Evaluation of a point-of-care test for the diagnosis of Taenia solium neurocysticercosis in rural southern Tanzania: a diagnostic accuracy study

Stelzle, Dominik; Makasi, Charles E; Schmidt, Veronika; Van Damme, Inge; Trevisan, Chiara; Ruether, Charlotte; Fleury, Agnès; Noh, John; Handali, Sukwan; Dorny, Pierre; Magnussen, Pascal; Zulu, Gideon; Mwape, Kabemba E; Bottieau, Emmanuel; Gabriël, Sarah; Ngowi, Bernard J; Winkler, Andrea S; Chabala, Chishala; Mubanga, Chishimba; Jansen, Famke; Phiri, Isaac K.; Mambo, Richard

doi:10.1016/s1473-3099(23)00378-x

Cited by 2 publications

(5 citation statements)

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“…Differences in test agreement among subgroups stratified by location and stage of the lesions [33] further suggests variability according to disease spectrum. Similarly, the TS POC CC test strip and serological tests showed a sensitivity of 44 to 50% for NCC diagnosis in hospital settings, but above 98% among patients with active lesions [14]. This study shows that agreement between serological tests is only minimal to moderate under field conditions, particularly in individuals not clinically suspect of NCC.…”

Section: Discussionmentioning

confidence: 66%

“…The copyright holder for this preprint this version posted June 24, 2024. ; https://doi.org/10.1101/2024.06.24.24309388 doi: medRxiv preprint cysticercosis testing. The evaluation of the TS POC CC test strip for NCC diagnosis is described elsewhere [14,15].…”

Section: Methodsmentioning

confidence: 99%

“…only focusing on T. solium taeniosis and cysticercosis testing. The evaluation of the TS POC CC test strip for NCC diagnosis is described elsewhere [14,15].…”

Section: Methodsmentioning

confidence: 99%

“…Individuals with signs/symptoms compatible with NCC (cohort 1) were consecutively recruited from Outpatient Departments (OPD) and the Mental Health Clinics (MHC). A questionnaire consisting of nine questions was used to assess if individuals fulfilled the criteria for epileptic seizures and/or severe progressive headache (S1 Appendix; more details can be found in Stelzle et al [14,16]). For cohort 2, individuals who presented at the OPD with complaints compatible with intestinal worm infection were included.…”

Section: Participantsmentioning

confidence: 99%

“…The evaluation of the TS POC test for the detection of T. solium taeniosis and cysticercosis at community level has been reported elsewhere [12,13]. Also the evaluation of the TS POC test for the neuroimaging-based diagnosis of NCC in both settings were reported elsewhere [14,15], and are thus out of the scope of this paper. The focus of this paper is the evaluation of the TS POC test for the detection of infection with the adult tapeworm (taeniosis) and/or the larval stage (cysticercosis) of T. solium in individuals attending district hospitals (Tier 2 level) in Tanzania.…”

Section: Introductionmentioning

confidence: 99%

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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

Van Damme,

Trevisan,

Kabululu

et al. 2024

Preprint

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The TS POC test,Taenia soliumpoint-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 againstT. soliumtaeniosis and cysticercosis, respectively.The objective of this study was to assess the diagnostic performance of the TS POC test for the detection ofT. soliumtaeniosis 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 symptoms (cohort 3). Lacking a gold standard test for both infections, evaluating the diagnostic accuracy measures was done using the results of different coprological and serological tests 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. Sensitivity values for the TS POC T test strip were 50.2% [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 suboptimal 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 for the development and validation of better diagnostic tests.Registration numberPACTR201712002788898Author summaryTaenia soliumposes significant public health concerns globally and is a leading cause of acquired epilepsy inT. soliumendemic areas. The parasite causes two distinct infections in humans: taeniosis, an intestinal infection, and cysticercosis, a tissue infection. The disease is particularly prevalent in low-resource settings, contributing to substantial morbidity and economic burdens. Recently, a test was specifically developed as an affordable and rapid diagnostic tool, tailored for deployment in resource-constrained regions. The TS POC test is composed of two test strips, one to detect taeniosis and one for cysticercosis. This study provides a critical assessment of the diagnostic efficacy of the TS POC test in Tanzanian district hospital settings. By evaluating the test’s performance across diverse cohorts and real-world conditions, the research sheds light on the limitations of existing diagnostic modalities and underscores the imperative for improved testing strategies. The findings offer valuable insights for public health practitioners and policymakers striving to enhance diagnostic capabilities and ultimately mitigate the burden ofT. soliuminfections in endemic regions.

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Section: Discussionmentioning

confidence: 66%

Section: Methodsmentioning

confidence: 99%

“…only focusing on T. solium taeniosis and cysticercosis testing. The evaluation of the TS POC CC test strip for NCC diagnosis is described elsewhere [14,15].…”

Section: Methodsmentioning

confidence: 99%

Section: Participantsmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

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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

Van Damme,

Trevisan,

Kabululu

et al. 2024

Preprint

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Neurocysticercosis Prevalence and Characteristics in Communities of Sinda District in Zambia: A Cross-Sectional Study

Zulu,

Stelzle,

Gabriël

et al. 2024

J Epidemiol Glob Health

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Background This study aimed at describing the epidemiology of (neuro)cysticercosis as well as its clinical and radiological characteristics in a Taenia solium endemic district of Zambia. Methods This was part of a cross-sectional community-based study conducted in Sinda district to evaluate an antibody-detecting T. solium point-of-care (TS POC) test for taeniosis and (neuro)cysticercosis. All TS POC cysticercosis positive (CC+) participants and a subset of the TS POC cysticercosis negative (CC-) received a clinical evaluation and cerebral computed tomography (CT) examination for neurocysticercosis (NCC) diagnosis and staging. Results Of the 1249 participants with a valid TS POC test result, 177 (14%) were TS POC CC+ . Cysticercosis sero-prevalence was estimated to be 20.1% (95% confidence intervals [CI] 14.6–27.0%). In total, 233 participants received a CT examination (151 TS POC CC+ , 82 TS POC CC-). Typical NCC lesions were present in 35/151 (23%) TS POC CC+ , and in 10/82 (12%) TS POC CC- participants. NCC prevalence was 13.5% (95% CI 8.4–21.1%) in the study population and 38.0% (95% CI 5.2–87.4%) among people reporting epileptic seizures. Participants with NCC were more likely to experience epileptic seizures (OR = 3.98, 95% CI 1.34–11.78, p = 0.01) than those without NCC, although only 7/45 (16%) people with NCC ever experienced epileptic seizures. The number of lesions did not differ by TS POC CC status (median: 3 [IQR 1–6] versus 2.5 [IQR 1–5.3], p = 0.64). Eight (23%) of the 35 TS POC CC+ participants with NCC had active stage lesions; in contrast none of the TS POC CC- participants was diagnosed with active NCC. Conclusion NCC is common in communities in the Eastern province of Zambia, but a large proportion of people remain asymptomatic.

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Evaluation of a point-of-care test for the diagnosis of Taenia solium neurocysticercosis in rural southern Tanzania: a diagnostic accuracy study

Cited by 2 publications

References 21 publications

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

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

Neurocysticercosis Prevalence and Characteristics in Communities of Sinda District in Zambia: A Cross-Sectional Study

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