Evaluación de la utilidad de la prueba rápida de casete por inmunocromatografía para el diagnóstico de dengue en una región endémica colombiana

Martínez-Vega, Ruth Aralí; Díaz-Quijano, Fredi Alexander; Coronel-Ruiz, Carolina; Gómez, Sergio Yebrail; Villar-Centeno, Luis Ángel

doi:10.7705/biomedica.v29i4.139

Cited by 5 publications

(5 citation statements)

References 23 publications

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“…The accuracy and reliability of ICTs for dengue NS1 are essential for guaranteeing quality tests. Still, few published studies on dengue have evaluated agreement between observers with different levels of training [ 19 ] or similar levels [ 14 , 20 ], varying from moderate to almost perfect agreement. No studies were identified that evaluated the reliability of ICTs according to the types of specimens (whole blood versus serum) or settings.…”

Section: Introductionmentioning

confidence: 99%

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

Mata¹,

Passos²,

Hökerberg³

et al. 2017

BMC Infect Dis

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BackgroundRapid immunochromatographic tests (ICT) for dengue non-structural protein 1 (NS1) have shown good performance for diagnosing acute-phase dengue in serum in laboratory settings, but rarely have been assessed in whole blood and at point of care (POC). This study compare the accuracy and inter- and intra-observer reliability of the NS1 Bioeasy™ ICT in whole blood at POC versus serum in the laboratory, during a DENV-1 epidemic.MethodsCross-sectional study involving 144 adults spontaneously demanding care in an emergency department within 4 days of onset of acute febrile illness. Accuracy of NS1 Bioeasy™ ICT was compared in whole blood and serum, both at 15 and 30 min, blinded to the reference RT-PCR or NS1 ELISA. Non-dengue patients were also tested for Zika virus with RT-PCR. Reliability of whole blood and serum readings by the same or different observers was measured by simple kappa (95% CI).ResultsAt 15 min, sensitivity (Sn) of NS1 Bioeasy™ ICT in whole blood/POC was 76.7% (95% CI: 68.0–84.1) and specificity (Sp) was 87.0% (95% CI: 66.4–97.2). Sn in serum/laboratory was 82% (95% CI: 74.1–88.6) and Sp 100% (95% CI: 85.8–100). Positive likelihood ratio was 5.9 (95% CI: 2.0–17.0) for whole blood/POC and 19.8 (95% CI: 2.9–135.1) for serum/laboratory. Reliability of matched readings of whole blood/POC and serum/laboratory by the same observer (k = 0.83, 95% CI: 0.74–0.93) or different observers (k = 0.81, 95% CI: 0.72–0.92) was almost perfect, with higher discordant levels in the absence of dengue. Results did not differ statistically at 5%.ConclusionsNS1 Bioeasy™ ICT in DENV-1 epidemics is a potentially confirmatory test. Invalid results at 15 min should be reread at 30 min. To optimize impact of implementing ICT in the management of false-negatives it should be incorporated into an algorithm according to setting and available specimen.Trial registration UTN U1111-1145-9451.

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Section: Introductionmentioning

confidence: 99%

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

Mata¹,

Passos²,

Hökerberg³

et al. 2017

BMC Infect Dis

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show abstract

“…As an example, the recently developed cassette colorimetric test from Panbio Diagnostics (Australia) was successfully applied to the diagnosis of acute-phase dengue disease in individuals from a South American-endemic region [9]. As an example, the recently developed cassette colorimetric test from Panbio Diagnostics (Australia) was successfully applied to the diagnosis of acute-phase dengue disease in individuals from a South American-endemic region [9].…”

Section: New Immunochromatographic Platformsmentioning

confidence: 99%

“…Dengue viruses have a capsid with three structural proteins, including a glycoprotein-E responsible for attachment to host cells and reconnaissance by specific antibodies. Longer acute febrile periods caused by dengue infections, when compared to other causes of acute fever syndromes, have been reported [9]. Apart the more common and less dangerous dengue fever, dengue hemorrhagic fever (DHF) or even dengue shock syndrome (DSS), both conditions requiring critical healthcare, may also occur.…”

Section: Introductionmentioning

confidence: 99%

Biosensors and rapid diagnostic tests on the frontier between analytical and clinical chemistry for biomolecular diagnosis of dengue disease: A review

Teles

2011

Analytica Chimica Acta

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The past decades have witnessed enormous technological improvements towards the development of simple, cost-effective and accurate rapid diagnostic tests for detection and identification of infectious pathogens. Among them is dengue virus, the etiologic agent of the mosquito-borne dengue disease, one of the most important emerging infectious pathologies of nowadays. Dengue fever may cause potentially deadly hemorrhagic symptoms and is endemic in the tropical and sub-tropical world, being also a serious threat to temperate countries in the developed world. Effective diagnostics for dengue should be able to discriminate among the four antigenically related dengue serotypes and fulfill the requirements for successful decentralized (point-of-care) testing in the harsh environmental conditions found in most tropical regions. The accurate identification of circulating serotypes is crucial for the successful implementation of vector control programs based on reliable epidemiological predictions. This paper briefly summarizes the limitations of the main conventional techniques for biomolecular diagnosis of dengue disease and critically reviews some of the most relevant biosensors and rapid diagnostic tests developed, implemented and reported so far for point-of-care testing of dengue infections. The invaluable contributions of microfluidics and nanotechnology encompass the whole paper, while evaluation concerns of rapid diagnostic tests and foreseen technological improvements in this field are also overviewed for the diagnosis of dengue and other infectious and tropical diseases as well.

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“…Despite its importance, agreement of test results is not often reported for RIT studies. Previously, four studies described moderate to almost perfect inter-observer agreement rates for commercial RIT Duo NS1/IgM/IgG 39 or IgM/IgG 8 , 33 , 40 tests. However, in three of them, 33 , 40 , 41 samples showed no dominance for any specific DENV serotype.…”

Section: Discussionmentioning

confidence: 99%

“…Previously, four studies described moderate to almost perfect inter-observer agreement rates for commercial RIT Duo NS1/IgM/IgG 39 or IgM/IgG 8 , 33 , 40 tests. However, in three of them, 33 , 40 , 41 samples showed no dominance for any specific DENV serotype. Only one of these studies reported raters’ expertise (heterogeneous pair, including a physician and a bacteriologist), confirming that RITs are easy to read.…”

Section: Discussionmentioning

confidence: 99%

Diagnostic parameters and reliability of four rapid immunochromatographic tests for dengue 4

Mata

Passos

Santos

et al. 2020

The Brazilian Journal of Infectious Diseases

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Evaluación de la utilidad de la prueba rápida de casete por inmunocromatografía para el diagnóstico de dengue en una región endémica colombiana

Cited by 5 publications

References 23 publications

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

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

Biosensors and rapid diagnostic tests on the frontier between analytical and clinical chemistry for biomolecular diagnosis of dengue disease: A review

Diagnostic parameters and reliability of four rapid immunochromatographic tests for dengue 4

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