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1.
Current Medical Research and Opinion ; JOUR:S13, 38(Supplement 2).
Article in English | EMBASE | ID: covidwho-2097016

ABSTRACT

Background: The COVID-19 pandemic worsened a nationwide technician shortage with negative impacts on pharmacy workflow and patient care. Barriers to entering the pharmacy field as a technician included lack of years of experience and training, specifically in specialty pharmacy technician (SPT) roles that require one year of experience and advanced certification. With our growing business, the ability to hire SPT's has been a challenge. Currently, Yale New Haven Health (YNHH) offers an ASHP/ACPE accredited Pharmacy Technician Training Program that prepares individuals for: a pharmacy career in all practice settings, the Pharmacy Technician Certification Board (PTCB) exam, as well as the opportunity for practical experience in multiple practice settings and areas, including specialty pharmacy. The twenty-three week long program (we have removed the PTCB requirement to align with the changes in job description across the system that requires PTCB within 1 year of hire) is equivalent to one year of pharmacy experience. The YNHH health system specialty pharmacy (HSSP) collaborated with the YNHH Pharmacy Technician Training Program to create a specialty pharmacy focused track. Objective(s): To increase the HSSP SPT candidate pool through the creation of a HSSP focused pharmacy technician training program rotation tract. Method(s): Rotation objectives were created to ensure compliance with American Society of Health-System Pharmacists (ASHP) accreditation standards, in addition to training objective that include exposure to all technician based positions within the specialty pharmacy realm. The traditional nineweek experiential rotation tract was adapted to allow seven weeks of specialty pharmacy focused rotations. Enrollment into the specialty pharmacy focused track was limited to one student per cohort for the first three rotation cycles. The number of students who completed the rotation and were retained as HSSP SPT's was tracked. Specialty technician content experts within the HSSP were identified to serve as program preceptors. Specialty Pharmacy Supervisors also serve as rotation site coordinators for this tract. Result(s): The development of the specialty pharmacy focused track of the YNHH Pharmacy Technician Training Program took five months. The specialty pharmacy focused track was first available to students on 28 March, 2022. Of the two students that entered the specialty pharmacy focused track, both students have completed the program and are being retained as SPT's. Conclusion(s): A specialty focused pharmacy technician training program can be a novel strategy to address HSSP pharmacy technician staffing shortage.

2.
Journal of Clinical Oncology ; 40(16), 2022.
Article in English | EMBASE | ID: covidwho-2005711

ABSTRACT

Background: Infections occur with up to twofold increased risk in patients with monoclonal gammopathy of undetermined significance (MGUS) and tenfold increased risk in multiple myeloma (MM). To reduce risk, revaccination following autologous hematopoietic cell transplantation (AHCT) is recommended to restore humoral immunity. We have previously shown that vaccine titers after AHCT have prognostic significance. In the COVID era, reliable clinical data about antibody titers is relevant yet scarce. We investigated the significance of different vaccine titers in newly diagnosed patients in different stages of the disease. Methods: The study population comprised of 77 patients with MGUS, smoldering multiple myeloma (SMM) and MM who were seen at a tertiary cancer center from 2018- 2022. All patients had antibody titers (B. pertussis, Diptheria, H. Influenzae B, Hepatitis, Influenza, Meningitis, Mumps, Rubeola, Rubella, Poliovirus, S. pneumoniae, Varicella Zoster and Tetanus) tested at the time of diagnosis, prior to start of treatment if indicated. Titers were interpreted in accordance with the manufacturers' recommendations. Patient characteristics were compared using the Kruskal- Wallis and Fisher's exact tests. Associations with % titer positivity were evaluated using the Kruskal- Wallis test. Results: There was significant difference in antibody titer positivity between the different patient groups (51.4% in MGUS, 40.5% in SMM and 34.2% in MM) (p < 0.001). There was no difference in antibody titer positivity depending on age, sex or race. Among individual pathogens, there was a significant difference between the three groups in regards to titers for Diphtheria, Mumps, Poliovirus 3, Strep pneumoniae 19, Strep pneumoniae 56 and Varicella Zoster. Conclusions: Antibody titers for vaccine preventable diseases are significantly different between patients with MGUS, SMM and MM at the time of diagnosis, with MGUS having the highest and MM having the lowest positivity. Patient related factors such as age, sex or race were not associated with antibody titer positivity. Current guidelines for revaccination are not extended to patients with MGUS and SMM and can be considered in prospective trials.

3.
Journal of Clinical Urology ; 15(1):5, 2022.
Article in English | EMBASE | ID: covidwho-1957019

ABSTRACT

Introduction: The COVID19 pandemic has led to unprecedented pressures on theatre waiting lists. The numbers of patients requiring regular ureteric stent changes under general anesthetic (GA) can be significant. We performed a regional study of these patients to assess;i) suitability for procedures under local anaesthetic (LA) and ii) outcomes for those then having LA rather than GA procedures. Patients and Methods: A retrospective cohort study from 3 urology centres was performed. Feasibility criteria for transition to LA stent change was determined on;comorbidities, indication for stent placement and operative factors. 2 centres subsequently initiated regular out-of-theatre LA stent change lists and outcomes were reviewed. Results: 216 cases were included. Median age was 68 and sex ratio 1:1 (M:F). Commonest indications for indwelling stents included benign strictures (37%), non-urological malignancy (24.1%) and urological malignancy (22.2%). 34 patients were suitable for/awaiting definitive procedures. Average number of changes was 2.4/year with 49% of patients being ASA3 or higher. LA stent changes were deemed feasible in 70 patients. 63 procedures were performed under LA with a 98% success rate. Complications (30d) included stent migration (2), haematuria (2) and infection (1). Conclusion: Innovation is required to deal with significant COVID-19 related problems. LA ureteric stent changes are safe and tolerable in appropriately selected patients. Performing these outside of the theatre environment increases capacity on surgical waiting lists. Patient benefits include reduced risks of multiple GA procedures in elderly and co-morbid patients. This data encourages expansion of this initiative.

4.
American Journal of Respiratory and Critical Care Medicine ; 205(1), 2022.
Article in English | EMBASE | ID: covidwho-1927900

ABSTRACT

Introduction: Activity monitoring is important in the ICU where delirium, sedation, and critical illness are associated with both inactivity and agitation. Staff monitoring of motion and sleep is intermittent and resource intense. Wearable actigraphic devices are poorly tolerated and limited to limb motion. Here we demonstrate continuous AI video monitoring in the ICU to provide alwayson, unobtrusive patient activity monitoring. Methods: We conducted a pilot study of AI video monitoring in the Duke University Hospital Medical Intensive Care Unit. Video carts continuously recorded data on encrypted hard drives. Second-by-second AI analysis generated binary motion “counts” that were summed to generate our patient motion metric: counts per minute (CPM). Scene intelligence from AI object and people detectors provided room environment information. These data streams along with de-identified (blurred) video data were used to generate prototype graphical and visual summaries of patient activity patterns and the hospital room environment. Results: We enrolled 22 patients and collected 2155 hours (116 days) of video. Representative time-series data streams are shown in the Figure (top left). These data were acquired from a 76-year-old with liver failure and an escalating nasal cannula oxygen requirement who was endotracheally intubated on the subsequent day. Note 1) the declining patient activity as the patient deteriorates and 2) the significant bedside activity (high acuity) throughout the day. We developed a prototype “overnight report” that summarizes patient activity and room environment. The Figure (bottom left) shows the overnight report for a 54-year-old post-COVID-19 patient admitted to the MICU for respiratory failure with hypoactive delirium that resolved per CAM-ICU on day 5 of data collection. Notably, our report demonstrates significant overnight movement, possibly consistent with a mixed or hyperactive delirium. To visually summarize patient motion, we generated activity “heat maps” over 10-minute intervals. As a control, we showed that the intubated and sedated liver failure patient generated a still heat map (Figure upper right). Further, we visualized daytime hypoactivity/sleep in the delirious post-COVID patient (Figure lower right), suggesting disrupted circadian rhythm, giving additional context to the negative CAM assessment. Conclusions: We demonstrated the feasibility of AI to monitor patient activity in a quaternary-care MICU. Our method has advantages compared to wearable actigraphic methods for monitoring patient activity, including being unobtrusive and being able to visualize and summarize wholebody motion. The data presented here suggest that such monitoring may be able to provide clinically actionable insights in delirium care and sedation weaning.

5.
Frontiers in Environmental Science ; 10, 2022.
Article in English | Scopus | ID: covidwho-1793030

ABSTRACT

Quantifying the resilience of ecological communities to increasingly frequent and severe environmental disturbance, such as natural disasters, requires long-term and continuous observations and a research community that is itself resilient. Investigators must have reliable access to data, a variety of resources to facilitate response to perturbation, and mechanisms for rapid and efficient return to function and/or adaptation to post-disaster conditions. There are always challenges to meeting these requirements, which may be compounded by multiple, co-occurring incidents. For example, travel restrictions resulting from the COVID-19 pandemic hindered preparations for, and responses to, environmental disasters that are the hallmarks of resilient research communities. During its initial years of data collection, a diversity of disturbances—earthquakes, wildfires, droughts, hurricanes and floods—have impacted sites at which the National Ecological Observatory Network (NEON) intends to measure organisms and environment for at least 30 years. These events strain both the natural and human communities associated with the Observatory, and additional stressors like public health crises only add to the burden. Here, we provide a case-study of how NEON has demonstrated not only internal resilience in the face of the public health crisis of COVID-19, but has also enhanced the resilience of ecological research communities associated with the network and provided crucial information for quantifying the impacts of and responses to disturbance events on natural systems—their ecological resilience. The key components discussed are: 1) NEON’s infrastructure and resources to support its core internal community, to adapt to rapidly changing situations, and to quickly resume operations following disruption, thus enabling the recovery of information flow crucial for data continuity;2) how NEON data, tools, and materials are foundational in supporting the continuation of research programs in the face of challenges like those of COVID-19, thus enhancing the resilience of the greater ecological research community;and 3) the importance of diverse and consistent data for defining baseline and post-disaster conditions that are required to quantify the effects of natural disasters on ecosystem patterns and processes. Copyright © 2022 Robinson, Barnett, Jones, Stanish and Parker.

6.
Wellcome Open Research ; 5:267, 2020.
Article in English | MEDLINE | ID: covidwho-1761253

ABSTRACT

The systemic challenges of the COVID-19 pandemic require cross-disciplinary collaboration in a global and timely fashion. Such collaboration needs open research practices and the sharing of research outputs, such as data and code, thereby facilitating research and research reproducibility and timely collaboration beyond borders. The Research Data Alliance COVID-19 Working Group recently published a set of recommendations and guidelines on data sharing and related best practices for COVID-19 research. These guidelines include recommendations for clinicians, researchers, policy- and decision-makers, funders, publishers, public health experts, disaster preparedness and response experts, infrastructure providers from the perspective of different domains (Clinical Medicine, Omics, Epidemiology, Social Sciences, Community Participation, Indigenous Peoples, Research Software, Legal and Ethical Considerations), and other potential users. These guidelines include recommendations for researchers, policymakers, funders, publishers and infrastructure providers from the perspective of different domains (Clinical Medicine, Omics, Epidemiology, Social Sciences, Community Participation, Indigenous Peoples, Research Software, Legal and Ethical Considerations). Several overarching themes have emerged from this document such as the need to balance the creation of data adherent to FAIR principles (findable, accessible, interoperable and reusable), with the need for quick data release;the use of trustworthy research data repositories;the use of well-annotated data with meaningful metadata;and practices of documenting methods and software. The resulting document marks an unprecedented cross-disciplinary, cross-sectoral, and cross-jurisdictional effort authored by over 160 experts from around the globe. This letter summarises key points of the Recommendations and Guidelines, highlights the relevant findings, shines a spotlight on the process, and suggests how these developments can be leveraged by the wider scientific community.

7.
Open Forum Infectious Diseases ; 8(SUPPL 1):S278, 2021.
Article in English | EMBASE | ID: covidwho-1746647

ABSTRACT

Background. Reports in adults with COVID-19 and acute otitis media (AOM) show that severe symptoms and hearing loss may be more common than with the clinical presentation of typical AOM. However, the association of SARS-CoV-2 with AOM in children is poorly understood. Methods. Cases were identified as a subpopulation enrolled in the NOTEARS prospective AOM study in Denver, CO from March-December 2020. Children enrolled were 6-35 months of age with uncomplicated AOM and prescribed amoxicillin. Children diagnosed with AOM and SARS-CoV-2, detected by polymerase chain reaction assay, were included in the case series. Data was obtained from electronic medical records and research case report forms. Patients completed surveys at enrollment and 5, 14 and 30 days after enrollment that included the Acute Otitis Media Severity of Symptoms (AOM-SOS©) scale. All patients had nasopharyngeal otopathogen testing completed. Results. A total of 108 patients had been enrolled through December 2020 (all of whom were subsequently tested for SARS CoV-2). During the study period for this case series, 16 patients were enrolled, and 7 (43.6%) were identified with AOM/SARS-CoV-2 co-infection. Among these 7 patients, fever was present in 3 children (29%). Four children (57%) attended daycare. Only 2 children (29%) had testing for SARS CoV-2 as part of their clinical workup. Mean AOM-SOS © scores were similar among the SARS CoV-2 positive and negative patients with no statistical significance noted with two-sided t-tests: 13.6 (± 4.5) vs 14.2 (± 4.9) at enrollment, 1.4 (± 1.8) vs 4.2 (±4.9) on Day 5, and 0.6 (± 0.9) vs. 2.5 (±6.1) on Day 14 (Table 1). Among the 7 patients, no child had an AOM treatment failure or recurrence. Of the 6 patients in whom bacterial and viral testing have been completed, a bacterial otopathogen was identified in 6 (100%), and a viral pathogen in 3 (50%) children (Table 2). Conclusion. SARS-CoV-2 can occur in children with AOM. It is important that providers maintain a high index of suspicion for COVID-19 even in patients with clinical evidence of AOM, particularly to ensure families are appropriately advised on isolation and quarantine requirements. AOM with SARS-CoV-2 does not appear to be more severe than AOM without SARS-CoV-2.

8.
Embase;
Preprint in English | EMBASE | ID: ppcovidwho-326994

ABSTRACT

Objective: SARS-CoV-2 infection induces significant inflammatory cytokine production in adults, but infant cytokine signatures in pregnancies affected by maternal SARS-CoV-2 are less well characterized. We aimed to evaluate cytokine profiles of mothers and their infants following COVID-19 in pregnancy. Study Design: Serum samples at delivery from 31 mother-infant dyads with maternal SARS-CoV-2 infection in pregnancy (COVID) were examined in comparison to 29 control dyads (Control). Samples were evaluated using a 13-plex cytokine assay. Results: In comparison with controls, interleukin (IL)-6 and interferon gamma-induced protein 10 (IP-10) were higher in COVID maternal and infant samples (p<0.05) and IL-8 uniquely elevated in COVID infant samples (p<0.05). Significant elevations in IL-6, IP-10 and IL-8 were found among both early (1st/2nd Trimester) and late (3rd Trimester) maternal SARS-CoV-2 infections. Conclusions: Maternal SARS-CoV-2 infections throughout gestation are associated with increased maternal and infant inflammatory cytokines at birth with potential to impact long-term infant health.

9.
Safety and Health at Work ; 13:S10, 2022.
Article in English | EMBASE | ID: covidwho-1676925

ABSTRACT

COVID has transformed work for many people. Projections are that higher levels of work from home will continue into the future as hybrid models become more common. This change, whilst giving rise to opportunities for workers such as greater job autonomy, also creates new - or heightens already well-understood - psychosocial risks for workers (such as social isolation, exclusion, increased work demands). At the same time, the digital agenda also has major implications for how people work. Algorithmic decision-making, for example, is pervading work contexts beyond the gig economy. Increasingly autonomous forms of automation likewise have significant implications for the roles humans carry out at work. In this presentation, I describe a work design perspective for understanding the implications of these large-scale future changes (e.g., increasing work from home, accelerated digitalization) on workers’ health and well-being. I introduce the SMART model of work design to describe both positive and negative potential implications of future work. SMART is a model of work design based on a higher-order factor analysis of more than 20 work characteristics, involving five higher-order elements: Stimulating, Mastery, Agency, Relational, and Tolerable. Using this model, I make the case that there are few deterministic impacts of digital technologies and other large-scale future work changes. Rather, there are positive choices that can be made (e.g., about the design of technology, how change is implemented, and leaders’ work design behaviors), complemented by appropriate health and safety policies, that strongly shape the impact of digital technologies and other such changes on worker health and well-being. Without a proactive approach in which positive evidence-based choices are consciously adopted, the risks to workers’ health and well-being are high. I conclude with suggestions for research directions and opportunities for change in practice and policy.

10.
Open Public Health Journal ; 14(1):388-398, 2021.
Article in English | EMBASE | ID: covidwho-1511928

ABSTRACT

Introduction: People’s confidence in the health system's capability in managing the COVID-19 pandemic can determine public support, risk perceptions, and compliance to the required behaviors during the pandemic. Therefore, this paper investigated people’s perception of health system capability to manage the COVID-19 pandemic in different spatial areas across the country using data from an online survey. Methods: Multivariate logistic regression models were used to examine factors associated with people’s perception of the health system capability to manage the COVID-19 pandemic at the national and provincial levels. Spatial comparative analysis was conducted to contrast spatial density indicators of the number of hospitals, hospital beds, and ICU beds per given population across various provinces. Results: Findings showed that South Africans had low confidence in the health system capability, with only two in five (40.7%) reporting that they thought that the country’s health system was able to manage the COVID-19 pandemic. Sex and knowledge on COVID-19 were significantly associated with the people’s perception of the health system capability to manage the pandemic at the national level and in four of the nine provinces. Conclusion: Overall, the findings of this study clearly highlight challenges facing the country’s health system, both perceived or real, that needed to be addressed as part of the preparation for the COVID-19 pandemic. Timeous implementation of a countrywide National Health Insurance (NHI) system is now more critical than ever in improving healthcare outcomes of the South African population beyond the existence of the COVID-19 epidemic.

11.
Wellcome Open Research ; 5:1-24, 2021.
Article in English | Scopus | ID: covidwho-1485512

ABSTRACT

The systemic challenges of the COVID-19 pandemic require crossdisciplinary collaboration in a global and timely fashion. Such collaboration needs open research practices and the sharing of research outputs, such as data and code, thereby facilitating research and research reproducibility and timely collaboration beyond borders. The Research Data Alliance COVID-19 Working Group recently published a set of recommendations and guidelines on data sharing and related best practices for COVID-19 research. These guidelines include recommendations for clinicians, researchers, policy- and decision-makers, funders, publishers, public health experts, disaster preparedness and response experts, infrastructure providers from the perspective of different domains (Clinical Medicine, Omics, Epidemiology, Social Sciences, Community Participation, Indigenous Peoples, Research Software, Legal and Ethical Considerations), and other potential users. These guidelines include recommendations for researchers, policymakers, funders, publishers and infrastructure providers from the perspective of different domains (Clinical Medicine, Omics, Epidemiology, Social Sciences, Community Participation, Indigenous Peoples, Research Software, Legal and Ethical Considerations). Several overarching themes have emerged from this document such as the need to balance the creation of data adherent to FAIR principles (findable, accessible, interoperable and reusable), with the need for quick data release;the use of trustworthy research data repositories;the use of well-annotated data with meaningful metadata;and practices of documenting methods and software. The resulting document marks an unprecedented cross-disciplinary, crosssectoral, and cross-jurisdictional effort authored by over 160 experts from around the globe. This letter summarises key points of the Recommendations and Guidelines, highlights the relevant findings, shines a spotlight on the process, and suggests how these developments can be leveraged by the wider scientific community. © 2021. Austin CC et al.

12.
Samj South African Medical Journal ; 111(9):818-818, 2021.
Article in English | Web of Science | ID: covidwho-1405734
13.
S Afr Med J ; 111(9): 13348, 2021 07 14.
Article in English | MEDLINE | ID: covidwho-1404041

ABSTRACT

Letter by Omar on letter by Jassat et al. (Jassat W, Brey Z, Parker S, et al. A call to action: Temporal trends of COVID-19 deaths in the South African Muslim community. S Afr Med J 2021;111(8):692-694. https://doi.org/10.7196/SAMJ.2021.v111i8.15878); and response by Jassat et al.


Subject(s)
COVID-19 , Humans , Islam , SARS-CoV-2 , South Africa
15.
Social Sciences-Basel ; 10(2):18, 2021.
Article in English | Web of Science | ID: covidwho-1365703

ABSTRACT

As colleges and universities rapidly closed due to COVID-19, students and faculty were faced with unique challenges. The pandemic forced the cancellation of all campus activities, both extra-curricular and program-focused, such as student teaching experiences and nursing clinical rotations. Additionally, instructors were forced to rethink content delivery as coursework was quickly moved online and administered remotely via virtual platforms. Students were impacted as university level programs underwent a major paradigm shift within a matter of days or weeks. This study examined perspectives of undergraduate and graduate students regarding their experiences with rapid conversion from on-ground, in-person courses to remote instruction during the spring 2020 semester. The researchers employed a QUAN-QUAL descriptive mixed methods design. Using questionnaires and semi-structured interviews, the researchers examined general perspectives on in-person learning before the pandemic;initial perceptions about remote learning;and perceptions of the students about effort, engagement, needs, and ethical behavior as they engaged in totally remote learning. Results, analyzed using SPSS (QUAN) and inter-coder agreement (QUAL), indicated that initially students were engaged and satisfied with their in-person instruction, but became less satisfied and engaged during remote instruction. Undergraduate students experienced feelings of increased frustration, decreased accountability and engagement during remote learning, and turned to collaboration to earn points as they finished the semester.

16.
J Hosp Infect ; 116: 37-46, 2021 Oct.
Article in English | MEDLINE | ID: covidwho-1360078

ABSTRACT

BACKGROUND: The risk of transmission of SARS-CoV-2 from aerosols generated by medical procedures is a cause for concern. AIM: To evaluate the evidence for aerosol production and transmission of respiratory infection associated with procedures that involve airway suctioning or induce coughing/sneezing. METHODS: The review was informed by PRISMA guidelines. Searches were conducted in PubMed for studies published between January 1st, 2003 and October 6th, 2020. Included studies examined whether nasogastric tube insertion, lung function tests, nasendoscopy, dysphagia assessment, or suctioning for airway clearance result in aerosol generation or transmission of SARS-CoV-2, SARS-CoV, MERS, or influenza. Risk of bias assessment focused on robustness of measurement, control for confounding, and applicability to clinical practice. FINDINGS: Eighteen primary studies and two systematic reviews were included. Three epidemiological studies found no association between nasogastric tube insertion and acquisition of respiratory infections. One simulation study found low/very low production of aerosols associated with pulmonary lung function tests. Seven simulation studies of endoscopic sinus surgery suggested significant increases in aerosols but findings were inconsistent; two clinical studies found airborne particles associated with the use of microdebriders/drills. Some simulation studies did not use robust measures to detect particles and are difficult to equate to clinical conditions. CONCLUSION: There was an absence of evidence to suggest that the procedures included in the review were associated with an increased risk of transmission of respiratory infection. In order to better target precautions to mitigate risk, more research is required to determine the characteristics of medical procedures and patients that increase the risk of transmission of SARS-CoV-2.


Subject(s)
Aerosols , COVID-19 , Aerosols/adverse effects , Air Microbiology , COVID-19/transmission , Humans , Respiratory Physiological Phenomena , SARS-CoV-2
19.
Open Public Health Journal ; 14(1):45-55, 2021.
Article in English | EMBASE | ID: covidwho-1186667

ABSTRACT

Background: Background: SARS-CoV-2 has resulted in the COVID-19 pandemic. Based on a nationally representative online survey conducted several weeks on the pandemic, this paper explores how South Africans responded to the compliance regulations laid down by the national government and factors associated with individuals’ confidence in their community adhering to lockdown regulations. Methods: The study was conducted using a closed-ended questionnaire on a data-free online platform. Additionally, a telephonic survey was included to accommodate individuals who do not have access to smart-phones. The study population consisted of respondents who were 18 years and older and living in South Africa (n=19 933). Data were benchmarked to the 2019 midyear population estimates. Descriptive statistics and bivariate logistic regression are presented. Results: Over a quarter (26.1%) of respondents reported that they had not left home, indicating compliance with the COVID-19 control regulations, and 55.3% who did leave their homes did so to purchase essential items. A small proportion (1.2%) reported that they had visited friends. People, classified as coloured, those who were more literate (those with secondary, matric and tertiary education status), those residing in disadvantaged areas (informal settlements, townships, rural areas and farms), and those who perceived their risk of contracting COVID-19 as moderate and high, reported not being confident of their community adhering to lockdown. Conclusion: Communication strategies must be employed to ensure that important information regarding the pandemic be conveyed in the most important languages and be dispatched via various communication channels to reach as many people as possible.

20.
EBioMedicine ; 64: 103236, 2021 Feb.
Article in English | MEDLINE | ID: covidwho-1083288

ABSTRACT

BACKGROUND: Detection of SARS-CoV-2 infections is important for treatment, isolation of infected and exposed individuals, and contact tracing. RT-qPCR is the "gold-standard" method to sensitively detect SARS-CoV-2 RNA, but most laboratory-developed RT-qPCR assays involve complex steps. Here, we aimed to simplify RT-qPCR assays by streamlining reaction setup, eliminating RNA extraction, and proposing reduced-cost detection workflows that avoid the need for expensive qPCR instruments. METHOD: A low-cost RT-PCR based "kit" was developed for faster turnaround than the CDC developed protocol. We demonstrated three detection workflows: two that can be deployed in laboratories conducting assays of variable complexity, and one that could be simple enough for point-of-care. Analytical sensitivity was assessed using SARS-CoV-2 RNA spiked in simulated nasal matrix. Clinical performance was evaluated using contrived human nasal matrix (n = 41) and clinical nasal specimens collected from individuals with respiratory symptoms (n = 110). FINDING: The analytical sensitivity of the lyophilised RT-PCR was 10 copies/reaction using purified SARS-CoV-2 RNA, and 20 copies/reaction when using direct lysate in simulated nasal matrix. Evaluation of assay performance on contrived human matrix showed 96.7-100% specificity and 100% sensitivity at ≥20 RNA copies. A head-to-head comparison with the standard CDC protocol on clinical specimens showed 83.8-94.6% sensitivity and 96.8-100% specificity. We found 3.6% indeterminate samples (undetected human control), lower than 8.1% with the standard protocol. INTERPRETATION: This preliminary work should support laboratories or commercial entities to develop and expand access to Covid-19 testing. Software guidance development for this assay is ongoing to enable implementation in other settings. FUND: USA NIH R01AI140845 and Seattle Children's Research Institute.


Subject(s)
COVID-19 Nucleic Acid Testing , COVID-19 , RNA, Viral/genetics , Real-Time Polymerase Chain Reaction , Reverse Transcriptase Polymerase Chain Reaction , SARS-CoV-2/genetics , COVID-19/diagnosis , COVID-19/genetics , Humans , Sensitivity and Specificity
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