The use of rapid dengue diagnostic tests in a routine clinical setting in a dengue-endemic area of Colombia

Abstract

There is insufficient evidence of the usefulness of dengue diagnostic tests under routine conditions. We sought to analyse how physicians are using dengue diagnostics to inform research and development. Subjects attending 14 health institutions in an endemic area of Colombia with either a clinical diagnosis of dengue or for whom a dengue test was ordered were included in the study. Patterns of test-use are described herein. Factors associated with the ordering of dengue diagnostic tests were identified using contingency tables, nonparametric tests and logistic regression. A total of 778 subjects were diagnosed with dengue by the treating physician, of whom 386 (49.5%) were tested for dengue. Another 491 dengue tests were ordered in subjects whose primary diagnosis was not dengue. Severe dengue classification [odds ratio (OR) 2.2; 95% confidence interval (CI) 1.1-4.5], emergency consultation (OR 1.9; 95% CI 1.4-2.5) and month of the year (OR 3.1; 95% CI 1.7-5.5) were independently associated with ordering of dengue tests. Dengue tests were used both to rule in and rule out diagnosis. The latter use is not justified by the sensitivity of current rapid dengue diagnostic tests. Ordering of dengue tests appear to depend on a combination of factors, including physician and institutional preferences, as well as other patient and epidemiological factors.

Validation and reliability of the rapid diagnostic test ‘SD Bioeasy Dengue Duo’ for dengue diagnosis in Brazil: a phase III study

“…Nonetheless, most of the available tests have not undergone extensive validation in the Brazilian population. Additionally, precise accuracy data are not currently available for clinicians acting in routine clinical settings ( Osorio et al 2015 ). Therefore, this research aims to estimate the accuracy and reliability of the SD Bioeasy Dengue Duo (Standard Diagnostic Inc., Korea) and its components to detect acute dengue infection in a consecutive sample of symptomatic residents in the Federal District (FD), Brazil.…”

Improving dengue case confirmation by combining rapid diagnostic test, clinical, and laboratory variables

“…Together, these different factors may not only help in understanding the rising incidence and prevalence rates in our country but also explain the increasingly frequent severe and fatal cases [30] Unfortunately, most of the reported dengue cases in Colombia are diagnosed by clinical criteria, and only a small percentage of the cases are confirmed by Immunoglobulin M (IgM) enzyme-linked immunosorbent assay (ELISA) test or reverse transcriptionpolymerase chain reaction (RT-PCR) (34.7%); only severe or fatal cases are investigated by non-structural protein-1 (NS1) ELISA or RT-PCR [44,45]. For these reasons, some secondary and tertiary care hospitals independently perform rapid diagnostic tests (RDT) for IgM/IgG or NS1 to improve the clinical diagnosis and treatment of cases suspected of dengue [46][47][48]. Despite the widespread use of RDT in Colombia, the few reports evaluating the performance of RDT suggest that a negative result in these tests does not rule out dengue; therefore, clinicians should be aware of dengue diagnosis and confirm cases by laboratory tests [47][48][49][50].…”

Impact of Dengue Rapid Diagnostic Tests on the Prescription of Antibiotics and Anti-Inflammatory Drugs by Physicians in an Endemic Area in Colombia

“…This technique yields results in 15 to 20 minutes, is easy to perform, is relatively inexpensive, and is more available in clinical laboratories than reference tests based on reverse-transcription polymerase chain reaction or ELISA. 9,10 The rapid tests that detect dengue-specific IgM and IgG have disadvantages that false positives occur because of cross-reactions with antibodies to other flaviviruses (including recent yellow fever vaccination), they have lower sensitivity than ELISA-based tests, and their performance varies between manufacturers. 9,11 The sensitivity of the rapid tests that detect NS1 antigen ranges from 40% to 100%, with specificity from 76% to 100%.…”

“…9 In Colombia, dRDTs are not recommended by national guidelines, 6 but they have become a tool of frequent use in health services. 10 Moreover, whether these dRDTs are helping the clinicians in their treatment decisions is unknown.…”