title: Sensitivity and Specificity of a Prototype Rapid Diagnostic Test for the Detection of Trypanosoma brucei gambiense Infection: A Multi-centric Prospective Study.
abstract: BACKGROUND
  A major challenge in the control of human African trypanosomiasis (HAT) is lack of reliable diagnostic tests that are rapid and easy to use in remote areas where the disease occurs. In Trypanosoma brucei gambiense HAT, the Card Agglutination Test for Trypanosomiasis (CATT) has been the reference screening test since 1978, usually on whole blood, but also in a 1/8 dilution (CATT 1/8) to enhance specificity. However, the CATT is not available in a single format, requires a cold chain for storage, and uses equipment that requires electricity. A solution to these challenges has been provided by rapid diagnostic tests (RDT), which have recently become available. A prototype immunochromatographic test, the SD BIOLINE HAT, based on two native trypanosomal antigens (VSG LiTat 1.3 and VSG LiTat 1.5) has been developed. We carried out a non-inferiority study comparing this prototype to the CATT 1/8 in field settings.
  
  
  RESULTS
  The prototype SD BIOLINE HAT, the CATT Whole Blood and CATT 1/8 were systematically applied on fresh blood samples obtained from 14,818 subjects, who were prospectively enrolled through active and passive screening in clinical studies in three endemic countries of central Africa: Angola, the Democratic Republic of the Congo and the Central African Republic. One hundred and forty nine HAT cases were confirmed by parasitology. The sensitivity and specificity of the prototype SD BIOLINE HAT was 89.26% (95% confidence interval (CI) = 83.27-93.28) and 94.58% (95% CI = 94.20-94.94) respectively. The sensitivity and specificity of the CATT on whole blood were 93.96% (95% CI = 88.92-96.79) and 95.91% (95% CI = 95.58-96.22), and of the CATT 1/8 were 89.26% (95% CI = 83.27-93.28) and 98.88% (95% CI = 98.70-99.04) respectively.
  
  
  CONCLUSIONS
  After further optimization, the prototype SD BIOLINE HAT could become an alternative to current screening methods in primary healthcare settings in remote, resource-limited regions where HAT typically occurs.
authors.affiliation: INSERM UMR1094, Institute of Neuroepidemiology and Tropical Neurology, Limoges, France.
authors.forename: Sylvie
authors.initials: S
authors.lastname: Bisser
authors.affiliation: Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), Kinshasa, Democratic Republic of the Congo.
authors.forename: Crispin
authors.initials: C
authors.lastname: Lumbala
authors.affiliation: Institut Centrafricain de la Recherche Agronomique (ICRA), Bangui, Central African Republic.
authors.forename: Etienne
authors.initials: E
authors.lastname: Nguertoum
authors.affiliation: Programme National de Lutte contre la Trypanosomiase Humaine Africaine (PNLTHA), Kinshasa, Democratic Republic of the Congo.
authors.forename: Victor
authors.initials: V
authors.lastname: Kande
authors.affiliation: Médecins Sans Frontières (MSF) Operational Centre Barcelona-Athens (OCBA), Barcelona, Spain.
authors.forename: Laurence
authors.initials: L
authors.lastname: Flevaud
authors.affiliation: Instituto de Combate e Controlo das Tripanossomiases, Luanda, Angola.
authors.forename: Gedeao
authors.initials: G
authors.lastname: Vatunga
authors.affiliation: Institute of Tropical Medicine Antwerp, Antwerpen, Belgium.
authors.forename: Marleen
authors.initials: M
authors.lastname: Boelaert
authors.affiliation: Institute of Tropical Medicine Antwerp, Antwerpen, Belgium.
authors.forename: Philippe
authors.initials: P
authors.lastname: Büscher
authors.affiliation: Instituto de Combate e Controlo das Tripanossomiases, Luanda, Angola.
authors.forename: Theophile
authors.initials: T
authors.lastname: Josenando
authors.affiliation: Epi Interventions Ltd., Edinburgh, United Kingdom.
authors.forename: Paul R
authors.initials: PR
authors.lastname: Bessell
authors.affiliation: Foundation for Innovative New Diagnostics, Campus Biotech, Geneva, Switzerland.
authors.forename: Sylvain
authors.initials: S
authors.lastname: Biéler
authors.affiliation: Foundation for Innovative New Diagnostics, Campus Biotech, Geneva, Switzerland.
authors.forename: Joseph M
authors.initials: JM
authors.lastname: Ndung'u
mesh_terms: D000810:Angola; D002488:Central African Republic; D002846:Chromatography, Affinity / Q000379:methods*; D015023:Democratic Republic of the Congo; D003955:Diagnostic Tests, Routine / Q000379:methods*; D006801:Humans; D011446:Prospective Studies; D012680:Sensitivity and Specificity; D013997:Time Factors; D014347:Trypanosoma brucei gambiense / Q000302:isolation & purification*; D014353:Trypanosomiasis, African / Q000175:diagnosis*