Evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in Tanzania: A prospective multicentre diagnostic accuracy study.
The TS POC test, Taenia solium point-of-care test, is a two-strip lateral flow assay using the recombinant antigen rES33 on the TS POC T test strip, and rT24H on the TS POC CC test strip, to detect antibodies against T. solium taeniosis and cysticercosis, respectively. The objective of this study wa...
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Public Library of Science (PLoS)
2025-03-01
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| Series: | PLoS Neglected Tropical Diseases |
| Online Access: | https://doi.org/10.1371/journal.pntd.0012310 |
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| author | Inge Van Damme Chiara Trevisan Mwemezi Kabululu Dominik Stelzle Charles E Makasi Veronika Schmidt-Urbaneja Kabemba E Mwape Chishimba Mubanga Gideon Zulu Karen Shou Møller Famke Jansen Dries Reynders John Noh Sukwan Handali Emmanuel Bottieau Andrea S Winkler Pierre Dorny Pascal Magnussen Sarah Gabriël Bernard Ngowi |
| author_facet | Inge Van Damme Chiara Trevisan Mwemezi Kabululu Dominik Stelzle Charles E Makasi Veronika Schmidt-Urbaneja Kabemba E Mwape Chishimba Mubanga Gideon Zulu Karen Shou Møller Famke Jansen Dries Reynders John Noh Sukwan Handali Emmanuel Bottieau Andrea S Winkler Pierre Dorny Pascal Magnussen Sarah Gabriël Bernard Ngowi |
| author_sort | Inge Van Damme |
| collection | DOAJ |
| description | The TS POC test, Taenia solium point-of-care test, is a two-strip lateral flow assay using the recombinant antigen rES33 on the TS POC T test strip, and rT24H on the TS POC CC test strip, to detect antibodies against T. solium taeniosis and cysticercosis, respectively. The objective of this study was to assess the diagnostic performance of the TS POC test for the detection of T. solium taeniosis and cysticercosis in individuals attending district hospitals in Tanzania. In this prospective two-phase diagnostic accuracy study, we recruited participants aged 10 and above, excluding pregnant women and those with acute severe illness. Participants were consecutively recruited in three cohorts according to their signs/symptoms: compatible with neurocysticercosis (cohort 1), intestinal worm infections (cohort 2), and other signs/symptoms (cohort 3). Lacking a gold standard test for both infections, diagnostic accuracy was evaluated using results of two coprological and two serological tests for taeniosis, and three serological tests for cysticercosis, in a Bayesian Latent Class Model approach. The TS POC test was conducted on 601 participants in cohort 1, 1661 participants in cohort 2, and 662 participants in cohort 3. Most individuals tested negative on both TS POC test strips, with proportions of 83% (n = 496), 97% (n = 1613) and 97% (n = 641) in cohorts 1, 2 and 3, respectively. Complete case data were available for 120, 114, and 53 participants for taeniosis, and 126, 122, and 55 participants for cysticercosis. Sensitivity values for the TS POC T test strip were 50.2% [95% credible interval 4.9 - 96.4], 40.8% [2.2 - 95.2], and 40.4% [2.3 - 95.0], while specificity values were 98.6% [97.1 - 99.6], 99.3% [98.7 - 99.7] and 99.4% [98.5 - 99.9], respectively. For the TS POC CC test strip, the sensitivity was 77.5% [37.8 - 99.2], 24.9% [95% CI 6.4 - 52.7] and 44.2% [6.6 - 91.5], and the specificity 92.3% [86.5 - 98.8], 99.1% [97.8 - 100], and 98.1% [96.1 - 99.7] across the respective cohorts. Although the TS POC test has a low sensitivity, it demonstrates a high specificity, which may have clinical utility to guide treatment and diagnostic decisions, or in epidemiological studies. An important strength of this study lies in its assessment of the TS POC test under real-world conditions, revealing divergent estimates across distinct cohorts. The study underscores the suboptimal performance of existing tests under field conditions, emphasizing the need to enhance and validate these tests for better performance in practical real-world settings. Registration number: PACTR201712002788898. |
| format | Article |
| id | doaj-art-8481ac632af54d9ca3fadddafb817f19 |
| institution | OA Journals |
| issn | 1935-2727 1935-2735 |
| language | English |
| publishDate | 2025-03-01 |
| publisher | Public Library of Science (PLoS) |
| record_format | Article |
| series | PLoS Neglected Tropical Diseases |
| spelling | doaj-art-8481ac632af54d9ca3fadddafb817f192025-08-20T02:26:41ZengPublic Library of Science (PLoS)PLoS Neglected Tropical Diseases1935-27271935-27352025-03-01193e001231010.1371/journal.pntd.0012310Evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in Tanzania: A prospective multicentre diagnostic accuracy study.Inge Van DammeChiara TrevisanMwemezi KabululuDominik StelzleCharles E MakasiVeronika Schmidt-UrbanejaKabemba E MwapeChishimba MubangaGideon ZuluKaren Shou MøllerFamke JansenDries ReyndersJohn NohSukwan HandaliEmmanuel BottieauAndrea S WinklerPierre DornyPascal MagnussenSarah GabriëlBernard NgowiThe TS POC test, Taenia solium point-of-care test, is a two-strip lateral flow assay using the recombinant antigen rES33 on the TS POC T test strip, and rT24H on the TS POC CC test strip, to detect antibodies against T. solium taeniosis and cysticercosis, respectively. The objective of this study was to assess the diagnostic performance of the TS POC test for the detection of T. solium taeniosis and cysticercosis in individuals attending district hospitals in Tanzania. In this prospective two-phase diagnostic accuracy study, we recruited participants aged 10 and above, excluding pregnant women and those with acute severe illness. Participants were consecutively recruited in three cohorts according to their signs/symptoms: compatible with neurocysticercosis (cohort 1), intestinal worm infections (cohort 2), and other signs/symptoms (cohort 3). Lacking a gold standard test for both infections, diagnostic accuracy was evaluated using results of two coprological and two serological tests for taeniosis, and three serological tests for cysticercosis, in a Bayesian Latent Class Model approach. The TS POC test was conducted on 601 participants in cohort 1, 1661 participants in cohort 2, and 662 participants in cohort 3. Most individuals tested negative on both TS POC test strips, with proportions of 83% (n = 496), 97% (n = 1613) and 97% (n = 641) in cohorts 1, 2 and 3, respectively. Complete case data were available for 120, 114, and 53 participants for taeniosis, and 126, 122, and 55 participants for cysticercosis. Sensitivity values for the TS POC T test strip were 50.2% [95% credible interval 4.9 - 96.4], 40.8% [2.2 - 95.2], and 40.4% [2.3 - 95.0], while specificity values were 98.6% [97.1 - 99.6], 99.3% [98.7 - 99.7] and 99.4% [98.5 - 99.9], respectively. For the TS POC CC test strip, the sensitivity was 77.5% [37.8 - 99.2], 24.9% [95% CI 6.4 - 52.7] and 44.2% [6.6 - 91.5], and the specificity 92.3% [86.5 - 98.8], 99.1% [97.8 - 100], and 98.1% [96.1 - 99.7] across the respective cohorts. Although the TS POC test has a low sensitivity, it demonstrates a high specificity, which may have clinical utility to guide treatment and diagnostic decisions, or in epidemiological studies. An important strength of this study lies in its assessment of the TS POC test under real-world conditions, revealing divergent estimates across distinct cohorts. The study underscores the suboptimal performance of existing tests under field conditions, emphasizing the need to enhance and validate these tests for better performance in practical real-world settings. Registration number: PACTR201712002788898.https://doi.org/10.1371/journal.pntd.0012310 |
| spellingShingle | Inge Van Damme Chiara Trevisan Mwemezi Kabululu Dominik Stelzle Charles E Makasi Veronika Schmidt-Urbaneja Kabemba E Mwape Chishimba Mubanga Gideon Zulu Karen Shou Møller Famke Jansen Dries Reynders John Noh Sukwan Handali Emmanuel Bottieau Andrea S Winkler Pierre Dorny Pascal Magnussen Sarah Gabriël Bernard Ngowi Evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in Tanzania: A prospective multicentre diagnostic accuracy study. PLoS Neglected Tropical Diseases |
| title | Evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in Tanzania: A prospective multicentre diagnostic accuracy study. |
| title_full | Evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in Tanzania: A prospective multicentre diagnostic accuracy study. |
| title_fullStr | Evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in Tanzania: A prospective multicentre diagnostic accuracy study. |
| title_full_unstemmed | Evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in Tanzania: A prospective multicentre diagnostic accuracy study. |
| title_short | Evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in Tanzania: A prospective multicentre diagnostic accuracy study. |
| title_sort | evaluation of a rapid lateral flow assay for the detection of taeniosis and cysticercosis at district hospital level in tanzania a prospective multicentre diagnostic accuracy study |
| url | https://doi.org/10.1371/journal.pntd.0012310 |
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