Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis.
Diagnosis of human African trypanosomiasis (HAT) remains a challenge both for active screening, which is critical in control of the disease, and in the point-of-care scenario where early and accurate diagnosis is essential. Recently, the first field deployment of a lateral flow rapid diagnostic test...
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ftdoajarticles:oai:doaj.org/article:5982b63b54214a55b292ec397b0b5b22 2023-05-15T15:14:46+02:00 Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis. Jeremy M Sternberg Marek Gierliński Sylvain Biéler Michael A J Ferguson Joseph M Ndung'u 2014-12-01T00:00:00Z https://doi.org/10.1371/journal.pntd.0003373 https://doaj.org/article/5982b63b54214a55b292ec397b0b5b22 EN eng Public Library of Science (PLoS) http://europepmc.org/articles/PMC4270746?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0003373 https://doaj.org/article/5982b63b54214a55b292ec397b0b5b22 PLoS Neglected Tropical Diseases, Vol 8, Iss 12, p e3373 (2014) Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 article 2014 ftdoajarticles https://doi.org/10.1371/journal.pntd.0003373 2022-12-31T14:37:43Z Diagnosis of human African trypanosomiasis (HAT) remains a challenge both for active screening, which is critical in control of the disease, and in the point-of-care scenario where early and accurate diagnosis is essential. Recently, the first field deployment of a lateral flow rapid diagnostic test (RDT) for HAT, "SD BIOLINE HAT" has taken place. In this study, we evaluated the performance of "SD BIOLINE HAT" and two new prototype RDTs.The performance of "SD BIOLINE HAT" and 2 prototype RDTs was tested using archived plasma from 250 Trypanosoma brucei gambiense patients, and 250 endemic controls. As well as comparison of the sensitivity and specificity of each device, the performance of individual antigens was assessed and the hypothetical performance of novel antigen combinations extrapolated. Neither of the prototype devices were inferior in sensitivity or specificity to "SD BIOLINE HAT" (sensitivity 0.82±0.01, specificity 0.97±0.01, 95% CI) at the 5% margins, while one of the devices (BBI) had significantly superior sensitivity (0.88±0.03). Analysis of the performance of individual antigens was used to model new antigen combinations to be explored in development of the next generation of HAT RDTs. The modelling showed that an RDT using two recombinant antigens (rLiTat1.5 and rISG65) would give a performance similar to the best devices in this study, and would also offer the most robust performance under deteriorating field conditions.Both "SD BIOLINE HAT" and the prototype devices performed comparably well to one another and also to the published performance range of the card agglutination test for trypanosomiasis in sensitivity and specificity. The performance of individual antigens enabled us to predict that an all-recombinant antigen RDT can be developed with an accuracy equivalent to " SD BIOLINE HAT." Such an RDT would have advantages in simplified manufacture, lower unit cost and assured reproducibility. Article in Journal/Newspaper Arctic Directory of Open Access Journals: DOAJ Articles Arctic PLoS Neglected Tropical Diseases 8 12 e3373 |
institution |
Open Polar |
collection |
Directory of Open Access Journals: DOAJ Articles |
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ftdoajarticles |
language |
English |
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 Jeremy M Sternberg Marek Gierliński Sylvain Biéler Michael A J Ferguson Joseph M Ndung'u Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis. |
topic_facet |
Arctic medicine. Tropical medicine RC955-962 Public aspects of medicine RA1-1270 |
description |
Diagnosis of human African trypanosomiasis (HAT) remains a challenge both for active screening, which is critical in control of the disease, and in the point-of-care scenario where early and accurate diagnosis is essential. Recently, the first field deployment of a lateral flow rapid diagnostic test (RDT) for HAT, "SD BIOLINE HAT" has taken place. In this study, we evaluated the performance of "SD BIOLINE HAT" and two new prototype RDTs.The performance of "SD BIOLINE HAT" and 2 prototype RDTs was tested using archived plasma from 250 Trypanosoma brucei gambiense patients, and 250 endemic controls. As well as comparison of the sensitivity and specificity of each device, the performance of individual antigens was assessed and the hypothetical performance of novel antigen combinations extrapolated. Neither of the prototype devices were inferior in sensitivity or specificity to "SD BIOLINE HAT" (sensitivity 0.82±0.01, specificity 0.97±0.01, 95% CI) at the 5% margins, while one of the devices (BBI) had significantly superior sensitivity (0.88±0.03). Analysis of the performance of individual antigens was used to model new antigen combinations to be explored in development of the next generation of HAT RDTs. The modelling showed that an RDT using two recombinant antigens (rLiTat1.5 and rISG65) would give a performance similar to the best devices in this study, and would also offer the most robust performance under deteriorating field conditions.Both "SD BIOLINE HAT" and the prototype devices performed comparably well to one another and also to the published performance range of the card agglutination test for trypanosomiasis in sensitivity and specificity. The performance of individual antigens enabled us to predict that an all-recombinant antigen RDT can be developed with an accuracy equivalent to " SD BIOLINE HAT." Such an RDT would have advantages in simplified manufacture, lower unit cost and assured reproducibility. |
format |
Article in Journal/Newspaper |
author |
Jeremy M Sternberg Marek Gierliński Sylvain Biéler Michael A J Ferguson Joseph M Ndung'u |
author_facet |
Jeremy M Sternberg Marek Gierliński Sylvain Biéler Michael A J Ferguson Joseph M Ndung'u |
author_sort |
Jeremy M Sternberg |
title |
Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis. |
title_short |
Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis. |
title_full |
Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis. |
title_fullStr |
Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis. |
title_full_unstemmed |
Evaluation of the diagnostic accuracy of prototype rapid tests for human African trypanosomiasis. |
title_sort |
evaluation of the diagnostic accuracy of prototype rapid tests for human african trypanosomiasis. |
publisher |
Public Library of Science (PLoS) |
publishDate |
2014 |
url |
https://doi.org/10.1371/journal.pntd.0003373 https://doaj.org/article/5982b63b54214a55b292ec397b0b5b22 |
geographic |
Arctic |
geographic_facet |
Arctic |
genre |
Arctic |
genre_facet |
Arctic |
op_source |
PLoS Neglected Tropical Diseases, Vol 8, Iss 12, p e3373 (2014) |
op_relation |
http://europepmc.org/articles/PMC4270746?pdf=render https://doaj.org/toc/1935-2727 https://doaj.org/toc/1935-2735 1935-2727 1935-2735 doi:10.1371/journal.pntd.0003373 https://doaj.org/article/5982b63b54214a55b292ec397b0b5b22 |
op_doi |
https://doi.org/10.1371/journal.pntd.0003373 |
container_title |
PLoS Neglected Tropical Diseases |
container_volume |
8 |
container_issue |
12 |
container_start_page |
e3373 |
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