A point-of-care cassette test for detection of Strongyloides stercoralis.

Strongyloides stercoralis is a parasite that causes strongyloidiasis worldwide. It may lead to a life-long infection in immunocompetent people and hyperinfection in immunosuppressed patients. A point-of-care (POC) rapid test is helpful for patient diagnosis in resource-limited settings and as a detection tool in elimination/control programs. Previously, we reported a rapid IgG4 dipstick test (Ss Rapid®) for Strongyloides suitable for a laboratory setting. A POC cassette format of the test, which is field-applicable, has since been developed. Here, we report on a laboratory-based evaluation of the Ss Rapid® cas sette test on 285 sera. We assessed the diagnostic sensitivity of the Ss Rapid® cas sette with 32 sera, comprising samples from larval and/or DNA positive individuals from three countries. Additionally, we also tested samples from 33 seropositive endemic areas residents. We evaluated the diagnostic specificity of the test using 220 samples, comprising sera from other infections (n = 101), allergy cases with high IgE antibodies (n = 4), and blood donors (n = 115). The test showed high diagnostic sensitivity (97%, 31/32), and all sera of the seropositive endemic residents were reactive. It also showed high diagnostic specificity (94.5%, 208/220), and all false-positive samples tested negative after sera adsorption using recombinant NIE-coated microsphere beads. Additionally, we showed that the test worked with spiked whole blood samples. The study results showed that the SsRapid® cas sette test merits further laboratory and field evaluations.