Accuracy of Individual Rapid Tests for Serodiagnosis of Gambiense Sleeping Sickness in West Africa

Jamonneau, Vincent; Camara, Oumou; Ilboudo, Hamidou; Peylhard, Moana; Koffi, Mathurin; Sakandé, Hassane; N'Dri, L.; Sanou, Djénéba; Dama, Emilie; Camara, Mamadou; Lejon, Veerle

doi:10.1371/journal.pntd.0003480

Cited by 47 publications

(51 citation statements)

References 15 publications

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“…Such an assay will become even more essential for the monitoring and surveillance of remote areas in view of the targeted continuing decline of the prevalence. A recent examination of the currently available RDTs for serodiagnosis of g- HAT in West Africa demonstrated a lower specificity than expected (88%) but suggested a parallel use of both available tests could increase specificity and sensitivity [ 14 ]. These first generation RDTs contain native (n) nLiTat 1.3 and nLiTat 1.5 as antigens but research is ongoing to replace them by second and future generation RDTs containing recombinant antigens.…”

Section: Discussionmentioning

confidence: 99%

“…Recent efforts to improve diagnosis have focussed on developing rapid immunochromatography-based serodiagnostic tests (RDT’s), which as point of care tests (POCT), should follow the WHO ASSURED criteria; affordable, sensitive, specific, user-friendly, rapid, equipment-free and deliverable to the people at need [ 11 ]. First generation RDTs look very promising but have lower specificity than expected when tested on a wider target area [ 12 – 14 ]. Current RDTs for HAT rely on the infection of rodents and the purification of the native VSGs LiTat 1.3 and LiTat 1.5, which do not represent all the variants encountered in the field.…”

Section: Introductionmentioning

confidence: 99%

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Expression of Trypanosoma brucei gambiense Antigens in Leishmania tarentolae. Potential for Use in Rapid Serodiagnostic Tests (RDTs)

et al. 2015

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The development of rapid serodiagnostic tests for sleeping sickness and other diseases caused by kinetoplastids relies on the affordable production of parasite-specific recombinant antigens. Here, we describe the production of recombinant antigens from Trypanosoma brucei gambiense (T.b. gambiense) in the related species Leishmania tarentolae (L. tarentolae), and compare their diagnostic sensitivity and specificity to native antigens currently used in diagnostic kits against a panel of human sera. A number of T.b. gambiense protein antigen candidates were chosen for recombinant expression in L. tarentolae based on current diagnostics in field use and recent findings on immunodiagnostic antigens found by proteomic profiling. In particular, the extracellular domains of invariant surface glycoprotein 65 (ISG65), variant surface glycoproteins VSG LiTat 1.3 and VSG LiTat 1.5 were fused with C-terminal histidine tags and expressed as soluble proteins in the medium of cultured, recombinant L. tarentolae. Using affinity chromatography, on average 10 mg/L of recombinant protein was purified from cultures and subsequently tested against a panel of sera from sleeping sickness patients from controls, i.e. persons without sleeping sickness living in HAT endemic countries. The evaluation on sera from 172 T.b. gambiense human African trypanosomiasis (HAT) patients and from 119 controls showed very high diagnostic potential of the two recombinant VSG and the rISG65 fragments with areas under the curve between 0.97 and 0.98 compared to 0.98 and 0.99 with native VSG LiTat 1.3 and VSG LiTat 1.5 (statistically not different). Evaluation on sera from 78 T.b. rhodesiense HAT patients and from 100 controls showed an acceptable diagnostic potential of rISG65 with an area under the curve of 0.83. These results indicate that a combination of these recombinant antigens has the potential to be used in next generation rapid serodiagnostic tests. In addition, the L. tarentolae expression system enables simple, cheap and efficient production of recombinant kinetoplatid proteins for use in diagnostic, vaccine and drug discovery research that does not rely on animal use to generate materials.

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Section: Discussionmentioning

confidence: 99%

Section: Introductionmentioning

confidence: 99%

Expression of Trypanosoma brucei gambiense Antigens in Leishmania tarentolae. Potential for Use in Rapid Serodiagnostic Tests (RDTs)

et al. 2015

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“…In addition to being more cost-effective, this algorithm is also the most effective in terms of the percentage of cases that are diagnosed and the DALYs that are averted. As well as being more cost-effective than CATT, the RDT has the added advantages of greater practicality by being a single use format and not requiring electricity and a cold chain [ 27 , 28 ]. These findings are relevant to the DRC in terms of the costs and test performance parameters.…”

Section: Discussionmentioning

confidence: 99%

Cost-effectiveness of using a rapid diagnostic test to screen for human African trypanosomiasis in the Democratic Republic of the Congo

Bessell¹,

Lumbala

Lutumba

et al. 2018

PLoS ONE

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New rapid diagnostic tests (RDTs) for screening human African trypanosomiasis (HAT) have been introduced as alternatives to the card agglutination test for trypanosomiasis (CATT). One brand of RDT, the SD BIOLINE HAT RDT has been shown to have lower specificity but higher sensitivity than CATT, so to make a rational choice between screening strategies, a cost-effectiveness analysis is a key element. In this paper we estimate the relative cost-effectiveness of CATT and the RDT when implemented in the Democratic Republic of the Congo (DRC). Data on the epidemiological parameters and costs were collected as part of a larger study. These data were used to model three different diagnostic algorithms in mobile teams and fixed health facilities, and the relative cost-effectiveness was measured as the average cost per case diagnosed. In both fixed facilities and mobile teams, screening of participants using the SD BIOLINE HAT RDT followed by parasitological confirmation had a lower cost-effectiveness ratio than in algorithms using CATT. Algorithms using the RDT were cheaper by 112.54 (33.2%) and 88.54 (32.92%) US dollars per case diagnosed in mobile teams and fixed health facilities respectively, when compared with algorithms using CATT. Sensitivity analysis demonstrated that these conclusions were robust to a number of assumptions, and that the results can be scaled to smaller or larger facilities, and a range of prevalences. The RDT was the most cost-effective screening test in all realistic scenarios and detected more cases than CATT. Thus, on this basis, the SD BIOLINE HAT RDT could be considered as the most cost-effective option for use in routine screening for HAT in the DRC.

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“…The other is the SD BIOLINE HAT produced by Alere/Standard Diagnostics (South Korea). A study that compared the performance of these two RDTs on stored plasma originating from Guinea and Côte d’Ivoire reported sensitivities of 99.1% and 99.6%, and specificities of 88.3% and 87.9% for the HAT Sero-K-SeT and the SD BIOLINE HAT, respectively [50]. A prototype version of the SD BIOLINE HAT was also evaluated in a prospective study in Angola, the DRC and the Central African Republic [51], without pre-selecting participants using CATT.…”

Section: Discussionmentioning

confidence: 99%

Evaluation of Antigens for Development of a Serological Test for Human African Trypanosomiasis

Biéler

Waltenberger²,

Barrett

et al. 2016

PLoS ONE

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BackgroundControl and elimination of human African trypanosomiasis (HAT) can be accelerated through the use of diagnostic tests that are more accurate and easier to deploy. The goal of this work was to evaluate the immuno-reactivity of antigens and identify candidates to be considered for development of a simple serological test for the detection of Trypanosoma brucei gambiense or T. b. rhodesiense infections, ideally both.Methodology/Principal FindingsThe reactivity of 35 antigens was independently evaluated by slot blot and ELISA against sera from both T. b. gambiense and T. b. rhodesiense infected patients and controls. The antigens that were most reactive by both tests to T. b. gambiense sera were the membrane proteins VSG LiTat 1.3, VSG LiTat 1.5 and ISG64. Reactivity to T. b. rhodesiense sera was highest with VSG LiTat 1.3, VSG LiTat 1.5 and SRA, although much lower than with T. b. gambiense samples. The reactivity of all possible combinations of antigens was also calculated. When the slot blot results of 2 antigens were paired, a VSG LiTat 1.3- ISG75 combination performed best on T. b. gambiense sera, while a VSG LiTat 1.3-VSG LiTat 1.5 combination was the most reactive using ELISA. A combination of SRA and either VSG LiTat 1.3 or VSG LiTat 1.5 had the highest reactivity on T. b. rhodesiense sera according to slot blot, while in ELISA, pairing SRA with either GM6 or VSG LiTat 1.3 yielded the best results.ConclusionsThis study identified antigens that were highly reactive to T. b. gambiense sera, which could be considered for developing a serological test for gambiense HAT, either individually or in combination. Antigens with potential for inclusion in a test for T. b. rhodesiense HAT were also identified, but because their reactivity was comparatively lower, a search for additional antigens would be required before developing a test for this form of the disease.

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Accuracy of Individual Rapid Tests for Serodiagnosis of Gambiense Sleeping Sickness in West Africa

Cited by 47 publications

References 15 publications

Expression of Trypanosoma brucei gambiense Antigens in Leishmania tarentolae. Potential for Use in Rapid Serodiagnostic Tests (RDTs)

Expression of Trypanosoma brucei gambiense Antigens in Leishmania tarentolae. Potential for Use in Rapid Serodiagnostic Tests (RDTs)

Cost-effectiveness of using a rapid diagnostic test to screen for human African trypanosomiasis in the Democratic Republic of the Congo

Evaluation of Antigens for Development of a Serological Test for Human African Trypanosomiasis

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