@article{fdi:010087558,
  title = {{P}erformance of clinical signs and symptoms, rapid and reference laboratory diagnostic tests for diagnosis of human {A}frican trypanosomiasis by passive screening in {G}uinea : a prospective diagnostic accuracy study},
  author = {{C}amara, {O}. and {C}amara, {M}. and {F}alzon, {L}. {C}. and {I}lboudo, {H}. and {K}abore, {J}. and {C}ompaore, {C}. {F}. {A}. and {F}evre, {E}. {M}. and {B}uscher, {P}. and {B}ucheton, {B}runo and {L}ejon, {V}eerle},
  editor = {},
  language = {{ENG}},
  abstract = {{B}ackground {P}assive diagnosis of human {A}frican trypanosomiasis ({HAT}) at the health facility level is a major component of {HAT} control in {G}uinea. {W}e examined which clinical signs and symptoms are associated with {HAT}, and assessed the performance of selected clinical presentations, of rapid diagnostic tests ({RDT}), and of reference laboratory tests on dried blood spots ({DBS}) for diagnosing {HAT} in {G}uinea. {M}ethod {T}he study took place in 14 health facilities in {G}uinea, where 2345 clinical suspects were tested with {RDT}s ({HAT} {S}ero-{K}-{S}et, r{HAT} {S}ero-{S}trip, and {SD} {B}ioline {HAT}). {S}eropositives underwent parasitological examination (reference test) to confirm {HAT} and their {DBS} were tested in indirect enzyme-linked immunoassay ({ELISA})/{T}rypanosoma brucei gambiense, trypanolysis, {L}oopamp {T}rypanosoma brucei {D}etection kit ({LAMP}) and m18{S} quantitative {PCR} (q{PCR}). {M}ultivariable regression analysis assessed association of clinical presentation with {HAT}. {S}ensitivity, specificity, positive and negative predictive values of key clinical presentations, of the {RDT}s and of the {DBS} tests for {HAT} diagnosis were determined. {R}esults {T}he {HAT} prevalence, as confirmed parasitologically, was 2.0% (48/2345, 95% {CI}: 1.5-2.7%). {O}dds ratios ({OR}) for {HAT} were increased for participants with swollen lymph nodes ({OR} = 96.7, 95% {CI}: 20.7-452.0), important weight loss ({OR} = 20.4, 95% {CI}: 7.05-58.9), severe itching ({OR} = 45.9, 95% {CI}: 7.3-288.7) or motor disorders ({OR} = 4.5, 95% {CI}: 0.89-22.5). {P}resence of at least one of these clinical presentations was 75.6% (95% {CI}: 73.8-77.4%) specific and 97.9% (95% {CI}: 88.9-99.9%) sensitive for {HAT}. {HAT} {S}ero-{K}-{S}et, r{HAT} {S}ero-{S}trip, and {SD} {B}ioline {HAT} were respectively 97.5% (95% {CI}: 96.8-98.1%), 99.4% (95% {CI}: 99.0-99.7%) and 97.9% (95% {CI}: 97.2-98.4%) specific, and 100% (95% {CI}: 92.5100.0%), 59.6% (95% {CI}: 44.3-73.3%) and 93.8% (95% {CI}: 82.8-98.7%) sensitive for {HAT}. {T}he {RDT}'s positive and negative predictive values ranged from 45.2-66.7% and 99.2-100% respectively. {A}ll {DBS} tests had specificities >= 92.9%. {W}hile {LAMP} and m18{S} q{PCR} sensitivities were below 50%, trypanolysis and {ELISA}/{T}.b. gambiense had sensitivities of 85.3% (95% {CI}: 68.9-95.0%) and 67.6% (95% {CI}: 49.5-82.6%). {C}onclusions {P}resence of swollen lymph nodes, important weight loss, severe itching or motor disorders are simple but accurate clinical criteria for {HAT} referral in {HAT} endemic areas in {G}uinea. {D}iagnostic performances of {HAT} {S}ero-{KS}et and {SD} {B}ioline {HAT} are sufficient for referring positives to microscopy. {T}rypanolysis on {DBS} may discriminate {HAT} patients from false {RDT} positives. {T}rial registration {T}he trial was registered under {NCT}03356665 in clinicaltrials.gov ({N}ovember 29, 2017, retrospectively registered https://clinicaltrials.gov/ct2/show/{NCT}03356665)},
  keywords = {{H}uman {A}frican trypanosomiasis ; {T}rypanosoma brucei gambiense ; {D}iagnosis ; {C}linical ; {R}apid diagnostic test ; {S}ensitivity ; {S}pecificity ; {D}ried blood spot ; {T}rypanolysis ; {GUINEE}},
  booktitle = {},
  journal = {{I}nfectious {D}iseases of {P}overty},
  volume = {12},
  numero = {1},
  pages = {22 [14 p.]},
  ISSN = {2095-5162},
  year = {2023},
  DOI = {10.1186/s40249-023-01076-1},
  URL = {https://www.documentation.ird.fr/hor/fdi:010087558},
}