The human element in molecular diagnostics: Competency-driven advantages of open RT-PCR over closed PCR systems

Background: The rapid adoption of cartridge-based closed molecular systems in clinical laboratories has created a misconception that automation alone ensures diagnostic accuracy. While these systems are convenient, they often come at the expense of technical competency and financial sustainability. This paper evaluates the comparative benefits of open PCR platforms over closed cartridge systems in terms of cost-effectiveness, flexibility, and skill development in diagnostic laboratories.Materials and Methods: A comparative analytical review was conducted using published cost-analysis data, peer-reviewed literature, and market pricing information from international sources. The study examined the operational economics, validation requirements, and workforce impact associated with open versus closed molecular diagnostic systems. Kits approved by national and international regulatory authorities, including NIV, ICMR, and FDA, were referenced as benchmarks for quality and compliance. Results: Closed systems were found to incur up to 70–80% higher annual costs due to single-use cartridges and proprietary consumables. Open real-time PCR platforms, when operated by trained molecular technologists, demonstrated significant cost reductions, multiplexing capability, and technical adaptability. Furthermore, open systems facilitated continuous skill development and competency retention among laboratory personnel. The financial savings from adopting open platforms could be strategically redirected toward recruiting skilled manpower, enhancing quality systems, and expanding patient-beneficial services. Conclusion: While closed cartridge systems offer convenience, they compromise long-term sustainability, flexibility, and technical growth. Open PCR systems, when supported by validated and regulatory-approved kits, provide a cost-effective and competency-driven alternative. The future of molecular diagnostics should prioritize technical expertise and operational efficiency over automation dependence, ensuring both economic sustainability and superior patient outcomes.