Detection of Leishmania in the blood of early kala-azar patients with the aid of the polymerase chain reaction.

Samples from 39 patients with symptoms suggestive of early visceral leishmaniasis were independently assayed by microscopy of tissue smears, enzyme-linked immunosorbent assay (ELISA) and polymerase chain reaction (PCR) of blood deoxyribonucleic acid. Of these patients, 19 were confirmed as positive or negative by all 3 tests; 11 patients (28%) negative by smear were positive by ELISA and PCR; and 7 (18%) were positive by PCR alone. These results demonstrate the high sensitivity of the non-invasive PCR and, to a smaller extent, ELISA, in the early diagnosis of visceral leishmaniasis.