Evaluation of the Performance of the Loopamp Trypanosoma cruzi Detection Kit for the Diagnosis of Chagas Disease in an Area Where It Is Not Endemic, Spain
Por:
Flores-Chavez, MD, Abras, A, Ballart, C, Perez, II, Perez-Gordillo, P, Gallego, M, Munoz, C, Moure, Z, Igual, ES, Nieto, J, Diez, EG, Cruz, I, Picado, A
Publicada:
1 may 2021
Resumen:
In Spain, PCR is the tool of choice for the diagnosis of congenital Chagas disease (CD) and serology for diagnosing chronic CD. A loop-mediated isothermal amplification test for Trypanosoma cruzi DNA detection showed good analytical performance and ease of use. We aimed to evaluate the performance of the Loopamp Trypanosoma cruzi detection kit (Eiken Chemical Co. Ltd., Japan) (Tcruzi-LAMP) for congenital and chronic CD diagnosis using well-characterized samples. We included samples from 39 congenital and 174 chronic CD cases and from 48 uninfected children born to infected mothers and 34 nonchagasic individuals. The sensitivity, specificity, and accuracy of Tcruzi-LAMP were estimated using standard case definitions for congenital CD (positive result by parasitological or PCR tests or serology after 9 months of age) and chronic CD (positive serology by at least two tests). The Tcruzi-LAMP results were read by visual examination and a real-time fluorimeter. For congenital CD, Tcruzi-LAMP sensitivity was 97% for both types of reading; specificity was 92% by visual examination and 94% by fluorimeter. For chronic CD, sensitivity was 47% and specificity 100%. The accuracy in congenital CD was >94% versus 56% in chronic CD. The agreement of Tcruzi-LAMP with PCR tests was better in congenital CD (kappa, 0.86 to 0.91) than in chronic CD (kappa, 0.67 to 0.83). The Loopamp Trypanosoma cruzi detection kit showed good performance for the diagnosis of congenital CD. Tcruzi-LAMP, like PCR, can be useful for the screening and early diagnosis of congenital infection.
Filiaciones:
Flores-Chavez, MD:
Inst Salud Carlos III, Natl Ctr Microbiol, Madrid, Spain
Fdn Mundo Sano Espana, Madrid, Spain
Abras, A:
Univ Barcelona, Fac Farm & Ciencies Alimentacio, Dept Biol Sanitat & Med Ambient, Secc Parasitol, Barcelona, Spain
Univ Girona, Dept Biol, Girona, Spain
Ballart, C:
Univ Barcelona, Fac Farm & Ciencies Alimentacio, Dept Biol Sanitat & Med Ambient, Secc Parasitol, Barcelona, Spain
Univ Barcelona, ISGlobal, Hosp Clin, Barcelona, Spain
Perez, II:
Inst Salud Carlos III, Natl Ctr Microbiol, Madrid, Spain
Perez-Gordillo, P:
Inst Salud Carlos III, Natl Ctr Microbiol, Madrid, Spain
Gallego, M:
Univ Barcelona, Fac Farm & Ciencies Alimentacio, Dept Biol Sanitat & Med Ambient, Secc Parasitol, Barcelona, Spain
Univ Barcelona, ISGlobal, Hosp Clin, Barcelona, Spain
Munoz, C:
Hosp Santa Creu & Sant Pau, Serv Microbiol, Barcelona, Spain
Univ Autonoma Barcelona, Dept Genet & Microbiol, Cerdanyola Del Valles, Spain
Moure, Z:
Hosp Valle De Hebron, Barcelona, Spain
Igual, ES:
Hosp Valle De Hebron, Barcelona, Spain
Nieto, J:
Inst Salud Carlos III, Natl Ctr Microbiol, Madrid, Spain
Diez, EG:
Inst Salud Carlos III, Natl Ctr Microbiol, Madrid, Spain
Cruz, I:
Inst Salud Carlos III, Natl Sch Publ Hlth, Madrid, Spain
Fdn Innovat New Diagnost FIND, Geneva, Switzerland
Picado, A:
Fdn Innovat New Diagnost FIND, Geneva, Switzerland
hybrid, Green Published
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