Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG
Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the de...
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| creator | Andries, Anne-Claire Duong, Veasna Ngan, Chantha Ong, Sivuth Huy, Rekol Sroin, Kim Kim Te, Vantha Y, Bunthin Try, Patrich Lorn Buchy, Philippe |
| description | Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory.
During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.
In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management. |
| doi_str_mv | 10.1371/journal.pntd.0001993 |
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During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.
In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management.</description><identifier>ISSN: 1935-2735</identifier><identifier>ISSN: 1935-2727</identifier><identifier>EISSN: 1935-2735</identifier><identifier>DOI: 10.1371/journal.pntd.0001993</identifier><identifier>PMID: 23301110</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Antibodies, Viral ; Antibodies, Viral - blood ; Antigens ; Antigens, Viral ; Antigens, Viral - blood ; Biology ; Cambodia ; Care and treatment ; Child ; Child, Preschool ; Clinical Laboratory Techniques ; Clinical Laboratory Techniques - methods ; Clinical medicine ; Dengue ; Dengue - diagnosis ; Dengue fever ; Diagnosis ; Diagnostic Tests, Routine ; Diagnostic Tests, Routine - methods ; Female ; Health aspects ; Hospitals ; Humans ; Immune status ; Immunoassay ; Immunoassay - methods ; Immunoglobulin G ; Immunoglobulin G - blood ; Immunoglobulin M ; Immunoglobulin M - blood ; Infections ; Laboratories ; Life Sciences ; Male ; Management decisions ; Medicine ; Microbiology and Parasitology ; Physicians ; Point-of-Care Systems ; Pregnancy ; Prospective Studies ; Quality assurance ; Reagent Kits, Diagnostic ; Retrospective Studies ; Sensitivity and Specificity ; Serology ; Tropical diseases ; Vector-borne diseases ; Viral Nonstructural Proteins ; Viral Nonstructural Proteins - blood ; Virology</subject><ispartof>PLoS neglected tropical diseases, 2012-12, Vol.6 (12), p.e1993-e1993</ispartof><rights>COPYRIGHT 2012 Public Library of Science</rights><rights>2012 Andries et al. This is an open-access article distributed under the terms of the Creative Commons Attribution License, which permits unrestricted use, distribution, and reproduction in any medium, provided the original author and source are credited: Andries A-C, Duong V, Ngan C, Ong S, Huy R, et al. (2012) Field Evaluation and Impact on Clinical Management of a Rapid Diagnostic Kit That Detects Dengue NS1, IgM and IgG. PLoS Negl Trop Dis 6(12): e1993. doi:10.1371/journal.pntd.0001993</rights><rights>Distributed under a Creative Commons Attribution 4.0 International License</rights><rights>2012 Andries et al 2012 Andries et al</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c662t-4499998d4370723126f3e17e64294f402c87b4e163b431519f555838200cd1e73</citedby><cites>FETCH-LOGICAL-c662t-4499998d4370723126f3e17e64294f402c87b4e163b431519f555838200cd1e73</cites><orcidid>0000-0003-0353-1678</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/PMC3531494/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC3531494/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,315,728,781,785,865,886,2103,2929,23870,27928,27929,53795,53797</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/23301110$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink><backlink>$$Uhttps://riip.hal.science/pasteur-00853141$$DView record in HAL$$Hfree_for_read</backlink></links><search><contributor>Farrar, Jeremy</contributor><creatorcontrib>Andries, Anne-Claire</creatorcontrib><creatorcontrib>Duong, Veasna</creatorcontrib><creatorcontrib>Ngan, Chantha</creatorcontrib><creatorcontrib>Ong, Sivuth</creatorcontrib><creatorcontrib>Huy, Rekol</creatorcontrib><creatorcontrib>Sroin, Kim Kim</creatorcontrib><creatorcontrib>Te, Vantha</creatorcontrib><creatorcontrib>Y, Bunthin</creatorcontrib><creatorcontrib>Try, Patrich Lorn</creatorcontrib><creatorcontrib>Buchy, Philippe</creatorcontrib><title>Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG</title><title>PLoS neglected tropical diseases</title><addtitle>PLoS Negl Trop Dis</addtitle><description>Dengue diagnosis is complex and until recently only specialized laboratories were able to definitively confirm dengue infection. Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory.
During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.
In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management.</description><subject>Antibodies, Viral</subject><subject>Antibodies, Viral - blood</subject><subject>Antigens</subject><subject>Antigens, Viral</subject><subject>Antigens, Viral - blood</subject><subject>Biology</subject><subject>Cambodia</subject><subject>Care and treatment</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Clinical Laboratory Techniques</subject><subject>Clinical Laboratory Techniques - methods</subject><subject>Clinical medicine</subject><subject>Dengue</subject><subject>Dengue - diagnosis</subject><subject>Dengue fever</subject><subject>Diagnosis</subject><subject>Diagnostic Tests, Routine</subject><subject>Diagnostic Tests, Routine - methods</subject><subject>Female</subject><subject>Health aspects</subject><subject>Hospitals</subject><subject>Humans</subject><subject>Immune status</subject><subject>Immunoassay</subject><subject>Immunoassay - 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Rapid tests are now available commercially making biological diagnosis possible in the field. The aim of this study was to evaluate a combined dengue rapid test for the detection of NS1 and IgM/IgG antibodies. The evaluation was made prospectively in the field conditions and included the study of the impact of its use as a point-of-care test for case management as well as retrospectively against a panel of well-characterized samples in a reference laboratory.
During the prospective study, 157 patients hospitalized for a suspicion of dengue were enrolled. In the hospital laboratories, the overall sensitivity, specificity, PPV and NPV of the NS1/IgM/IgG combination tests were 85.7%, 83.9%, 95.6% and 59.1% respectively, whereas they were 94,4%, 90.0%, 97.5% and 77.1% respectively in the national reference laboratory at Institut Pasteur in Cambodia. These results demonstrate that optimal performances require adequate training and quality assurance. The retrospective study showed that the sensitivity of the combined kit did not vary significantly between the serotypes and was not affected by the immune status or by the interval of time between onset of fever and sample collection. The analysis of the medical records indicates that the physicians did not take into consideration the results obtained with the rapid test including for care management and use of antibiotic therapy.
In the context of our prospective field study, we demonstrated that if the SD Bioline Dengue Duo kit is correctly used, a positive result highly suggests a dengue case but a negative result doesn't rule out a dengue infection. Nevertheless, Cambodian pediatricians in their daily practice relied on their clinical diagnosis and thus the false negative results obtained did not directly impact on the clinical management.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>23301110</pmid><doi>10.1371/journal.pntd.0001993</doi><orcidid>https://orcid.org/0000-0003-0353-1678</orcidid><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
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| ispartof | PLoS neglected tropical diseases, 2012-12, Vol.6 (12), p.e1993-e1993 |
| issn | 1935-2735 1935-2727 1935-2735 |
| language | eng |
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| source | MEDLINE; DOAJ Directory of Open Access Journals; PubMed Central Open Access; Public Library of Science (PLoS) Journals Open Access; EZB-FREE-00999 freely available EZB journals; PubMed Central |
| subjects | Antibodies, Viral Antibodies, Viral - blood Antigens Antigens, Viral Antigens, Viral - blood Biology Cambodia Care and treatment Child Child, Preschool Clinical Laboratory Techniques Clinical Laboratory Techniques - methods Clinical medicine Dengue Dengue - diagnosis Dengue fever Diagnosis Diagnostic Tests, Routine Diagnostic Tests, Routine - methods Female Health aspects Hospitals Humans Immune status Immunoassay Immunoassay - methods Immunoglobulin G Immunoglobulin G - blood Immunoglobulin M Immunoglobulin M - blood Infections Laboratories Life Sciences Male Management decisions Medicine Microbiology and Parasitology Physicians Point-of-Care Systems Pregnancy Prospective Studies Quality assurance Reagent Kits, Diagnostic Retrospective Studies Sensitivity and Specificity Serology Tropical diseases Vector-borne diseases Viral Nonstructural Proteins Viral Nonstructural Proteins - blood Virology |
| title | Field evaluation and impact on clinical management of a rapid diagnostic kit that detects dengue NS1, IgM and IgG |
| url | https://sfx.bib-bvb.de/sfx_tum?ctx_ver=Z39.88-2004&ctx_enc=info:ofi/enc:UTF-8&ctx_tim=2024-12-17T06%3A50%3A36IST&url_ver=Z39.88-2004&url_ctx_fmt=infofi/fmt:kev:mtx:ctx&rfr_id=info:sid/primo.exlibrisgroup.com:primo3-Article-gale_plos_&rft_val_fmt=info:ofi/fmt:kev:mtx:journal&rft.genre=article&rft.atitle=Field%20evaluation%20and%20impact%20on%20clinical%20management%20of%20a%20rapid%20diagnostic%20kit%20that%20detects%20dengue%20NS1,%20IgM%20and%20IgG&rft.jtitle=PLoS%20neglected%20tropical%20diseases&rft.au=Andries,%20Anne-Claire&rft.date=2012-12-01&rft.volume=6&rft.issue=12&rft.spage=e1993&rft.epage=e1993&rft.pages=e1993-e1993&rft.issn=1935-2735&rft.eissn=1935-2735&rft_id=info:doi/10.1371/journal.pntd.0001993&rft_dat=%3Cgale_plos_%3EA314800286%3C/gale_plos_%3E%3Curl%3E%3C/url%3E&disable_directlink=true&sfx.directlink=off&sfx.report_link=0&rft_id=info:oai/&rft_pqid=1288113480&rft_id=info:pmid/23301110&rft_galeid=A314800286&rft_doaj_id=oai_doaj_org_article_82a463a96e6e483fbdcf2f0a02c5ce13&rfr_iscdi=true |