Comparison of the diagnostic accuracy of commercial NS1-based diagnostic tests for early dengue infection

Background: We compared the diagnostic accuracy and reproducibility of commercially available NS1-based dengue tests and explored factors influencing their sensitivities. Methods: Paired 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 (TM) Dengue NS1 Ag, second generation Pan-E (TM) Dengue Early ELISA, SD Dengue NS1 Ag ELISA, Dengue NS1 Ag STRIP (TM), and SD BIOLINE (TM) Dengue Duo (NS1/IgM/IgG). Results: SD BIOLINE (TM) 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 (TM) 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. Conclusions: The 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.