@article{fdi:010091094,
  title = {{S}pecificity of serological screening tests and reference laboratory tests to diagnose gambiense human {A}frican trypanosomiasis : a prospective clinical performance study},
  author = {{N}'{D}jetchi, {M}. {K}. and {C}amara, {O}. and {K}offi, {M}. and {C}amara, {M}. and {K}aba, {D}. and {K}abor{\'e}, {J}. and {T}all, {A}. and {R}otureau, {B}. and {G}lover, {L}. and {T}raor{\'e}, {M}. {B}. and {K}on{\'e}, {M}. and {C}oulibaly, {B}. and {A}dingra, {G}. {P}. and {S}oumah, {A}. and {G}assama, {M}. and {C}amara, {A}. {D}. and {C}ompaor{\'e}, {C}. {F}. {A}. and {C}amara, {A}. and {B}oiro, {S}. and {A}nton, {E}. {P}. and {B}essell, {P}. and {V}an {R}eet, {N}. and {B}ucheton, {B}runo and {J}amonneau, {V}incent and {B}art, {J}ean-{M}athieu and {S}olano, {P}hilippe and {B}i{\'e}ler, {S}. and {L}ejon, {V}eerle},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {S}erological screening tests play a crucial role to diagnose gambiense human {A}frican trypanosomiasis (g{HAT}). {P}resently, they preselect individuals for microscopic confirmation, but in future "screen and treat" strategies they will identify individuals for treatment. {V}ariability in reported specificities, the development of new rapid diagnostic tests ({RDT}) and the hypothesis that malaria infection may decrease {RDT} specificity led us to evaluate the specificity of 5 g{HAT} screening tests. {M}ethods {D}uring active screening, venous blood samples from 1095 individuals from {C}ote d'{I}voire and {G}uinea were tested consecutively with commercial ({CATT}, {HAT} {S}ero-{K}-{S}e{T}, {A}bbott {B}ioline {HAT} 2.0) and prototype ({DCN} {HAT} {RDT}, {HAT} {S}ero-{K}-{S}e{T} 2.0) g{HAT} screening tests and with a malaria {RDT}. {I}ndividuals with >= 1 positive g{HAT} screening test underwent microscopy and further immunological (trypanolysis with {T}.b. gambiense {L}i{T}at 1.3, 1.5 and 1.6; indirect {ELISA}/{T}.b. gambiense; {T}.b. gambiense inhibition {ELISA} with {T}.b. gambiense {L}i{T}at 1.3 and 1.5 {VSG}) and molecular reference laboratory tests ({PCR} {TBRN}3, 18{S} and {T}gs{GP}; {SHERLOCK} 18{S} {T}ids, 7{SL} {Z}oon, and {T}gs{GP}; {T}rypanozoon {S}-2-{RT}-q{PCR} 18{S}2, 177{T}, {GPI}-{PLC} and {T}gs{GP} in multiplex; {RT}-q{PCR} {DT}8, {DT}9 and {T}gs{GP} in multiplex). {M}icroscopic trypanosome detection confirmed g{HAT}, while other individuals were considered g{HAT} free. {D}ifferences in fractions between groups were assessed by {C}hi square and differences in specificity between 2 tests on the same individuals by {M}c{N}emar. {R}esults {O}ne g{HAT} case was diagnosed. {O}verall test specificities (n = 1094) were: {CATT} 98.9% (95% {CI}: 98.1-99.4%); {HAT} {S}ero-{K}-{S}e{T} 86.7% (95% {CI}: 84.5-88.5%); {B}ioline {HAT} 2.0 82.1% (95% {CI}: 79.7-84.2%); {DCN} {HAT} {RDT} 78.2% (95% {CI}: 75.7-80.6%); and {HAT} {S}ero-{K}-{S}e{T} 2.0 78.4% (95% {CI}: 75.9-80.8%). {I}n malaria positives, g{HAT} screening tests appeared less specific, but the difference was significant only in {G}uinea for {A}bbott {B}ioline {HAT} 2.0 ({P} = 0.03) and {HAT} {S}ero-{K}-{S}et 2.0 ({P} = 0.0006). {T}he specificities of immunological and molecular laboratory tests in g{HAT} seropositives were 98.7-100% (n = 399) and 93.0-100% (n = 302), respectively. {A}mong 44 reference laboratory test positives, only the confirmed g{HAT} patient and one screening test seropositive combined immunological and molecular reference laboratory test positivity. {C}onclusions {A}lthough a minor effect of malaria cannot be excluded, g{HAT} {RDT} specificities are far below the 95% minimal specificity stipulated by the {WHO} target product profile for a simple diagnostic tool to identify individuals eligible for treatment. {U}nless specificity is improved, an {RDT}-based "screen and treat" strategy would result in massive overtreatment. {I}n view of their inconsistent results, additional comparative evaluations of the diagnostic performance of reference laboratory tests are indicated for better identifying, among screening test positives, those at increased suspicion for g{HAT}.},
  keywords = {{H}uman {A}frican trypanosomiasis ; {T}rypanosoma brucei gambiense ; {D}iagnosis ; {S}pecificity ; {R}apid diagnostic test ; {I}mmunological test ; {M}olecular test ; {REPUBLIQUE} {DEMOCRATIQUE} {DU} {CONGO} ; {COTE} {D}'{IVOIRE} ; {GUINEE} ; {AFRIQUE} {SUBSAHARIENNE}},
  booktitle = {},
  journal = {{I}nfectious {D}iseases of {P}overty},
  volume = {13},
  numero = {1},
  pages = {53 [16 p.]},
  ISSN = {2095-5162},
  year = {2024},
  DOI = {10.1186/s40249-024-01220-5},
  URL = {https://www.documentation.ird.fr/hor/fdi:010091094},
}