Development and clinical evaluation of a highly accurate dengue NS1 rapid test: from the preparation of a soluble NS1 antigen to the construction of an RDT

Lee, Jihoo; Kim, Hee Young; Chong, Chom-Kyu; Song, Hyun-Ok

doi:10.1016/j.diagmicrobio.2015.03.009

Cited by 17 publications

(12 citation statements)

References 36 publications

(35 reference statements)

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“…In the subset of patients with results for both IgG assays, the presence of anti-ZIKV NS1 IgG accounted for virtually all false-negative NS1 results. Although such antibodies have been known to reduce NS1 detection in secondary cases (Jayathilaka et al 2018;Lee et al 2015;Lima Mda et al 2014), the pathophysiologic significance of anti-NS1 antibodies in human DENV infections remains unclear (Glasner et al 2018;Jayathilaka et al 2018). We demonstrate that these antibodies can be detected in the acute-phase and, in combination with anti-DENV IgG, are more common among hospitalized dengue cases.…”

Section: Discussionmentioning

confidence: 58%

Peer Review #2 of "Characterization of dengue cases among patients with an acute illness, Central Department, Paraguay (v0.1)"

2019

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Background. In 2018, Paraguay experienced a large dengue virus (DENV) outbreak. The primary objective of this study was to characterize dengue cases in the Central Department, where the majority of cases occur, and identify factors associated with DENV infection. Methods. Patients were enrolled from January-May 2018 if they presented with a suspected arboviral illness. Acute-phase specimens (≤8 days after symptom onset) were tested using rRT-PCR, a rapid diagnostic test for DENV nonstructural protein 1 (NS1) and anti-DENV IgM and IgG, and ELISA for IgG against NS1 from Zika virus (ZIKV). Results. 231 patients were enrolled (95.2% adults) at two sites: emergency care and an outpatient clinical site. Patients included 119 (51.5%) dengue cases confirmed by rRT-PCR (n=115, 96.6%) and/or the detection of NS1 and anti-DENV IgM (n=4, 3.4%). DENV-1 was the predominant serotype (109/115, 94.8%). Epidemiologically, dengue cases and non-dengue cases were similar, though dengue cases were less likely to reside in a house/apartment or report a previous dengue case. Clinical and laboratory findings associated with dengue included red eyes, absence of sore throat, leucopenia and thrombocytopenia. At an emergency care site, 26% of dengue cases (26/100) required hospitalization. In univariate analysis, hospitalization was associated with increased viral load, anti-DENV IgG, and thrombocytopenia. Among dengue cases that tested positive for IgG against ZIKV NS1, the odds of DENV NS1 detection in the acute phase were decreased 10-fold (OR 0.1, 0.0-0.3). Conclusions. Findings from a predominantly adult population demonstrate clinical and laboratory factors associated with DENV infections and the potential severity of dengue in

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Section: Discussionmentioning

confidence: 58%

Peer Review #2 of "Characterization of dengue cases among patients with an acute illness, Central Department, Paraguay (v0.1)"

2019

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“…In order to purify YF NS1 protein, we used an affinity column that was developed in a preceding study [16] in which anti-dengue NS1 polyclonal antibodies are conjugated with cyanogen bromide (CNBr) beads (GE Healthcare, Chicago, Illinois, USA). After equilibrating the affinity column with 20 mM KH 2 PO 4 (pH 7.4), the acquired YF virus culture medium was loaded.…”

Section: Methodsmentioning

confidence: 99%

“…Procedures to produce mAb against NS1 of YF were followed the methods described earlier [16,17] with some modifications. Briefly, a 6-week SPF female mouse (Samtaco, Suwon, Korea) was immunized primarily with yellow fever NS1 25 μg in 25 μl PBS mixed with Freund’s Complete adjuvant (Sigma Chem Co., St. Louis, Missouri, USA) of 1:1 volume.…”

Section: Methodsmentioning

confidence: 99%

Development and Clinical Evaluation of a Rapid Diagnostic Test for Yellow Fever Non-Structural Protein 1

Kim

Park

et al. 2019

Korean J Parasitol

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A rapid diagnostic test (RDT) kit was developed to detect non-structural protein 1 (NS1) of yellow fever virus (YFV) using monoclonal antibody. NS1 protein was purified from the cultured YFV and used to immunize mice. Monoclonal antibody to NS1 was selected and conjugated with colloidal gold to produce the YFV NS1 RDT kit. The YFV RDTs were evaluated for sensitivity and specificity using positive and negative samples of monkeys from Brazil and negative human blood samples from Korea. Among monoclonal antibodies, clones 3A11 and 3B7 proved most sensitive, and used for YFV RDT kit. Diagnostic accuracy of YFV RDT was fairly high; Sensitivity was 0.0% and specificity was 100% against Dengue viruses type 2 and 3, Zika, Chikungunya and Mayaro viruses. This YFV RDT kit could be employed as a test of choice for point-of-care diagnosis and large scale surveys of YFV infection under clinical or field conditions in endemic areas and on the globe.

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“…Isotypes of mAbs were determined using goat anti-mouse immunoglobulins (Sigma-Aldrich Corp.) as previously described 40 . Briefly, each isotype of the goat anti-mouse antibody was coated on the well.…”

Section: Methodsmentioning

confidence: 99%

Enhanced performance of an innovative dengue IgG/IgM rapid diagnostic test using an anti-dengue EDI monoclonal antibody and dengue virus antigen

Lee¹,

Kim²,

Kim³

et al. 2015

Sci Rep

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High levels of anti-dengue IgM or IgG can be detected using numerous rapid diagnostic tests (RDTs). However, the sensitivity and specificity of these tests are reduced by changes in envelope glycoprotein antigenicity that inevitably occur in limited expression systems. A novel RDT was designed to enhance diagnostic sensitivity. Dengue viruses cultured in animal cells were used as antigens to retain the native viral coat protein. Monoclonal antibodies (mAbs) were then developed, for the first time, against domain I of envelope glycoprotein (EDI). The anti-dengue EDI mAb was employed as a capturer, and EDII and EDIII, which are mainly involved in the induction of neutralizing antibodies in patients, were fully available to bind to anti-dengue IgM or IgG in patients. A one-way automatic blood separation device prevented reverse migration of plasma and maximize the capture of anti-dengue antibodies at the test lines. A clinical evaluation in the field proved that the novel RDT (sensitivities of 96.5% and 96.7% for anti-dengue IgM and IgG) is more effective in detecting anti-dengue antibodies than two major commercial tests (sensitivities of 54.8% and 82% for SD BIOLINE; 50.4% and 75.3% for PanBio). The innovative format of RDT can be applied to other infectious viral diseases.

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Development and clinical evaluation of a highly accurate dengue NS1 rapid test: from the preparation of a soluble NS1 antigen to the construction of an RDT

Cited by 17 publications

References 36 publications

Peer Review #2 of "Characterization of dengue cases among patients with an acute illness, Central Department, Paraguay (v0.1)"

Peer Review #2 of "Characterization of dengue cases among patients with an acute illness, Central Department, Paraguay (v0.1)"

Development and Clinical Evaluation of a Rapid Diagnostic Test for Yellow Fever Non-Structural Protein 1

Enhanced performance of an innovative dengue IgG/IgM rapid diagnostic test using an anti-dengue EDI monoclonal antibody and dengue virus antigen

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