Portable RT-PCR System: a Rapid and Scalable Diagnostic Tool for COVID-19 Testing

Abstract

Combating the ongoing coronavirus disease 2019 (COVID-19) pandemic demands accurate, rapid, and point-of-care testing with fast results to triage cases for isolation and treatment. The current testing relies on RT-PCR, which is routinely performed in well-equipped laboratories by trained professionals at specific locations. However, during busy periods high numbers of samples queued for testing can delay the test results, impacting upon efforts to reduce the infection risk. Besides, the absence of well-established laboratories at remote sites and low-resourced environments can contribute to a silent spread of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). These reasons compel the need to accommodate point-of-care testing for COVID-19 that meets the ASSURED criteria (Affordable, Sensitive, Specific, User-friendly, Rapid, robust, Equipment-free, and Deliverable). This study assessed the agreement and accuracy of the portable Biomeme SARS-CoV-2 system against the gold standard tests. Nasopharyngeal and nasal swabs were used. Of the 192 samples tested using the Biomeme SARS-CoV-2 system, the results from 189 samples (98.4%) were in agreement with the reference standard-of-care RT-PCR testing for SARS-CoV-2. The portable system generated simultaneous results for nine samples in 80 mins with high positive and negative percent agreements of 99.0% and 97.8%, respectively. We performed separate testing in a sealed glove box, offering complete biosafety containment. Thus, the Biomeme SARS-CoV-2 system can help decentralize COVID-19 testing and offer rapid test results for patients in remote and low-resourced settings. Single Sentence Summary The Biomeme SARS-CoV-2 system can help decentralize COVID-19 testing and offer rapid test results for patients in remote sites and low-resourced settings.

Diagnostic assay and technology advancement for detecting SARS-CoV-2 infections causing the COVID-19 pandemic

“…Despite these drawbacks, RT-PCR is still the gold standard for verifying COVID-19 diagnosis. Since the outbreak of the pandemic, numerous efforts have been made to produce handheld PCR devices [56,57]. CovidNudge, a lab-on-a-chip device, can conduct sample preparation and real-time RT-PCR in remote locations.…”

Strategies for the preparation of non-amplified and amplified genomic dengue gene samples for electrochemical DNA biosensing applications

“…The successful use of the Biomeme PCR machine as portable PCR apparatus for the rapid testing of COVID-19 was also documented in the work of Zowawi et al 29 Other previous works have shown the successful design and development of portable PCR techniques, such as RT-PCR-assisted lab-ona chip-based optical detection, 30 portable rotary real-time uorescent PCR, 31 a miniaturized PCR-based portable bioaerosol, 32 and others. These breakthroughs pave a path for the future development of miniaturized PCR-based electrochemical biosensors, which have the potential to revolutionize healthcare, particularly in dengue diagnostics.…”

Management of COVID-19 Patients in the Emergency Department

“…If a space does not exist for an isobox, then even a well-ventilated room inside the built structure or a well signaled tent outside could be the solution for small healthcare facilities. Additionally, in the triage area, a uni-directional flow of patients in one-way in and one-way out, an emergency isolation pathway for critically ill patients, available COVID-19 testing for early evaluation in ER area, and a secured connection into an intensive care unit (ICU) or advanced healthcare care and resources, should be obtained [ 3 , 4 ]. Dedicated clinical staff should be assigned for the evaluation of patients presenting with COVID-19 symptoms at triage.…”

“…A limited number of family members and caregivers can accompany patients who need assistance and must always be in accordance with COVID-19 national guidelines and local protocols. Each healthcare facility should follow previously agreed local or regional preventive protocols against contamination of COVID-19 in the ED, including screening for COVID-19 among triage patients [ 4 , 10 ].…”