Table 1.
Demographic and clinical data for American tegumentary leishmaniasis (ATL) patients from endemic areas.
Fig 1.
Geographic distribution of 343 American tegumentary leishmaniasis patients (panel 2) according to the likely site of infection.
ATL–American tegumentary leishmaniasis. The map was generated through RStudio, version 4.3.2, using the geobr package from rstudio.com [33].
Table 2.
Samples from patients with American tegumentary leishmaniasis characterized by infecting species (N = 45) used in the rLb6H-ELISA to construct the ROC curve.
Fig 2.
A. Electrophoretic profile of rLb6H protein on SDS-PAGE, applying 18 ng of protein per well. B. Immunoblotting reactivity profile of rLb6H. 1- Molecular weight control stained with Ponceau S. 2—High titer leishmaniasis positive control. 3 –Low titer leishmaniasis positive control. 4—Negative control.
Fig 3.
Performance of rLb6H-ELISA for IgG antibodies in reference panel (Panel 1) (N = 140).
A—Percentage of absorbance of the positive standard (ABS%) obtained in the rLb6H-ELISA; *p < 0.0001 compared to the control, Mann–Whitney test. B—ROC (receiver operating characteristic) curve constructed with ABS% values; ** p-value < 0.0001 means the test significantly discriminates between American tegumentary leishmaniasis patients and controls.
Table 3.
Diagnostic performance of rLb6H-ELISA, using 70 samples from American tegumentary leishmaniasis patients and 70 healthy controls as determined by the ROC curve (Panel 1).
Table 4.
Sensitivity of rLb6H-ELISA using 393 samples from patients with American tegumentary leishmaniasis (Panel 2).
Table 5.
Specificity of rLb6H-ELISA using samples from healthy controls (Panel 3) after the Chagas test1 and rheumatoid factor test2.
Fig 4.
Reactivity index of samples from other diseases obtained by rLb6H-ELISA RI—Reactivity index.
The black dotted line represents the cut-off.
Table 6.
Cross-reactivity of 166 samples from patients with other diseases in the rLb6H-ELISA.
Fig 5.
Diagnostic gain using rLb6H-ELISA as a complementary test.
Blue bars show the number of samples that were positive by the test at the collection centers. Dark pink bars show the number of samples that were negative by the test at the collection centers but positive by rLb6H-ELISA. The percentages of positivity in the collection centers appear between the colored bars. The percentages at the top of the bars refer to the sum of positive samples at the collection centers plus positive samples in the rLb6H-ELISA that were negative by the previous test. IFAT**–immunofluorescent antibody test with L. major-like (Sao Paulo) and L. braziliensis (Manaus); IHC–immunohistochemistry; ELISA*–enzyme-linked immunosorbent assay with L. major-like; PCR–polymerase chain reaction; LST–leishmanin skin test.