Performance Comparison of In-House and Commercial Biosynex Helmints AMPLIQUICK^® Real-Time PCR Assays for the Diagnosis of <i>Schistosoma mansoni</i> and <i>Strongyloides stercoralis</i> in Stool Samples.

ABSTRACT: Background/Objectives: The timely diagnosis of schistosomiasis and strongyloidiasis is important because of their potentially severe, even lethal, consequences. European diagnostic laboratories must comply with the European In Vitro Diagnostic (IVD) Regulation, which requires justifying the use of in-house assays when CE-IVD-marked kits are available. We aimed to compare the performance of the Biosynex Helminths AMPLIQUICK^® RT-PCR and the multiplex in-house RT-PCR for the diagnosis of Schistosoma mansoni and Strongyloides stercoralis currently used in our department, an Italian reference centre for tropical diseases. Methods: We conducted a performance comparison study on biobanked frozen stool samples classified as cases or controls according to PCR

SUBMITTER: Treggiari D 

PROVIDER: S-EPMC12650956 | biostudies-literature | 2025 Nov

REPOSITORIES: biostudies-literature