Accuracy and reliability of an NS1 rapid immunochromatographic test for DENV-1 diagnosis at point of care and in the laboratory

Mata, Verónica Elizabeth; Passos, Sônia Regina Lambert; Hökerberg, Yara Hahr Marques; Berardinelli, Guilherme Miguéis; Santos, Maria Angélica Borges dos; Fukuoka, Levy Vilas Boas; Maciel, Anna Carolina Fontoura Seixas Rangel; Rodrigues, Cintia Damasceno dos Santos; Santos, Aline da Silva; Oliveira, Raquel de Vasconcellos Carvalhaes de

doi:10.1186/s12879-017-2679-z

Cited by 10 publications

(6 citation statements)

References 29 publications

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“…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: 52%

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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Section: Discussionsupporting

confidence: 52%

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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“…After removing duplicates, we reviewed 3,783 abstracts, and selected 108 articles for reading the full-texts, of which 57 were selected for this review (Figure 1). The studies assessed multiple ICT brand tests with different analytes: five assessed IgA 24,25,26,27,28 , 21 NS1 10,27,29,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47 , 12 IgM/IgG 27,34,48,49,50,51,52,53,54,55,56,57 , and 25 NS1/IgM/IgG 29,36,37,40,46,58,59,60,61,62,63,…”

Section: Characteristics Of Included Studiesmentioning

confidence: 99%

“…According to the assessment of methodological quality conducted with the QUADAS 2 tool, of the 57 included studies, only six 29,30,38,39,69,78 did not show risk of bias, and 25 (43.8%) of the them showed high risk of bias regarding the patient selection process (Figure 2), mainly due to case-control design. Ten of them showed high risk of bias concerning flow and timing, mainly for excluding patients from analysis or for adopting inappropriate intervals between index and reference tests.…”

Section: Quality Assessment Of the Studiesmentioning

confidence: 99%

“…Tests based exclusively on NS1 evaluated three brands up to 2014: Bio-Rad, Panbio, Alere/Bio_Easy. These totalized 21 studies up to the seventh day of the disease 10,27,30,31,32,33,34,35,36,37,38,39,40,41,42,43,44,45,46,47,50 , one of which 34 presented the results of two settings, one in Malaysia and the other in Vietnam. The tests were assessed in 6,618 samples from patients with suspected dengue (median 241).…”

Section: Rapid Immunochromatographic Tests With Ns1 Detectionmentioning

confidence: 99%

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Rapid immunochromatographic tests for the diagnosis of dengue: a systematic review and meta-analysis

et al. 2020

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Abstract: Dengue is an important arthropod-borne viral disease in terms of morbidity, mortality, economic impact and challenges in vector control. Benchmarks are expensive, time consuming and require trained personnel. Preventing dengue complications with rapid diagnosis has been based on the testing of easy-to-perform optimized immunochromatographic methods (ICT). This is a systematic meta-analysis review of the diagnostic accuracy of IgA, NS1, IgM and/or IgG ICT studies in suspected cases of acute or convalescent dengue, using a combination of RT-PCR, ELISA NS1, IgM IgG or viral isolation as a reference standard. This protocol was registered in PROSPERO (CRD42014009885). Two pairs of reviewers searched the PubMed, BIREME, Science Direct, Scopus, Web of Science, Ovid MEDLINE JBrigs, SCIRUS and EMBASE databases, selected, extracted, and quality-assessed by QUADAS 2. Of 3,783 studies, we selected 57, of which 40 in meta-analyses according to the analyte tested, with high heterogeneity (I2 > 90%), as expected for diagnostic tests. We detected higher pooled sensitivity in acute phase IgA (92.8%) with excellent (90%) specificity. ICT meta-analysis with NS1/IgM/IgG showed 91% sensitivity and 96% specificity. Poorer screening performance was for IgM/IgG ICT (sensitivity = 56%). Thus, the studies with NS1/IgM/IgG ICT showed the best combined performance in the acute phase of the disease.

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“…These studies show high variability in the sensitivity, specificity, and predictive values due to factors like patient population enrolled, differences in the DENV serotypes, timing of sample collection, and the test or tests considered as reference standards. However, these studies shed light on the usefulness of these approaches for dengue case confirmation and establish their potential as predictors of the disease severity [34,[61][62][63][64][65][66][67][68][69].…”

Section: Introductionmentioning

confidence: 99%

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

Coronel-Ruiz

Velandia-Romero

Calvo

et al. 2021

Preprint

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Background Dengue is the most widely distributed arboviral disease in tropical and subtropical countries. Early diagnosis is difficult, and most of the suspected cases are diagnosed according to clinical criteria. In underdeveloped countries, laboratory tests are done on a proportion of dengue with warning signs or severe dengue suspect cases. This study aimed to design a diagnostic algorithm using rapid diagnostic tests (RDT), ELISA tests together with clinical and hematology variables to confirm dengue cases in febrile patients from an endemic area in Colombia. Methods and results. A total of 505 samples were collected from patients with the acute febrile syndrome (<7 days) assisted to the Municipal Hospital in Girardot (Colombia). Serum samples were evaluated by rapid diagnostic tests -RDT- (IgM and IgG antibodies and NS1 antigen immunochromatographic assay), capture ELISAs (IgM, IgG, and NS1 antigen), and by RT-PCR. We analyzed individual test performance to determine which were the most useful to confirm dengue cases. Individual results for IgM, IgG, and NS1 RDT yield low sensitivity and specificity values than the reference standard. A high sensitivity (96.3%) and specificity (96.4%) were obtained after combining the IgM and NS1 ELISAs results. The analysis using the combined NS1 RDT and IgM ELISA results showed 90.3% sensitivity and 96.2% specificity. Adjusted odd ratios (aOR) were calculated including data from symptoms, signs, and diagnostic laboratory tests to differentiate dengue from other febrile illnesses (OFI). Myalgia (aOR: 1.87, CI95%: 1.04-3.38), abdominal tenderness (aOR: 1.89, CI95%: 1.14-3.10), platelets count <140.000/mm3 (aOR: 2.19 CI95%: 1.31-3.67). The analysis using the results of the diagnostic test yields significant ratios for IgM RDT (aOR:2.63 CI95%: 1.59-4.33) and NS1 RDT also differentiate dengue cases from OFI. Combined positive IgM or NS1 RDT and the one that combined positive NS1 RDT or IgM ELISA detect dengue cases in 81.6% and 90.6%, respectively (p<0.001). Conclusion. Our findings showed that only clinical diagnosis does not confirm true dengue cases dengue and needs to be complemented by laboratory diagnostic tests to establish the diagnosis. We also demonstrate the usefulness of rapid tests in diagnosis, suggesting their implementation with IgM ELISA test to better confirm dengue cases.

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Accuracy and reliability of an NS1 rapid immunochromatographic test for DENV-1 diagnosis at point of care and in the laboratory

Cited by 10 publications

References 29 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

Rapid immunochromatographic tests for the diagnosis of dengue: a systematic review and meta-analysis

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

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