Evaluation of Two New Commercial Tests for the Diagnosis of Acute Dengue Virus Infection Using NS1 Antigen Detection in Human Serum

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Abstract
We compared the performance of two new commercial tests for the detection of dengue NS1 protein during the clinical phase of dengue virus (DENV) infection—an immunochromatographic test allowing rapid detection of the NS1 antigen, Dengue NS1 Ag STRIP (Bio-Rad Laboratories - Marnes La Coquette, France), and a two-step sandwich-format microplate enzyme-linked immunosorbent assay (ELISA), pan-E Dengue Early ELISA (Panbio - Brisbane, Australia)—with a one-step sandwich-format microplate ELISA, the Platelia Dengue NS1 Ag test (Bio-Rad). We tested 272 serum samples from patients with dengue disease. Of these, 222 were from patients with acute infection of one of the four dengue serotypes, detected by RT-PCR and/or virus isolation. Forty-eight acute-phase serum samples from patients not infected with dengue virus were also included. The sensitivity of the Platelia Dengue NS1 Ag test on acute serum samples (n = 222) was 87.4% (95% confidence interval: 82.3% to 91.5%); that of Dengue NS1 Ag STRIP was 81.5% (95% CI: 75.8% to 86.4%) after 15 minutes and 82.4% (95% CI: 76.8% to 87.2%) after 30 minutes. Both tests had a specificity of 100% (97.5% CI, one-sided test: 92.6% to 100.0%). The pan-E Dengue Early ELISA had a sensitivity of 60.4% (95% CI: 53.4% to 66.8%) and a specificity of 97.9% (95% CI: 88.9% to 99.9%). Our findings support the use of diagnostic tools based on the NS1 antigen detection for the diagnosis of acute DENV infection. The immunochromatographic test, Dengue NS1 Ag STRIP—the first rapid diagnostic test for DENV infection—was highly sensitive and specific, and would therefore be a suitable first-line test in the field. The pan-E Dengue Early ELISA was less sensitive than the Platelia test; this two-step ELISA should be combined with DENV IgM antibody detection for the diagnosis of DENV infection. Dengue is a viral disease transmitted by mosquitoes that is endemic in more than 100 countries in tropical areas, threatening over 2.5 billion people. It causes a wide range of symptoms and has severe forms. In reference laboratories, dengue disease is confirmed by virus isolation or genome detection during the acute phase, and by serological methods during the early convalescent phase. The viral NS1 protein circulates in the sera of infected patients throughout the clinical phase of the disease. Novel diagnostic tests based on NS1 detection have been recently developed and marketed. We compared the performance of two tests for detecting dengue NS1 protein during the clinical phase of dengue infection (an immunochromatographic test (ICT) from Bio-Rad allowing rapid detection of the NS1 antigen and a two-step sandwich-format ELISA from Panbio) with the one-step sandwich-format microplate ELISA (Bio-Rad). The ICT test performed better than the ELISA test from Panbio. This study confirms that diagnostic tests based on NS1 could be used in routine clinical practice in poorly equipped laboratories and that dengue diagnosis could therefore be confirmed without the need for testing in reference laboratories. This represents a crucial step towards the control of dengue disease in the human population.

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