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. 2019 Aug 5;8(1):1178–1185. doi: 10.1080/22221751.2019.1635430

Table 2. Sensitivity (S) and Specificity (Sp) values for the Duplex VL-LFD compared with the commercial assay and with values from other published studies using rK39-based ICTs for diagnosis of human VL in Brazil.

Assay % Sensitivity (S, 95% CI) % Specificity (Sp, 95% CI) Year of study Reference
DUPLEX VL-LFD* 90.9 (78.9–100) 98.7 (96.1–100) 2019 This study
IT-LEISH®* 77.3 (59.8–94.8) 94.7 (89.6–99.8) 2019 This study
OnSite™ Leishmania IgG/IgM Combo 91.2 (84.5–95.1) 94.5 (86.7–97.9) 2018 [37]
DiaMed-IT LEISH® 90.0–96.0 93.0–100.0 2015 [28]
Kalazar Detect™* 72.4 (64.6–79) 99.6 (97.6–99.9) 2013 [30]
Kalazar Detect™* 46.6 (30.7–62.6) 97.1 (90.0–99.6) 2013 [4]
CrystalKA 61.5 (55.2–67.4) 98.4 (95.9–99.4) 2012 [29]
DiaMed-IT LEISH® 92.0 (87.8–94.8) 95.6 (92.2–97.5)    
Kalazar Detect™ 84.7 (79.7–88.7) 96.8 (93.9–98.4)    
Signal–KA 79.2 (73.7–83.8) 98.8 (96.6–99.6)    
Kalazar Detect™
IT-LEISH®
88.1 (83.0–92.3)
93.3 (89.0–96.4)
90.6 (82.3–96.0)
96.5 (90.0–99.3)
2012 [38]
IT-LEISH® 93 (89.2–96.4) 97.0 (92.0–99.1) 2011 [39]
rK39 (TRAld)* 88.9 96.0 2009 [31]
DiaMed IT-LEISH® 93.0 97.0 2008 [40]

*These studies were done specifically in the city of Belo Horizonte in Minas Gerais State. Values for S and Sp for studies done in countries other than Brazil with endemic VL and also prior to 2008 are available in the systematic reviews from Maia et al. [25] and Boelaert et al. [26].