ArticleCureus2025
Bridging the Diagnostic Gap: A Rapid, Cost-Effective, and Equitable Hepatitis C Virus RNA Detection Method for Resource-Limited Settings.
Article in Cureus, 2025. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Not yet cited in PubMed.
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The abstract states no effect estimate the extractor could read, or names no intervention and outcome on the map, so this paper lights no cell and moves no belief. It is still indexed, cited and linked below.
The trial behind it
Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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0 citing papers in PubMed.
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Authors and funding
8 authors.
Funding
No grant is acknowledged in the PubMed record.
Abstract
Hepatitis C virus (HCV) remains a major global health challenge, particularly in resource-limited settings where access to molecular diagnostics is restricted. The loop-mediated isothermal amplification (LAMP) assay offers a rapid, cost-effective alternative to polymerase chain reaction (PCR) for HCV RNA detection. Unlike PCR, LAMP uses isothermal amplification (60-65°C), eliminating the need for expensive thermal cyclers and yielding results in under 60 minutes. We evaluated two LAMP detection methods - hydroxynaphthol blue (HNB, colorimetric) and calcein (fluorescent) - against an in-house TaqMan qPCR assay. Both LAMP methods demonstrated high sensitivity (99.6%) and specificity (95.6% for HNB, 99.2% for calcein), with a broad dynamic range (10-10⁶ copies/mL). Clinical validation against real-time PCR showed strong agreement, with a positive predictive value of 98.6% and a negative predictive value of 94.4%. The HNB-LAMP assay, in particular, provides a simple visual readout (blue to sky blue), requiring no specialized equipment, while calcein-LAMP offers fluorescence-based detection under UV light. Both methods showed no significant correlation (p > 0.5), confirming their reliability. LAMP's advantages - minimal infrastructure, ambient temperature stability, and low cost (<$5 per test) - make it ideal for decentralized testing in low-resource settings. This approach could revolutionize HCV diagnosis by enabling same-day test-and-treat strategies, improving linkage to care, and supporting global HCV elimination efforts. Future steps include field validation in remote clinics, manufacturing scale-up, and integration into point-of-care platforms to maximize accessibility. By bridging the diagnostic gap, LAMP can potentially transform HCV management in underserved regions worldwide.
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