Title
Field Evaluation of a Hemozoin-Based Malaria Diagnostic Device in Puerto Lempira, Honduras
Date Issued
01 May 2022
Access level
open access
Resource Type
journal article
Author(s)
Fontecha G.
Escobar D.
Ortiz B.
Pinto A.
Serrano D.
Naval Medical Research
Publisher(s)
Multidisciplinary Digital Publishing Institute (MDPI)
Abstract
The diagnosis of malaria in Honduras is based mainly on microscopic observation of the parasite in thick smears or the detection of parasite antigens through rapid diagnostic tests when microscopy is not available. The specific treatment of the disease depends exclusively on the positive result of one of these tests. Given the low sensitivity of conventional methods, new diagnostic approaches are needed. This study evaluates the in-field performance of a device (Gazelle™) based on the detection of hemozoin. This was a double-blind study evaluating symptomatic individuals with suspected malaria in the department of Gracias a Dios, Honduras, using blood samples collected from 2021 to 2022. The diagnostic performance of Gazelle™ was compared with microscopy and nested 18ssr PCR as references. The sensitivity and specificity of Gazelle™ were 59.7% and 98.6%, respectively, while microscopy had a sensitivity of 64.9% and a specificity of 100%. The kappa index between microscopy and Gazelle™ was 0.9216 using microscopy as a reference. Both methods show similar effectiveness and predictive values. No statistical differences were observed between the results of the Gazelle™ compared to light microscopy (p = 0.6831). The turnaround time was shorter for Gazelle™ than for microscopy, but the cost per sample was slightly higher for Gazelle™. Gazelle™ showed more false-negative cases when infections were caused by Plasmodium falciparum compared to P. vivax. Conclusions: The sensitivity and specificity of Gazelle™ are comparable to microscopy. The simplicity and ease of use of the Gazelle™, the ability to run on batteries, and the immediacy of its results make it a valuable tool for malaria detection in the field. However, further development is required to differentiate Plasmodium species, especially in those regions requiring differentiated treatment.
Volume
12
Issue
5
Language
English
OCDE Knowledge area
Medicina tropical Parasitología
Scopus EID
2-s2.0-85130581965
Source
Diagnostics
ISSN of the container
20754418
Sponsor(s)
for this study was provided by the Genetic Research Center, CIG-UNAH, and by the Armed Forces Health Surveillance Division (AFHSD), Global Emerging Infections Surveillance (GEIS) Branch, ProMIS ID P0074_21_N6_01 for FY2021. The funders had no role in study design, data collection, analysis, decision to publish, or preparation of the manuscript. Funding: Funding for this study was provided by the Genetic Research Center, CIG-UNAH, and by the Armed Forces Health Surveillance Division (AFHSD), Global Emerging Infections Surveillance (GEIS) Branch, ProMIS ID P0074_21_N6_01 for FY2021. The funders had no role in study design, data collection, analysis, decision to publish, or preparation of the manuscript.
Sources of information: Directorio de Producción Científica Scopus