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Volume 15
Issue 22
10.3390/diagnostics15222928
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This is an early access version, the complete PDF, HTML, and XML versions will be available soon.
Article

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

by
Davide Treggiari
1,†,
Francesca Tamarozzi
1,*,†,
Fabio Formenti
1,
Salvatore Scarso
1,
Barbara Pajola
1,
Lavinia Nicolini
1,
Cristina Mazzi
2 and
Francesca Perandin
1
1
Department of Infectious-Tropical Diseases and Microbiology, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy
2
Clinical Research Unit, IRCCS Sacro Cuore Don Calabria Hospital, 37024 Negrar di Valpolicella, Verona, Italy
*
Author to whom correspondence should be addressed.
†
These authors contributed equally to this work.
Diagnostics 2025, 15(22), 2928; https://doi.org/10.3390/diagnostics15222928
Submission received: 10 October 2025 / Revised: 8 November 2025 / Accepted: 17 November 2025 / Published: 19 November 2025
(This article belongs to the Section Diagnostic Microbiology and Infectious Disease)
Versions Notes

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 and/or copromicroscopy at diagnosis. Both RT-PCRs were performed on DNA re-extracted from the same stool aliquot. Sensitivity and specificity were compared using McNemar’s Chi-squared test, while agreement was assessed using Gwet’s AC1 and Cohen’s K coefficients, and Bland–Altman analysis. Results: A total of 45 S. mansoni cases with 52 controls and 29 S. stercoralis cases with 54 controls were analyzed. For both S. mansoni and S. stercoralis, sensitivity and specificity were not significantly different between RT-PCRs (p = 1). Concordance was perfect for controls (AC1 = 1) in both cohorts, but was poor for S. mansoni cases (AC1 = 0.38) and good for S. stercoralis cases (AC1 = 0.78). Conclusions: Performance was not significantly different between in-house and Biosynex RT-PCRs. Nevertheless, careful assessment of the specific molecular targets included in the panels and prospective evaluation of any newly introduced tests should be implemented to minimize the impact of clinically significant discrepancies.
Keywords: Schistosoma mansoni; Strongyloides stercoralis; stool; molecular diagnosis; RT-PCR Schistosoma mansoni; Strongyloides stercoralis; stool; molecular diagnosis; RT-PCR

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MDPI and ACS Style

Treggiari, D.; Tamarozzi, F.; Formenti, F.; Scarso, S.; Pajola, B.; Nicolini, L.; Mazzi, C.; Perandin, F. Performance Comparison of In-House and Commercial Biosynex Helmints AMPLIQUICK® Real-Time PCR Assays for the Diagnosis of Schistosoma mansoni and Strongyloides stercoralis in Stool Samples. Diagnostics 2025, 15, 2928. https://doi.org/10.3390/diagnostics15222928

AMA Style

Treggiari D, Tamarozzi F, Formenti F, Scarso S, Pajola B, Nicolini L, Mazzi C, Perandin F. Performance Comparison of In-House and Commercial Biosynex Helmints AMPLIQUICK® Real-Time PCR Assays for the Diagnosis of Schistosoma mansoni and Strongyloides stercoralis in Stool Samples. Diagnostics. 2025; 15(22):2928. https://doi.org/10.3390/diagnostics15222928

Chicago/Turabian Style

Treggiari, Davide, Francesca Tamarozzi, Fabio Formenti, Salvatore Scarso, Barbara Pajola, Lavinia Nicolini, Cristina Mazzi, and Francesca Perandin. 2025. "Performance Comparison of In-House and Commercial Biosynex Helmints AMPLIQUICK® Real-Time PCR Assays for the Diagnosis of Schistosoma mansoni and Strongyloides stercoralis in Stool Samples" Diagnostics 15, no. 22: 2928. https://doi.org/10.3390/diagnostics15222928

APA Style

Treggiari, D., Tamarozzi, F., Formenti, F., Scarso, S., Pajola, B., Nicolini, L., Mazzi, C., & Perandin, F. (2025). Performance Comparison of In-House and Commercial Biosynex Helmints AMPLIQUICK® Real-Time PCR Assays for the Diagnosis of Schistosoma mansoni and Strongyloides stercoralis in Stool Samples. Diagnostics, 15(22), 2928. https://doi.org/10.3390/diagnostics15222928

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