Pluslife's Patented RHAM Technology Excels in SARS-CoV-2 Detection: A Retrospective Study Reveals High Diagnostic Accuracy

Recently, Pluslife Mini Dock RHAM technology has demonstrated exceptional diagnostic accuracy in an independent evaluation study. Conducted in collaboration with the Pfützner Science & Health Institute, Charité - Universitätsmedizin Berlin, DHS - Diagnostic HealthCare Solutions GmbH in Germany, and the University for Digital Technologies in Medicine and Dentistry in Luxembourg, the study results have been published in the esteemed journal, Scientific Reports.

Title: A Retrospective Evaluation of the Diagnostic Accuracy of Pluslife MiniDock RHAM Technology Compared to Abbott ID Now and Cepheid GenXpert

Journal: Scientific Reports

Publication Date: June 2024

Background:

Since the outbreak of the COVID-19 pandemic caused by the SARS-CoV-2 in December 2019, the world has faced an unprecedented public health challenge. This pandemic has highlighted the critical role of rapid and accurate pathogen detection in controlling the spread of the epidemic. Rapid antigen tests (RATs) played a significant role in the early detection of infections during the pandemic, but their sensitivity is relatively low, particularly in the absence of symptoms, often failing to detect the pathogen. While real-time PCR (RT-PCR) is the gold standard for detecting SARS-CoV-2 with its high sensitivity and specificity, its application is limited by laboratory infrastructure, professional technical personnel, and high costs.

Therefore, the development of a rapid and accurate point-of-care testing (POCT) technology, such as Pluslife RNase HII-assisted amplification (RHAM) technology, is of great significance for the effective management of future epidemics. This study aims to evaluate the diagnostic accuracy of Pluslife's proprietary RHAM technology in detecting SARS-CoV-2 and its variants, and to compare it with the traditional RT-PCR technology.

Design and Result:

The study compared the diagnostic accuracy of Pluslife MiniDock, which utilizes RHAM technology, with two other major point-of-care (POC) testing devices on the market: Abbott ID Now and Cepheid GeneXpert IV, in detecting SARS-CoV-2. The results showed that Pluslife MiniDock achieved a Positive Percent Agreement (PPA) of 99.00%, comparable to Abbott ID Now's 100.00%, and Cepheid GeneXpert's 98.99%. In terms of Negative Percent Agreement (NPA), Pluslife Mini Dock outperformed the other technologies with a perfect score of 100.00%.

The study also assessed the capability of Pluslife MiniDock in detecting different SARS-CoV-2 variants, including Delta and Omicron. The device demonstrated effective detection of all analyzed variants, further proving its broad applicability and efficacy.

The outcomes of this study confirm that Pluslife MiniDock not only rivals the gold standard PCR techniques in diagnostic accuracy but also offers faster detection speeds and greater convenience. This is of significant importance for rapid and effective pathogen detection on a global scale, making it highly suitable for use in areas with limited medical resources and playing a key role in epidemiological investigations and pandemic management.

Pluslife is committed to continuing the advancement of RHAM technology to address global health challenges. For more detailed results of the study, please refer to the article in Scientific Reports, which can be accessed via this link: https://doi.org/10.1038/s41598-024-64406-9. We are looking forward to bringing this innovative technology to those who need it, in collaboration with partners around the world.