TABLE 1.
Country | No. of samples that were |
Total | ELISA description |
IFAT description | IHAT description | Antigen used | Definition (per in-country guidelines) of: |
Reference(s) | |||||
---|---|---|---|---|---|---|---|---|---|---|---|---|---|
Positive | Negative | From patients with other infections | I | II | Positive sample | Negative sample | Discordant samples | ||||||
Argentina | 40 | 51 | 10 | 101 | In-house protocol (cutoff, 0.2 + SD) | In-house protocol (cutoff, 1:32) | In-house protocol (cutoff, 1:32) | T. cruzi epimastigotes, Tulahuén strain | A sample was considered seropositive if at least two serological tests were positive following testing by ELISA, IHAT, and IFAT | Readings were negative following testing by three different tests (ELISA, IFAT, and IHA) | Readings were discordant following testing by three different tests (ELISA, IFAT, and IHAT) | 9, 19 | |
Ecuador | 51 | 8 | 41 | 100 | Chagas III (BiosChile Ingeniería Genética S.A., Santiago, Chile) (cutoff, [CPos + CNeg]·0.35) | Chagatek ELISA (bioMérieux, Buenos Aires, Argentina) (cutoff, CNeg·0.100) | ND | ND | Commercial kit antigen | Readings were positive following testing by two different ELISAs | Readings were negative following testing by two different ELISAs | Readings were discordant following testing by two different ELISAs, or one reading was close to the test's cutoff (±10%); the third reading by either test was considered definitive | 1 |
Mexico | 40 | 50 | 10 | 100 | Kit Chagas III (BiosChile Ingenieria Genetica S.A., Santiago, Chile) (cutoff, [CPos + CNeg]·0.35) | ND | ND | Commercial kit antigen | Readings were positive following testing by two different ELISAs | Reading was negative following testing by one ELISA | Readings were discordant following testing by two different ELISAs, or one reading was close to the test's cutoff; the third reading by either test was considered definitive | N. Pavia-Ruzb | |
Venezuela | 40 | 25 | 65 | In-house protocol (cutoff, 0.2 + 2 SD) | ND | In-house protocol (cutoff, 1:4) | T. cruzi epimastigotes, PM strain locally isolated from a patient in 1985 | Readings were positive by serological testing of two patient samples taken 1 month apart | Reading was negative following testing by one ELISA | Readings were discordant following testing by two different ELISAs, or one reading was close to the test's cutoff; the third reading by either test was considered definitive | 10, 13 |
Positive and negative samples included samples that had previously tested positive and negative by serological methods, as per in-country Chagas disease diagnostic guidelines. Abbreviations: CPos and CNeg, optical density value of positive and negative controls, respectively; ND, not done.
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