@article{fdi:010092131,
  title = {{A}nalytical {S}ensitivity analysis and clinical impact modeling of rapigen rapid diagnostic tests for malaria},
  author = {{G}olden, {A}. and {S}later, {H}. {C}. and {J}ang, {I}. {K}. and {W}alke, {S}. and {P}han, {T}. {T}. and {B}izilj, {G}. {T}. and {R}ashid, {A}. and {B}arney, {R}. and {D}as, {S}. and {R}ist, {M}. {J}. and {M}c{C}arthy, {J}. {S}. and {N}osten, {F}. and {L}andier, {J}ordi and {I}mwong, {M}. and {H}ume, {J}. {C}. {C}. and {S}agara, {I}. and {H}ealy, {S}. {A}. and {D}uffy, {P}. {E}. and {N}tuku, {H}. and {M}umbengegwi, {D}. and {H}siang, {M}. {S}. and {M}urphy, {S}. {C}. and {R}ek, {J}. and {T}orres, {K}. and {G}amboa, {D}. and {D}omingo, {G}. {J}.},
  editor = {},
  language = {{ENG}},
  abstract = {{L}aboratory benchmarking allows objective analysis of the analytical performance of malaria rapid diagnostic tests ({RDT}s). {W}e present the analytical detection limits of the {R}apigen {BIOCREDIT} {M}alaria {A}g {P}f/{P}v (p{LDH}/p{LDH}), the {R}apigen {BIOCREDIT} {M}alaria {A}g {P}f (p{LDH}/{HRPII}), and two best-in-class {WHO}-prequalified comparator {RDT}s, generated using standardized panels containing recombinant antigen, in vitro cultured parasites, international standards, and clinical samples. {D}etection limit antigen concentrations of {HRP}2, {P}f{LDH}, and {P}v{LDH} were determined for the {R}apigen and comparator {RDT}s. {D}etection of antigens in international units ({IU})/m{L} was also evaluated. {T}he {R}apigen {A}g {P}f (p{LDH}/ {HRPII}) detected 3.9 and 3.9 {IU}/m{L} for {P}f{LDH} and {HRP}2, respectively, and the {A}g {P}f/{P}v (p{LDH}/p{LDH}) detected 3.9 and 5.0 {IU}/m{L} for {P}f{LDH} and {P}v{LDH}, respectively. {T}he comparator {HRP}2/{P}f{LDH} and {HRP}2/{P}v{LDH} detected 15.6 and 31.3 {IU}/m{L} for {HRP}2 and {P}f{LDH} and 15.6 and 50.0 {IU}/m{L} for {HRP}2 and {P}v{LDH}, respectively. {T}he {RDT} clinical sensitivity was predicted through application of analytical detection limits to antigen concentration distributions from clinical symptomatic and asymptomatic cases. {F}ebrile cases would be detected in a majority by both standard and {R}apigen {RDT}s, but incremental increases in sensitivity in the {R}apigen {RDT}s may be important for clinical cases currently missed by microscopy. {R}apigen {RDT}s were predicted to have improved detection of asymptomatic cases and infections with parasites carrying hrp2 deletions through more sensitive {P}f{LDH} detection. {T}hrough the benchmarking and simulation of clinical sensitivity, a method for rapidly assessing the ability of new {RDT}s to meet clinical needs using high-sensitivity antigen distribution data is presented.},
  keywords = {},
  booktitle = {},
  journal = {{A}merican {J}ournal of {T}ropical {M}edicine and {H}ygiene},
  volume = {111},
  numero = {5},
  pages = {956--966 [11 p.]},
  ISSN = {0002-9637},
  year = {2024},
  DOI = {10.4269/ajtmh.24-0003},
  URL = {https://www.documentation.ird.fr/hor/fdi:010092131},
}