Qiang Wang, Qin Du, Bin Guo, Yangliu Guo, Li Fang, Xiaolan Guo
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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. \n \n \nResult \ns 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. \n \n \nConclusion \nThe 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. \n \n \nKey words: \nCoronavirus; 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":0.0000,"publicationDate":"2020-02-27","publicationTypes":"Journal Article","fieldsOfStudy":null,"isOpenAccess":false,"openAccessPdf":"","citationCount":"2","resultStr":"{\"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\":null,\"url\":null,\"abstract\":\"Objective \\nTo 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). \\n \\n \\nMethods \\nA 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. \\n \\n \\nResult \\ns 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. \\n \\n \\nConclusion \\nThe 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. \\n \\n \\nKey words: \\nCoronavirus; 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\":0.0000,\"publicationDate\":\"2020-02-27\",\"publicationTypes\":\"Journal Article\",\"fieldsOfStudy\":null,\"isOpenAccess\":false,\"openAccessPdf\":\"\",\"citationCount\":\"2\",\"resultStr\":null,\"platform\":\"Semanticscholar\",\"paperid\":null,\"PeriodicalName\":\"中华检验医学杂志\",\"FirstCategoryId\":\"3\",\"ListUrlMain\":\"https://doi.org/10.3760/CMA.J.CN114452-20200219-00091\",\"RegionNum\":0,\"RegionCategory\":null,\"ArticlePicture\":[],\"TitleCN\":null,\"AbstractTextCN\":null,\"PMCID\":null,\"EPubDate\":\"\",\"PubModel\":\"\",\"JCR\":\"Q4\",\"JCRName\":\"Health Professions\",\"Score\":null,\"Total\":0}","platform":"Semanticscholar","paperid":null,"PeriodicalName":"中华检验医学杂志","FirstCategoryId":"3","ListUrlMain":"https://doi.org/10.3760/CMA.J.CN114452-20200219-00091","RegionNum":0,"RegionCategory":null,"ArticlePicture":[],"TitleCN":null,"AbstractTextCN":null,"PMCID":null,"EPubDate":"","PubModel":"","JCR":"Q4","JCRName":"Health Professions","Score":null,"Total":0}
引用次数: 2
摘要
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
Performance of urea-mediated dissociation in reducing false-positive of 2019-nCoV IgM test
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
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