Multicountry Prospective Clinical Evaluation of Two Enzyme-Linked Immunosorbent Assays and Two Rapid Diagnostic Tests for Diagnosing Dengue Fever

Pal, Subhamoy; Dauner, Allison L.; Valks, Andrea; Forshey, Brett M.; Long, Kanya C.; Thaisomboonsuk, Butsaya; Sierra, Gloria; Picos, Victor; Talmage, Sara; Morrison, Amy C.; Halsey, Eric S.; Comach, Guillermo; Yasuda, Chadwick Y.; Loeffelholz, Michael J.; Jarman, Richard G.; Fernandez, Stefan; An, Ung Sam; Kochel, Tadeusz J.; Jasper, Louis E.; Wu, Shuenn Jue L.

doi:10.1128/jcm.03042-14

Cited by 49 publications

(44 citation statements)

References 52 publications

Supporting

Mentioning

Contrasting

Order By: Relevance

“…Most published dengue RDT evaluation studies used serum samples. Some studies also used whole blood specimen and only one used capillary blood [26][27][28][29]. The excellent agreement between the results tested on capillary, venous, and serum samples in this study demonstrated that all three of them can be used on RDT, provided that anticoagulant-coated tool is used for the collection of whole blood specimen.…”

Section: Discussionsupporting

confidence: 53%

Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia

et al. 2020

View full text Add to dashboard Cite

Background: Dengue is an emerging infectious disease that infects up to 390 million people yearly. The growing demand of dengue diagnostics especially in low-resource settings gave rise to many rapid diagnostic tests (RDT). This study evaluated the accuracy and utility of ViroTrack Dengue Acute -a new biosensors-based dengue NS1 RDT, SD Bioline Dengue Duo NS1/IgM/IgG combo -a commercially available RDT, and SD Dengue NS1 Ag enzymelinked immunosorbent assay (ELISA), for the diagnosis of acute dengue infection. Methods: This prospective cross-sectional study consecutively recruited 494 patients with suspected dengue from a health clinic in Malaysia. Both RDTs were performed onsite. The evaluated ELISA and reference tests were performed in a virology laboratory. The reference tests comprised of a reverse transcription-polymerase chain reaction and three ELISAs for the detection of dengue NS1 antigen, IgM and IgG antibodies, respectively. The diagnostic performance of evaluated tests was computed using STATA version 12. Results: The sensitivity and specificity of ViroTrack were 62.3% (95%CI 55.6-68.7) and 95.0% (95%CI 91.7-97.3), versus 66.5% (95%CI 60.0-72.6) and 95.4% (95%CI 92.1-97.6) for SD NS1 ELISA, and 52.4% (95%CI 45.7-59.1) and 97.7% (95%CI 95.1-99.2) for NS1 component of SD Bioline, respectively. The combination of the latter with its IgM and IgG components were able to increase test sensitivity to 82.4% (95%CI 76.8-87.1) with corresponding decrease in specificity to 87.4% . Although a positive test on any of the NS1 assays would increase the probability of dengue to above 90% in a patient, a negative result would only reduce this probability to 23.0-29.3%. In contrast, this probability of false negative diagnosis would be further reduced to 14.7% if SD Bioline NS1/IgM/IgG combo was negative. Conclusions: The performance of ViroTrack Dengue Acute was comparable to SD Dengue NS1 Ag ELISA. Addition of serology components to SD Bioline Dengue Duo significantly improved its sensitivity and reduced its false negative rate such that it missed the fewest dengue patients, making it a better point-of-care diagnostic tool. New RDT like ViroTrack Dengue Acute may be a potential alternative to existing RDT if its combination with serology components is proven better in future studies.

show abstract

Section: Discussionsupporting

confidence: 53%

Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia

et al. 2020

View full text Add to dashboard Cite

show abstract

“…However, leukopaenia and DOF were statistically significant predictors only in the model without RDT results. This could be explained by the adequate performance of the rapid tests in this setting, and the likelihood of clinicians to rely on such a test when they have access to them . Thrombocytopaenia and abdominal pain however, were significant and consistent predictors throughout the entire set of our analysis, indicating that regardless of the presence or performance of RDTs, these factors are essential predictors of dengue identification in the clinical practice .…”

Section: Discussionmentioning

confidence: 84%

Burden of dengue among febrile patients at the time of chikungunya introduction in Piedecuesta, Colombia

Carabalí

Lim

Palencia

et al. 2018

Tropical Med Int Health

View full text Add to dashboard Cite

show abstract

“…Most studies of dengue RDTs have been retrospective and used archived specimens to determine test sensitivity and specificity (24)(25)(26)28). In those studies, the overall sensitivity varied from 48.5 to 72.4%, and the specificity varied from 88.8 to 100%.…”

Section: Discussionmentioning

confidence: 99%

Use of a Rapid Test for Diagnosis of Dengue during Suspected Dengue Outbreaks in Resource-Limited Regions

Hunsperger

Sharp

Lalita³

et al. 2016

J Clin Microbiol

View full text Add to dashboard Cite

G lobally, over 2.5 billion people are estimated to be at risk of dengue virus (DENV) infection with an estimated 96 million symptomatic cases of dengue occurring annually (1). Despite ongoing research efforts, there are no sustainable vector control approaches or effective antiviral drugs to prevent or treat dengue, and vaccines have only recently been licensed by few countries and with suboptimal efficacy (2, 3, 4, 5). However, improvements in patient clinical management has been shown to reduce mortality among patients with severe dengue from 5% to Ͻ0.5% (6-9).Delayed dengue case identification often occurs in areas with limited diagnostics or surveillance resources, especially where dengue outbreaks are episodic or have been under-recognized (e.g., Africa and Oceania) (10, 11). These factors decrease health care provider awareness to include dengue in the differential diagnosis with other acute febrile illnesses (AFIs) such as malaria, leptospirosis, and influenza (12). Lastly, minimal or no laboratory infrastructure to conduct standard dengue diagnostic assays or perform them in a timely manner limits their utility for case management (13).Laboratory diagnosis of dengue can be achieved with a single serum specimen obtained during the febrile phase of the illness by testing for DENV analytes (e.g., nucleic acid, nonstructural protein 1 [NS1], and anti-DENV IgM) (14). DENV viremia occurs for up to 7 days after the onset of fever, and anti-DENV IgM begins to appear around 3 days after fever onset (15, 16). Although detection of DENV nucleic acid by real-time reverse transcriptase PCR (rRT-PCR) is the most sensitive and specific means to detect DENV viremia (17), immunoassays to detect DENV NS1 antigen provide acceptable levels of detection sensitivity and specificity (18,19). Immunoassays with good sensitivities and specificities to detect anti-DENV IgM are also widely available (20). However, both of these diagnostic approaches are instrument dependent and require facilities capable of performing complex diagnostic tests.The availability of dengue rapid diagnostic tests (RDTs) has the potential to change the current situation in resource-limited areas and improve dengue clinical management. We evaluated an RDT that detected both DENV NS1 antigen and anti-DENV IgM for its ability to provide accurate information for detecting dengue from outbreaks as the main cause of febrile illness in areas without ongoing laboratory testing. In all settings, a suspected dengue case was defined as a person with an AFI presenting for medical care. Serum specimens were collected from all suspected dengue cases upon initial presentation along with patient demographics, days post onset of illness (DPO), and specimen collection date (Table 1). Second convalescent specimens were not collected for patients, and only specimens collected upon patient presentation to hospital or clinic were used in this study. MATERIALS AND METHODS Study design. The Centers for Disease Control and PreventionDiagnostic testing. The RDT used during each ...

show abstract

Multicountry Prospective Clinical Evaluation of Two Enzyme-Linked Immunosorbent Assays and Two Rapid Diagnostic Tests for Diagnosing Dengue Fever

Cited by 49 publications

References 52 publications

Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia

Diagnostic accuracy and utility of three dengue diagnostic tests for the diagnosis of acute dengue infection in Malaysia

Burden of dengue among febrile patients at the time of chikungunya introduction in Piedecuesta, Colombia

Use of a Rapid Test for Diagnosis of Dengue during Suspected Dengue Outbreaks in Resource-Limited Regions

Contact Info

Product

Resources

About