Evaluation of a new rapid fluorescence immunoassay for the diagnosis of dengue and Zika virus infection

•We evaluated a rapid Europium-based fluorescence serological test for DENV and ZIKV.•In acute dengue, combination of FIA-NS1Ag and/or IgM showed a sensitivity of 100%.•In past DENV, FIA-IgG test showed a sensitivity of 70%.•In acute ZIKV, combination of FIA-ZIKV Ag and/or IgM showed a sensitivity o...

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Veröffentlicht in:Journal of clinical virology 2019-03, Vol.112, p.34-39
Hauptverfasser: Zammarchi, Lorenzo, Colao, Maria Grazia, Mantella, Antonia, Capobianco, Teresa, Mazzarelli, Gianna, Ciccone, Nunziata, Tekle Kiros, Seble, Mantengoli, Elisabetta, Rossolini, Gian Maria, Bartoloni, Alessandro
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container_title Journal of clinical virology
container_volume 112
creator Zammarchi, Lorenzo
Colao, Maria Grazia
Mantella, Antonia
Capobianco, Teresa
Mazzarelli, Gianna
Ciccone, Nunziata
Tekle Kiros, Seble
Mantengoli, Elisabetta
Rossolini, Gian Maria
Bartoloni, Alessandro
description •We evaluated a rapid Europium-based fluorescence serological test for DENV and ZIKV.•In acute dengue, combination of FIA-NS1Ag and/or IgM showed a sensitivity of 100%.•In past DENV, FIA-IgG test showed a sensitivity of 70%.•In acute ZIKV, combination of FIA-ZIKV Ag and/or IgM showed a sensitivity of 72.7%.•In past ZIKV infection combination of FIA-ZIKV IgG and IgM an overall 90% sensitivity. Dengue (DENV) and Zika virus (ZIKV) are important mosquito-transmitted viruses. To investigate the performance of Standard F, Fluorescence Immunoassay (FIA, SD Biosensor Inc., Suwon, South Korea) providing results in 15 min to detect DENV IgG, IgM and NS1Ag, and ZIKV IgG, IgM, and Ag. A well-characterized panel of patient samples (11 acute DENV, 11 acute ZIKV, 10 past DENV, 10 past ZIKV infection, 36 with other conditions) were tested with the FIA test. In acute DENV infection, the combination of FIA-NS1Ag and/or IgM positivity showed a sensitivity of 100%. In past DENV, FIA-IgG test showed a sensitivity of 70%. Specificity of FIA-DENV NS1Ag, IgG, and IgM was 87.5%, 83.5%, and 91.7%, respectively. The sensitivity of FIA-ZIKV IgM and FIA-ZIKV Ag, in confirmed acute infection, was 72.7% and 9.1%, respectively. FIA-ZIKV Ag did not improve the sensitivity in detecting acute ZIKV infection, being positive only in one IgM positive sample. In past ZIKV infection (32–183 days after symptom onset), FIA-ZIKV IgG and IgM showed a sensitivity of 40% and 80% respectively, generating an overall 90% sensitivity. Specificity of FIA-ZIKV Ag, IgM, and IgG was 92.6%, 100%, and 97%, respectively. FIA test, a rapid and easy to perform assay, showed high sensitivity to detect acute DENV infection, but lower in acute ZIKV infection. In past ZIKV infections, the best performance of FIA test is obtained by combining detection of IgG and IgM.
doi_str_mv 10.1016/j.jcv.2019.01.011
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Dengue (DENV) and Zika virus (ZIKV) are important mosquito-transmitted viruses. To investigate the performance of Standard F, Fluorescence Immunoassay (FIA, SD Biosensor Inc., Suwon, South Korea) providing results in 15 min to detect DENV IgG, IgM and NS1Ag, and ZIKV IgG, IgM, and Ag. A well-characterized panel of patient samples (11 acute DENV, 11 acute ZIKV, 10 past DENV, 10 past ZIKV infection, 36 with other conditions) were tested with the FIA test. In acute DENV infection, the combination of FIA-NS1Ag and/or IgM positivity showed a sensitivity of 100%. In past DENV, FIA-IgG test showed a sensitivity of 70%. Specificity of FIA-DENV NS1Ag, IgG, and IgM was 87.5%, 83.5%, and 91.7%, respectively. The sensitivity of FIA-ZIKV IgM and FIA-ZIKV Ag, in confirmed acute infection, was 72.7% and 9.1%, respectively. FIA-ZIKV Ag did not improve the sensitivity in detecting acute ZIKV infection, being positive only in one IgM positive sample. In past ZIKV infection (32–183 days after symptom onset), FIA-ZIKV IgG and IgM showed a sensitivity of 40% and 80% respectively, generating an overall 90% sensitivity. Specificity of FIA-ZIKV Ag, IgM, and IgG was 92.6%, 100%, and 97%, respectively. FIA test, a rapid and easy to perform assay, showed high sensitivity to detect acute DENV infection, but lower in acute ZIKV infection. 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Dengue (DENV) and Zika virus (ZIKV) are important mosquito-transmitted viruses. To investigate the performance of Standard F, Fluorescence Immunoassay (FIA, SD Biosensor Inc., Suwon, South Korea) providing results in 15 min to detect DENV IgG, IgM and NS1Ag, and ZIKV IgG, IgM, and Ag. A well-characterized panel of patient samples (11 acute DENV, 11 acute ZIKV, 10 past DENV, 10 past ZIKV infection, 36 with other conditions) were tested with the FIA test. In acute DENV infection, the combination of FIA-NS1Ag and/or IgM positivity showed a sensitivity of 100%. In past DENV, FIA-IgG test showed a sensitivity of 70%. Specificity of FIA-DENV NS1Ag, IgG, and IgM was 87.5%, 83.5%, and 91.7%, respectively. The sensitivity of FIA-ZIKV IgM and FIA-ZIKV Ag, in confirmed acute infection, was 72.7% and 9.1%, respectively. FIA-ZIKV Ag did not improve the sensitivity in detecting acute ZIKV infection, being positive only in one IgM positive sample. In past ZIKV infection (32–183 days after symptom onset), FIA-ZIKV IgG and IgM showed a sensitivity of 40% and 80% respectively, generating an overall 90% sensitivity. Specificity of FIA-ZIKV Ag, IgM, and IgG was 92.6%, 100%, and 97%, respectively. FIA test, a rapid and easy to perform assay, showed high sensitivity to detect acute DENV infection, but lower in acute ZIKV infection. In past ZIKV infections, the best performance of FIA test is obtained by combining detection of IgG and IgM.</description><subject>Antibodies, Viral - blood</subject><subject>Antigens, Viral - immunology</subject><subject>Cross Reactions</subject><subject>Dengue</subject><subject>Dengue - diagnosis</subject><subject>Dengue - immunology</subject><subject>Dengue Virus</subject><subject>Fluorescence</subject><subject>Fluorescent Antibody Technique</subject><subject>Humans</subject><subject>Immunoglobulin G - blood</subject><subject>Immunoglobulin M - blood</subject><subject>Rapid</subject><subject>Sensitivity and Specificity</subject><subject>Serologic Tests</subject><subject>Serology</subject><subject>Zika</subject><subject>Zika Virus</subject><subject>Zika Virus Infection - diagnosis</subject><subject>Zika Virus Infection - immunology</subject><issn>1386-6532</issn><issn>1873-5967</issn><fulltext>true</fulltext><rsrctype>article</rsrctype><creationdate>2019</creationdate><recordtype>article</recordtype><sourceid>EIF</sourceid><recordid>eNp9kEFrGzEUhEVJqR23PyCXomMu67wn7a5keirBbQKBXnLqRShayZWzK7nSroP_fbU4zTEw8N5hZmA-Qq4Q1gjY3uzXe3NcM8DNGrAIP5AlSsGrZtOKi_Jz2VZtw9mCXOa8B8CG1-ITWXAQXPK2XZLd9qj7SY8-Bhod1TTYF5r0wXfU9VNMNhsbjKV-GKYQdc76RF1MdPxjaef1LsTs85zsbNhNlurQ0d_-WdOjT1OmPjhr5vLP5KPTfbZfXu-KPP7YPt7eVQ-_ft7ffn-oDG_4WEnHTY2irhuNAJxJYZ5YEdTOARhmpAPpagAtudOCaVkjdwYbJiRrNnxFrs-1hxT_TjaPavBlQd_rYOOUFcMyu26E5MWKZ6tJMedknTokP-h0Ughqxqv2quBVM14FWIQl8_W1fnoabPeW-M-zGL6dDbZsPHqbVDZ-Btj5VECoLvp36v8B0V2K6w</recordid><startdate>201903</startdate><enddate>201903</enddate><creator>Zammarchi, Lorenzo</creator><creator>Colao, Maria Grazia</creator><creator>Mantella, Antonia</creator><creator>Capobianco, Teresa</creator><creator>Mazzarelli, Gianna</creator><creator>Ciccone, Nunziata</creator><creator>Tekle Kiros, Seble</creator><creator>Mantengoli, Elisabetta</creator><creator>Rossolini, Gian Maria</creator><creator>Bartoloni, Alessandro</creator><general>Elsevier B.V</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>7X8</scope><orcidid>https://orcid.org/0000-0003-0892-8404</orcidid></search><sort><creationdate>201903</creationdate><title>Evaluation of a new rapid fluorescence immunoassay for the diagnosis of dengue and Zika virus infection</title><author>Zammarchi, Lorenzo ; Colao, Maria Grazia ; Mantella, Antonia ; Capobianco, Teresa ; Mazzarelli, Gianna ; Ciccone, Nunziata ; Tekle Kiros, Seble ; Mantengoli, Elisabetta ; Rossolini, Gian Maria ; Bartoloni, Alessandro</author></sort><facets><frbrtype>5</frbrtype><frbrgroupid>cdi_FETCH-LOGICAL-c353t-8f3c417445a1003287cb2cb204ff00c2c8f08f400a83fa72a8413fc152782593</frbrgroupid><rsrctype>articles</rsrctype><prefilter>articles</prefilter><language>eng</language><creationdate>2019</creationdate><topic>Antibodies, Viral - blood</topic><topic>Antigens, Viral - immunology</topic><topic>Cross Reactions</topic><topic>Dengue</topic><topic>Dengue - diagnosis</topic><topic>Dengue - immunology</topic><topic>Dengue Virus</topic><topic>Fluorescence</topic><topic>Fluorescent Antibody Technique</topic><topic>Humans</topic><topic>Immunoglobulin G - blood</topic><topic>Immunoglobulin M - blood</topic><topic>Rapid</topic><topic>Sensitivity and Specificity</topic><topic>Serologic Tests</topic><topic>Serology</topic><topic>Zika</topic><topic>Zika Virus</topic><topic>Zika Virus Infection - diagnosis</topic><topic>Zika Virus Infection - immunology</topic><toplevel>peer_reviewed</toplevel><toplevel>online_resources</toplevel><creatorcontrib>Zammarchi, Lorenzo</creatorcontrib><creatorcontrib>Colao, Maria Grazia</creatorcontrib><creatorcontrib>Mantella, Antonia</creatorcontrib><creatorcontrib>Capobianco, Teresa</creatorcontrib><creatorcontrib>Mazzarelli, Gianna</creatorcontrib><creatorcontrib>Ciccone, Nunziata</creatorcontrib><creatorcontrib>Tekle Kiros, Seble</creatorcontrib><creatorcontrib>Mantengoli, Elisabetta</creatorcontrib><creatorcontrib>Rossolini, Gian Maria</creatorcontrib><creatorcontrib>Bartoloni, Alessandro</creatorcontrib><collection>Medline</collection><collection>MEDLINE</collection><collection>MEDLINE (Ovid)</collection><collection>MEDLINE</collection><collection>MEDLINE</collection><collection>PubMed</collection><collection>CrossRef</collection><collection>MEDLINE - Academic</collection><jtitle>Journal of clinical virology</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Zammarchi, Lorenzo</au><au>Colao, Maria Grazia</au><au>Mantella, Antonia</au><au>Capobianco, Teresa</au><au>Mazzarelli, Gianna</au><au>Ciccone, Nunziata</au><au>Tekle Kiros, Seble</au><au>Mantengoli, Elisabetta</au><au>Rossolini, Gian Maria</au><au>Bartoloni, Alessandro</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Evaluation of a new rapid fluorescence immunoassay for the diagnosis of dengue and Zika virus infection</atitle><jtitle>Journal of clinical virology</jtitle><addtitle>J Clin Virol</addtitle><date>2019-03</date><risdate>2019</risdate><volume>112</volume><spage>34</spage><epage>39</epage><pages>34-39</pages><issn>1386-6532</issn><eissn>1873-5967</eissn><abstract>•We evaluated a rapid Europium-based fluorescence serological test for DENV and ZIKV.•In acute dengue, combination of FIA-NS1Ag and/or IgM showed a sensitivity of 100%.•In past DENV, FIA-IgG test showed a sensitivity of 70%.•In acute ZIKV, combination of FIA-ZIKV Ag and/or IgM showed a sensitivity of 72.7%.•In past ZIKV infection combination of FIA-ZIKV IgG and IgM an overall 90% sensitivity. Dengue (DENV) and Zika virus (ZIKV) are important mosquito-transmitted viruses. To investigate the performance of Standard F, Fluorescence Immunoassay (FIA, SD Biosensor Inc., Suwon, South Korea) providing results in 15 min to detect DENV IgG, IgM and NS1Ag, and ZIKV IgG, IgM, and Ag. A well-characterized panel of patient samples (11 acute DENV, 11 acute ZIKV, 10 past DENV, 10 past ZIKV infection, 36 with other conditions) were tested with the FIA test. In acute DENV infection, the combination of FIA-NS1Ag and/or IgM positivity showed a sensitivity of 100%. In past DENV, FIA-IgG test showed a sensitivity of 70%. Specificity of FIA-DENV NS1Ag, IgG, and IgM was 87.5%, 83.5%, and 91.7%, respectively. The sensitivity of FIA-ZIKV IgM and FIA-ZIKV Ag, in confirmed acute infection, was 72.7% and 9.1%, respectively. FIA-ZIKV Ag did not improve the sensitivity in detecting acute ZIKV infection, being positive only in one IgM positive sample. In past ZIKV infection (32–183 days after symptom onset), FIA-ZIKV IgG and IgM showed a sensitivity of 40% and 80% respectively, generating an overall 90% sensitivity. Specificity of FIA-ZIKV Ag, IgM, and IgG was 92.6%, 100%, and 97%, respectively. FIA test, a rapid and easy to perform assay, showed high sensitivity to detect acute DENV infection, but lower in acute ZIKV infection. In past ZIKV infections, the best performance of FIA test is obtained by combining detection of IgG and IgM.</abstract><cop>Netherlands</cop><pub>Elsevier B.V</pub><pmid>30738366</pmid><doi>10.1016/j.jcv.2019.01.011</doi><tpages>6</tpages><orcidid>https://orcid.org/0000-0003-0892-8404</orcidid></addata></record>
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subjects Antibodies, Viral - blood
Antigens, Viral - immunology
Cross Reactions
Dengue
Dengue - diagnosis
Dengue - immunology
Dengue Virus
Fluorescence
Fluorescent Antibody Technique
Humans
Immunoglobulin G - blood
Immunoglobulin M - blood
Rapid
Sensitivity and Specificity
Serologic Tests
Serology
Zika
Zika Virus
Zika Virus Infection - diagnosis
Zika Virus Infection - immunology
title Evaluation of a new rapid fluorescence immunoassay for the diagnosis of dengue and Zika virus infection
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