Abstract
BackgroundWe compared the diagnostic accuracy and reproducibility of commercially available NS1-based dengue tests and explored factors influencing their sensitivities.MethodsPaired analysis of 310 samples previously characterized as positive (n = 218) and negative (n = 92) for viral isolation and/or RT-PCR and/or IgM seroconversion. Masked samples were tested by two observers with Platelia™ Dengue NS1 Ag, second generation Pan-E™ Dengue Early ELISA, SD Dengue NS1 Ag ELISA, Dengue NS1 Ag STRIP™, and SD BIOLINE™ Dengue Duo (NS1/IgM/IgG).ResultsSD BIOLINE™ NS1/IgM/IgG had the highest sensitivity (80.7% 95%CI 75-85.7) with likelihood ratios of 7.4 (95%CI 4.1-13.8) and 0.21 (95%CI 0.16-0.28). The ELISA-format tests showed comparable sensitivities; all below 75%. STRIP™ and SD NS1 had even lower sensitivities (<65%). The sensitivities significantly decreased in samples taken after 3 days of fever onset, in secondary infections, viral serotypes 2 and 4, and severe dengue. Adding IgM or IgG to SD NS1 increased its sensitivity in all these situations.ConclusionsThe simultaneous detection of NS1/IgM/IgG would be potentially useful for dengue diagnosis in both endemic and non endemic areas. A negative result does not rule out dengue. Further studies are required to assess the performance and impact of early laboratory diagnosis of dengue in the routine clinical setting.
Highlights
We compared the diagnostic accuracy and reproducibility of commercially available NS1-based dengue tests and explored factors influencing their sensitivities
15-30 min Results A total of 310 samples were included in the study from which 210 were classified as dengue and 100 as nondengue
Eight samples initially classified as non-dengue based on IgM negative results in paired serum samples were RT-PCR-positive and were reclassified as dengue
Summary
We compared the diagnostic accuracy and reproducibility of commercially available NS1-based dengue tests and explored factors influencing their sensitivities. Dengue is a vector borne disease rapidly spreading in urban areas in tropical and subtropical countries. It is estimated that at least 10% of dengue fever cases evolve to severe and eventually lethal forms of the disease. The clinical and laboratory findings in dengue are very similar to those of other febrile diseases that are prevalent in the same geographical regions [1]. A dengue diagnostic test is required for adequate case management and to reduce misclassification in the dengue surveillance system. Dengue diagnosis in the first days of fever is yet problematic. There are three main laboratory methods to diagnose dengue infection: viral isolation in culture, detection of viral RNA, and specific IgM/IgG antibodies in paired
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