Table 1. Diagnostic performance of rKLO8 – and rK39 ELISA, rK39 strip test (ST) and DAT for visceral leishmaniasis in Sudan.
Serological test | TP | FN | TN | FP | Sensitivity (n = 106) | Specificity (n = 77) | PPV | NPV |
Estimated values at 95% CI | ||||||||
rKLO8 ELISA | 104 | 2 | 74 | 3 | 98.1% | 96.1% | 97.2% | 97.4% |
rK39 ELISA | 102 | 4 | 73 | 4 | 96.2% | 94.8% | 97.2% | 94.8% |
rK39 ST (Bio Rad) | 86 | 20 | 76 | 1 | 81.1% | 98.7% | 98.9% | 79.2% |
DAT (ITMA) | 100 | 6 | 77 | 0 | 94.3% | 100% | 100% | 92.8% |
Abbreviations: TP, true positive; FN, false negative; TN, true negative; FP, false positive; PPV, positive predictive value; NPV, negative predictive value; CI, confidence interval; DAT, direct agglutination test; ITMA, Institute of Tropical Medicine Antwerp.
ELISA values were calculated combining results obtained at serum dilutions of 1∶800 and 1∶100. Detection of Leishmania in lymph node smears was used as reference. Specificity was calculated using 77 confirmed negative sera, including healthy controls, malaria -, TB-, and leukemia patients.