<p>During the COVID-19 pandemic, the efficiency and superiority of nucleic acid amplification tests (NAATs) was established as molecular diagnostics for screening and diagnosis of covid-19 infected individuals. To perform the NAAT-based diagnosis of infectious and non-infectious individuals, logistics of the samples from rural/remote areas emerged as a great challenge. The success of a NAAT is primarily due to its reliance on transport media, such as Viral Transport Media (VTM), Universal Transport Media (UTM), etc. for the storage of viral samples. These transport media requires cold-chain storage and transport facilities to avoid degradation of viral samples. These facilities are not only expensive but also cause significant delay in the process of diagnosis and treatment in infrastructure and resource-limited countries/geographies. Therefore, in the current work, a new tool named BioSampler device has been designed, fabricated and evaluated for the storage and transport of viral samples in a dried format without losing its potency for any NAATs. The proposed BioSampler device provides a stable microenvironment for the storage of COVID-19 RNA samples at temperatures up to 30&#xa0;°C and relative humidity of 50%. The viral samples stored in a BioSampler device showed great potential for qPCR analysis even after 28&#xa0;days of sample storage. The cyclic threshold (<i>C</i><sub><i>t</i></sub>) value remained within the acceptable range for the molecular diagnosis and was observed to be comparable to the results obtained, through NAAT performed on RNA samples stored, in commercial VTM samples. Thus, the BioSampler device offers a promising solution for RNA specimen storage and transportation, particularly in resource-limited settings.</p>

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BioSampler Device for Collection and Storage of RNA Samples to Diagnose SARS-CoV-2

  • Vidisha Septa,
  • Pragyan Ray,
  • Bhirab Mondal,
  • Vaibhav Shitole,
  • Prasoon Kumar

摘要

During the COVID-19 pandemic, the efficiency and superiority of nucleic acid amplification tests (NAATs) was established as molecular diagnostics for screening and diagnosis of covid-19 infected individuals. To perform the NAAT-based diagnosis of infectious and non-infectious individuals, logistics of the samples from rural/remote areas emerged as a great challenge. The success of a NAAT is primarily due to its reliance on transport media, such as Viral Transport Media (VTM), Universal Transport Media (UTM), etc. for the storage of viral samples. These transport media requires cold-chain storage and transport facilities to avoid degradation of viral samples. These facilities are not only expensive but also cause significant delay in the process of diagnosis and treatment in infrastructure and resource-limited countries/geographies. Therefore, in the current work, a new tool named BioSampler device has been designed, fabricated and evaluated for the storage and transport of viral samples in a dried format without losing its potency for any NAATs. The proposed BioSampler device provides a stable microenvironment for the storage of COVID-19 RNA samples at temperatures up to 30 °C and relative humidity of 50%. The viral samples stored in a BioSampler device showed great potential for qPCR analysis even after 28 days of sample storage. The cyclic threshold (Ct) value remained within the acceptable range for the molecular diagnosis and was observed to be comparable to the results obtained, through NAAT performed on RNA samples stored, in commercial VTM samples. Thus, the BioSampler device offers a promising solution for RNA specimen storage and transportation, particularly in resource-limited settings.