Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China
Background. Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China. Automated chemiluminescence immunoassay (CLIA) and electrochemiluminescence immunoassay (ECLIA) had been used in clinical laboratories but not applied to screen HIV among blood...
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| description | Background. Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China. Automated chemiluminescence immunoassay (CLIA) and electrochemiluminescence immunoassay (ECLIA) had been used in clinical laboratories but not applied to screen HIV among blood donors. This study aimed to evaluate the performance of ELISA, CLIA, and ECLIA, focusing on the feasibility of CLIA/ECLIA for blood screening. Method. 1029 blood donations from 14 blood centers screened by ELISA were enrolled in the study. All plasma samples were tested by eight ELISA assays in 16 blood centers, followed by the detection of CLIA and ECLIA methods in the National Center for Clinical Laboratories (NCCL), further confirmed by nucleic acid testing (NAT) and Western blot (WB). Results. Of 1029 samples, 136 were confirmed as HIV positive. CLIA and ECLIA assay had similar sensitivities with ELISAs but showed higher specificity (CLIA: 99.1%, 885/893; ECLIA: 99.0%, 884/893), concordance rate (CLIA: 99.2%, 1021/1029; ECLIA: 99.1%, 1020/1029), and positive predictive value (PPV) (CLIA: 94.4%, 136/144; ECLIA: 93.8%, 136/145) than most of ELISA kits (>5 ELISAs) (P |
| doi_str_mv | 10.1155/2020/2164685 |
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Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China. Automated chemiluminescence immunoassay (CLIA) and electrochemiluminescence immunoassay (ECLIA) had been used in clinical laboratories but not applied to screen HIV among blood donors. This study aimed to evaluate the performance of ELISA, CLIA, and ECLIA, focusing on the feasibility of CLIA/ECLIA for blood screening. Method. 1029 blood donations from 14 blood centers screened by ELISA were enrolled in the study. All plasma samples were tested by eight ELISA assays in 16 blood centers, followed by the detection of CLIA and ECLIA methods in the National Center for Clinical Laboratories (NCCL), further confirmed by nucleic acid testing (NAT) and Western blot (WB). Results. Of 1029 samples, 136 were confirmed as HIV positive. CLIA and ECLIA assay had similar sensitivities with ELISAs but showed higher specificity (CLIA: 99.1%, 885/893; ECLIA: 99.0%, 884/893), concordance rate (CLIA: 99.2%, 1021/1029; ECLIA: 99.1%, 1020/1029), and positive predictive value (PPV) (CLIA: 94.4%, 136/144; ECLIA: 93.8%, 136/145) than most of ELISA kits (>5 ELISAs) (P<0.05). Kappa values of CLIA (0.967) and ECLIA (0.963) were the highest among all the serologic assays. Among 451 samples with initial ELISA reactivity, 315 were negatives, of which 307 (97.5%) and 306 (97.1%) were detected as nonreactive by CLIA (8 nonspecific reactions) and ECLIA (9 nonspecific reactions), respectively. Conclusion. Compared with ELISA, CLIA and ECLIA are more specific and accurate in detecting HIV antibody/antigen and can keep more nonspecifically reactive donors detected by ELISA. CLIA and ECLIA can be used for the improvement of serological blood screening strategy to avoid the unnecessary loss of blood donors.</description><identifier>ISSN: 1712-9532</identifier><identifier>EISSN: 1918-1493</identifier><identifier>DOI: 10.1155/2020/2164685</identifier><identifier>PMID: 32855748</identifier><language>eng</language><publisher>Cairo, Egypt: Hindawi Publishing Corporation</publisher><subject>Analysis ; Antibodies ; Antigens ; Automation ; Blood ; Blood & organ donations ; Blood banks ; Blood donors ; Chemiluminescence ; Comparative analysis ; Diagnostic tests ; Electrochemiluminescence ; Electronic components industry ; Enzyme-linked immunosorbent assay ; Enzymes ; Health aspects ; HIV ; HIV (Viruses) ; HIV infection ; HIV testing ; Human immunodeficiency virus ; Immunoassay ; Infectious diseases ; Laboratories ; Medical examination ; Medical laboratories ; Nucleic acids ; Performance evaluation ; Pharmacy ; Prevention ; Risk factors ; Screening ; Serology</subject><ispartof>The Canadian journal of infectious diseases & medical microbiology, 2020-08, Vol.2020 (2020), p.1-9</ispartof><rights>Copyright © 2020 Le Chang et al.</rights><rights>COPYRIGHT 2020 John Wiley & Sons, Inc.</rights><rights>Copyright © 2020 Le Chang et al. This is an open access article distributed under the Creative Commons Attribution License (the “License”), which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited. Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License. http://creativecommons.org/licenses/by/4.0</rights><rights>Copyright © 2020 Le Chang et al. 2020</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c787t-d3c64f93c5ae81f8115cbda11a583e2405112547b3c78d16078e1cb5a26a82053</citedby><cites>FETCH-LOGICAL-c787t-d3c64f93c5ae81f8115cbda11a583e2405112547b3c78d16078e1cb5a26a82053</cites><orcidid>0000-0002-8208-1718 ; 0000-0003-3163-7891</orcidid></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443234/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC7443234/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,727,780,784,864,877,885,2102,27924,27925,53791,53793</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/32855748$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><contributor>Lopalco, Lucia</contributor><contributor>Lucia Lopalco</contributor><creatorcontrib>Wang, Lunan</creatorcontrib><creatorcontrib>Zhang, Lu</creatorcontrib><creatorcontrib>Ji, Huimin</creatorcontrib><creatorcontrib>Guo, Fei</creatorcontrib><creatorcontrib>Zhao, Junpeng</creatorcontrib><creatorcontrib>Chang, Le</creatorcontrib><creatorcontrib>Jiang, Xinyi</creatorcontrib><title>Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China</title><title>The Canadian journal of infectious diseases & medical microbiology</title><addtitle>Can J Infect Dis Med Microbiol</addtitle><description>Background. Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China. Automated chemiluminescence immunoassay (CLIA) and electrochemiluminescence immunoassay (ECLIA) had been used in clinical laboratories but not applied to screen HIV among blood donors. This study aimed to evaluate the performance of ELISA, CLIA, and ECLIA, focusing on the feasibility of CLIA/ECLIA for blood screening. Method. 1029 blood donations from 14 blood centers screened by ELISA were enrolled in the study. All plasma samples were tested by eight ELISA assays in 16 blood centers, followed by the detection of CLIA and ECLIA methods in the National Center for Clinical Laboratories (NCCL), further confirmed by nucleic acid testing (NAT) and Western blot (WB). Results. Of 1029 samples, 136 were confirmed as HIV positive. CLIA and ECLIA assay had similar sensitivities with ELISAs but showed higher specificity (CLIA: 99.1%, 885/893; ECLIA: 99.0%, 884/893), concordance rate (CLIA: 99.2%, 1021/1029; ECLIA: 99.1%, 1020/1029), and positive predictive value (PPV) (CLIA: 94.4%, 136/144; ECLIA: 93.8%, 136/145) than most of ELISA kits (>5 ELISAs) (P<0.05). Kappa values of CLIA (0.967) and ECLIA (0.963) were the highest among all the serologic assays. Among 451 samples with initial ELISA reactivity, 315 were negatives, of which 307 (97.5%) and 306 (97.1%) were detected as nonreactive by CLIA (8 nonspecific reactions) and ECLIA (9 nonspecific reactions), respectively. Conclusion. Compared with ELISA, CLIA and ECLIA are more specific and accurate in detecting HIV antibody/antigen and can keep more nonspecifically reactive donors detected by ELISA. CLIA and ECLIA can be used for the improvement of serological blood screening strategy to avoid the unnecessary loss of blood donors.</description><subject>Analysis</subject><subject>Antibodies</subject><subject>Antigens</subject><subject>Automation</subject><subject>Blood</subject><subject>Blood & organ donations</subject><subject>Blood banks</subject><subject>Blood donors</subject><subject>Chemiluminescence</subject><subject>Comparative analysis</subject><subject>Diagnostic tests</subject><subject>Electrochemiluminescence</subject><subject>Electronic components industry</subject><subject>Enzyme-linked immunosorbent assay</subject><subject>Enzymes</subject><subject>Health aspects</subject><subject>HIV</subject><subject>HIV (Viruses)</subject><subject>HIV infection</subject><subject>HIV testing</subject><subject>Human immunodeficiency virus</subject><subject>Immunoassay</subject><subject>Infectious diseases</subject><subject>Laboratories</subject><subject>Medical examination</subject><subject>Medical laboratories</subject><subject>Nucleic acids</subject><subject>Performance evaluation</subject><subject>Pharmacy</subject><subject>Prevention</subject><subject>Risk factors</subject><subject>Screening</subject><subject>Serology</subject><issn>1712-9532</issn><issn>1918-1493</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2020</creationdate><recordtype>article</recordtype><sourceid>RHX</sourceid><sourceid>ABUWG</sourceid><sourceid>AFKRA</sourceid><sourceid>AZQEC</sourceid><sourceid>BENPR</sourceid><sourceid>CCPQU</sourceid><sourceid>DWQXO</sourceid><sourceid>DOA</sourceid><recordid>eNqNk1tv0zAUgCMEYmPwxjOyQEJIrFt8S5wXpNIVVqmIBy6v1onjtK5Su7OTov0FfjVOW7YWjWmKZB-dfP7sOOckyUucnmHM-TlJSXpOcMYywR8lx7jAYoBZQR_HOMdkUHBKjpJnISzSlGYE50-TI0oE5zkTx8nvkVuuwENr1hqN19B0MXQWga3QFw2h8xq5Gg2V6jyo6z4eTyffhuEUjaaTfurJ8SZGtfOonWt0oVutNpqIX05-oomtdwlYOjtDHxvnKnThrPMBGYtGc2PhefKkhiboF7v5JPnxafx9dDmYfv08GQ2nA5WLvB1UVGWsLqjioAWuRbwEVVaAMXBBNWEpx5hwlpc08hXO0lxorEoOJANBUk5PksnWWzlYyJU3S_DX0oGRm4TzMwm-NarRshSU0LQCDaJkFIuC1mXFFCGQ14LjLLo-bF2rrlzqSmnbemgOpIdvrJnLmVvLnLGoZlHwbifw7qrToZVLE5RuGrDadUESRkWWF1lRRPTNP-jCdd7Gq-qpjHLMMbmlZhA_wNjaxX1VL5VDgRkWWSGKe6mMioikm8O9voNSK3Ml91X_hfZNZ3dA8an00ihndW1i_uCAD1qwv8PbvQVzDU07D67p-qoLh-Z7wX3j6RZU3oXgdX3zW3Eq-9aTfevJXetF_NV-KdzAf3stAu-3QCz2Cn6ZB-p0ZHQNtzSmBY7DH5kINkk</recordid><startdate>20200814</startdate><enddate>20200814</enddate><creator>Wang, Lunan</creator><creator>Zhang, Lu</creator><creator>Ji, Huimin</creator><creator>Guo, Fei</creator><creator>Zhao, Junpeng</creator><creator>Chang, Le</creator><creator>Jiang, Xinyi</creator><general>Hindawi Publishing Corporation</general><general>Hindawi</general><general>John Wiley & Sons, Inc</general><general>Hindawi Limited</general><scope>ADJCN</scope><scope>AHFXO</scope><scope>RHU</scope><scope>RHW</scope><scope>RHX</scope><scope>NPM</scope><scope>AAYXX</scope><scope>CITATION</scope><scope>3V.</scope><scope>7T7</scope><scope>7X7</scope><scope>7XB</scope><scope>8FD</scope><scope>8FI</scope><scope>8FJ</scope><scope>8FK</scope><scope>8FQ</scope><scope>8FV</scope><scope>ABUWG</scope><scope>AFKRA</scope><scope>AZQEC</scope><scope>BENPR</scope><scope>C1K</scope><scope>CCPQU</scope><scope>DWQXO</scope><scope>FR3</scope><scope>FYUFA</scope><scope>GHDGH</scope><scope>K9.</scope><scope>M0S</scope><scope>P64</scope><scope>PIMPY</scope><scope>PQEST</scope><scope>PQQKQ</scope><scope>PQUKI</scope><scope>Q9U</scope><scope>7X8</scope><scope>5PM</scope><scope>DOA</scope><orcidid>https://orcid.org/0000-0002-8208-1718</orcidid><orcidid>https://orcid.org/0000-0003-3163-7891</orcidid></search><sort><creationdate>20200814</creationdate><title>Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China</title><author>Wang, Lunan ; Zhang, Lu ; Ji, Huimin ; Guo, Fei ; Zhao, Junpeng ; Chang, Le ; Jiang, Xinyi</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c787t-d3c64f93c5ae81f8115cbda11a583e2405112547b3c78d16078e1cb5a26a82053</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2020</creationdate><topic>Analysis</topic><topic>Antibodies</topic><topic>Antigens</topic><topic>Automation</topic><topic>Blood</topic><topic>Blood & organ donations</topic><topic>Blood banks</topic><topic>Blood donors</topic><topic>Chemiluminescence</topic><topic>Comparative analysis</topic><topic>Diagnostic tests</topic><topic>Electrochemiluminescence</topic><topic>Electronic components industry</topic><topic>Enzyme-linked immunosorbent assay</topic><topic>Enzymes</topic><topic>Health aspects</topic><topic>HIV</topic><topic>HIV (Viruses)</topic><topic>HIV infection</topic><topic>HIV testing</topic><topic>Human immunodeficiency virus</topic><topic>Immunoassay</topic><topic>Infectious diseases</topic><topic>Laboratories</topic><topic>Medical examination</topic><topic>Medical laboratories</topic><topic>Nucleic acids</topic><topic>Performance evaluation</topic><topic>Pharmacy</topic><topic>Prevention</topic><topic>Risk factors</topic><topic>Screening</topic><topic>Serology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Wang, Lunan</creatorcontrib><creatorcontrib>Zhang, Lu</creatorcontrib><creatorcontrib>Ji, Huimin</creatorcontrib><creatorcontrib>Guo, Fei</creatorcontrib><creatorcontrib>Zhao, Junpeng</creatorcontrib><creatorcontrib>Chang, Le</creatorcontrib><creatorcontrib>Jiang, Xinyi</creatorcontrib><collection>الدوريات العلمية والإحصائية - e-Marefa Academic and Statistical Periodicals</collection><collection>معرفة - المحتوى العربي الأكاديمي المتكامل - e-Marefa Academic Complete</collection><collection>Hindawi Publishing Complete</collection><collection>Hindawi Publishing Subscription Journals</collection><collection>Hindawi Publishing Open Access Journals</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>ProQuest Central (Corporate)</collection><collection>Industrial and Applied Microbiology Abstracts (Microbiology A)</collection><collection>Health & Medical Collection</collection><collection>ProQuest Central (purchase pre-March 2016)</collection><collection>Technology Research Database</collection><collection>Hospital Premium Collection</collection><collection>Hospital Premium Collection (Alumni Edition)</collection><collection>ProQuest Central (Alumni) (purchase pre-March 2016)</collection><collection>Canadian Business & Current Affairs Database</collection><collection>Canadian Business & Current Affairs Database (Alumni Edition)</collection><collection>ProQuest Central (Alumni Edition)</collection><collection>ProQuest Central UK/Ireland</collection><collection>ProQuest Central Essentials</collection><collection>ProQuest Central</collection><collection>Environmental Sciences and Pollution Management</collection><collection>ProQuest One Community College</collection><collection>ProQuest Central Korea</collection><collection>Engineering Research Database</collection><collection>Health Research Premium Collection</collection><collection>Health Research Premium Collection (Alumni)</collection><collection>ProQuest Health & Medical Complete (Alumni)</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Publicly Available Content Database</collection><collection>ProQuest One Academic Eastern Edition (DO NOT USE)</collection><collection>ProQuest One Academic</collection><collection>ProQuest One Academic UKI Edition</collection><collection>ProQuest Central Basic</collection><collection>MEDLINE - Academic</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>The Canadian journal of infectious diseases & medical microbiology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Wang, Lunan</au><au>Zhang, Lu</au><au>Ji, Huimin</au><au>Guo, Fei</au><au>Zhao, Junpeng</au><au>Chang, Le</au><au>Jiang, Xinyi</au><au>Lopalco, Lucia</au><au>Lucia Lopalco</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China</atitle><jtitle>The Canadian journal of infectious diseases & medical microbiology</jtitle><addtitle>Can J Infect Dis Med Microbiol</addtitle><date>2020-08-14</date><risdate>2020</risdate><volume>2020</volume><issue>2020</issue><spage>1</spage><epage>9</epage><pages>1-9</pages><issn>1712-9532</issn><eissn>1918-1493</eissn><abstract>Background. Enzyme-linked immunosorbent assay (ELISA) is the only serological method approved for blood screening in China. Automated chemiluminescence immunoassay (CLIA) and electrochemiluminescence immunoassay (ECLIA) had been used in clinical laboratories but not applied to screen HIV among blood donors. This study aimed to evaluate the performance of ELISA, CLIA, and ECLIA, focusing on the feasibility of CLIA/ECLIA for blood screening. Method. 1029 blood donations from 14 blood centers screened by ELISA were enrolled in the study. All plasma samples were tested by eight ELISA assays in 16 blood centers, followed by the detection of CLIA and ECLIA methods in the National Center for Clinical Laboratories (NCCL), further confirmed by nucleic acid testing (NAT) and Western blot (WB). Results. Of 1029 samples, 136 were confirmed as HIV positive. CLIA and ECLIA assay had similar sensitivities with ELISAs but showed higher specificity (CLIA: 99.1%, 885/893; ECLIA: 99.0%, 884/893), concordance rate (CLIA: 99.2%, 1021/1029; ECLIA: 99.1%, 1020/1029), and positive predictive value (PPV) (CLIA: 94.4%, 136/144; ECLIA: 93.8%, 136/145) than most of ELISA kits (>5 ELISAs) (P<0.05). Kappa values of CLIA (0.967) and ECLIA (0.963) were the highest among all the serologic assays. Among 451 samples with initial ELISA reactivity, 315 were negatives, of which 307 (97.5%) and 306 (97.1%) were detected as nonreactive by CLIA (8 nonspecific reactions) and ECLIA (9 nonspecific reactions), respectively. Conclusion. Compared with ELISA, CLIA and ECLIA are more specific and accurate in detecting HIV antibody/antigen and can keep more nonspecifically reactive donors detected by ELISA. CLIA and ECLIA can be used for the improvement of serological blood screening strategy to avoid the unnecessary loss of blood donors.</abstract><cop>Cairo, Egypt</cop><pub>Hindawi Publishing Corporation</pub><pmid>32855748</pmid><doi>10.1155/2020/2164685</doi><tpages>9</tpages><orcidid>https://orcid.org/0000-0002-8208-1718</orcidid><orcidid>https://orcid.org/0000-0003-3163-7891</orcidid><oa>free_for_read</oa></addata></record> |
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| source | DOAJ Directory of Open Access Journals; Elektronische Zeitschriftenbibliothek - Frei zugängliche E-Journals; Wiley-Blackwell Open Access Titles; PubMed Central; Alma/SFX Local Collection |
| subjects | Analysis Antibodies Antigens Automation Blood Blood & organ donations Blood banks Blood donors Chemiluminescence Comparative analysis Diagnostic tests Electrochemiluminescence Electronic components industry Enzyme-linked immunosorbent assay Enzymes Health aspects HIV HIV (Viruses) HIV infection HIV testing Human immunodeficiency virus Immunoassay Infectious diseases Laboratories Medical examination Medical laboratories Nucleic acids Performance evaluation Pharmacy Prevention Risk factors Screening Serology |
| title | Comparative Evaluation and Measure of Accuracy of ELISAs, CLIAs, and ECLIAs for the Detection of HIV Infection among Blood Donors in China |
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