Amplified parallel antigen rapid test for point-of-care salivary detection of SARS-CoV-2 with improved sensitivity.

In the ongoing COVID-19 pandemic, simple, rapid, point-of-care tests not requiring trained personnel for primary care testing are essential. Saliva-based antigen rapid tests (ARTs) can fulfil this need, but these tests require overnight-fasted samples; without which independent studies have demonstrated sensitivities of only 11.7 to 23.1%. Herein, we report an Amplified Parallel ART (AP-ART) with sensitivity above 90%, even with non-fasted samples. The virus was captured multimodally, using both anti-spike protein antibodies and Angiotensin Converting Enzyme 2 (ACE2) protein. It also featured two parallel flow channels. The first contained spike protein binding gold nanoparticles which produced a visible red line upon encountering the virus. The second contained signal amplifying nanoparticles that complex with the former and amplify the signal without any linker. Compared to existing dual gold amplification techniques, a limit of detection of one order of magnitude lower was achieved (0.0064 ng·mL-1). AP-ART performance in detecting SARS-CoV-2 in saliva of COVID-19 patients was investigated using a case-control study (139 participants enrolled and 162 saliva samples tested). Unlike commercially available ARTs, the sensitivity of AP-ART was maintained even when non-fasting saliva was used. Compared to the gold standard reverse transcription-polymerase chain reaction testing on nasopharyngeal samples, non-fasting saliva tested on AP-ART showed a sensitivity of 97.0% (95% CI: 84.7-99.8); without amplification, the sensitivity was 72.7% (95% CI: 83.7-94.8). Thus, AP-ART has the potential to be developed for point-of-care testing, which may be particularly important in resource-limited settings, and for early diagnosis to initiate newly approved therapies to reduce COVID-19 severity.

Virtual Multidisciplinary Review of a Complex Case Using a Digital Clinical Decision Support Tool to Improve Workflow Efficiency.

OBJECTIVE: Integration of distinct clinical perspectives in multi-disciplinary tumor board meetings is critical to determine optimal patient care. Digital tools can support the data consolidation needed for meeting preparation and data sharing during complex case reviews. In this paper, we assessed the value of a clinical decision support tool on workflow efficiency and conducting a complex case review of a dermatofibrosarcoma protuberans (DFSP) tumor. METHODS: Case presentation was performed by each unique clinical specialty that had relevant information about the patient; an oncologist, a pathologist, and a radiologist. Virtual discussion was completed online with case presentation and documentation with NAVIFY Tumor Board. Workflow efficiency assessment was done through interviews and observation of the # of steps across different team members involved in preparing and conducting cancer multidisciplinary team (MDT) meetings before and after the implementation of the NAVIFY Tumor Board solution. RESULTS: Case review consisted of surgical and therapeutic intervention history, distinct histological and sequencing patterns representative of DFSP, with radiological review to determine areas for surgical intervention. Consolidation of clinical input led to a recommendation of a formal external hemipelvectomy with potential chemotherapy. Workflow assessment demonstrated a 46% total reduction in the # of steps for meeting preparation (from 69 to 37), with specific changes based on role: data manager (33 to 15), pathologist (26 to 13), radiologist (no change), and logistics (5 to 4). There was a 31% total reduction in the # of steps for conducting the meeting (from 51 to 35). CONCLUSION: Utilizing a digital clinical decision support tool helped to consolidate patient data and improved case presentation through workflow efficiency. This allowed for improved interdisciplinary discussion on a complex DFSP case and supported the determination of a clinical decision.