Sensitivity and specificity of HAT Sero-K-SeT, a rapid diagnostic test for serodiagnosis of sleeping sickness caused by Trypanosoma brucei gambiense: a case-control study

Büscher, Philippe; Mertens, Pascal; Leclipteux, T.; Gilleman, Quentin; Jacquet, D.; Ngoyi, Dieudonné Mumba; Pyana, Pati Patient; Boelaert, Marleen; Lejon, Veerle

doi:10.1016/s2214-109x(14)70203-7

Cited by 73 publications

(78 citation statements)

References 9 publications

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“…The methods include serological, parasitological, and those for staging the disease [6]. Recently, more serological tests with improved sensitivity and specificity have been developed, namely, T. brucei gambiense -specific SD Bioline HAT test [7, 8] and HAT sero-k-seT [9, 10], although further improvement is still required. Other recently launched tests include the T. brucei specific simple LED fluorescence microscope [11] and nucleic acid detecting RIME loop-mediated isothermal amplification (LAMP) test [12].…”

Section: Introductionmentioning

confidence: 99%

Loop-Mediated Isothermal Amplification Test forTrypanosoma gambienseGroup 1 with Stem Primers: A Molecular Xenomonitoring Test for Sleeping Sickness

Njiru

Mbae

Mburugu

2017

Journal of Tropical Medicine

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The World Health Organization has targeted Human African Trypanosomiasis (HAT) for elimination by 2020 with zero incidence by 2030. To achieve and sustain this goal, accurate and easy-to-deploy diagnostic tests for Gambian trypanosomiasis which accounts for over 98% of reported cases will play a crucial role. Most needed will be tools for surveillance of pathogen in vectors (xenomonitoring) since population screening tests are readily available. The development of new tests is expensive and takes a long time while incremental improvement of existing technologies that have potential for xenomonitoring may offer a shorter pathway to tools for HAT surveillance. We have investigated the effect of including a second set of reaction accelerating primers (stem primers) to the standard T. brucei gambiense LAMP test format. The new test format was analyzed with and without outer primers. Amplification was carried out using Rotorgene 6000 and the portable ESE Quant amplification unit capable of real-time data output. The stem LAMP formats indicated shorter time to results (~8 min), were 10–100-fold more sensitive, and indicated higher diagnostic sensitivity and accuracy compared to the standard LAMP test. It was possible to confirm the predicted product using ESE melt curves demonstrating the potential of combining LAMP and real-time technologies as possible tool for HAT molecular xenomonitoring.

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Section: Introductionmentioning

confidence: 99%

Loop-Mediated Isothermal Amplification Test forTrypanosoma gambienseGroup 1 with Stem Primers: A Molecular Xenomonitoring Test for Sleeping Sickness

Njiru

Mbae

Mburugu

2017

Journal of Tropical Medicine

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“…Rapid tests are now available and are very promising but have been employed mainly for passive mode detection (Büscher et al, 2014). However, their observed specificity was relatively low.…”

Section: Resultsmentioning

confidence: 99%

“…However, this latter is very useful for passive mode detection but not for mass screening survey (Büscher et al, 2014). The search of new biomarker candidates will permit an improvement to HAT diagnostic test based on CATT (Bonnet et al, 2015).…”

Section: Introductionmentioning

confidence: 99%

Confirmation of antibodies against L-tryptophan-like epitope in human African trypanosomosis serological diagnostic

Semballa¹,

Nzoumbou‐Boko²,

Holzmüller³

et al. 2016

Afr. J. Biotechnol.

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Antibodies directed against L-tryptophan epitope (WE -W for tryptophan, E for epitope), a constant epitope borne by variant surface glycoproteins (VSG), have been detected in sera of all 152 Human African Trypanosomosis (HAT) patients from Angola. The WE is present in VSG hydrophobic regions of the C terminal domains. In the assay, L-tryptophan was linked to bovine serum albumin (BSA) with glutaraldehyde to synthesize W-G-BSA conjugate which was used in an enzyme-linked immunosorbent assay (ELISA) to detect the antibodies. A significant difference was found between HAT patients and controls confirming previous results obtained with a lower number of patients in Congo. A diagnostic test based on this synthetic epitope, especially in combination with other tests, might improve the HAT diagnostic test in field conditions.

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“…Indeed, since this study was carried out, two RDTs for gambiense HAT have been developed and commercialized, both using these two antigens. One is the HAT Sero- K -SeT manufactured by Coris BioConcept (Belgium), with a reported sensitivity of 93.9% and a specificity of 99.0% using archived sera [23], as well as a sensitivity of 98.5% and a specificity of 98.6% in a prospective passive screening trial [49]. The other is the SD BIOLINE HAT produced by Alere/Standard Diagnostics (South Korea).…”

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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Sensitivity and specificity of HAT Sero-K-SeT, a rapid diagnostic test for serodiagnosis of sleeping sickness caused by Trypanosoma brucei gambiense: a case-control study

Abstract: The diagnostic accuracy of HAT Sero-K-SeT is adequate for T b gambiense antibody detection in local health centres and could be used for active screening whenever a cold chain and electricity supply are unavailable and CATT/T b gambiense cannot be done.

Cited by 73 publications

References 9 publications

Loop-Mediated Isothermal Amplification Test forTrypanosoma gambienseGroup 1 with Stem Primers: A Molecular Xenomonitoring Test for Sleeping Sickness

Loop-Mediated Isothermal Amplification Test forTrypanosoma gambienseGroup 1 with Stem Primers: A Molecular Xenomonitoring Test for Sleeping Sickness

Confirmation of antibodies against L-tryptophan-like epitope in human African trypanosomosis serological diagnostic

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

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