A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus.
Serological assays for human IgG4 to the Onchocerca volvulus antigen Ov16 have been used to confirm elimination of onchocerciasis in much of the Americas and parts of Africa. A standardized source of positive control antibody (human anti-Ov16 IgG4) will ensure the quality of surveillance data using...
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ftdoajarticles:oai:doaj.org/article:fc119ed08a81444787e314d1af42cc83 2023-05-15T15:16:10+02:00 A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus. Allison Golden Eric J Stevens Lindsay Yokobe Dunia Faulx Michael Kalnoky Roger Peck Melissa Valdez Cathy Steel Potochoziou Karabou Méba Banla Peter T Soboslay Kangi Adade Afework H Tekle Vitaliano A Cama Peter U Fischer Thomas B Nutman Thomas R Unnasch Tala de los Santos Gonzalo J Domingo 2016-01-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0004292 https://doaj.org/article/fc119ed08a81444787e314d1af42cc83 EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC4706346?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0004292 https://doaj.org/article/fc119ed08a81444787e314d1af42cc83 PLoS Neglected Tropical Diseases, Vol 10, Iss 1, p e0004292 (2016) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2016 ftdoajarticles https://doi.org/10.1371/journal.pntd.0004292 2022-12-31T01:09:27Z Serological assays for human IgG4 to the Onchocerca volvulus antigen Ov16 have been used to confirm elimination of onchocerciasis in much of the Americas and parts of Africa. A standardized source of positive control antibody (human anti-Ov16 IgG4) will ensure the quality of surveillance data using these tests.A recombinant human IgG4 antibody to Ov16 was identified by screening against a synthetic human Fab phage display library and converted into human IgG4. This antibody was developed into different positive control formulations for enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT) platforms. Variation in ELISA results and utility as a positive control of the antibody were assessed from multiple laboratories. Temperature and humidity conditions were collected across seven surveillance activities from 2011-2014 to inform stability requirements for RDTs and positive controls. The feasibility of the dried positive control for RDT was evaluated during onchocerciasis surveillance activity in Togo, in 2014. When the anti-Ov16 IgG4 antibody was used as a standard dilution in horseradish peroxidase (HRP) and alkaline phosphatase (AP) ELISAs, the detection limits were approximately 1ng/mL by HRP ELISA and 10ng/mL by AP ELISA. Positive control dilutions and spiked dried blood spots (DBS) produced similar ELISA results. Used as a simple plate normalization control, the positive control antibody may improve ELISA data comparison in the context of inter-laboratory variation. The aggregate temperature and humidity monitor data informed temperature parameters under which the dried positive control was tested and are applicable inputs for testing of diagnostics tools intended for sub-Saharan Africa. As a packaged positive control for Ov16 RDTs, stability of the antibody was demonstrated for over six months at relevant temperatures in the laboratory and for over 15 weeks under field conditions.The recombinant human anti-Ov16 IgG4 antibody-based positive control will benefit inter-laboratory validation ... Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLOS Neglected Tropical Diseases 10 1 e0004292 |
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topic |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
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Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 Allison Golden Eric J Stevens Lindsay Yokobe Dunia Faulx Michael Kalnoky Roger Peck Melissa Valdez Cathy Steel Potochoziou Karabou Méba Banla Peter T Soboslay Kangi Adade Afework H Tekle Vitaliano A Cama Peter U Fischer Thomas B Nutman Thomas R Unnasch Tala de los Santos Gonzalo J Domingo A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Serological assays for human IgG4 to the Onchocerca volvulus antigen Ov16 have been used to confirm elimination of onchocerciasis in much of the Americas and parts of Africa. A standardized source of positive control antibody (human anti-Ov16 IgG4) will ensure the quality of surveillance data using these tests.A recombinant human IgG4 antibody to Ov16 was identified by screening against a synthetic human Fab phage display library and converted into human IgG4. This antibody was developed into different positive control formulations for enzyme-linked immunosorbent assay (ELISA) and rapid diagnostic test (RDT) platforms. Variation in ELISA results and utility as a positive control of the antibody were assessed from multiple laboratories. Temperature and humidity conditions were collected across seven surveillance activities from 2011-2014 to inform stability requirements for RDTs and positive controls. The feasibility of the dried positive control for RDT was evaluated during onchocerciasis surveillance activity in Togo, in 2014. When the anti-Ov16 IgG4 antibody was used as a standard dilution in horseradish peroxidase (HRP) and alkaline phosphatase (AP) ELISAs, the detection limits were approximately 1ng/mL by HRP ELISA and 10ng/mL by AP ELISA. Positive control dilutions and spiked dried blood spots (DBS) produced similar ELISA results. Used as a simple plate normalization control, the positive control antibody may improve ELISA data comparison in the context of inter-laboratory variation. The aggregate temperature and humidity monitor data informed temperature parameters under which the dried positive control was tested and are applicable inputs for testing of diagnostics tools intended for sub-Saharan Africa. As a packaged positive control for Ov16 RDTs, stability of the antibody was demonstrated for over six months at relevant temperatures in the laboratory and for over 15 weeks under field conditions.The recombinant human anti-Ov16 IgG4 antibody-based positive control will benefit inter-laboratory validation ... |
format |
Article in Journal/Newspaper |
author |
Allison Golden Eric J Stevens Lindsay Yokobe Dunia Faulx Michael Kalnoky Roger Peck Melissa Valdez Cathy Steel Potochoziou Karabou Méba Banla Peter T Soboslay Kangi Adade Afework H Tekle Vitaliano A Cama Peter U Fischer Thomas B Nutman Thomas R Unnasch Tala de los Santos Gonzalo J Domingo |
author_facet |
Allison Golden Eric J Stevens Lindsay Yokobe Dunia Faulx Michael Kalnoky Roger Peck Melissa Valdez Cathy Steel Potochoziou Karabou Méba Banla Peter T Soboslay Kangi Adade Afework H Tekle Vitaliano A Cama Peter U Fischer Thomas B Nutman Thomas R Unnasch Tala de los Santos Gonzalo J Domingo |
author_sort |
Allison Golden |
title |
A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus. |
title_short |
A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus. |
title_full |
A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus. |
title_fullStr |
A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus. |
title_full_unstemmed |
A Recombinant Positive Control for Serology Diagnostic Tests Supporting Elimination of Onchocerca volvulus. |
title_sort |
recombinant positive control for serology diagnostic tests supporting elimination of onchocerca volvulus. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2016 |
url |
https://doi.org/10.1371/journal.pntd.0004292 https://doaj.org/article/fc119ed08a81444787e314d1af42cc83 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 10, Iss 1, p e0004292 (2016) |
op_relation |
http://europepmc.org/articles/PMC4706346?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0004292 https://doaj.org/article/fc119ed08a81444787e314d1af42cc83 |
op_doi |
https://doi.org/10.1371/journal.pntd.0004292 |
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PLOS Neglected Tropical Diseases |
container_volume |
10 |
container_issue |
1 |
container_start_page |
e0004292 |
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1766346463546179584 |