GenHome®: Development of a Next-Generation All-in-One Molecular Point-of-Care Testing Platform with High Sensitivity and Accessibility

ABSTRACT

SARS-CoV-2 (COVID-19) pandemic has highlighted the need for rapid and accurate molecular point-of-care testing (mPOCT). Here, we describe the development of GenHome®, a fully integrated, single-use cartridge platform that performs sample loading, direct nucleic-acid preparation, loop-mediated isothermal amplification (LAMP), and lateral-flow readout within a closed-system workflow, minimizing user intervention and providing results within 30 min. As the first cartridge of its type, we validated the GenHome® SARS-CoV-2 cartridge targeting the ORF1ab gene from SARS-CoV-2. Under optimized conditions (65 °C, 20 min), GenHome® achieved a limit of detection (LoD) of 194 copies/µL by probit analysis. Furthermore, analytical specificity testing revealed no cross-reactivity against a respiratory panel consisting of 33 viruses. Lastly, clinical evaluation of 466 nasopharyngeal specimens pre-verified by RT-PCR revealed a positive percentage agreement (PPA) of 94.7%, negative percentage agreement (NPA) of 92.6%, and overall agreement of 92.8%. Moreover, Ct-stratified analysis demonstrated PPA of 100% for Ct < 30, 88.9% for 30 ≤ Ct ≤ 35, and 30% for Ct > 35. These findings highlight the potential of GenHome® to deliver high clinical concordance with RT-PCR while retaining the ease-of-use and rapid turnaround critical for mPOCT. With its cartridge-integrated design and room-temperature-stable workflow, GenHome® is well-suited for widespread applications across diverse infectious-disease diagnostic applications.