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 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.

VS, JN and SH were involved in the development of the TS POC test. ITM (Nationalestraat 155, B-2000 Antwerp, Belgium) is the sponsor of the study. The funders had no role in the design of the study, in the collection, analyses, or interpretation of data, in the writing of the manuscript, or in the decision to publish the results.

PACTR201712002788898

https://doi.org/10.3390/diagnostics11091528

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The details of the IRB/oversight body that provided approval or exemption for the research described are given below:

The study adhered to the principles outlined in the Declaration of Helsinki and obtained ethical approval from the National Ethics Health Research Committee (NatREC) of Tanzania (NIMR/HQ/R.8a/Vol.IX/2597), the Institute of Tropical Medicine (IRB/AB/ac/112 Ref 1177/17) through the ethics committee of the University of Antwerp (EC UZA 17/31/352), and the Technical University of Munich via their Ethics Committee at the Klinikum rechts der Isar, Munich (299/18S).

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