@article{fdi:010068911, title = {{D}iagnosis of persistent fever in the tropics : set of standard operating procedures used in the {NIDIAG} febrile syndrome study}, author = {{A}lirol, {E}. and {H}orie, {N}. {S}. and {B}arbe, {B}. and {L}ejon, {V}eerle and {V}erdonck, {K}. and {G}illet, {P}. and {J}acobs, {J}. and {B}uscher, {P}. and {K}anal, {B}. and {B}hattarai, {N}. {R}. and {E}l {S}afi, {S}. and {P}he, {T}. and {L}im, {K}. and {L}eng, {L}. and {L}utumba, {P}. and {M}ukendi, {D}. and {B}ottieau, {E}. and {B}oelaert, {M}. and {R}ijal, {S}. and {C}happuis, {F}.}, editor = {}, language = {{ENG}}, abstract = {{I}n resource-limited settings, the scarcity of skilled personnel and adequate laboratory facilities makes the differential diagnosis of fevers complex [1-5]. {F}ebrile illnesses are diagnosed clinically in most rural centers, and both {R}apid {D}iagnostic {T}ests ({RDT}s) and clinical algorithms can be valuable aids to health workers and facilitate therapeutic decisions [6,7]. {T}he persistent fever syndrome targeted by {NIDIAG} is defined as presence of fever for at least one week. {T}he {NIDIAG} clinical research consortium focused on potentially severe and treatable infections and therefore targeted the following conditions as differential diagnosis of persistent fever: visceral leishmaniasis ({VL}), human {A}frican trypanosomiasis ({HAT}), enteric (typhoid and paratyphoid) fever, brucellosis, melioidosis, leptospirosis, malaria, tuberculosis, amoebic liver abscess, relapsing fever, {HIV}/{AIDS}, rickettsiosis, and other infectious diseases (e.g., pneumonia). {F}rom {J}anuary 2013 to {O}ctober 2014, a prospective clinical phase {III} diagnostic accuracy study was conducted in one site in {C}ambodia, two sites in {N}epal, two sites in {D}emocratic {R}epublic of the {C}ongo ({DRC}), and one site in {S}udan (clinicaltrials.gov no. {NCT}01766830). {T}he study objectives were to (1) determine the prevalence of the target diseases in patients presenting with persistent fever, (2) assess the predictive value of clinical and first-line laboratory features, and (3) assess the diagnostic accuracy of several {RDT}s for the diagnosis of the different target conditions. {I}n order to ensure consistency across study sites and compliance with {G}ood {C}linical ({L}aboratory) {P}ractices ({GC}[{L}]{P}) and other applicable regulatory requirements, a robust quality assurance system was developed and implemented prior to recruitment start. {T}his symposium describes the different components of the quality assurance system, introduces the set of standard operating procedures ({SOP}s) specifically developed for the {NIDIAG} persistent fever syndrome study, and identifies key challenges encountered by study sites in conducting the study in compliance with this quality framework.}, keywords = {{CAMBODGE} ; {SOUDAN} ; {NEPAL} ; {REPUBLIQUE} {DEMOCRATIQUE} {DU} {CONGO}}, booktitle = {}, journal = {{P}los {N}eglected {T}ropical {D}iseases}, volume = {10}, numero = {11}, pages = {e0004749 [7 p.]}, ISSN = {1935-2735}, year = {2016}, DOI = {10.1371/journal.pntd.0004749}, URL = {https://www.documentation.ird.fr/hor/fdi:010068911}, }