Research Article

Evaluation of the Diagnostic Sensitivity of the VIASURE Leishmania Real-Time PCR Detection Kit Prototype for the Diagnosis of Cutaneous and Visceral Leishmaniasis

Table 2

Clinical performance based on analysis of DNA samples (n = 49): mean Ct values of the duplicate samples for each qPCR kit.

Sample IDCultureVIASURE CtSACACE
Ct
Clinical form/sampleSpecies
identification
Sample IDCultureVIASURE CtSACACE CtClinical
form/sample
Species
identification

1Neg36.94435.852CL/SB26Neg28.81828.950CL/SB
2NegNegNegCL/SB27NegNegNegCL/SB
3NegNegNegCL/SB28Neg36.27435.693CL/SB
4NegNegNegCL/SB29NegNegNegCL/SB
5NegNegNegCL/SB30Pos16.29916.664CL/SBL. infantum
6NegNegNegCL/SB31Neg32.43733.767CL/SB
7Pos21.02819.867CL/SBL. braziliensis32Neg33.37034.922CL/SB
8Neg31.40131.326CL/SB33Neg38.23138.497CL/SB
9NegNegNegCL/SB34Pos33.47632.940CL/SBL. panamensis
10Neg32.81233.210CL/SB35NegNeg37.799CL/SB
11NegNeg37.669CL/SB36NegNegNegCL/SB
12Pos20.92223.568CL/SBL. infantum37Neg33.86731.056CL/SB
13Pos18.02921.003CL/SBL. infantum38NegNegNegCL/SB
14Neg39.64936.799CL/SB39NegNegNegCL/SB
15Pos24.63025.873CL/SBL. infantum40NegNegNegCL/SB
16Pos28.13128.439CL/SBL. major41Pos26.84129.345CL/SBL. infantum
17NegNegNegCL/SB42NegNegNegCL/SB
18Pos27.00527.643CL/SBL. major43NegNegNegCL/SB
19NegNeg36.215CL/SB44NegNegNegCL/SB
20Pos31.95030.948CL/SBL. major45Neg26.48526.871VL/LB
21NegNeg37.315CL/SB46Pos22.66822.829VL/BML. infantum
22NegNeg37.171CL/SB47Pos29.20127.664VL/BML. infantum
23Neg34.78732.655CL/SB48Pos32.35332.874VL/PBL. infantum
24Neg29.51228.445CL/SB49NegNeg36.435VL/BM
25Neg25.60423.391CL/SBTotal POS13/4927/4933/49

CL: cutaneous leishmaniasis, VL: visceral leishmaniasis, SB: skin biopsy, BM: bone marrow, LB: liver biopsy, PB: peripheral blood; Positive result by the STAT-NAT® Leishmania spp. Kit (Sentinel, Milano, Italy). Characterization was done by hsp70 gene sequencing and MALDI-TOF MS [21].