Comparison of Parasitological, Serological, and Molecular Tests for Visceral Leishmaniasis in HIV-Infected Patients: A Cross-Sectional Delayed-Type Study

Abstract

Abstract. The aim of this study was to evaluate the accuracy of invasive and non-invasive tests for diagnosis of visceral leishmaniasis (VL) in a large series of human immunodeficiency virus (HIV)-infected patients. In this delayedtype cross-sectional study, 113 HIV-infected symptomatic patients were evaluated by an adjudication committee after clinical follow-up to establish the presence or absence of VL as the target condition (reference test). The index tests were recombinant K39 antigen-based immunochromatographic test (rK39), indirect fluorescent antibody test (IFAT), prototype kit of direct agglutination test (DAT-LPC), and real-time polymerase chain reaction (qPCR) in peripheral blood. Compared with parasitological test and adjudication committee diagnosis or latent class model analyses, IFAT and rk39 dipstick test presented the lowest sensitivity. DAT-LPC exhibited good overall performance, and there was no statistical difference between DAT-LPC and qPCR diagnosis accuracy. Real-time PCR emerges as a less invasive alternative to parasitological examination for confirmation of cases not identified by DAT.

Performance of a rapid diagnostic test for the detection of visceral leishmaniasis in a large urban setting

“…For example, among immunocompromised patients, the sensitivity of RDTs seems to be lower, with one study reporting an estimation of 77.3% 16 . Moreover, in a previous Brazilian study, the performance of the rK39 RDT was inferior to the use of a parasitological method, real-time PCR in peripheral blood and a prototype kit for a direct agglutination test (DAT) among human immunodefi ciency virus (HIV)-positive patients 22 .…”

Budgetary impact of diagnostic tests for visceral leishmaniasis in Brazil

“…In immunocompromised patients, the estimated sensitivity of DAT is 89.7% and the specificity is 85.3% 9 . This test is simple and easy to interpret, requires a simple laboratory infrastructure with a centrifuge and pipettes, and can replace the IFAT in routine clinical laboratories, thereby increasing efficiency, operability, and speed.…”

Diagnosing Neglected Tropical Diseases in HIV Coinfection

“…[105][106][107][108][109] According to data obtained from a study evaluating the accuracy of invasive and noninvasive tests for diagnosis of VL in a large series of HIV-infected patients at a reference center in Brazil, serological tests, such as indirect fluorescent antibody test and ELISA, showed lower sensitivity (,60%) when compared to the direct agglutination test (DAT), the sensitivity of which was 85%. 105 DAT is considered a highly sensitive and easy-to-use test and may be a good alternative for screening VL in HIV-infected patients. Molecular methods based on PCR have been evaluated as sensitive and specific methods to diagnose leishmaniasis both in non-HIV-infected and in HIV-infected patients.…”

“…104,105 Serological tests have a high diagnostic value for VL diagnosis in immunocompetent patients, [106][107][108] but their value is limited in HIV-infected patients. [105][106][107][108][109] According to data obtained from a study evaluating the accuracy of invasive and noninvasive tests for diagnosis of VL in a large series of HIV-infected patients at a reference center in Brazil, serological tests, such as indirect fluorescent antibody test and ELISA, showed lower sensitivity (,60%) when compared to the direct agglutination test (DAT), the sensitivity of which was 85%. 105 DAT is considered a highly sensitive and easy-to-use test and may be a good alternative for screening VL in HIV-infected patients.…”