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1.
Telerheumatology: Origins, Current Practice, and Future Directions ; : 101-111, 2022.
Article in English | Scopus | ID: covidwho-2318176

ABSTRACT

Billing and coding of telerheumatology encounter types has become more complex, as opportunities to provide telerheumatology services have expanded, with a major increase due to the COVID-19 pandemic. This chapter provides an overview of telerheumatology billing and coding prior to the COVID-19 pandemic. It outlines how geographic criteria for providing telerheumatology care have changed during the COVID-19 pandemic. It identifies specific billing codes, and criteria for their use, which are most relevant to rheumatology care teams. These include discussions of synchronous audio and visual encounters, audio-only encounters, E-visits, virtual check-ins, and interprofessional electronic consults (also known as eConsults). We discuss modifiers and place of service codes which may be required, as well as telehealth codes which may be used by nonphysician members of a rheumatology care team, such as nurse practitioners, physician assistants, physical therapists, and occupational therapists. Finally, this chapter compares payment policies between Medicare and commercial payers, and briefly looks toward possible future trends in telerheumatology coverage policies. © The Author(s), under exclusive license to Springer Nature Switzerland AG 2022. All rights reserved.

2.
South African Journal of Sports Medicine ; 33, 2023.
Article in English | Africa Wide Information | ID: covidwho-2290440

ABSTRACT

AJOL : The coronavirus disease 2019 (COVID-19) pandemic has caused disruption to professional and recreational sports across the world. The SARS-CoV-2 virus can be transmitted by relatively large respiratory droplets that behave ballistically, and exhaled aerosol droplets, which potentially pose a greater risk. This review provides a summary of end-to-end SARS-CoV-2 transmission risk factors for sport and an overview of transmission mechanisms to be considered by all stakeholders. The risk of SARS-CoV-2 transmission is greatest indoors, and primarily influenced by the ventilation of the environment and the close proximity of individuals. The SARS-CoV-2 transmission risks outdoors, e.g. via water, and from fomites, appear less than initially thought. Mitigation strategies include good end-to-end scenario planning of activities to optimise physical distancing, face mask wearing and hygiene practice of individuals, the environment and equipment. The identification and removal of infectious individuals should be undertaken by means of the taking of temperature and COVID-19 symptom screening, and the use of diagnostic monitoring tests to identify asymptomatic individuals. Using adequate video footage, data from proximity technology and subject interviews, the identification and isolation of 'close contacts' should also be undertaken to limit SARS-CoV-2 transmission within sporting environments and into the wider community. Sports should aim to undertake activities outdoors where possible, given the lower SARS-CoV-2 transmission risk, in comparison to indoor environments

3.
Groupwork ; 30(2):38-53, 2023.
Article in English | Scopus | ID: covidwho-2301795

ABSTRACT

The Covid-19 pandemic has created an epistemological rupture for social work. Research is beginning to examine and articulate the practice knowledge that has arisen as a result of the pandemic. This article is based on a social work student placement at a community-based, rural hospice, which occurred during the Covid-19 pandemic. This article focuses on virtual social work and groupwork, and discusses ethics, the digital divide, and social presence. © 2023 Whiting and Birch. All rights reserved.

4.
Clin Infect Dis ; 76(8): 1358-1363, 2023 04 17.
Article in English | MEDLINE | ID: covidwho-2302049

ABSTRACT

BACKGROUND: In the United States, influenza activity during the 2021-2022 season was modest and sufficient enough to estimate influenza vaccine effectiveness (VE) for the first time since the beginning of the coronavirus disease 2019 pandemic. We estimated influenza VE against laboratory-confirmed outpatient acute illness caused by predominant A(H3N2) viruses. METHODS: Between October 2021 and April 2022, research staff across 7 sites enrolled patients aged ≥6 months seeking outpatient care for acute respiratory illness with cough. Using a test-negative design, we assessed VE against influenza A(H3N2). Due to strong correlation between influenza and severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) vaccination, participants who tested positive for SARS-CoV-2 were excluded from VE estimations. Estimates were adjusted for site, age, month of illness, race/ethnicity, and general health status. RESULTS: Among 6260 participants, 468 (7%) tested positive for influenza only, including 440 (94%) for A(H3N2). All 206 sequenced A(H3N2) viruses were characterized as belonging to genetic group 3C.2a1b subclade 2a.2, which has antigenic differences from the 2021-2022 season A(H3N2) vaccine component that belongs to clade 3C.2a1b subclade 2a.1. After excluding 1948 SARS-CoV-2-positive patients, 4312 patients were included in analyses of influenza VE; 2463 (57%) were vaccinated against influenza. Effectiveness against A(H3N2) for all ages was 36% (95% confidence interval, 20%-49%) overall. CONCLUSIONS: Influenza vaccination in 2021-2022 provided protection against influenza A(H3N2)-related outpatient visits among young persons.


Subject(s)
COVID-19 , Influenza Vaccines , Influenza, Human , Humans , United States/epidemiology , Influenza, Human/epidemiology , Influenza, Human/prevention & control , Influenza A Virus, H3N2 Subtype , Seasons , Vaccine Efficacy , COVID-19/epidemiology , COVID-19/prevention & control , SARS-CoV-2 , Vaccination , Influenza B virus
5.
American Educational Research Journal ; 2022.
Article in English | Web of Science | ID: covidwho-2198380

ABSTRACT

Before the 2020-2021 school year, policymakers and parents confronted the uncertain trade-offs implied by the health, educational, and economic consequences of offering instruction remotely, in person, or through a hybrid of the two. Most public schools in the United States chose remote-only instruction, and enrollment fell dramatically (i.e., a loss 1.1 million K-12 students). We examine the impact of these choices on public-school enrollment using panel data that combine district-level information on enrollment and instructional mode. We find offering remote-only instead of in-person instruction reduced enrollment by 1.1 percentage points (i.e., 42% greater disenrollment). The disenrollment effects of remote instruction are concentrated in kindergarten and, more modestly, elementary schools. We do not find evidence that hybrid instruction had an impact.

6.
Open Forum Infectious Diseases ; 9(Supplement 2):S477-S478, 2022.
Article in English | EMBASE | ID: covidwho-2189772

ABSTRACT

Background. Effective therapeutic agents for the treatment of COVID-19 have been investigated since the onset of the pandemic. Monoclonal antibodies targeting the spike protein of SARS-CoV-2 have been developed for treatment of mild or moderate COVID disease in high-risk populations. Despite widespread use in the adult population, data are limited on the safety and efficacy of monoclonal antibody infusions in the adolescent and young adult population. Methods. Patients who received bamlanivimab, bamlanivimab-etesevimab, casirivimab-imdevimab, or sotrovimab for treatment of mild COVID disease at Cincinnati Children's Hospital Medical Center from 5/1/2020 through 3/1/2022 were identified retrospectively. In accordance with the FDA EUA, patients were eligible for monoclonal antibody administration if they were >=12 years of age, weighed >=40kg, and were at high risk of progressing to severe disease or hospitalization. Results. Ninety-four patients received monoclonal antibody therapy, of which 14 (13.5%) received either bamlanivimab or bamlanivimab-etesevimab, 54 (51.9%) received casirivimab-imdevimab, and 26 (25%) received sotrovimab. Ten patients (10.6%) experienced one or more adverse events. Of those, 2 (14.3%) received either bamlanivimab or bamlanivimab-etesivimab, 7 (12.9%) received casirivimab-imdevimab, and 1 (3.8%) received sotrovimab. Most common symptoms include rash, nausea, and throat irritation (table R1), the majority (90%) of which were mild, either self-resolving with infusion cessation (60%) or persistent but requiring no medical intervention (30%) (table R2). Of the patients who experienced adverse events, only 1 (10%) received medical intervention - epinephrine. No life-threatening events or deaths occurred. Within 90 days of receiving a monoclonal antibody, 15 patients (15.9%) required additional medical care for ongoing COVID symptoms (table R3). Eight (53.3%) of these were either hospitalized or received escalation of care while already in the hospital. Classification of adverse events by grade and monoclonal antibody. Grade I events are defined as mild and generally not bothersome. Grade II events are defined as moderate: bothersome, but not dangerous. Grade III events are defined as medically significant, but not immediately life-threatening, and often require medical intervention. Patients who required additional medical care for ongoing COVID-19 symptoms within 90 days of receiving a monoclonal antibody. Conclusion. Overall, monoclonal antibodies are safe, largely well-tolerated COVID-19 therapies in high-risk adolescent and young adult populations.

7.
AJNR Am J Neuroradiol ; 2022 Dec 01.
Article in English | MEDLINE | ID: covidwho-2141564

ABSTRACT

BACKGROUND AND PURPOSE: Social media has made inroads in medical education. We report the creation and 3-year (2018-2021) longitudinal assessment of the American Society of Head and Neck Radiology Case of the Week (#ASHNRCOTW), assessing viewership, engagement, and impact of the coronavirus disease 2019 (COVID-19) pandemic on this Twitter-based education initiative. MATERIALS AND METHODS: Unknown cases were tweeted from the American Society of Head and Neck Radiology account weekly. Tweet impressions (number of times seen), engagements (number of interactions), and new followers were tabulated. A social media marketing platform identified worldwide distribution of Twitter followers. Summary and t test statistics were performed. RESULTS: #ASHNRCOTW was highly visible with 2,082,280 impressions and 203,137 engagements. There were significantly greater mean case impressions (9917 versus 6346), mean case engagements (1305 versus 474), case engagement rates (13.06% versus 7.76%), mean answer impressions (8760 versus 5556), mean answer engagements (908 versus 436), answer engagement rates (10.38% versus 7.87%), mean total (case + answer) impressions (18,677 versus 11,912), mean total engagements (2214 versus 910), and total engagement rates (11.79% versus 7.69%) for cases published after the pandemic started (all P values < .001). There was a significant increase in monthly new followers after starting #ASHNRCOTW (mean, 134 versus 6; P < .001) and significantly increased monthly new followers after the pandemic started compared with prepandemic (mean, 178 versus 101; P = .003). The American Society of Head and Neck Radiology has 7564 Twitter followers throughout 130 countries (66% outside the United States). CONCLUSIONS: Social media affords substantial visibility, engagement, and global outreach for radiology education. #ASHNRCOTW viewership and engagement increased significantly during the COVID-19 pandemic.

9.
Journal of Oral and Maxillofacial Surgery ; 80(9):S62-S63, 2022.
Article in English | EMBASE | ID: covidwho-2041964

ABSTRACT

Problem: Clinicians treating postprocedure acute pain after third molar removal face a twofold challenge: attenuating pain levels while simultaneously limiting leftover opioid doses. Strategies for achieving the dual goals range from “letting patients decide,” which can lead to leftover doses and misuse, or “letting clinicians decide,” only prescribing opioids for those predicted to experience severe discomfort, which risks under-managing acute pain. A hybrid strategy relies on joint decision-making between the patient and clinician. The hypothesis for this IRB-approved prospective study was that a hybrid-strategy would be successful in moderating acute pain and reducing leftover opioid doses. Methods and Materials: This study included patients who met the American Society of Anesthesiologists, risk classification I or II, ages 18 to 35 years, with at least 2 mandibular third molars removed. Patients being treated for opioid addiction/abuse were excluded. All enrolled subject patients were consented and treated with a multimodal analgesic protocol consisting of intraoperative IV preventive antibiotics, dexamethasone, ketorolac, ondansetron, local anesthetics including liposomal bupivacaine and postoperative cold therapy, and scheduled ibuprofen. Patients were given 2 prescriptions (Rx), each for 4 doses of Hydrocodone/APAP 5/325, to be taken as needed for pain;1 Rx could be filled on the day of surgery, the second on any subsequent day. Opioid Rx data were retrieved from patient records and North Carolina Controlled Substances Reporting System. Pain scores and opioid-use data for each postsurgery day (PSD) were derived from a 14-day diary recorded by subjects. For the patients in this series, the goal was median pain levels ranked 1 or 2 on a 7-point scale, meaning no pain and minimal pain by postoperative day (POD) 3. Descriptive statistics were used for analyses. Results: Data were analyzed from 96 eligible patients treated consecutively from 2018 to 22, with a 15-month hiatus from COVID-19. Fifty-two patients (54%) did not fill an opioid prescription. Twenty-seven patients (28%) filled 1 opioid prescription and 17 patients (18%) filled 2 of the prescriptions. The patients who filled 1 prescription had 72 leftover doses (67% of possible doses), and the patients who filled 2 prescriptions had 50 leftover doses (74% of possible doses). Median worst pain levels reached 1 to 2 out of 7 on POD 4;median average pain on POD 3. Conclusions: The hybrid strategy reduced the number of opioid doses in circulation without compromising the patient's postoperative pain level. Decreasing the number of leftover opioid doses is an important step toward addressing opioid addiction and overdose. References: 1 Magraw CBL, Pham M, Neal T, Kendell B, Reside G, Phillips C, White RP Jr: A multimodal analgesic protocol may reduce opioid use after third molar surgery: A pilot study. Oral Surg Oral Med Oral Path Oral Radiol 126:214, 2018. 2 Pham M, Magraw C, Neal T, Kendell B, Reside G, Phillips C, White R: A Multi-modal Analgesic Protocol reduced opioid use/misuse after 3rd Molar Surgery: An Exploratory Study. Submitted Oral Surg Oral Med Oral Path Oral Radiol March 2019 3 Pham M, Magraw C, Neal T, Kendell B, Reside G, Phillips C, White R: A Multimodal Analgesic Protocol reduced acute pain levels after 3rd molar surgery. In preparation JOMS 4 White RP Jr, Shugars DA, Shafer DM, Laskin DM, Buckley MJ, Phillips C: Recovery after third molar surgery: clinical and health-related quality of life outcomes. J Oral and Maxillofacial Surgery 61:535, 2003. 5 American Society of Anesthesiologists Task Force on Acute Pain Management. Anesthesiology 116:248, 2012 6-Savarese JJ, Tabler NG Jr: Multimodal analgesia as an alternative to the risks of opioid monotherapy in surgical pain management. J Health Care Risk Manag 37:24, 2017

10.
Assistive Technology Outcomes and Benefits ; 16(Special Issue 2):111-126, 2022.
Article in English | Scopus | ID: covidwho-2012291

ABSTRACT

In July 2020, the CDC Foundation partnered with the Center for Inclusive Design and Innovation (CIDI) at the Georgia Institute of Technology to deliver critical COVID-19 guidance to people with disabilities, their families, and caregivers. The project made information from the Centers for Disease Control and Prevention (CDC) accessible for audiences with vision and hearing disabilities and extremely low literacy levels. The dissemination challenge was communicating the availability of the products in digital and embossed Braille, American Sign Language videos, and simplified text products to the intended users. Working with the American Association on Health and Disability, a project partner, CIDI constructed a network of organizations to disseminate information about project services through virtual speaking appearances, webinars, and social media messaging to organizations that reach the intended audiences. The accessible products are distributed to the target audiences through a website and key partnerships for the physical distribution of embossed braille products. © ATIA 2022.

11.
Assistive Technology Outcomes and Benefits ; 16(Special Issue 2):86-103, 2022.
Article in English | Scopus | ID: covidwho-2010788

ABSTRACT

It is essential that people with disabilities have equitable access to COVID-19 communication resources to protect themselves, their families, and their communities. The Accessible Materials and Culturally Relevant Messages for Individuals with Disabilities project aimed to deliver essential COVID-19 information in braille, American Sign Language (ASL), simplified text, and other alternative formats, along with providing additional tools and trainings that people with disabilities and organizations that serve them can use to apply the COVID-19 guidance. Lessons learned from this project can be implemented in future public health emergencies as well as in general public health messaging for people with disabilities. This project, led by Georgia Tech’s Center for Inclusive Design and Innovation (CIDI) and with technical assistance from the Centers for Disease Control and Prevention (CDC), was supported by the CDC Foundation, using funds from the CDC Foundation’s COVID-19 Emergency Response Fund. © ATIA 2022.

12.
Supportive Care in Cancer ; 30:S25-S26, 2022.
Article in English | EMBASE | ID: covidwho-1935806

ABSTRACT

Introduction According to Braun and Clarke, thematic analysis (TA) is a family of methods that entail familiarization with the data;generating initial codes;conceptualizing, reviewing, naming, and defining themes;and writing a report. We conducted a multicentric qualitative study investigating the experiences of individuals treated for cancer during the COVID-19 pandemic in different language regions and countries. We aim to describe our procedures for selecting an approach to TA;generating codes;and conceptualizing themes and sub themes capturing common and distinct experiences across sites. Methods Our team was comprised of multilingual investigators from Switzerland and the United States. We formed site-specific workgroups to recruit local participants and conduct interviews in one of five languages. Principal challenges were to (a) ensure consistency in qualitative data collection;(b) construct shared interpretations of qualitative data while preserving context-specific nuance;and (c) develop and maintain a large data set supporting iterative analyses by multiple workgroups. Results Adopting a pragmatic worldview, we planned and conducted a codebook TA. We validated data collection materials with each workgroup;developed a codebook;analyzed data deductively and inductively;and used MAX QDA software to facilitate data management. Table 1 details our approach. Conclusions Investigators using TA in disparate contexts face unique methodological challenges. Research to establish best practices is warranted.

13.
Supportive Care in Cancer ; 30:S20-S21, 2022.
Article in English | EMBASE | ID: covidwho-1935786

ABSTRACT

Introduction Cancer patients have experienced higher rates of distress than the general population during the COVID-19 pandemic. We aimed to provide a thorough overview of studies assessing distress and resilience reflecting distinct temporal and geographical characteristics of the COVID-19 pandemic. Methods A search was conducted through PubMed to identify studies that measured distress and/or resilience in cancer patients during the COVID-19 pandemic. Information about each study's country, instruments, data collection period, and scores were extracted by two researchers as part of an analysis of approaches to capture cancer patients' experiences. Reports of daily new cases per country were retrieved from the WHO database. Results We identified 13 studies that assessed distress and/or resilience from 10 countries. The Distress thermometer (n=9) and the Connor-Davidson Resilience Scale (n=3) were the most common measures. Data collection ranged from December 2019 to August 2021, with 7 studies conducted during the first wave (March-July 2020), 4 between July 2020- March 2021, and 2 after June 2021. Overall, the highest scores of distress were seen in the first phase of the pandemic and resilience scores were similar to the mean score described for cancer patients. Conclusions Distress values might be influenced by temporal and local circumstances. Due to the disparate evolution of the pandemic across countries, special attention should be given to describing the specific context when reporting psycho-social data.

14.
Journal of Allergy and Clinical Immunology ; 149(2):AB174-AB174, 2022.
Article in English | Web of Science | ID: covidwho-1798104
15.
Clin Radiol ; 77(3): 231-235, 2022 03.
Article in English | MEDLINE | ID: covidwho-1568610

ABSTRACT

AIM: To follow-up previous work evaluating incidental findings of COVID-19 signs on computed tomography (CT) images of major trauma patients to include the second wave prior to any major effects from vaccines. MATERIALS AND METHODS: The study population included all patients admitted following major trauma between 1 January 2020 and 28 February 2021 with CT including the lungs (n=1776). Major trauma patients admitted pre-COVID-19 from alternate months from January 2019 to November 2019 comprised a control group (n=837). The assessing radiologists were blinded to the time period and used double reading in consensus to determine if the patient had signs of COVID-19. Lung appearances were classified as no evidence of COVID-19, minor signs, or major signs. RESULTS: The method successfully tracked the second wave of the COVID-19 pandemic in London. The estimated population affected by the disease based on those with major signs was similar to estimates of the proportion of the population in London with antibodies (around 30% by end February 2021) and the total of major and minor signs produced a much higher figure of 68%, which may include all those with both antibody and just T-cell responses. CONCLUSIONS: Incidental findings on CT from major trauma patients may provide a novel and sensitive way of tracking the virus. It is recommended that all major trauma units include a simple question on signs of COVID-19 to provide an early warning system for further waves.


Subject(s)
COVID-19/epidemiology , Lung/diagnostic imaging , Tomography, X-Ray Computed , Wounds and Injuries/diagnostic imaging , Wounds and Injuries/epidemiology , Aged, 80 and over , COVID-19/diagnostic imaging , Comorbidity , Female , Humans , Incidental Findings , London/epidemiology , Male , Middle Aged , Pandemics , Prevalence , United Kingdom/epidemiology
16.
Gut ; 70(SUPPL 3):A18-A20, 2021.
Article in English | EMBASE | ID: covidwho-1467712

ABSTRACT

Assess (the situation) From the start of 2021, as the UK entered another COVID19 lockdown, we noticed a stark increase in the numbers of patients presenting with, or developing, Delirium Tremens (DTs). While historically, it had been rare to see DTs within our organisation, it became a frequent occurrence and concerns were raised about staff safety and adverse outcomes for patients. Diagnose (identify the problem) We (Alcohol Care Team) identified a knowledge gap in the recognition, treatment and nursing management of acute alcohol withdrawal amongst ward staff which was contributing to the onwards progression of DTs in patients. Plan Using our Trust guidelines for alcohol withdrawal and team expertise, we developed a nursing care plan for patients experiencing acute alcohol withdrawal, outlining optimal care and highlighting key elements of the Trust policy. Implement (deliver the plan) We used the care plan as a framework to guide informal teaching to staff on the Gastro/Hepatology wards. Furthermore, we made ourselves increasingly available when patients were in DTs and prioritised supporting staff in the hands on/active management of patients in DTs (akin to a low dose, high frequency approach, Jhpiego 2016)1 in order to maintain safety, optimise patient care and demonstrate clinical leadership. Evaluate (did the plan work? Where are we now?) The care plan has been well received by staff. It is due to be submitted through our internal governance structure in order for it to be used as a clinical tool in practice. (Figure Presented).

17.
Frontiers in Education ; 6, 2021.
Article in English | Scopus | ID: covidwho-1268241

ABSTRACT

The COVID-19 pandemic has caused, and continues to cause, unprecedented disruption in England. The impact of the pandemic on the English education system has been significant, especially for children and young people with special educational needs and disabilities (SEND). While it was encouraging that the educational rights of children and young people with SEND were highlighted during the COVID-19 pandemic, Government decision-making appeared to be centered around the needs of pupils in mainstream schools. In this article, co-authored by an academic researcher and senior leaders from the Pan London Autism Schools Network (PLASN;a collective of special schools in London and the South East of England, catering for pupils on the autistic spectrum), we reflect on the impact of the COVID-19 pandemic on special schools in England. We document and discuss a range of challenges experienced by PLASN schools, including the educational inequalities that were exposed and perpetuated by the COVID-19 pandemic, as well as the manner in which the needs and realities of special schools were overlooked by the Government. We also detail the creative and innovative solutions implemented by PLASN schools to overcome barriers that they encountered. These solutions centered on facilitating holistic approaches to support, ensuring clear and regular communication with families, providing effective support for home learning, and promoting collaborative ways of working;all of which align with good practice principles in autism education more generally, and are essential elements of practice to maintain post-pandemic. We additionally reflect on how the COVID-19 pandemic could be a catalyst for much-needed change to the SEND system: leading to better educational provision, and therefore better outcomes, for pupils with SEND. © Copyright © 2021 Crane, Adu, Arocas, Carli, Eccles, Harris, Jardine, Phillips, Piper, Santi, Sartin, Shepherd, Sternstein, Taylor and Wright.

18.
Applied Radiology ; 50(3):56-56, 2021.
Article in English | CINAHL | ID: covidwho-1232869
19.
AJNR Am J Neuroradiol ; 42(3): E12, 2021 03.
Article in English | MEDLINE | ID: covidwho-1229151
20.
Open Forum Infectious Diseases ; 7(SUPPL 1):S278, 2020.
Article in English | EMBASE | ID: covidwho-1185786

ABSTRACT

Background: The BioFire® COVID-19 Test is a qualitative test for use on the FilmArray® 2.0 and Torch systems for the detection of SARS-CoV-2 RNA in nasopharyngeal swabs (NPS) in transport media. This test received Emergency Use Authorization from the FDA. A closed, disposable pouch contains all the necessary reagents for sample preparation, nucleic acid extraction, reverse transcription, polymerase chain reaction (PCR), and amplified nucleic acid detection to identify RNA from SARS-CoV-2 virus in an NPS specimen. Internal controls monitor all stages of the test process. Once an NPS sample (0.3 mL) is loaded into the system disposable pouch (Figure 1), the fully automated test returns results within an hour. As an additional resource, the BioFire® COVID-19 Test External Control Kit (+) includes positive external control material that may be used for quality control and laboratory verification. Methods: The following were evaluated: • Limit of Detection (LoD) • Positive and Negative Percent Agreement (PPA and NPA, respectively) for clinical contrived samples and a limited number of clinical specimens • Exclusivity Results: • LoD The LoD was evaluated using live SARS-CoV-2 virus (cultured from the USA- WA1/2020 strain obtained from World Reference Center for Emerging Viruses and Arboviruses (WRCEVA)). The LoD was determined to be 3.3E+02 GC/mL (2.2E-02 TCID50/mL). • Clinical Contrived Accurate detection of virus in clinical matrix was demonstrated at various LoD levels using thirty contrived individual unique clinical samples (PPA), and 66 individual unique negative clinical specimens (NPA). • Clinical Samples Positive samples were collected from patients presenting with signs or symptoms of COVID-19, and who were previously identified as positive for SARS-CoV-2 by another EUA test. Negative samples were collected in 2018, and therefore presumed negative for SARS-CoV-2. • Exclusivity The potential for cross-reactivity was evaluated for six viruses from the same genetic family as SARS- CoV-2, and for an additional 30 high priority organisms/viruses. No cross-reactivity was observed. Conclusion: The BioFire COVID-19 Test reliably detects SARS-CoV-2 virus RNA in clinically relevant samples. (Table Presented).

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