/66) specificity and 84.76% (139/164) sensitivity, P<0.01.The AUCs of WBC, CRP, and SAA for predicting severe and critically severe COVID-19 were 0.799, 0.779, and 0.886 , respectively (P<0.01), and the AUC of the combination of three indexes for the diagnosis of severe and critically severe COVID-19 was 0.924, with 78.67% (118/150) specificity and 14/14 sensitivity (P<0.01). Conclusion Combining detection of WBC, CRP and SAA can improve the specificity and sensitivity of COVID-19 diagnosis, with a high diagnostic value for severe and critically severe COVID-19. Key words: Inflammation; Coronavirus; Pneumonia, viral; Leukocyte count; C-reactive protein; Serum amyloid A protein; Sensitivity and specificity
{"title":"Expressions of multiple inflammation markers in the patients with COVID-19 and their clinical values","authors":"Yaling Shi, Jingyi Ou, Xing Chen, M. Tan, Fang Li, Yanxia Liu","doi":"10.3760/CMA.J.CN114452-20200214-00073","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114452-20200214-00073","url":null,"abstract":"Objective \u0000To explore the Expressions of multiple inflammation markers in the patients with 2019 novel coronavirus pneumonia (COVID-19) and their clinical values, and to provide theoretical basis for clinical diagnosis and treatment. \u0000 \u0000 \u0000Methods \u0000A total of 164 patients, diagnosed with COVID-19 and admitted to Guangzhou Eighth People's Hospital from January to February 2020, were selected as the research group and divided into three groups (ordinary, severe, and critically severe pneumonia) according to the disease severity. Meandwhile 66 non-infected patients during the same period were selected as negative control group. The expressions of WBC, LYM, CRP, SAA, and PCT were retrospective studied and compared between groups. The diagnostic values of WBC, CRP, SAA and the combination of these three markers in all patients with COVID-19 and in different severity groups were analyzed by ROC curve. \u0000 \u0000 \u0000Results \u0000Compared with control group (WBC count :8.13(6.51,9.42)×109/L, LYM count:2.00(1.28,2.43)×109/L), WBC count [4.94(4.05, 6.67) ×109/L] and LYM count [1.33(0.94, 1.96) ×109/L] of COVID-19 patients were significantly reduced (Z=-7.435, P<0.01; Z=-4.906, P<0.01) . Compared with the control group [CRP: 1.36 (0.57~5.67) mg/ml; SAA:[4.98 (4.80~15.75) mg/mL], CRP [7.93 (2.45~23.98) mg/ml] and SAA [34.13 (4.83~198.40) mg/ml] were increased in research group (Z=-5.72, P<0.01; Z=-4.166, P<0.01) . PCT in the control group and the research group were 0.100 0(0.030 6~0.100 0)ng/ml and 0.044 5(0.031 6~0.077 0)ng/ml, respectively. There was no statistical difference between two groups (Z=-1.451, P=0.147) . The areas under the ROC curve (AUC) of WBC, CRP and SAA in patients with COVID-19 were 0.814, 0.742, 0.673, respectively (P<0.01), while the AUC of the combination of three indexes for COVID-19 diagnosis was 0.882, with 83.33%(55/66) specificity and 84.76% (139/164) sensitivity, P<0.01.The AUCs of WBC, CRP, and SAA for predicting severe and critically severe COVID-19 were 0.799, 0.779, and 0.886 , respectively (P<0.01), and the AUC of the combination of three indexes for the diagnosis of severe and critically severe COVID-19 was 0.924, with 78.67% (118/150) specificity and 14/14 sensitivity (P<0.01). \u0000 \u0000 \u0000Conclusion \u0000Combining detection of WBC, CRP and SAA can improve the specificity and sensitivity of COVID-19 diagnosis, with a high diagnostic value for severe and critically severe COVID-19. \u0000 \u0000 \u0000Key words: \u0000Inflammation; Coronavirus; Pneumonia, viral; Leukocyte count; C-reactive protein; Serum amyloid A protein; Sensitivity and specificity","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"238 1","pages":"346-351"},"PeriodicalIF":0.0,"publicationDate":"2020-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"77013328","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 : 2020-02-22DOI: 10.3760/CMA.J.CN114452-20200215-00075
Q. Ye, Wei Li, Ming-Ming Zhou, Junfen Fu, Q. Shu, Fangqi Gong, S. Shang
Laboratory testing plays an important role in the diagnosis and treatment of patients with Novel Coronavirus pneumonia. However, the lack of understanding of the virus in the early stage led to great difficulties in biosafety protection for clinical laboratories. Based on the latest researches and findings about the virus, this paper provides some personal opinions on the biosafety prevention in clinical laboratorians under epidemic condition for the reference of laboratory workers. Key words: Coronavirus; Pneumonia, viral; Containment of biohazards
{"title":"Prevention and consideration for the biosafety of laboratory testing under epidemic condition","authors":"Q. Ye, Wei Li, Ming-Ming Zhou, Junfen Fu, Q. Shu, Fangqi Gong, S. Shang","doi":"10.3760/CMA.J.CN114452-20200215-00075","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114452-20200215-00075","url":null,"abstract":"Laboratory testing plays an important role in the diagnosis and treatment of patients with Novel Coronavirus pneumonia. However, the lack of understanding of the virus in the early stage led to great difficulties in biosafety protection for clinical laboratories. Based on the latest researches and findings about the virus, this paper provides some personal opinions on the biosafety prevention in clinical laboratorians under epidemic condition for the reference of laboratory workers. \u0000 \u0000Key words: \u0000Coronavirus; Pneumonia, viral; Containment of biohazards","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"68 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-02-22","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"89200579","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 : 2020-02-21DOI: 10.3760/CMA.J.CN114452-20200214-00070
Yu-ling Xiao, Xiao-jun Lu, M. Kang, Dongdong Li, Hong Jiang, Jie Chen, B. Ying, Yi Xie
During the outbreak of coronavirus disease-19 (COVID-19), the clinical laboratories of hospitals designated for the disease treatment is undertaking a lot of clinical testing work of infectious specimens. How to manage the biosafety risk is a major problem that the clinical laboratory and the nosocomial infection control department are facing. This article introduces the hierarchical prevention and control biosafety measures in the clinical laboratory from the perspective of the laboratory, with a view to provide reasonable and feasible methods for the clinical laboratories of hospitals at various levels during the outbreak. Key words: Coronavirus; Coronavirus infections; Severe acute respiratory syndrome; Communicable disease control
{"title":"The management of biosafety risk in clinical laboratory of hospital during the outbreak of 2019 Novel Coronavirus disease/ 中华检验医学杂志","authors":"Yu-ling Xiao, Xiao-jun Lu, M. Kang, Dongdong Li, Hong Jiang, Jie Chen, B. Ying, Yi Xie","doi":"10.3760/CMA.J.CN114452-20200214-00070","DOIUrl":"https://doi.org/10.3760/CMA.J.CN114452-20200214-00070","url":null,"abstract":"During the outbreak of coronavirus disease-19 (COVID-19), the clinical laboratories of hospitals designated for the disease treatment is undertaking a lot of clinical testing work of infectious specimens. How to manage the biosafety risk is a major problem that the clinical laboratory and the nosocomial infection control department are facing. This article introduces the hierarchical prevention and control biosafety measures in the clinical laboratory from the perspective of the laboratory, with a view to provide reasonable and feasible methods for the clinical laboratories of hospitals at various levels during the outbreak. \u0000 \u0000Key words: \u0000Coronavirus; Coronavirus infections; Severe acute respiratory syndrome; Communicable disease control","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"16 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-02-21","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"85705521","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 : 2020-02-19DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.0009
Xiuying Zhao
An outbreak of Novel Coronavirus (2019-nCoV), results in Coronavirus disease that began in Wuhan, China, has spread rapidly with cases now confirmed in multiple countries. Nucleic acid amplification test (NAAT), represent by reverse-transcriptase polymerase chain reaction (RT-PCR) plays an important role in disease diagnosis and treatment evaluation. The test results by RT-PCR have attracted much attention recently. As understanding to this novel pathogen is still limited, it would be much help to combine the knowledge about its pathogenesis to judge the test results, in addition to review the quality control in laboratory. This review will focus on understanding the specific RT-PCR performance of the 2019-nCoV, under the background of viral pneumonia. The purpose of this review is to add value to NAAT of 2019-nCoV, with combined knowledge of epidemiology, pathogenesis, clinical characteristics and pre-analysis quality control from viral pneumonia. Key words: Pneumonia, viral; Coronavirus; Nucleic acids; Clinical laboratory techniques; Quality control
{"title":"Suggestions casted to the novel coronavirus nucleic acid amplification test from viral pneumonia pathogenesis/ 中华检验医学杂志","authors":"Xiuying Zhao","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.0009","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.0009","url":null,"abstract":"An outbreak of Novel Coronavirus (2019-nCoV), results in Coronavirus disease that began in Wuhan, China, has spread rapidly with cases now confirmed in multiple countries. Nucleic acid amplification test (NAAT), represent by reverse-transcriptase polymerase chain reaction (RT-PCR) plays an important role in disease diagnosis and treatment evaluation. The test results by RT-PCR have attracted much attention recently. As understanding to this novel pathogen is still limited, it would be much help to combine the knowledge about its pathogenesis to judge the test results, in addition to review the quality control in laboratory. This review will focus on understanding the specific RT-PCR performance of the 2019-nCoV, under the background of viral pneumonia. The purpose of this review is to add value to NAAT of 2019-nCoV, with combined knowledge of epidemiology, pathogenesis, clinical characteristics and pre-analysis quality control from viral pneumonia. \u0000 \u0000Key words: \u0000Pneumonia, viral; Coronavirus; Nucleic acids; Clinical laboratory techniques; Quality control","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"54 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-02-19","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"84466057","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 : 2020-02-16DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.0008
Yue Tao, Q. Fu, X. Mo
As one of the two methods for 2019 novel coronavirus (2019-nCoV), gene sequencing is different from quantitative real-time PCR (RT-PCR) in detection principles. Therefore, gene sequencing has its own pros and cons in clinical application. Currently, metagenomic next-generation sequencing (mNGS) is the most commonly used technology in clinical application. Due to its broad coverage of all types of pathogens, mNGS demonstrates incomparable advantage in rapid identification of novel pathogens such as 2019-nCoV. In addition, it can simultaneously identify other pathogens except 2019-nCoV and mixed infections. On the other hand, however, due to the complexity of mNGS and long detection time, it is unlikely to achieve the purpose of wide-range and rapid diagnosis of 2019 n-CoV. Therefore, mNGS can complement RT-PCR to achieve best clinical application.
{"title":"Advantages and challenges of metagenomic next-generation sequencing (mNGS) in the detection of 2019 novel coronavirus/ 中华检验医学杂志","authors":"Yue Tao, Q. Fu, X. Mo","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.0008","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.0008","url":null,"abstract":"As one of the two methods for 2019 novel coronavirus (2019-nCoV), gene sequencing is different from quantitative real-time PCR (RT-PCR) in detection principles. Therefore, gene sequencing has its own pros and cons in clinical application. Currently, metagenomic next-generation sequencing (mNGS) is the most commonly used technology in clinical application. Due to its broad coverage of all types of pathogens, mNGS demonstrates incomparable advantage in rapid identification of novel pathogens such as 2019-nCoV. In addition, it can simultaneously identify other pathogens except 2019-nCoV and mixed infections. On the other hand, however, due to the complexity of mNGS and long detection time, it is unlikely to achieve the purpose of wide-range and rapid diagnosis of 2019 n-CoV. Therefore, mNGS can complement RT-PCR to achieve best clinical application.","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"1 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-02-16","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"83509035","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 : 2020-02-15DOI: 10.3760/CMA.J.ISSN.1009-9158.2010.0007
Wenhao Hua, Linjun Sheng, Li-hong Song, Qingtao Wang
The outbreak of 2019 Novel Coronavirus (2019-nCoV) has spread from Wuhan to the whole country. After the Spring Festival, workers will return to workplace and students will return to school. There is an increasing risk of 2019-nCoV cases being imported into provinces and cities. In order to promote the prevention and control of 2019-nCoV infection, reduce the risk of transmission in medical institutions, and ensure medical quality and medical safety, it is necessary to carry out the detection test of 2019-nCoV in biosafety class II laboratory. In order to achieve the goal of zero infection of the laboratory personnel, different preventive measures should be taken to assess the risk of the experimental activities. Key words: Coronavirus; Coronavirus infections; Risk assessment; Containment of Biohazards
{"title":"The laboratory risk assessment and control testing 2019 novel coronavirus in biosafety class II laboratories/ 中华检验医学杂志","authors":"Wenhao Hua, Linjun Sheng, Li-hong Song, Qingtao Wang","doi":"10.3760/CMA.J.ISSN.1009-9158.2010.0007","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2010.0007","url":null,"abstract":"The outbreak of 2019 Novel Coronavirus (2019-nCoV) has spread from Wuhan to the whole country. After the Spring Festival, workers will return to workplace and students will return to school. There is an increasing risk of 2019-nCoV cases being imported into provinces and cities. In order to promote the prevention and control of 2019-nCoV infection, reduce the risk of transmission in medical institutions, and ensure medical quality and medical safety, it is necessary to carry out the detection test of 2019-nCoV in biosafety class II laboratory. In order to achieve the goal of zero infection of the laboratory personnel, different preventive measures should be taken to assess the risk of the experimental activities. \u0000 \u0000Key words: \u0000Coronavirus; Coronavirus infections; Risk assessment; Containment of Biohazards","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"50 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-02-15","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"86522146","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 : 2020-02-14DOI: 10.3760/CMA.J.ISSN.1009-9158.2010.0006
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 NCP (Novel Coronavirus Pneumonia). 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":"Analysis of false-negative results for 2019 novel coronavirus nucleic acid test and related countermeasures/ 中华检验医学杂志","authors":"Jin Li, Guangming Ye, Liangjun Chen, Jiajun Wang, Yirong Li","doi":"10.3760/CMA.J.ISSN.1009-9158.2010.0006","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2010.0006","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 NCP (Novel Coronavirus Pneumonia). 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 \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":"3 1","pages":""},"PeriodicalIF":0.0,"publicationDate":"2020-02-14","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"76001582","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 : 2020-02-11DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.02.005
Wei Guo
With the development of precision oncology, a large number of clinical studies have confirmed the great potential of ctDNA in tumor management. However, the effectiveness and versatility of ctDNA detection are still questioned, which hinder the realization of clinical application of ctDNA detection, so there is an urgent need to develop unified quality control standards. The standardized pre-analytical processes for ctDNA analysis are the prerequisite to ensure the subsequent molecular detection. This paper will focus on the factors of quality control of pre-analytical processes for ctDNA analysis, in order to promote the standardized management of ctDNA detection. Key words: Circulating tumor DNA; Clinical laboratory techniques; Quality control
{"title":"Quality control of pre-analytical processes for ctDNA analysis","authors":"Wei Guo","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.02.005","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.02.005","url":null,"abstract":"With the development of precision oncology, a large number of clinical studies have confirmed the great potential of ctDNA in tumor management. However, the effectiveness and versatility of ctDNA detection are still questioned, which hinder the realization of clinical application of ctDNA detection, so there is an urgent need to develop unified quality control standards. The standardized pre-analytical processes for ctDNA analysis are the prerequisite to ensure the subsequent molecular detection. This paper will focus on the factors of quality control of pre-analytical processes for ctDNA analysis, in order to promote the standardized management of ctDNA detection. \u0000 \u0000 \u0000Key words: \u0000Circulating tumor DNA; Clinical laboratory techniques; Quality control","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"23 1","pages":"120-123"},"PeriodicalIF":0.0,"publicationDate":"2020-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"81884678","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 : 2020-02-11DOI: 10.3760/CMA.J.ISSN.1009-9158.2020.02.003
Zhen Cai, Lei Zheng, Jingping Liu, S. Pan
As "seeds" of tumor metastasis, circulating tumor cell (CTC) has important clinical application value in early diagnosis, immunotherapy and prognosis evaluation of tumors. With a deep understanding of CTC, its applied research has switched from cell enumeration to the molecular typing and single-cell sequencing. However, the standardization of CTC detection is still at a primary stage, opportunities and challenges coexist. This paper will review the current status and challenges in clinical applications of CTC detection, and make some suggestions for future development. Key words: Neoplastic cells, circulating; Liquid biopsy; Genetic heterogeneity; Reference standards; Biomarkers, tumor
{"title":"Circulating tumor cell detection approaching to clinical application","authors":"Zhen Cai, Lei Zheng, Jingping Liu, S. Pan","doi":"10.3760/CMA.J.ISSN.1009-9158.2020.02.003","DOIUrl":"https://doi.org/10.3760/CMA.J.ISSN.1009-9158.2020.02.003","url":null,"abstract":"As \"seeds\" of tumor metastasis, circulating tumor cell (CTC) has important clinical application value in early diagnosis, immunotherapy and prognosis evaluation of tumors. With a deep understanding of CTC, its applied research has switched from cell enumeration to the molecular typing and single-cell sequencing. However, the standardization of CTC detection is still at a primary stage, opportunities and challenges coexist. This paper will review the current status and challenges in clinical applications of CTC detection, and make some suggestions for future development. \u0000 \u0000 \u0000Key words: \u0000Neoplastic cells, circulating; Liquid biopsy; Genetic heterogeneity; Reference standards; Biomarkers, tumor","PeriodicalId":10096,"journal":{"name":"中华检验医学杂志","volume":"25 1","pages":"111-114"},"PeriodicalIF":0.0,"publicationDate":"2020-02-11","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":null,"resultStr":null,"platform":"Semanticscholar","paperid":"88227373","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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