Evaluation of an antigen assay for diagnosing acute and chronic hepatitis E genotype 4 infection
Background and Aim Results obtained from different hepatitis E virus (HEV) tests are usually inconsistent. The detection of serum HEV antigen (Ag) has been suggested to be more sensitive for the diagnosis of genotypes 1 and 3 HEV. Methods We compared the diagnostic accuracies of serum HEV Ag and HEV...
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| Veröffentlicht in: | Journal of gastroenterology and hepatology 2019-02, Vol.34 (2), p.458-465 |
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| creator | Zhang, Haiying Rao, Huiying Wang, Yijin Wang, Jianghua Kong, Xiangsha Ji, Ying Zhu, Ling Liu, Yan Fang, Jilian Yang, Ming Luo, Bifen Wang, Zhenyu Shi, Yijun Wang, Yu Wang, Hao Zhao, Jingmin Wei, Lai |
| description | Background and Aim
Results obtained from different hepatitis E virus (HEV) tests are usually inconsistent. The detection of serum HEV antigen (Ag) has been suggested to be more sensitive for the diagnosis of genotypes 1 and 3 HEV.
Methods
We compared the diagnostic accuracies of serum HEV Ag and HEV RNA by using 202 serum samples from patients suspected acute viral hepatitis.
Results
The HEV Ag assay was 100% specific. The lower detected levels of viremia ranged from 102 to 103 copies/mL. The sensitivity of the HEV Ag test was 90.5%. One of the 42 cases was negative for anti‐HEV IgM, but HEV Ag was still detectable. The detectable period of HEV Ag was in concordance with the detectable period of HEV RNA. Serum HEV Ag was persistently detected in two cases of chronic hepatitis E, confirmed by the persistent presence of HEV RNA despite being negative for anti‐HEV IgM. HEV Ag demonstrated good consistency with positive HEV RNA (k = 0.938, P 0.095 to predict HEV patients with 95.24% sensitivity and 98.75% specificity, and the area under the curve was 0.9887, which was higher than that of three commercial anti‐HEV IgM ELISA tests.
Conclusions
The presence of HEV Ag has good consistency with HEV RNA in both acute and chronic genotype 4 hepatitis E. HEV Ag is a more promising serum marker to identify active genotype 4 HEV infection than anti‐HEV IgM and HEV RNA. |
| doi_str_mv | 10.1111/jgh.14405 |
| format | Article |
| fullrecord | <record><control><sourceid>proquest_cross</sourceid><recordid>TN_cdi_proquest_miscellaneous_2082093764</recordid><sourceformat>XML</sourceformat><sourcesystem>PC</sourcesystem><sourcerecordid>2082093764</sourcerecordid><originalsourceid>FETCH-LOGICAL-c3535-334b4d9e8f031212fdb3a23a49c5e87d700a42a57ca0917287b70426f53c09e23</originalsourceid><addsrcrecordid>eNp1kE1LAzEQhoMotlYP_gEJeNHD6uRrszlKqVYRvOg5ptlsm7Ld1M2u0n9vatWD4DDwXp55GF6ETglckTTXy_niinAOYg8Nt5kRyfN9NISCiEwxogboKMYlAHCQ4hANGECuFIUhep28m7o3nQ8NDhU2TdrOz13KGM0GV6HFpTfzJkTfzLGxfecSUmK7aEPjLV64dbrufMQTnM5Ct1k7zLFvKme31mN0UJk6upPvHKGX28nzeJo9Pt3dj28eM8sEExljfMZL5YoKGKGEVuWMGcoMV1a4QpYSwHBqhLQGFJG0kDMJnOaVYBaUo2yELnbedRveehc7vfLRuro2jQt91BQKCorJnCf0_A-6DH3bpO80TeqcCKYgUZc7yrYhxtZVet36lWk3moDe1q5T7fqr9sSefRv72cqVv-RPzwm43gEfvnab_0364W66U34CN9CKGQ</addsrcrecordid><sourcetype>Aggregation Database</sourcetype><iscdi>true</iscdi><recordtype>article</recordtype><pqid>2172615390</pqid></control><display><type>article</type><title>Evaluation of an antigen assay for diagnosing acute and chronic hepatitis E genotype 4 infection</title><source>MEDLINE</source><source>Access via Wiley Online Library</source><creator>Zhang, Haiying ; Rao, Huiying ; Wang, Yijin ; Wang, Jianghua ; Kong, Xiangsha ; Ji, Ying ; Zhu, Ling ; Liu, Yan ; Fang, Jilian ; Yang, Ming ; Luo, Bifen ; Wang, Zhenyu ; Shi, Yijun ; Wang, Yu ; Wang, Hao ; Zhao, Jingmin ; Wei, Lai</creator><creatorcontrib>Zhang, Haiying ; Rao, Huiying ; Wang, Yijin ; Wang, Jianghua ; Kong, Xiangsha ; Ji, Ying ; Zhu, Ling ; Liu, Yan ; Fang, Jilian ; Yang, Ming ; Luo, Bifen ; Wang, Zhenyu ; Shi, Yijun ; Wang, Yu ; Wang, Hao ; Zhao, Jingmin ; Wei, Lai</creatorcontrib><description>Background and Aim
Results obtained from different hepatitis E virus (HEV) tests are usually inconsistent. The detection of serum HEV antigen (Ag) has been suggested to be more sensitive for the diagnosis of genotypes 1 and 3 HEV.
Methods
We compared the diagnostic accuracies of serum HEV Ag and HEV RNA by using 202 serum samples from patients suspected acute viral hepatitis.
Results
The HEV Ag assay was 100% specific. The lower detected levels of viremia ranged from 102 to 103 copies/mL. The sensitivity of the HEV Ag test was 90.5%. One of the 42 cases was negative for anti‐HEV IgM, but HEV Ag was still detectable. The detectable period of HEV Ag was in concordance with the detectable period of HEV RNA. Serum HEV Ag was persistently detected in two cases of chronic hepatitis E, confirmed by the persistent presence of HEV RNA despite being negative for anti‐HEV IgM. HEV Ag demonstrated good consistency with positive HEV RNA (k = 0.938, P < 0.001). Receiver operating characteristic analysis of HEV Ag suggested a second cut‐off value of >0.095 to predict HEV patients with 95.24% sensitivity and 98.75% specificity, and the area under the curve was 0.9887, which was higher than that of three commercial anti‐HEV IgM ELISA tests.
Conclusions
The presence of HEV Ag has good consistency with HEV RNA in both acute and chronic genotype 4 hepatitis E. HEV Ag is a more promising serum marker to identify active genotype 4 HEV infection than anti‐HEV IgM and HEV RNA.</description><identifier>ISSN: 0815-9319</identifier><identifier>EISSN: 1440-1746</identifier><identifier>DOI: 10.1111/jgh.14405</identifier><identifier>PMID: 30069920</identifier><language>eng</language><publisher>Australia: Wiley Subscription Services, Inc</publisher><subject>Acute Disease ; Adolescent ; Adult ; Aged ; Antigens ; Antigens, Viral - blood ; Antigens, Viral - immunology ; Biomarkers - blood ; chronic hepatitis E ; Chronic infection ; Enzyme-Linked Immunosorbent Assay ; Female ; Genotype ; Genotype & phenotype ; Genotypes ; Hepatitis ; Hepatitis Antibodies - blood ; Hepatitis E - diagnosis ; Hepatitis E - virology ; Hepatitis E virus - genetics ; Hepatitis E virus - immunology ; hepatitis E virus infection ; Hepatitis, Chronic - blood ; Hepatitis, Chronic - diagnosis ; Hepatitis, Chronic - virology ; HEV antigen ; Humans ; Immunoglobulin M ; Male ; Middle Aged ; Predictive Value of Tests ; Reproducibility of Results ; Ribonucleic acid ; RNA ; RNA, Viral - blood ; RNA, Viral - genetics ; Viremia ; Young Adult</subject><ispartof>Journal of gastroenterology and hepatology, 2019-02, Vol.34 (2), p.458-465</ispartof><rights>2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd</rights><rights>2018 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd.</rights><rights>2019 Journal of Gastroenterology and Hepatology Foundation and John Wiley & Sons Australia, Ltd</rights><lds50>peer_reviewed</lds50><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c3535-334b4d9e8f031212fdb3a23a49c5e87d700a42a57ca0917287b70426f53c09e23</citedby><cites>FETCH-LOGICAL-c3535-334b4d9e8f031212fdb3a23a49c5e87d700a42a57ca0917287b70426f53c09e23</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://onlinelibrary.wiley.com/doi/pdf/10.1111%2Fjgh.14405$$EPDF$$P50$$Gwiley$$H</linktopdf><linktohtml>$$Uhttps://onlinelibrary.wiley.com/doi/full/10.1111%2Fjgh.14405$$EHTML$$P50$$Gwiley$$H</linktohtml><link.rule.ids>314,780,784,1417,27924,27925,45574,45575</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/30069920$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Zhang, Haiying</creatorcontrib><creatorcontrib>Rao, Huiying</creatorcontrib><creatorcontrib>Wang, Yijin</creatorcontrib><creatorcontrib>Wang, Jianghua</creatorcontrib><creatorcontrib>Kong, Xiangsha</creatorcontrib><creatorcontrib>Ji, Ying</creatorcontrib><creatorcontrib>Zhu, Ling</creatorcontrib><creatorcontrib>Liu, Yan</creatorcontrib><creatorcontrib>Fang, Jilian</creatorcontrib><creatorcontrib>Yang, Ming</creatorcontrib><creatorcontrib>Luo, Bifen</creatorcontrib><creatorcontrib>Wang, Zhenyu</creatorcontrib><creatorcontrib>Shi, Yijun</creatorcontrib><creatorcontrib>Wang, Yu</creatorcontrib><creatorcontrib>Wang, Hao</creatorcontrib><creatorcontrib>Zhao, Jingmin</creatorcontrib><creatorcontrib>Wei, Lai</creatorcontrib><title>Evaluation of an antigen assay for diagnosing acute and chronic hepatitis E genotype 4 infection</title><title>Journal of gastroenterology and hepatology</title><addtitle>J Gastroenterol Hepatol</addtitle><description>Background and Aim
Results obtained from different hepatitis E virus (HEV) tests are usually inconsistent. The detection of serum HEV antigen (Ag) has been suggested to be more sensitive for the diagnosis of genotypes 1 and 3 HEV.
Methods
We compared the diagnostic accuracies of serum HEV Ag and HEV RNA by using 202 serum samples from patients suspected acute viral hepatitis.
Results
The HEV Ag assay was 100% specific. The lower detected levels of viremia ranged from 102 to 103 copies/mL. The sensitivity of the HEV Ag test was 90.5%. One of the 42 cases was negative for anti‐HEV IgM, but HEV Ag was still detectable. The detectable period of HEV Ag was in concordance with the detectable period of HEV RNA. Serum HEV Ag was persistently detected in two cases of chronic hepatitis E, confirmed by the persistent presence of HEV RNA despite being negative for anti‐HEV IgM. HEV Ag demonstrated good consistency with positive HEV RNA (k = 0.938, P < 0.001). Receiver operating characteristic analysis of HEV Ag suggested a second cut‐off value of >0.095 to predict HEV patients with 95.24% sensitivity and 98.75% specificity, and the area under the curve was 0.9887, which was higher than that of three commercial anti‐HEV IgM ELISA tests.
Conclusions
The presence of HEV Ag has good consistency with HEV RNA in both acute and chronic genotype 4 hepatitis E. HEV Ag is a more promising serum marker to identify active genotype 4 HEV infection than anti‐HEV IgM and HEV RNA.</description><subject>Acute Disease</subject><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Antigens</subject><subject>Antigens, Viral - blood</subject><subject>Antigens, Viral - immunology</subject><subject>Biomarkers - blood</subject><subject>chronic hepatitis E</subject><subject>Chronic infection</subject><subject>Enzyme-Linked Immunosorbent Assay</subject><subject>Female</subject><subject>Genotype</subject><subject>Genotype & phenotype</subject><subject>Genotypes</subject><subject>Hepatitis</subject><subject>Hepatitis Antibodies - blood</subject><subject>Hepatitis E - diagnosis</subject><subject>Hepatitis E - virology</subject><subject>Hepatitis E virus - genetics</subject><subject>Hepatitis E virus - immunology</subject><subject>hepatitis E virus infection</subject><subject>Hepatitis, Chronic - blood</subject><subject>Hepatitis, Chronic - diagnosis</subject><subject>Hepatitis, Chronic - virology</subject><subject>HEV antigen</subject><subject>Humans</subject><subject>Immunoglobulin M</subject><subject>Male</subject><subject>Middle Aged</subject><subject>Predictive Value of Tests</subject><subject>Reproducibility of Results</subject><subject>Ribonucleic acid</subject><subject>RNA</subject><subject>RNA, Viral - blood</subject><subject>RNA, Viral - genetics</subject><subject>Viremia</subject><subject>Young Adult</subject><issn>0815-9319</issn><issn>1440-1746</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp1kE1LAzEQhoMotlYP_gEJeNHD6uRrszlKqVYRvOg5ptlsm7Ld1M2u0n9vatWD4DDwXp55GF6ETglckTTXy_niinAOYg8Nt5kRyfN9NISCiEwxogboKMYlAHCQ4hANGECuFIUhep28m7o3nQ8NDhU2TdrOz13KGM0GV6HFpTfzJkTfzLGxfecSUmK7aEPjLV64dbrufMQTnM5Ct1k7zLFvKme31mN0UJk6upPvHKGX28nzeJo9Pt3dj28eM8sEExljfMZL5YoKGKGEVuWMGcoMV1a4QpYSwHBqhLQGFJG0kDMJnOaVYBaUo2yELnbedRveehc7vfLRuro2jQt91BQKCorJnCf0_A-6DH3bpO80TeqcCKYgUZc7yrYhxtZVet36lWk3moDe1q5T7fqr9sSefRv72cqVv-RPzwm43gEfvnab_0364W66U34CN9CKGQ</recordid><startdate>201902</startdate><enddate>201902</enddate><creator>Zhang, Haiying</creator><creator>Rao, Huiying</creator><creator>Wang, Yijin</creator><creator>Wang, Jianghua</creator><creator>Kong, Xiangsha</creator><creator>Ji, Ying</creator><creator>Zhu, Ling</creator><creator>Liu, Yan</creator><creator>Fang, Jilian</creator><creator>Yang, Ming</creator><creator>Luo, Bifen</creator><creator>Wang, Zhenyu</creator><creator>Shi, Yijun</creator><creator>Wang, Yu</creator><creator>Wang, Hao</creator><creator>Zhao, Jingmin</creator><creator>Wei, Lai</creator><general>Wiley Subscription Services, Inc</general><scope>CGR</scope><scope>CUY</scope><scope>CVF</scope><scope>ECM</scope><scope>EIF</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>7T5</scope><scope>7U9</scope><scope>H94</scope><scope>7X8</scope></search><sort><creationdate>201902</creationdate><title>Evaluation of an antigen assay for diagnosing acute and chronic hepatitis E genotype 4 infection</title><author>Zhang, Haiying ; Rao, Huiying ; Wang, Yijin ; Wang, Jianghua ; Kong, Xiangsha ; Ji, Ying ; Zhu, Ling ; Liu, Yan ; Fang, Jilian ; Yang, Ming ; Luo, Bifen ; Wang, Zhenyu ; Shi, Yijun ; Wang, Yu ; Wang, Hao ; Zhao, Jingmin ; Wei, Lai</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c3535-334b4d9e8f031212fdb3a23a49c5e87d700a42a57ca0917287b70426f53c09e23</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Acute Disease</topic><topic>Adolescent</topic><topic>Adult</topic><topic>Aged</topic><topic>Antigens</topic><topic>Antigens, Viral - blood</topic><topic>Antigens, Viral - immunology</topic><topic>Biomarkers - blood</topic><topic>chronic hepatitis E</topic><topic>Chronic infection</topic><topic>Enzyme-Linked Immunosorbent Assay</topic><topic>Female</topic><topic>Genotype</topic><topic>Genotype & phenotype</topic><topic>Genotypes</topic><topic>Hepatitis</topic><topic>Hepatitis Antibodies - blood</topic><topic>Hepatitis E - diagnosis</topic><topic>Hepatitis E - virology</topic><topic>Hepatitis E virus - genetics</topic><topic>Hepatitis E virus - immunology</topic><topic>hepatitis E virus infection</topic><topic>Hepatitis, Chronic - blood</topic><topic>Hepatitis, Chronic - diagnosis</topic><topic>Hepatitis, Chronic - virology</topic><topic>HEV antigen</topic><topic>Humans</topic><topic>Immunoglobulin M</topic><topic>Male</topic><topic>Middle Aged</topic><topic>Predictive Value of Tests</topic><topic>Reproducibility of Results</topic><topic>Ribonucleic acid</topic><topic>RNA</topic><topic>RNA, Viral - blood</topic><topic>RNA, Viral - genetics</topic><topic>Viremia</topic><topic>Young Adult</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zhang, Haiying</creatorcontrib><creatorcontrib>Rao, Huiying</creatorcontrib><creatorcontrib>Wang, Yijin</creatorcontrib><creatorcontrib>Wang, Jianghua</creatorcontrib><creatorcontrib>Kong, Xiangsha</creatorcontrib><creatorcontrib>Ji, Ying</creatorcontrib><creatorcontrib>Zhu, Ling</creatorcontrib><creatorcontrib>Liu, Yan</creatorcontrib><creatorcontrib>Fang, Jilian</creatorcontrib><creatorcontrib>Yang, Ming</creatorcontrib><creatorcontrib>Luo, Bifen</creatorcontrib><creatorcontrib>Wang, Zhenyu</creatorcontrib><creatorcontrib>Shi, Yijun</creatorcontrib><creatorcontrib>Wang, Yu</creatorcontrib><creatorcontrib>Wang, Hao</creatorcontrib><creatorcontrib>Zhao, Jingmin</creatorcontrib><creatorcontrib>Wei, Lai</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>Immunology Abstracts</collection><collection>Virology and AIDS Abstracts</collection><collection>AIDS and Cancer Research Abstracts</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of gastroenterology and hepatology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zhang, Haiying</au><au>Rao, Huiying</au><au>Wang, Yijin</au><au>Wang, Jianghua</au><au>Kong, Xiangsha</au><au>Ji, Ying</au><au>Zhu, Ling</au><au>Liu, Yan</au><au>Fang, Jilian</au><au>Yang, Ming</au><au>Luo, Bifen</au><au>Wang, Zhenyu</au><au>Shi, Yijun</au><au>Wang, Yu</au><au>Wang, Hao</au><au>Zhao, Jingmin</au><au>Wei, Lai</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of an antigen assay for diagnosing acute and chronic hepatitis E genotype 4 infection</atitle><jtitle>Journal of gastroenterology and hepatology</jtitle><addtitle>J Gastroenterol Hepatol</addtitle><date>2019-02</date><risdate>2019</risdate><volume>34</volume><issue>2</issue><spage>458</spage><epage>465</epage><pages>458-465</pages><issn>0815-9319</issn><eissn>1440-1746</eissn><abstract>Background and Aim
Results obtained from different hepatitis E virus (HEV) tests are usually inconsistent. The detection of serum HEV antigen (Ag) has been suggested to be more sensitive for the diagnosis of genotypes 1 and 3 HEV.
Methods
We compared the diagnostic accuracies of serum HEV Ag and HEV RNA by using 202 serum samples from patients suspected acute viral hepatitis.
Results
The HEV Ag assay was 100% specific. The lower detected levels of viremia ranged from 102 to 103 copies/mL. The sensitivity of the HEV Ag test was 90.5%. One of the 42 cases was negative for anti‐HEV IgM, but HEV Ag was still detectable. The detectable period of HEV Ag was in concordance with the detectable period of HEV RNA. Serum HEV Ag was persistently detected in two cases of chronic hepatitis E, confirmed by the persistent presence of HEV RNA despite being negative for anti‐HEV IgM. HEV Ag demonstrated good consistency with positive HEV RNA (k = 0.938, P < 0.001). Receiver operating characteristic analysis of HEV Ag suggested a second cut‐off value of >0.095 to predict HEV patients with 95.24% sensitivity and 98.75% specificity, and the area under the curve was 0.9887, which was higher than that of three commercial anti‐HEV IgM ELISA tests.
Conclusions
The presence of HEV Ag has good consistency with HEV RNA in both acute and chronic genotype 4 hepatitis E. HEV Ag is a more promising serum marker to identify active genotype 4 HEV infection than anti‐HEV IgM and HEV RNA.</abstract><cop>Australia</cop><pub>Wiley Subscription Services, Inc</pub><pmid>30069920</pmid><doi>10.1111/jgh.14405</doi><tpages>8</tpages></addata></record> |
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| subjects | Acute Disease Adolescent Adult Aged Antigens Antigens, Viral - blood Antigens, Viral - immunology Biomarkers - blood chronic hepatitis E Chronic infection Enzyme-Linked Immunosorbent Assay Female Genotype Genotype & phenotype Genotypes Hepatitis Hepatitis Antibodies - blood Hepatitis E - diagnosis Hepatitis E - virology Hepatitis E virus - genetics Hepatitis E virus - immunology hepatitis E virus infection Hepatitis, Chronic - blood Hepatitis, Chronic - diagnosis Hepatitis, Chronic - virology HEV antigen Humans Immunoglobulin M Male Middle Aged Predictive Value of Tests Reproducibility of Results Ribonucleic acid RNA RNA, Viral - blood RNA, Viral - genetics Viremia Young Adult |
| title | Evaluation of an antigen assay for diagnosing acute and chronic hepatitis E genotype 4 infection |
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