Bead-based immunoassay allows sub-picogram detection of histidine-rich protein 2 from Plasmodium falciparum and estimates reliability of malaria rapid diagnostic tests
Detection of histidine-rich protein 2 (HRP2) from the malaria parasite Plasmodium falciparum provides evidence for active or recent infection, and is utilized for both diagnostic and surveillance purposes, but current laboratory immunoassays for HRP2 are hindered by low sensitivities and high costs....
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| Veröffentlicht in: | PloS one 2017-02, Vol.12 (2), p.e0172139-e0172139 |
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| creator | Rogier, Eric Plucinski, Mateusz Lucchi, Naomi Mace, Kimberly Chang, Michelle Lemoine, Jean Frantz Candrinho, Baltazar Colborn, James Dimbu, Rafael Fortes, Filomeno Udhayakumar, Venkatachalam Barnwell, John |
| description | Detection of histidine-rich protein 2 (HRP2) from the malaria parasite Plasmodium falciparum provides evidence for active or recent infection, and is utilized for both diagnostic and surveillance purposes, but current laboratory immunoassays for HRP2 are hindered by low sensitivities and high costs. Here we present a new HRP2 immunoassay based on antigen capture through a bead-based system capable of detecting HRP2 at sub-picogram levels. The assay is highly specific and cost-effective, allowing fast processing and screening of large numbers of samples. We utilized the assay to assess results of HRP2-based rapid diagnostic tests (RDTs) in different P. falciparum transmission settings, generating estimates for true performance in the field. Through this method of external validation, HRP2 RDTs were found to perform well in the high-endemic areas of Mozambique and Angola with 86.4% and 73.9% of persons with HRP2 in their blood testing positive by RDTs, respectively, and false-positive rates of 4.3% and 0.5%. However, in the low-endemic setting of Haiti, only 14.5% of persons found to be HRP2 positive by the bead assay were RDT positive. Additionally, 62.5% of Haitians showing a positive RDT test had no detectable HRP2 by the bead assay, likely indicating that these were false positive tests. In addition to RDT validation, HRP2 biomass was assessed for the populations in these different settings, and may provide an additional metric by which to estimate P. falciparum transmission intensity and measure the impact of interventions. |
| doi_str_mv | 10.1371/journal.pone.0172139 |
| format | Article |
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Here we present a new HRP2 immunoassay based on antigen capture through a bead-based system capable of detecting HRP2 at sub-picogram levels. The assay is highly specific and cost-effective, allowing fast processing and screening of large numbers of samples. We utilized the assay to assess results of HRP2-based rapid diagnostic tests (RDTs) in different P. falciparum transmission settings, generating estimates for true performance in the field. Through this method of external validation, HRP2 RDTs were found to perform well in the high-endemic areas of Mozambique and Angola with 86.4% and 73.9% of persons with HRP2 in their blood testing positive by RDTs, respectively, and false-positive rates of 4.3% and 0.5%. However, in the low-endemic setting of Haiti, only 14.5% of persons found to be HRP2 positive by the bead assay were RDT positive. Additionally, 62.5% of Haitians showing a positive RDT test had no detectable HRP2 by the bead assay, likely indicating that these were false positive tests. In addition to RDT validation, HRP2 biomass was assessed for the populations in these different settings, and may provide an additional metric by which to estimate P. falciparum transmission intensity and measure the impact of interventions.</description><identifier>ISSN: 1932-6203</identifier><identifier>EISSN: 1932-6203</identifier><identifier>DOI: 10.1371/journal.pone.0172139</identifier><identifier>PMID: 28192523</identifier><language>eng</language><publisher>United States: Public Library of Science</publisher><subject>Adolescent ; Adult ; Aged ; Aged, 80 and over ; Amino Acid Sequence ; Analysis ; Angola - epidemiology ; Antigens ; Antigens, Protozoan - analysis ; Biology and Life Sciences ; Care and treatment ; Child ; Child, Preschool ; Cross-Sectional Studies ; Diagnosis ; Diagnostic systems ; Diagnostic tests ; Diagnostic Tests, Routine - methods ; Disease control ; Disease prevention ; Endemic Diseases ; Erythrocytes ; Haiti - epidemiology ; Health aspects ; Health Surveys - methods ; Health Surveys - statistics & numerical data ; Histidine ; Host-Parasite Interactions ; Humans ; Immunoassay ; Immunoassay - methods ; Immunoassays ; Immunoglobulins ; Infant ; Infections ; Malaria ; Malaria, Falciparum - diagnosis ; Malaria, Falciparum - epidemiology ; Malaria, Falciparum - parasitology ; Medical diagnosis ; Medicine and Health Sciences ; Microscopy ; Middle Aged ; Mozambique - epidemiology ; Parasites ; Parasitic diseases ; People and Places ; Plasmodium falciparum ; Plasmodium falciparum - genetics ; Plasmodium falciparum - metabolism ; Plasmodium falciparum - physiology ; Polyvinyl alcohol ; Product testing ; Proteins ; Protozoan Proteins - analysis ; Protozoan Proteins - genetics ; Reproducibility of Results ; Research and Analysis Methods ; Sensitivity and Specificity ; Vector-borne diseases ; Womens health ; Young Adult</subject><ispartof>PloS one, 2017-02, Vol.12 (2), p.e0172139-e0172139</ispartof><rights>COPYRIGHT 2017 Public Library of Science</rights><rights>This is an open access article, free of all copyright, and may be freely reproduced, distributed, transmitted, modified, built upon, or otherwise used by anyone for any lawful purpose. The work is made available under the Creative Commons CC0 public domain dedication: https://creativecommons.org/publicdomain/zero/1.0/ (the “License”). Notwithstanding the ProQuest Terms and Conditions, you may use this content in accordance with the terms of the License.</rights><lds50>peer_reviewed</lds50><oa>free_for_read</oa><woscitedreferencessubscribed>false</woscitedreferencessubscribed><citedby>FETCH-LOGICAL-c655t-ff75ab2f92a79c22eae167eff9ca713ea3243b5cdcdea52b736c692b5e6cbb333</citedby><cites>FETCH-LOGICAL-c655t-ff75ab2f92a79c22eae167eff9ca713ea3243b5cdcdea52b736c692b5e6cbb333</cites></display><links><openurl>$$Topenurl_article</openurl><openurlfulltext>$$Topenurlfull_article</openurlfulltext><thumbnail>$$Tsyndetics_thumb_exl</thumbnail><linktopdf>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5305216/pdf/$$EPDF$$P50$$Gpubmedcentral$$Hfree_for_read</linktopdf><linktohtml>$$Uhttps://www.ncbi.nlm.nih.gov/pmc/articles/PMC5305216/$$EHTML$$P50$$Gpubmedcentral$$Hfree_for_read</linktohtml><link.rule.ids>230,314,723,776,780,860,881,2096,2915,23845,27901,27902,53766,53768,79342,79343</link.rule.ids><backlink>$$Uhttps://www.ncbi.nlm.nih.gov/pubmed/28192523$$D View this record in MEDLINE/PubMed$$Hfree_for_read</backlink></links><search><creatorcontrib>Rogier, Eric</creatorcontrib><creatorcontrib>Plucinski, Mateusz</creatorcontrib><creatorcontrib>Lucchi, Naomi</creatorcontrib><creatorcontrib>Mace, Kimberly</creatorcontrib><creatorcontrib>Chang, Michelle</creatorcontrib><creatorcontrib>Lemoine, Jean Frantz</creatorcontrib><creatorcontrib>Candrinho, Baltazar</creatorcontrib><creatorcontrib>Colborn, James</creatorcontrib><creatorcontrib>Dimbu, Rafael</creatorcontrib><creatorcontrib>Fortes, Filomeno</creatorcontrib><creatorcontrib>Udhayakumar, Venkatachalam</creatorcontrib><creatorcontrib>Barnwell, John</creatorcontrib><title>Bead-based immunoassay allows sub-picogram detection of histidine-rich protein 2 from Plasmodium falciparum and estimates reliability of malaria rapid diagnostic tests</title><title>PloS one</title><addtitle>PLoS One</addtitle><description>Detection of histidine-rich protein 2 (HRP2) from the malaria parasite Plasmodium falciparum provides evidence for active or recent infection, and is utilized for both diagnostic and surveillance purposes, but current laboratory immunoassays for HRP2 are hindered by low sensitivities and high costs. Here we present a new HRP2 immunoassay based on antigen capture through a bead-based system capable of detecting HRP2 at sub-picogram levels. The assay is highly specific and cost-effective, allowing fast processing and screening of large numbers of samples. We utilized the assay to assess results of HRP2-based rapid diagnostic tests (RDTs) in different P. falciparum transmission settings, generating estimates for true performance in the field. Through this method of external validation, HRP2 RDTs were found to perform well in the high-endemic areas of Mozambique and Angola with 86.4% and 73.9% of persons with HRP2 in their blood testing positive by RDTs, respectively, and false-positive rates of 4.3% and 0.5%. However, in the low-endemic setting of Haiti, only 14.5% of persons found to be HRP2 positive by the bead assay were RDT positive. Additionally, 62.5% of Haitians showing a positive RDT test had no detectable HRP2 by the bead assay, likely indicating that these were false positive tests. In addition to RDT validation, HRP2 biomass was assessed for the populations in these different settings, and may provide an additional metric by which to estimate P. falciparum transmission intensity and measure the impact of interventions.</description><subject>Adolescent</subject><subject>Adult</subject><subject>Aged</subject><subject>Aged, 80 and over</subject><subject>Amino Acid Sequence</subject><subject>Analysis</subject><subject>Angola - epidemiology</subject><subject>Antigens</subject><subject>Antigens, Protozoan - analysis</subject><subject>Biology and Life Sciences</subject><subject>Care and treatment</subject><subject>Child</subject><subject>Child, Preschool</subject><subject>Cross-Sectional Studies</subject><subject>Diagnosis</subject><subject>Diagnostic systems</subject><subject>Diagnostic tests</subject><subject>Diagnostic Tests, Routine - methods</subject><subject>Disease control</subject><subject>Disease prevention</subject><subject>Endemic Diseases</subject><subject>Erythrocytes</subject><subject>Haiti - 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Academic</collection><collection>ProQuest Engineering Collection</collection><collection>ProQuest Biological Science Collection</collection><collection>Agricultural Science Database</collection><collection>Health & Medical Collection (Alumni Edition)</collection><collection>Medical Database</collection><collection>Algology Mycology and Protozoology Abstracts (Microbiology C)</collection><collection>Biological Science Database</collection><collection>Engineering Database</collection><collection>Nursing & Allied Health Premium</collection><collection>Advanced Technologies & Aerospace Database</collection><collection>ProQuest Advanced Technologies & Aerospace Collection</collection><collection>Biotechnology and BioEngineering Abstracts</collection><collection>Environmental Science Database</collection><collection>Materials Science Collection</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>Engineering Collection</collection><collection>Environmental Science Collection</collection><collection>Genetics Abstracts</collection><collection>MEDLINE - Academic</collection><collection>ASFA: Aquatic Sciences and Fisheries Abstracts</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 1: Biological Sciences & Living Resources</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) 3: Aquatic Pollution & Environmental Quality</collection><collection>Aquatic Science & Fisheries Abstracts (ASFA) Professional</collection><collection>PubMed Central (Full Participant titles)</collection><collection>DOAJ Directory of Open Access Journals</collection><jtitle>PloS one</jtitle></facets><delivery><delcategory>Remote Search Resource</delcategory><fulltext>fulltext</fulltext></delivery><addata><au>Rogier, Eric</au><au>Plucinski, Mateusz</au><au>Lucchi, Naomi</au><au>Mace, Kimberly</au><au>Chang, Michelle</au><au>Lemoine, Jean Frantz</au><au>Candrinho, Baltazar</au><au>Colborn, James</au><au>Dimbu, Rafael</au><au>Fortes, Filomeno</au><au>Udhayakumar, Venkatachalam</au><au>Barnwell, John</au><format>journal</format><genre>article</genre><ristype>JOUR</ristype><atitle>Bead-based immunoassay allows sub-picogram detection of histidine-rich protein 2 from Plasmodium falciparum and estimates reliability of malaria rapid diagnostic tests</atitle><jtitle>PloS one</jtitle><addtitle>PLoS One</addtitle><date>2017-02-13</date><risdate>2017</risdate><volume>12</volume><issue>2</issue><spage>e0172139</spage><epage>e0172139</epage><pages>e0172139-e0172139</pages><issn>1932-6203</issn><eissn>1932-6203</eissn><abstract>Detection of histidine-rich protein 2 (HRP2) from the malaria parasite Plasmodium falciparum provides evidence for active or recent infection, and is utilized for both diagnostic and surveillance purposes, but current laboratory immunoassays for HRP2 are hindered by low sensitivities and high costs. Here we present a new HRP2 immunoassay based on antigen capture through a bead-based system capable of detecting HRP2 at sub-picogram levels. The assay is highly specific and cost-effective, allowing fast processing and screening of large numbers of samples. We utilized the assay to assess results of HRP2-based rapid diagnostic tests (RDTs) in different P. falciparum transmission settings, generating estimates for true performance in the field. Through this method of external validation, HRP2 RDTs were found to perform well in the high-endemic areas of Mozambique and Angola with 86.4% and 73.9% of persons with HRP2 in their blood testing positive by RDTs, respectively, and false-positive rates of 4.3% and 0.5%. However, in the low-endemic setting of Haiti, only 14.5% of persons found to be HRP2 positive by the bead assay were RDT positive. Additionally, 62.5% of Haitians showing a positive RDT test had no detectable HRP2 by the bead assay, likely indicating that these were false positive tests. In addition to RDT validation, HRP2 biomass was assessed for the populations in these different settings, and may provide an additional metric by which to estimate P. falciparum transmission intensity and measure the impact of interventions.</abstract><cop>United States</cop><pub>Public Library of Science</pub><pmid>28192523</pmid><doi>10.1371/journal.pone.0172139</doi><tpages>e0172139</tpages><oa>free_for_read</oa></addata></record> |
| fulltext | fulltext |
| identifier | ISSN: 1932-6203 |
| ispartof | PloS one, 2017-02, Vol.12 (2), p.e0172139-e0172139 |
| issn | 1932-6203 1932-6203 |
| language | eng |
| recordid | cdi_plos_journals_1870231047 |
| source | Public Library of Science (PLoS) Journals Open Access; MEDLINE; DOAJ Directory of Open Access Journals; EZB-FREE-00999 freely available EZB journals; PubMed Central; Free Full-Text Journals in Chemistry |
| subjects | Adolescent Adult Aged Aged, 80 and over Amino Acid Sequence Analysis Angola - epidemiology Antigens Antigens, Protozoan - analysis Biology and Life Sciences Care and treatment Child Child, Preschool Cross-Sectional Studies Diagnosis Diagnostic systems Diagnostic tests Diagnostic Tests, Routine - methods Disease control Disease prevention Endemic Diseases Erythrocytes Haiti - epidemiology Health aspects Health Surveys - methods Health Surveys - statistics & numerical data Histidine Host-Parasite Interactions Humans Immunoassay Immunoassay - methods Immunoassays Immunoglobulins Infant Infections Malaria Malaria, Falciparum - diagnosis Malaria, Falciparum - epidemiology Malaria, Falciparum - parasitology Medical diagnosis Medicine and Health Sciences Microscopy Middle Aged Mozambique - epidemiology Parasites Parasitic diseases People and Places Plasmodium falciparum Plasmodium falciparum - genetics Plasmodium falciparum - metabolism Plasmodium falciparum - physiology Polyvinyl alcohol Product testing Proteins Protozoan Proteins - analysis Protozoan Proteins - genetics Reproducibility of Results Research and Analysis Methods Sensitivity and Specificity Vector-borne diseases Womens health Young Adult |
| title | Bead-based immunoassay allows sub-picogram detection of histidine-rich protein 2 from Plasmodium falciparum and estimates reliability of malaria rapid diagnostic tests |
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