Point-of-Care RNA-Based Diagnostic Device for COVID-19

At the end of 2019, the novel coronavirus disease (COVID-19), a fast-spreading respiratory disease caused by severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2), was reported in Wuhan, China and has now affected over 123 countries globally [...].

facilitate the RPA reaction. The tube was then inverted several times and incubated at 63 degrees Celsius for 40 min. Because they did not have access to actual COVID-19 samples, Song et al. used samples of healthy nasal mucosa spiked with inactivated HIV particles and other pathogens as their test materials. The Penn-RAMP process provided greater sensitivity than RT-PCR or LAMP alone. When using limited viral load, Penn-RAMP provided 100 times better sensitivity than a single LAMP test. Compared to a LAMP assay, which requires sophisticated equipment and must be run at a fixed temperature, the Penn-RAMP process requires less energy cost, is easier to execute, and can be completed in clinical or home settings.
The abovementioned research describes essential materials and protocol for a single-tube COVID-19 test that can be completed without visiting a clinical setting. Because standard clinical RT-PCR testing is unlikely to meet rising test demand, there is a critical need for the development of alternative approaches for home-based point-of-care (POC) testing. These approaches may include LAMP assay and lateral flow assay techniques. Here, we describe a potential RNA-based POC diagnostic device for detecting COVID-19 that combines both a paper-based POC diagnostic device and LAMP assay technology. This convenient device can be integrated with a smartphone application to provide a rapid, sensitive, and highly accessible COVID-19 diagnostic tool ( Figure 1). The Penn-RAMP process provided greater sensitivity than RT-PCR or LAMP alone. When using limited viral load, Penn-RAMP provided 100 times better sensitivity than a single LAMP test. Compared to a LAMP assay, which requires sophisticated equipment and must be run at a fixed temperature, the Penn-RAMP process requires less energy cost, is easier to execute, and can be completed in clinical or home settings. The abovementioned research describes essential materials and protocol for a single-tube COVID-19 test that can be completed without visiting a clinical setting. Because standard clinical RT-PCR testing is unlikely to meet rising test demand, there is a critical need for the development of alternative approaches for home-based point-of-care (POC) testing. These approaches may include LAMP assay and lateral flow assay techniques. Here, we describe a potential RNA-based POC diagnostic device for detecting COVID-19 that combines both a paper-based POC diagnostic device and LAMP assay technology. This convenient device can be integrated with a smartphone application to provide a rapid, sensitive, and highly accessible COVID-19 diagnostic tool ( Figure 1). diagnostic device. In this figure, the conceptual workflow of integrating both point-of-care diagnostic and loop-mediated isothermal amplification (LAMP) assay with mobile device was presented. People at home quarantine can collect their infectious specimen through nasal swab; after adding specific reagents for LAMP reaction, the colorimetric result can be observed on paper. By recording the colorimetric change through a mobile phone camera, the user could upload the result to cloud storage by Internet. Clinicians or health-care specialist could thus analyze the result and offer immediate information for both patient and the government. Since the whole diagnostic process can be performed at home, the suspected case does not need to travel to hospital and can in turns lower the risk of spreading the disease.
The concept for this tool is derived from previous research on paper-based nucleic acid detection employing RT-LAMP assay amplification [6]. Paper-based diagnostic tools have been widely applied for a variety of biochemical assays due to their low cost, ease of use, and speed. They have been employed to test a range of sample sources, including blood, urine, tears, and vaginal fluid, and could be easily adapted to accept nasal swab samples for viral detection. We have previously developed a diagnostic device. In this figure, the conceptual workflow of integrating both point-of-care diagnostic and loop-mediated isothermal amplification (LAMP) assay with mobile device was presented. People at home quarantine can collect their infectious specimen through nasal swab; after adding specific reagents for LAMP reaction, the colorimetric result can be observed on paper. By recording the colorimetric change through a mobile phone camera, the user could upload the result to cloud storage by Internet. Clinicians or health-care specialist could thus analyze the result and offer immediate information for both patient and the government. Since the whole diagnostic process can be performed at home, the suspected case does not need to travel to hospital and can in turns lower the risk of spreading the disease.
The concept for this tool is derived from previous research on paper-based nucleic acid detection employing RT-LAMP assay amplification [6]. Paper-based diagnostic tools have been widely applied for a variety of biochemical assays due to their low cost, ease of use, and speed. They have been employed to test a range of sample sources, including blood, urine, tears, and vaginal fluid, and could be easily adapted to accept nasal swab samples for viral detection. We have previously developed a paper-based platform for fluorescent nucleic acid screening using nucleic ladders. This research provided considerable insight into fluorescent probe selection and viral detection and required only a small sample volume. The potential rapid and easy-to-use paper-based LAMP assay for COVID-19 could be used in combination with a smartphone application to facilitate test results recording/sharing. Using this tool, a home-quarantined individual could easily self-collect a nasal swab sample; perform a LAMP assay; and observe a visible, colorimetric test result that could then be recorded and shared with clinicians or healthcare professionals via the internet.
As the number of confirmed cases of COVID-19 rises rapidly throughout the world, more and more patients will require reliable testing. A rapid, inexpensive, and easy-to-use POC diagnostic device integrated with a smartphone could reduce transportation needs, lower the risk of spreading infection, alleviate the strain on the healthcare system, and mitigate the cost of care for both individuals and the government. We believe that research into the development of a paper-based RNA assay for use in combination with a smartphone application can provide new insights into designing POC COVID-19 diagnostics and ultimately improve the health care system to combat this and similar diseases.