Sensitivity and specificity of a rapid diagnostic test for chronic Chagas disease at a referral center in Brazil - can it be included as a standard serological diagnostic test in the clinical practice of a referral center?

Alejandro M Hasslocher-Moreno,Mauro F F Mediano,Ingebourg Georg,Luiz H C Sangenis

doi:10.54034/mic.e1236

Alejandro M Hasslocher-Moreno, Mauro F F Mediano + Show 2 more

Open Access

https://doi.org/10.54034/mic.e1236

Copy DOI

Abstract

Introduction: Chagas disease (CD) is a neglected tropical disease. In the chronic phase of CD, the diagnosis is essentially serologic. Conventional reactions are currently in use. More recently, the use of rapid diagnostic testing (RDT) is indicated when conventional techniques are not available. Objective: To evaluate the sensitivity and specificity of RDTs for chronic CD diagnosis. Methodology: Individuals under suspicion of CD were evaluated using ELISA, Chemiluminescence (ChLIA) and RDT tests. Results: The RDT showed 95.1% sensitivity and 96.7% specificity, respectively. Conclusion: The findings of the present study showed that RDT used in the diagnosis of CD at a referral center in Brazil were not able to detect all CD cases when compared to Elisa and ChLIA.

Highlights

Chagas disease (CD) is a neglected tropical disease
The Infectious Diseases (INI)-Fiocruz is a reference center for CD that provides diagnostic interpretation for patients referred from blood banks, primary and secondary care units, private health services, or by spontaneous demand, offering integral and multidisciplinary clinical care for patients with CD(6)
Due to the low parasitemia in the chronic phase of the disease, the diagnosis of T. cruzi infection is performed using serological or molecular methods, with serological methods being the preferred choice for the diagnosis of chronic CD(7)

Summary

Introduction

Chagas disease (CD) is considered a neglected tropical disease by the World Health Organization, with an estimated 6-7 million people infected worldwide(1). In the chronic phase of CD, the diagnosis is essentially serologic and must be performed using a test with high sensitivity in conjunction with another having high specificity, and both must be reactive (3). Conventional reactions such as the enzyme-linked immunosorbent assay (ELISA) test, indirect immunofluorescence (IFI), indirect hemagglutination (IHA) and, chemiluminescence (ChLIA) are currently under use (4). The use of rapid diagnostic testing (RDT) are indicated in order to improve the diagnosis in remote areas in which conventional techniques are not available (5)

Objectives

Methods

Conclusion