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

Abstract

AbstractThe 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.