Diagnostic accuracy of 5 different brands of dengue virus non-structural protein 1 (NS1) antigen rapid diagnostic tests (RDT) in Indonesia

Santoso, Marsha S.; Yohan, Benediktus; Denis, Dionisius; Hayati, Rahma; Haryanto, Sotianingsih; Trianty, Leily; Noviyanti, Rintis; Hibberd, Martin L.; Sasmono, R. Tedjo

doi:10.1016/j.diagmicrobio.2020.115116

Cited by 24 publications

(19 citation statements)

References 28 publications

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“…To the best of our knowledge, only one recent retrospective study reported data on the Biosynex dengue NS1 RDT [15]. The performance observed for the Biosynex RDT in our study is very similar to that reported in the previously published study.…”

Section: Discussionsupporting

confidence: 89%

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Prospective Evaluation of a Commercial Dengue NS1 Antigen Rapid Diagnostic Test in New Caledonia

Alidjinou

Tardieu²,

Vrenken³

et al. 2022

Microorganisms

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Dengue virus infection is endemic in New Caledonia, with outbreaks occurring every year. We evaluated the Biosynex® Dengue NS1 antigen rapid diagnostic test (RDT) for the early diagnosis of dengue in patients attending a local hospital in northern New Caledonia. Samples collected from patients suspected of dengue infection were tested with RDT at the local laboratory, and then sent to the reference laboratory for confirmation with real-time RT-PCR. A total of 472 samples were included during the study period. RT-PCR yielded a positive result in 154 samples (32.6%). The sensitivity and specificity of the NS1 antigen RDT were 79.9% and 96.2%, respectively. The performance of the RDT varied by the time of sampling and dengue virus serotype. In conclusion, Biosynex® Dengue NS1 antigen RDT showed a sensitivity and a specificity in the upper range usually reported for this type of test. Several factors can lead to a suboptimal sensitivity, and negative samples with suggestive clinical features should be retested with reference methods.

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Section: Discussionsupporting

confidence: 89%

“…Data from significant recent evaluation studies [15][16][17][18][19][20][21][22][23], using RT-PCR as reference, are summarized in Table 3. These data confirm the variable performance observed in earlier studies.…”

Section: Discussionmentioning

confidence: 99%

Prospective Evaluation of a Commercial Dengue NS1 Antigen Rapid Diagnostic Test in New Caledonia

Alidjinou

Tardieu²,

Vrenken³

et al. 2022

Microorganisms

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“…However, the PAD provided a positive predictive value (PPV) of 84.62% and an accuracy of 87.67%. The sensitivity and specificity of many commercial RDTs (Chong et al, 2020;Gaikwad et al, 2017;Jang et al, 2019;Lee et al, 2019;Piedrahita et al, 2016;Santoso et al, 2020;Shukla et al, 2017;Simonnet et al, 2017;Suzuki et al, 2019;Thai et al, 2010;Vivek et al, 2017) show variability (Table S3), which might be due to difference in study design, population, reference standard, and other characteristics (Kohn et al, 2013;Leeflang, 2014;Whiting et al, 2011). It is challenging to compare the diagnostic performance between different studies without proper assessment since there were differences in study characteristics.…”

Section: Discussionmentioning

confidence: 99%

Clinical evaluation of a developed paper-based Dengue NS1 rapid diagnostic test for febrile illness patients

Prabowo

Chatchen

Rijiravanich

et al. 2021

International Journal of Infectious Diseases

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This study aimed to evaluate a microfluidic paper-based analytical device (DEN-NS1-PAD) based on a rapid NS1 antigen test for diagnosing dengue at the point of care. Methods: 219 serum samples from suspected dengue cases were tested with the developed DEN-NS1-PAD and commercial RDT by SD BIOLINE. The results were compared with the nested-PCR results. Results: The limit of detection of DEN-NS1-PAD was 0.78 ng mL À1 . It showed 88.89% sensitivity, 86.67% specificity, and a substantial agreement correlation (k = 0.7522) compared with nested-PCR. In contrast, SD BIOLINE for NS1 (SD-NS1) detection showed 87.88% sensitivity, 90.00% specificity, and had a substantial agreement correlation with nested-PCR (k = 0.7788). Conclusions: DEN-NS1-PAD is a valuable tool for diagnosing DENV infections, especially for diagnosed patients with early acute phase samples with high viral load. DEN-NS1-PAD has better sensitivity than SD-NS1 but less specificity.

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“…Recently, the WHO has advocated for the use of rapid diagnostic tests (RDTs) to improve dengue case detection and management in low resource, regional health care facilities [ 16 ]. Numerous quick, easy-to-use and inexpensive commercial RDTs are now available which can detect different markers of infection [ 17 , 18 ]. The dengue NS1 RDT detects the dengue non-structural protein 1 (NS1), which is secreted into the blood during, and slightly after, the viraemic phase of disease.…”

Section: Introductionmentioning

confidence: 99%

Combining rapid diagnostic tests to estimate primary and post-primary dengue immune status at the point of care

Biggs

Ashall

et al. 2022

PLoS Negl Trop Dis

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Background Characterising dengue virus (DENV) infection history at the point of care is challenging as it relies on intensive laboratory techniques. We investigated how combining different rapid diagnostic tests (RDTs) can be used to accurately determine the primary and post-primary DENV immune status of reporting patients during diagnosis. Methods and findings Serum from cross-sectional surveys of acute suspected dengue patients in Indonesia (N:200) and Vietnam (N: 1,217) were assayed using dengue laboratory assays and RDTs. Using logistic regression modelling, we determined the probability of being DENV NS1, IgM and IgG RDT positive according to corresponding laboratory viremia, IgM and IgG ELISA metrics. Laboratory test thresholds for RDT positivity/negativity were calculated using Youden’s J index and were utilized to estimate the RDT outcomes in patients from the Philippines, where only data for viremia, IgM and IgG were available (N:28,326). Lastly, the probabilities of being primary or post-primary according to every outcome using all RDTs, by day of fever, were calculated. Combining NS1, IgM and IgG RDTs captured 94.6% (52/55) and 95.4% (104/109) of laboratory-confirmed primary and post-primary DENV cases, respectively, during the first 5 days of fever. Laboratory test predicted, and actual, RDT outcomes had high agreement (79.5% (159/200)). Among patients from the Philippines, different combinations of estimated RDT outcomes were indicative of post-primary and primary immune status. Overall, IgG RDT positive results were confirmatory of post-primary infections. In contrast, IgG RDT negative results were suggestive of both primary and post-primary infections on days 1–2 of fever, yet were confirmatory of primary infections on days 3–5 of fever. Conclusion We demonstrate how the primary and post-primary DENV immune status of reporting patients can be estimated at the point of care by combining NS1, IgM and IgG RDTs and considering the days since symptoms onset. This framework has the potential to strengthen surveillance operations and dengue prognosis, particularly in low resource settings.

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Diagnostic accuracy of 5 different brands of dengue virus non-structural protein 1 (NS1) antigen rapid diagnostic tests (RDT) in Indonesia

Cited by 24 publications

References 28 publications

Prospective Evaluation of a Commercial Dengue NS1 Antigen Rapid Diagnostic Test in New Caledonia

Prospective Evaluation of a Commercial Dengue NS1 Antigen Rapid Diagnostic Test in New Caledonia

Clinical evaluation of a developed paper-based Dengue NS1 rapid diagnostic test for febrile illness patients

Combining rapid diagnostic tests to estimate primary and post-primary dengue immune status at the point of care

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