R&D Department, Mylab Discovery Solutions Pvt. Ltd., Pune, Maharashtra, India.
R&D Department, Mylab Discovery Solutions Pvt. Ltd., Pune, Maharashtra, India.
J Virol Methods. 2023 May;315:114714. doi: 10.1016/j.jviromet.2023.114714. Epub 2023 Mar 18.
We present the point-of-care (POC) molecular diagnostic solution, evaluated during COVID-19 pandemic caused by SARS-CoV-2 (Dec 2021). The POC comprised of a complete platform from self-sampling to RT-PCR testing of SARS-CoV-2 and its variants on portable Compact Q Real time polymerase chain reaction system. The multiplex assay was designed to target S, ORF1, and N genes of SARS-CoV-2 genome in a single tube with RNaseP as endogenous internal control. The present POC enables high accuracy (>95%) and high-throughput testing with a turnaround time of 45 min. It provides a unique platform from self-sample collection to report generation with rapid protocol, pipette and expert-free operation, long shelf-life stability and room temperature storage which enable to increase the efficiency of molecular testing. This novel test named "CoviSwift™ COVID-19 S PLUS RAPID PCR KIT" has been approved by CDSCO, Indian National Regulatory Authority, India, and is in use for clinical settings in India.
我们展示了即时护理（POC）分子诊断解决方案，该方案在由 SARS-CoV-2 引起的 COVID-19 大流行期间进行了评估（2021 年 12 月）。该 POC 由一个完整的平台组成，从自我采样到 SARS-CoV-2 及其变体的 RT-PCR 测试，使用便携式 Compact Q 实时聚合酶链反应系统。该多重分析旨在针对 SARS-CoV-2 基因组的 S、ORF1 和 N 基因进行单一管检测，同时将 RNaseP 作为内源性内部对照。该即时护理检测具有高准确性（>95%）和高通量检测能力，检测周转时间为 45 分钟。它提供了一个从自我采样到报告生成的独特平台，具有快速的协议、移液操作和无需专家操作、长保质期稳定性和室温储存，从而能够提高分子检测的效率。这种名为“CoviSwift™ COVID-19 S PLUS RAPID PCR KIT”的新型检测已获得印度国家药品监管机构 CDSCO 的批准，并在印度的临床环境中使用。
