Performance evaluation demonstrates real-time PCR reliably detects trichuriasis and strongyloidiasis in clinical samples, suggesting it aids diagnostics in low-resource settings.
Background Nucleic acid amplification tests have shown promising results for the diagnosis of soil-transmitted helminths (STH). The implementation of real-time PCR (qPCR) in low-resource settings is, however, still hampered by multiple logistical challenges. In this study, we assessed the diagnostic performance of a cartridge-based real-time PCR system ( diaxxoPCR ) for the detection of DNA of Trichuris trichiura , Ascaris lumbricoides, and Strongyloides stercoralis in clinical samples, using qPCR as the reference test. Methodology Initially, a technical validation of the diaxxoPCR system in a singleplex pod (cartridge) design was performed using 37 predefined DNA samples (Study A), followed by a diagnostic comparison between the diaxxoPCR system (singleplex) and qPCR on DNA samples extracted from 325 stools collected in a clinical trial in a rural area of Mozambique (Study B). Finally, one negative and one positive DNA sample were used to demonstrate the technical performance of a multiplex pod design as a potential use-case for the diaxxoPCR system (Study C). Principal findings Study A demonstrated that the diaxxoPCR system performed reliably for each of the three STH targets, with minimal intra- and inter-assay variation and sufficient output reproducibility. Study B, performed in Mozambique, showed a positive qPCR result in 57.5% (187), 15.4% (50), and 0.3% (1) of the 325 DNA trial samples for T. trichiura , A. lumbricoides, and S. stercoralis , respectively. The diaxxoPCR system demonstrated sensitivities and specificities above 97% and 94% for each target, resulting in nearly perfect to perfect qualitative agreements with the reference test. Quantitatively, significant and positive associations were seen between the Ct-values (qPCR) and Cq-values ( diaxxoPCR ). In Study C, the diaxxoPCR system correctly detected all 3 targets in the multiplex pod design. Conclusion With refinements regarding faecal DNA extraction procedures, the diaxxoPCR system has potential to provide accurate and easy-to-use real-time molecular diagnostics of STH in low resource laboratories.
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Messa et al. (2025) studied this question.
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