Comparative study of two commercial tests for Strongyloides stercoralis serologic diagnosis

Background: Serological diagnosis of Strongyloides stercoralis is often limited by its low specificity due to cross-reactivity with other parasitic nematodes. Novel serological tests assumed to be more specific have been recently developed. The aim of our study was to compare two commercial tests based on different antigens for S. stercoralis diagnosis in humans from a non-endemic area. Methods: A retrospective laboratory-based study was conducted in the Hospital Universitario 12 de Octubre, Madrid, Spain. Samples from patients with a requested S. stercoralis serology from January 2013 to October 2016 were tested with two commercial enzyme-linked immunosorbent assay (ELISA) tests (crude larval suspension ELISA [CrAg-ELISA] and recombinant antigen ELISA [NIE-ELISA]). Sensitivity, specificity and predictive values were calculated using primary and composite gold standards. The κ index was calculated. Results: A total of 249 samples from 233 patients were tested (κ=0.735). The CrAg-ELISA yielded sensitivities from 89.2% (95% confidence interval [CI] 80.7 to 94.2) to 94.7% (95% CI 75.4 to 99.0) and the NIE-ELISA from 72.3% (95% CI 58.2 to 83.1) to 78.9% (95% CI 56.7 to 91.5). Specificity ranged from 72.3% (95% CI 58.2 to 83.1) to 89.3% (95% CI 83.1 to 93.4) for the CrAg-ELISA and from 85.1% (95% CI 72.3 to 92.6) to 93.6% (95% CI 88.2 to 96.6) for the NIE-ELISA. Conclusions: The NIE-ELISA is more specific than the CrAg-ELISA, but its low sensitivity limits its use in S. stercoralis screening. New diagnostic tests are needed for the diagnosis of S. stercoralis.