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Randomized Controlled Trial
. 2018 Jun 4;12(6):e0006562.
doi: 10.1371/journal.pntd.0006562. eCollection 2018 Jun.

Diagnostic comparison between FECPAKG2 and the Kato-Katz method for analyzing soil-transmitted helminth eggs in stool

Affiliations
Randomized Controlled Trial

Diagnostic comparison between FECPAKG2 and the Kato-Katz method for analyzing soil-transmitted helminth eggs in stool

Wendelin Moser et al. PLoS Negl Trop Dis. .

Abstract

Background: Over one billion people are infected with soil-transmitted helminths (STH), i.e. Ascaris lumbricoides, hookworm and Trichuris trichiura. For estimating drug efficacy and monitoring anthelminthic drug resistance, accurate diagnostic methods are critical. FECPAKG2 is a new remote-diagnostic tool used in veterinary medicine, which produces an image of the stool sample that can be stored on an internet cloud. We compared for the first time FECPAKG2 with the recommended Kato-Katz method.

Methodology/principal findings: Two stool samples were collected from adolescent participants (age 15-18 years) at baseline and 14 to 21 days after treatment in the framework of a randomized clinical trial on Pemba Island, Tanzania. Stool samples were analyzed with different diagnostic efforts: i) one or ii) two Kato-Katz thick smears from the first sample, iii) two Kato-Katz thick smears from two samples and iv) FECPAKG2 from the first sample. Parameters were calculated based on a hierarchical Bayesian egg count model. Complete data for all diagnostic efforts were available from 615 participants at baseline and 231 hookworm-positive participants at follow-up. At baseline FECPAKG2 revealed a sensitivity of 75.6% (72.0-77.7) for detecting A. lumbricoides, 71.5% (67.4-95.3) for hookworm and 65.8% (64.9-66.2) for T. trichiura, which was significantly lower (all p<0.05) than any of the Kato-Katz methods and highly dependent on infection intensity. Despite that the egg counts based on FECPAKG2 were relatively lower compared to Kato-Katz by a ratio of 0.38 (0.32-0.43) for A. lumbricoides, 0.36 (0.33-0.40) for hookworm and 0.08 (0.07-0.09) for T. trichiura, the egg reduction rates (ERR) were correctly estimated with FECPAKG2.

Conclusions/significance: The sensitivity to identify any STH infection was considerably lower for FECPAKG2 compared to Kato-Katz. Following rigorous development, FECPAKG2 might be an interesting tool with unique features for epidemiological and clinical studies.

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Conflict of interest statement

We have read the journal's policy and the authors of this manuscript have the following competing interests: GJM is managing director of Techion Group Ltd, which developed FECPAKG2. He was not involved in the study design, implementation, analyzing and interpreting of the data, to prevent any conflict of interest.

Figures

Fig 1
Fig 1. Study flow of stool samples collection and analysis using the single, duplicate, quadruplicate Kato-Katz and FECPAKG2.
Fig 2
Fig 2. The estimated sensitivity of FECPAKG2 based on the infection intensity.
Fig 3
Fig 3. Scatter plot of the egg counts based on FECPAKG2 and duplicate Kato-Katz egg counts.
Red line indicates egg density-ratio between Kato-Katz and FECPAKG2.
Fig 4
Fig 4. True cure rates (True) and cure rates based on a single (KK1) duplicate (KK2), quadruplicate Kato-Katz (KK4) and FECPAKG2 (FP) against hookworm and T. trichiura for the four different treatment arms.
Cure rates against A. lumbricoides are not presented.
Fig 5
Fig 5. True egg reduction rates (ERR) and ERRs based on single (KK1), duplicate (KK2), quadruplicate Kato-Katz (KK4) and FECPAKG2 after treatment with tribendimidine (TRB), tribendimidine-ivermectin (TRB-IVR), tribendimidine-oxantel pamoate (TRB-OXP) and albendazole-oxantel pamoate (ALB-OXP).
Egg reduction rates against A. lumbricoides are not presented.

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