Evaluation of OneStep Dengue NS1 RapiDip™ InstaTest and OneStep Dengue Fever IgG/IgM RapiCard™ InstaTest during the course of a dengue type 1 epidemic

Vickers, Ivan; Harvey, Kevin; Nelson, Kereann; Brown, Michelle; Bullock-DuCasse, Marion; Lindo, John

doi:10.1016/j.diagmicrobio.2017.08.019

Cited by 10 publications

(5 citation statements)

References 35 publications

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“…Therefore, a combination of NS1 and IgM antibody tests is recommended [8]. When we combined the NS1 antigen and IgM antibody results, the RDTs and ELISAs had similar performance, confirming previous reports that RDTs could be useful in clinical settings [3111213]. In our study, the sensitivity of the Euroimmun ELISA for IgM detection was as low as 38.1%.…”

supporting

confidence: 84%

Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies

et al. 2019

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ELISAs and rapid diagnostic tests (RDTs) are widely used for diagnosing dengue virus (DENV) infection. Using 138 single blood samples, we compared the ability to detect non-structural (NS)-1 antigen and anti-DENV IgM/IgG antibodies among (1) DENV Detect NS1 ELISA, DENV Detect IgM capture ELISA and DENV Detect IgG ELISA (InBios International, Inc.); (2) Anti-Dengue virus IgM Human ELISA and Anti-Dengue virus IgG Human ELISA (Abcam); (3) Dengue virus NS1 ELISA, Anti-Dengue virus ELISA (IgM) and Anti-Dengue virus ELISA (IgG) (Euroimmun); (4) Asan Easy Test Dengue NS1 Ag 100 and Asan Easy Test Dengue IgG/IgM (Asan Pharm); (5) SD BIOLINE Dengue Duo (Standard Diagnostics); and (6) Ichroma Dengue NS1 and Ichroma Dengue IgG/IgM (Boditech Med). For NS1 antigen detection, InBios and Euroimmun showed higher sensitivities (100%) than the RDTs (42.9–64.3%). All tests demonstrated variable sensitivities for IgM (38.1–90.5%) and IgG (65.7–100.0%). InBios and Boditech Med demonstrated higher sensitivity (95.6% and 88.2%, respectively) than the other tests for combined NS1 antigen and IgM antibody. Five NS1 antigen tests had good agreement (92.8–98.6%) without showing positivity for chikungunya. However, all IgG tests demonstrated potential false-positivity with variable ranges. Clinical laboratories should note performance variations across tests and potential cross-reactivity.

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supporting

confidence: 84%

Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies

et al. 2019

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“…The ten studies included prospective and retrospective cohort studies [25] , [26] , [27] , [28] , [29] , [30] , [31] , [32] , [33] , [34] . Four dengue RDT brands were represented: SD BIOLINE Dengue Duo (Alere/Abbott), Panbio Dengue Duo (Alere/Abbott), OneStep Dengue Fever IgG/IgM RapiCard InstaTest (Cortez), and the GenBody Dengue IgG/IgM test.…”

Section: Resultsmentioning

confidence: 99%

Rapid diagnostic tests for determining dengue serostatus: a systematic review and key informant interviews

Luo

Fongwen

Kelly-Cirino

et al. 2019

Clinical Microbiology and Infection

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Objectives Vaccination for dengue with the live attenuated tetravalent CYD-TDV vaccine (Dengvaxia®) is only recommended in individuals who have had prior dengue virus (DENV) infection. Rapid diagnostic tests (RDT) for past DENV infection would offer a convenient method for pre-vaccination screening at point-of-care. A systematic review was conducted to evaluate the performance of current dengue RDTs for determining dengue serostatus, using IgG antibodies against DENV as a marker of past infection. Methods PubMed and EMBASE databases were searched from 2000 to 2018 to identify studies evaluating dengue RDTs in individuals with known or possible previous DENV infection. Study quality was evaluated using GRADE and QUADAS-2 criteria. Semi-structured interviews were also performed with available dengue RDT manufacturers. Results The performance of four dengue IgG RDTs was determined in 3137 individuals across ten studies conducted in 13 countries, with serum used in most of the studies. No studies reported data for determining dengue serostatus, and limited data were available regarding cross-reactivity with other viruses. The majority of studies demonstrated sensitivities and specificities between 80% and 100% for dengue IgG detection in samples from secondary infection or convalescent time-points after recent infection. Conclusions Although current dengue IgG RDTs have shown reasonable performance compared with laboratory-based tests in secondary infection, additional research is needed to determine how RDTs would perform in relevant populations targeted for vaccination. New RDTs or modifications to current RDTs are feasible and may optimize the performance of these tests for use in a pre-vaccination screening approach.

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“…However, the decline in performance was more obvious for SD NS1 RDT as reducing level of NS1 towards the end of the week might produce a test line too faint to be detected with naked eyes [8]. On the contrary, serology-only assays performed better after day 5 when IgM and IgG started to be secreted to counter the infectious agent [5,7,17,18,22,29,30,[40][41][42][43][44]. The observation that SD IgM performed better than IgG, especially after day 5, is most likely due to the use of IgM ELISA in the definition of the reference standard.…”

Section: Discussionmentioning

confidence: 99%

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

et al. 2020

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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.

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Evaluation of OneStep Dengue NS1 RapiDip™ InstaTest and OneStep Dengue Fever IgG/IgM RapiCard™ InstaTest during the course of a dengue type 1 epidemic

Cited by 10 publications

References 35 publications

Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies

Comparison of Six Commercial Diagnostic Tests for the Detection of Dengue Virus Non-Structural-1 Antigen and IgM/IgG Antibodies

Rapid diagnostic tests for determining dengue serostatus: a systematic review and key informant interviews

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

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