title: Field evaluation of the InBios Chagas detect plus rapid test in serum and whole-blood specimens in Bolivia.
abstract: Trypanosoma cruzi causes Chagas disease, which affects an estimated 7 million to 8 million people. Chagas disease is endemic throughout Latin America, with the highest prevalence in Bolivia. Conventional diagnosis requires a well-equipped laboratory with experienced personnel. We evaluated the Chagas Detect Plus (CDP) (InBios, Seattle, WA), a rapid immunochromatographic assay for IgG antibodies to T. cruzi. CDP performance was compared to infection status based on results obtained by indirect hemagglutination assay, immunofluorescent-antibody test, and enzyme-linked immunosorbent assay. Confirmed infection required positive results by at least 2 conventional assays. We used specimens from adults of both sexes in a general hospital in the city of Santa Cruz and from pregnant women in a hospital and children in villages in the Bolivian Chaco, an area of hyperendemicity. CDP was performed in paired whole-blood and serum specimens from 385 individuals in the two hospital studies and in 200 serum specimens from the community study. CDP showed sensitivities/specificities of 96.2% (95% confidence interval, 92.7 to 98.4)/98.8% (95.9 to 99.9) in whole blood and 99.3% (97.5 to 99.9)/96.9% (94.2 to 98.6) in serum, with no differences by sex, age group, or study site. CDP showed excellent sensitivity and specificity in our study population, comparable to those of conventional serology. The test is reliable for field surveys, requires no laboratory equipment, and performed well in serum and whole blood. The CDP could also be used for accurate maternal screening to identify neonates at risk of congenital transmission. CDP performance data in diverse geographic areas are needed to strengthen the evidence base for its use.
authors.affiliation: Saint Louis University School of Medicine, St. Louis, Missouri, USA.
authors.forename: Vishal
authors.initials: V
authors.lastname: Shah
authors.affiliation: Universidad Catolica Boliviana, Santa Cruz, Plurinational State of Bolivia.
authors.forename: Lisbeth
authors.initials: L
authors.lastname: Ferrufino
authors.affiliation: Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
authors.forename: Robert H
authors.initials: RH
authors.lastname: Gilman
authors.affiliation: Universidad Catolica Boliviana, Santa Cruz, Plurinational State of Bolivia.
authors.forename: Margot
authors.initials: M
authors.lastname: Ramirez
authors.affiliation: Universidad Catolica Boliviana, Santa Cruz, Plurinational State of Bolivia.
authors.forename: Eliana
authors.initials: E
authors.lastname: Saenza
authors.affiliation: Laboratorio de Investigación en Enfermedades Infecciosas, Facultad de Ciencias y Filosofías, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Edith
authors.initials: E
authors.lastname: Malaga
authors.affiliation: Laboratorio de Investigación en Enfermedades Infecciosas, Facultad de Ciencias y Filosofías, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Gerardo
authors.initials: G
authors.lastname: Sanchez
authors.affiliation: New York University School of Medicine, New York, New York, USA.
authors.forename: Emi E
authors.initials: EE
authors.lastname: Okamoto
authors.affiliation: New York University School of Medicine, New York, New York, USA.
authors.forename: Jacqueline E
authors.initials: JE
authors.lastname: Sherbuck
authors.affiliation: Baylor College of Medicine, Houston, Texas, USA.
authors.forename: Eva H
authors.initials: EH
authors.lastname: Clark
authors.affiliation: Universidad Catolica Boliviana, Santa Cruz, Plurinational State of Bolivia Johns Hopkins University Bloomberg School of Public Health, Baltimore, Maryland, USA.
authors.forename: Gerson
authors.initials: G
authors.lastname: Galdos-Cardenas
authors.affiliation: Hospital Municipal Camiri, Camiri, Plurinational State of Bolivia.
authors.forename: Ricardo
authors.initials: R
authors.lastname: Bozo
authors.affiliation: Universidad Catolica Boliviana, Santa Cruz, Plurinational State of Bolivia.
authors.forename: Jorge Luis
authors.initials: JL
authors.lastname: Flores-Franco
authors.affiliation: Universidad Catolica Boliviana, Santa Cruz, Plurinational State of Bolivia.
authors.forename: Rony
authors.initials: R
authors.lastname: Colanzi
authors.affiliation: Laboratorio de Investigación en Enfermedades Infecciosas, Facultad de Ciencias y Filosofías, Universidad Peruana Cayetano Heredia, Lima, Peru.
authors.forename: Manuela
authors.initials: M
authors.lastname: Verastegui
authors.affiliation: University of California San Francisco, San Francisco, California, USA Caryn.Bern2@UCSF.EDU.
authors.forename: Caryn
authors.initials: C
authors.lastname: Bern
mesh_terms: D000293:Adolescent; D000328:Adult; D000368:Aged; D000369:Aged, 80 and over; D000913:Antibodies, Protozoan / Q000097:blood*; D001838:Bolivia; D014355:Chagas Disease / Q000175:diagnosis*; D002648:Child; D002675:Child, Preschool; D002846:Chromatography, Affinity / Q000379:methods*; D005260:Female; D006801:Humans; D007223:Infant; D008297:Male; D008875:Middle Aged; D011247:Pregnancy; D012680:Sensitivity and Specificity; D044967:Serum; D014349:Trypanosoma cruzi / Q000276:immunology*
chemical_list: D000913:Antibodies, Protozoan