Evaluation of a rapid immunochromatographic test for diagnosis of dengue virus infection - PubMed (original) (raw)

Evaluation of a rapid immunochromatographic test for diagnosis of dengue virus infection

D W Vaughn et al. J Clin Microbiol. 1998 Jan.

Abstract

A rapid (<7-min) immunochromatographic test for immunoglobulin M (IgM) and IgG antibodies to dengue viruses was evaluated by using hospital admission and discharge sera from 124 patients. The reference laboratory diagnosis was based on the results of virus isolation, hemagglutination-inhibition assay (HAI), and enzyme immunoassay (EIA). By the standard assays, patients experienced primary dengue virus infection (n = 30), secondary dengue virus infection (n = 48), Japanese encephalitis (JE) virus infection (n = 20), or no flavivirus infection (n = 26). The rapid test demonstrated 100% sensitivity in the diagnosis of dengue virus infection and was able to distinguish between primary and secondary dengue virus infections through the separate determinations of IgM and IgG. For all patients with primary dengue virus infection a positive test for IgM to dengue virus and a negative test for IgG to dengue virus were obtained, whereas for 46 of 48 patients (96%) with secondary dengue virus infection, a positive test for IgG to dengue virus with or without a positive test for IgM to dengue virus was obtained. The remaining two patients with secondary dengue virus infection had positive IgM test results and negative IgG test results. Furthermore, the rapid test was positive for patients confirmed to be infected with different dengue virus serotypes (12 infected with dengue virus serotype 1, 4 infected with dengue virus serotype 2, 3 infected with dengue virus serotype 3, and 2 infected with dengue virus serotype 4). The specificity of the test for nonflavivirus infections was 88% (3 of 26 positive), while for JE virus infections the specificity of the test was only 50% (10 of 20). However, most patients with secondary dengue virus infection were positive for both IgM and IgG antibodies to dengue virus, while no patients with JE virus infection had this profile, so cross-reactivity was only a concern for a small proportion of patients with secondary dengue infections. The rapid test demonstrated a good correlation with the reference EIA and HAI and should be useful for the rapid diagnosis of dengue virus infections.

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Figures

FIG. 1

FIG. 1

Inside view of PanBio Dengue Rapid Test device showing general instructions for use. The locations of the antigen pad, gold conjugate pad, and absorbent pad are indicated, as are the anti-human IgG line, the anti-human IgM line, the control line, and the limit line.

FIG. 2

FIG. 2

PanBio Dengue Rapid Test device showing the result obtained with serum taken from a patient with secondary dengue virus infection (the IgM, IgG, and control lines are visible). The interpretation criteria for the test are also printed on the front of the device.

FIG. 3

FIG. 3

Comparison of Dengue Rapid Test IgM score (0 = negative; 0.5 = faintly positive; 1 = distinctly positive; 2 = strongly positive) and dengue virus-specific IgM test result by EIA (A) or Dengue Rapid Test IgG score (the scoring system is the same as that for IgM) versus dengue virus-specific IgG test result by EIA (B). The cutoff in the in-house IgM EIA is 40 U, and the cutoff of the in-house IgG EIA is 100 U (shown by broken lines).

FIG. 4

FIG. 4

Relationship between the sensitivity of the Dengue Rapid Test and the days after the onset of illness. The sensitivities with the use of IgM only (circles), the use of IgG only (squares), and the combined use of IgM and IgG (triangles) are shown.

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