VirologyEvaluation of a novel commercial rapid test for dengue diagnosis based on specific IgA detection☆,☆☆,★
Introduction
Dengue is nowadays the most important mosquito-borne viral disease affecting humans. It is caused by infection with any of the 4 serotypes of dengue virus (DENV) and is transmitted to humans by mosquitoes of the genus Aedes, namely, A. aegypti and A. albopictus. DENV infection can be asymptomatic, and the clinical manifestations of DENV infection can range from classical dengue fever to the more severe and life-threatening form of the disease: dengue hemorrhagic fever (Martina et al., 2009). Due mainly to the most severe forms of the disease, it is estimated that the DENV causes more than half a million hospitalizations annually, with mortality rates ranging between 1% and 5%, mostly in children (Wilder-Smith et al., 2010). In addition, DENV infections impose a heavy economic burden on the health systems of endemic countries (Suaya et al., 2009). Nowadays, dengue is considered endemic in over 100 countries and an estimate of nearly 3 billion people are living in risk areas, and there is a need for efficient, inexpensive dengue diagnostic tests (Peeling et al., 2010).
The DENV belongs to the genus Flavivirus within the family Flaviviridae. The virion is enveloped and the genome consists of a single-stranded RNA molecule of positive polarity of approximately 11 kb. The DENV genome encodes for 3 structural (capsid; precursor membrane and membrane; envelope) and for 7 nonstructural proteins (NS1, NS2A, NS2B, NS3, NS4A, NS4B, NS5), which are derived all from the proteolytic processing of a poly-protein of approximately 3400 amino acids (Rodenhuis-Zybert et al., 2010). The NS1 protein is secreted from infected cells and circulates at high levels in patients' sera during acute infection (Alcon et al., 2002, Young et al., 2000). Thus, NS1 detection has become a valuable marker for DENV diagnosis (Shu and Huang, 2004).
Currently, there are no licensed vaccines or specific treatment for dengue (Murphy and Whitehead, 2011, Wilder-Smith et al., 2010). Accurate diagnosis of dengue disease during the acute phase is useful for the clinical management of the patient and for disease control. Several approaches have been used for the laboratory diagnosis of DENV infections. Virus isolation, detection of virus genomes, virus antigens, or virus specific immunoglobulin has all been used as a reliable method for dengue diagnosis (Peeling et al., 2010, Shu and Huang, 2004). However, in most clinical settings, DENV diagnosis is carried out using commercial tests, available both in enzyme-linked immunoabsorbent assay (ELISA) or in immunochromatographic test formats, designed to detect either the presence of the NS1 protein and/or the presence of specific IgM or IgG in patients' sera. The increasing disease burden and costs that dengue represent have driven the proliferation of rapid tests for dengue diagnosis. To ensure quality and to corroborate manufactures' claims of test performance, there is a need for the independent evaluation of dengue diagnostic tests (Peeling et al., 2010). In this study, the evaluation of a novel rapid immunochromatographic commercial test (ASSURE® Dengue IgA Rapid test, MP Diagnostics, Singapore) for early DENV diagnosis, based on the detection of specific IgA, is presented.
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Serum specimens
A total of 225 sera were used for this evaluation. One hundred and seventy-two sera were collected during the years 2009 and 2010 from dengue patients in regional public health diagnosis laboratories as part of the national surveillance program for dengue in Mexico and remitted to Instituto Nacional de Referencia Epidemiológica (InDRE) in Mexico City for further analysis. Sera from dengue patients were classified according to the onset of fever, and day 0 was defined as sera collected within 24
Results
The 172 sera collected from dengue patients were previously tested and found positive for NS1 antigens using the Platelia™ NS1 Ag ELISA test in regional public health laboratories (unpublished results). As indicated in the protocol of the national program for dengue surveillance, sera found positive for NS1 are sent from the regional laboratories to the Department of Virology of InDRE, where they are subjected to real-time RT-PCR to identify the infecting DENV serotype. The results obtained
Discussion
Timely and accurate DENV diagnosis could improve the clinical management of patients and also help in disease control (Peeling et al., 2010). The usefulness of IgA detection in sera for DENV diagnosis has been recognized using ELISA and immunofluorescence assays (Balmaseda et al., 2003, Balmaseda et al., 2008, Groen et al., 1999, Koraka et al., 2001, Nawa et al., 2005, Talarmin et al., 1998). In this study, the first evaluation independent of the manufacturers of a novel rapid test (ASSURE®)
Acknowledgments
The authors wish to thanks the arbovirus laboratory personnel at InDRE for their valuable help with the RT-PCR and serologic assays.
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The MP Diagnostics ASSURE® Dengue IgA Rapid Tests used in this study were provided by MP Biomedicals Asia Pacific, Singapore.
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The authors declare no financial conflict of interest.