Clinical and laboratory risk factors for death from visceral leishmaniasis (VL) are
relatively known, but quantitative real-time polymerase chain reaction (qPCR) might
assess the role of parasite load in determining clinical outcome. The aim of this
study was to identify risk factors, including parasite load in peripheral blood, for
VL poor outcome among children. This prospective cohort study evaluated children aged
≤ 12 years old with VL diagnosis at three times: pre-treatment (T0), during treatment
(T1) and post-treatment (T2). Forty-eight patients were included and 16 (33.3%) met
the criteria for poor outcome. Age ≤ 12 months [relative risk (RR) 3.51; 95%
confidence interval (CI) 1.89-6.52], tachydyspnoea (RR 3.46; 95% CI 2.19-5.47),
bacterial infection (RR 3.08; 95% CI 1.27-7.48), liver enlargement (RR 3.00; 95% CI
1.44-6.23) and low serum albumin (RR 7.00; 95% CI 1.80-27.24) were identified as risk
factors. qPCR was positive in all patients at T0 and the parasite DNA was
undetectable in 76.1% of them at T1 and in 90.7% at T2. There was no statistical
association between parasite load at T0 and poor outcome.
A kDNA PCR enzyme-linked immunosorbent assay (kDNA PCR-ELISA) for the diagnosis of human visceral leishmaniasis (HVL) was developed. The detection limit of the reaction, precision measurements, and cut-off of the kDNA PCR-ELISA were defined in a proof-of-concept phase. A reference strain of Leishmania (Leishmania) infantum and a bank of 14 peripheral blood samples from immunocompetent patients with VL were characterized using techniques considered gold standards, and 11 blood samples obtained from healthy individuals of an endemic area were also assessed. Phase II evaluation determined the performance of the assay in peripheral blood samples from 105 patients with VL (adults and children), 25 patients with Leishmania/HIV coinfection, 40 healthy individuals, and 33 asymptomatic individuals living in endemic areas. The kDNA PCR-ELISA exhibited satisfactory precision, with a detection limit of 0.07 fg of DNA from L. (L.) infantum and 1 parasite/mL blood. The overall sensitivity of the assay for all groups studied was 100% (95% confidence interval [CI]: 97.1–100%), and the specificity was 95% (95% CI: 83.5–98.6%). The kDNA PCR-ELISA was shown to be a useful tool for VL symptomatic and asymptomatic individuals diagnosis and its use in endemic countries may help monitor control interventions.
Surgical procedures and CVC usage were significant risk factors for LCBI. Therefore, prevention practices for safe surgery and CVC insertion and manipulation are essential to reduce these infections, in addition to training and continuing education to surgical and assistance teams.
Introduction: Rapid diagnostic tests (RDTs) may improve the early detection of visceral leishmaniasis (VL), but their real-world performance requires additional study. Therefore, we evaluated the performance of an rK39-based RDT (Kalazar Detect TM ) for the detection of VL in an endemic, large urban area. Methods: Data were collected from a registry of rK39 RDT performed at 11 emergency care units in Belo Horizonte, Brazil, and from a national database of reportable communicable diseases of the Sistema de Informação de Agravos de Notifi cação (SINAN). Results: The rapid rK39 test was performed in 476 patients, with 114 (23.9%) positive results. The analysis of rK39 RDT performance was based on 381 (80%) cases reported to the SINAN database, of which 145 (38.1%) were confi rmed cases. Estimates for sensitivity and specifi city were 72.4% (95% CI: 64.6-79%) and 99.6% (95%CI: 97.6-99.9%), respectively. Positive and negative predictive values were estimated at 99.1% (95%CI: 94.9-99.8%) and 85.5% (95%CI: 80.8-89.1%), respectively. In addition, close agreement between the rK39 RDT and indirect immunofl uorescence was observed. Conclusions: In summary, the rK39 RDT showed a high specifi city but only moderate sensitivity. In endemic areas for VL, treatment may be considered in cases with clinical manifestations and a positive rK39 RDT, but those with a negative test should be subjected to further investigation.
The use of standardized criteria for reporting infections is necessary for the construction of indicators in neonatology, which are scarce in the country and highlight the need for evaluation of national criteria proposed by National Agency of Sanitary Surveillance (ANVISA).
The use of standardized criteria for reporting infections is necessary for the construction of indicators in neonatology, which are scarce in the country and highlight the need for evaluation of national criteria proposed by National Agency of Sanitary Surveillance (ANVISA).
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