Accuracy of rapid diagnostic tests for Strongyloides stercoralis detection: a systematic review and meta-analysis

Strongyloidiasis is a widely distributed, potentially fatal, neglected parasitic disease caused by the soil-transmitted helminth Strongyloides stercoralis. WHO has recently issued the target product profile (TPP) for new diagnostics to be deployed for public health control of strongyloidiasis in endemic areas. The TPP reports the minimum and ideal characteristics of a test that could facilitate field work compared with the available diagnostic methods.

This systematic review and meta-analysis was performed between May 5 and May 7, 2025. We searched the literature in PubMed, Embase, and CENTRAL for original peer-reviewed cross-sectional, cohort, case-control, and diagnostic accuracy studies assessing the sensitivity and specificity of rapid diagnostic tests (RDTs) compared with S stercoralis-specific reference assays. Risk of bias was assessed using the QUADAS-2 tool. A proportional meta-analysis pooling sensitivity and specificity independently was performed using a random-effects model. The study protocol was registered with PROSPERO (CRD420251051263).

Of the 213 papers identified, 21 full texts were assessed for eligibility, and 18 were finally included. The pooled sensitivity of RDTs was 88·2% (95% CI 84·1-91·7), and the pooled specificity was 89·9% (95% CI 83·0-95·4). Sensitivity was significantly higher for tests detecting IgG compared with those capturing IgG4 (p=0·0013), and for tests based on native rather than recombinant antigens (p=0·0023). Specificity did not significantly differ between tests based on different antibody-antigen combinations. Heterogeneity was substantial (I² 84·6-95·4%). Sixteen of 18 (88.9%) studies had a high risk of bias concerning the patient selection domain, owing to a case-control design.

Overall, RDT performance was in line with that indicated in the TPP. Hence, their further development for commercialisation for use in a public health context seems consonant. However, as part of this way forward, further research should support these results with properly designed studies, preferably prospective cohort studies with appropriate statistical methods that apply in the absence of a gold standard.

Italian Ministry of Health.