bluuebunny/crossref_metadata_2025_split huggingface dataset:
458. Molecular SARS-CoV-2 Testing During the COVID-19 Outbreak: Experiences of a Hospital in Southeast Michigan, USA
Authors: Mathew Trini A , Hopkins Jonathan , Kamerer Diane , Ali Shagufta N , Ortiz Daniel , Johnson Paul , Chittick Paul , Carpenter Christopher F 
Published: January 2021

Abstract

Background
The novel Coronavirus SARS CoV-2 (COVID-19) outbreak was complicated by the lack of diagnostic testing kits. In early March 2020, leadership at Beaumont Hospital, Royal Oak Michigan (Beaumont) identified the need to develop high capacity testing modalities with appropriate sensitivity and specificity and rapid turnaround time. We describe the molecular diagnostic testing experience since initial rollout on March 16, 2020 at Beaumont, and results of repeat testing during the peak of the COVID-19 pandemic in MI.

Methods
Beaumont is an 1100 bed hospital in Southeast MI. In March, testing was initially performed with the EUA Luminex NxTAG CoV Extended Panel until March 28, 2020 when testing was converted to the EUA Cepheid Xpert Xpress SARS-CoV-2 for quicker turnaround times. Each assay was validated with a combination of patient samples and contrived specimens.

Results
During the initial week of testing there was &gt; 20 % specimen positivity. As the prevalence grew the positivity rate reached 68% by the end of March (Figure 1). Many state and hospital initiatives were implemented during the outbreak, including social distancing and screening of asymptomatic patients to increase case-finding and prevent transmission. We also adopted a process for clinical review of symptomatic patients who initially tested negative for SARS-CoV-2 by a group of infectious disease physicians (Figure 2). This process was expanded to include other trained clinicians who were redeployed from other departments in the hospital. Repeat testing was performed to allow consideration of discontinuation of isolation precautions. During the surge of community cases from March 16 to April 30, 2020, we identified patients with negative PCR tests who subsequently had repeat testing based on clinical evaluation, with 7.1% (39/551) returning positive for SARS- CoV2. Of the patients who expired due to COVID-19 during this period, 4.3% (9/206) initially tested negative before ultimately testing positive.
Figure 1 BH RO testing Epicurve

Figure 2: Screening tool for repeat COVID19 testing and precautions

Conclusion
Many state and hospital initiatives helped us flatten the curve for COVID-19. Our hospital testing experience indicate that repeat testing may be warranted for those patients with clinical features suggestive of COVID-19. We will further analyze these cases and clinical features that prompted repeat testing.

Disclosures
All Authors: No reported disclosures
462. Prevalence and Outcome of Asymptomatic Procedural Patients with COVID-19 Infection
Authors: Maki Gina , Abdollah Firas , Dabaja Ali , Suleyman Geehan 
Published: January 2021

Abstract

Background
Guidelines recommend testing for SARS-COV-2 in asymptomatic individuals who are undergoing time-sensitive major surgery or aerosol generating procedures (AGPs) to guide infection prevention practices, including PPE use, and minimize risk of potential poor outcomes associated with COVID-19 infection by delaying the procedure in positive patients. However, evidence to support these recommendations are limited. We describe the outcome of asymptomatic patients with SARS-COV-2 undergoing surgery or AGPs.

Methods
We implemented a system-wide policy to test all patients requiring intubation or other AGPs at Henry Ford Health System (HFHS), a 5-hospital system in southeast Michigan. This was a retrospective review of asymptomatic surgical patients with COVID-19 infection between 5/1/2020–5/31/2020. All patients with positive polymerase chain reaction (PCR) of upper respiratory tract were included. Demographics, comorbidities, procedural/surgical categories, symptoms and outcomes were evaluated.

Results
4381 COVID-19 PCR tests were performed pre-procedurally during the study period, of which 18 (0.4%) were positive. Summary of characteristics is presented in Table 1. Mean age was 49.7 years, and the majority were female (61%) and black (67%). Six (33%) of 18 surgeries were performed despite positive COVID-19 PCR as shown in Table 2. Of those who had the procedure performed, none developed symptoms within 14 days. Two (11%) patients developed symptoms within 14 days of positive PCR after their procedures were canceled. None of those who had their procedure delayed developed any symptoms. Of the total patients, none required hospitalization or died.
Table 1. Characteristics of asymptomatic patients with COVID-19 infection

Table 2. Outcome of procedure in asymptomatic patients with COVID-19

Conclusion
The prevalence of COVID-19 infection was very low in our asymptomatic patient population. Decisions around SARS-CoV-2 testing in asymptomatic patients undergoing procedures should be based on exposure history and prevalence of disease in the community to avoid unnecessary testing and diversion of resources away from symptomatic patients.

Disclosures
All Authors: No reported disclosures
463. Random Sampling of Asymptomatic Hospital Employees: A Period Prevalence Study
Authors: Huang Felicia Scaggs , Schaffzin Joshua K , Simmons Jeff , Goebel Mary Jo , Thrasher Terri , Wong Hector , Macaluso Maurizio 
Published: January 2021

Abstract

Background
Novel coronavirus disease 2019 (COVID-19) has had a significant impact on the work force in hospital settings. Despite rigorous screening practices implemented at many institutions, reports have documented transmission from asymptomatic and presymptomatic individuals in community environments. Evidence of nosocomial transmission between healthcare workers and patients in the early phase of the pandemic has further compounded the fears of safety in the workplace. We sought to determine the asymptomatic carriage rate of employees to inform messaging and response in the context of universal masking and eye protection.

Methods
We conducted a period prevalence study in asymptomatic hospital employees at a quaternary pediatric hospital during April to June 2020. Eligible employees included clinical staff, administrative staff, food services workers, and environmental services workers who had passed the temperature and symptom screening evaluation on entry to the campus. Samples were obtained from both nares of consenting individuals and ran daily on a validated polymerase chain reaction (PCR) platform.

Results
A total of 1394 employees consented to participate by June 15, 2020 and none of them had a positive result for COVID-19. Thus, the prevalence rate among asymptomatic employees was zero during this period (95%CI 0%-0.26%). Thirteen employees developed symptoms after initial enrollment and testing of which 1 tested positive for COVID-19. Based on these data, we estimate a monthly incidence rate of 0.8 new COVID-19 cases per 1000 asymptomatic employees (95%CI 0.2 - 4.4 per 1000). Of note, at the time of submission the R0 for our region was 1.4, and the prevalence of COVID-19 infection among symptomatic employees was 9.9% (68/686 tested in our system, 95%CI: 7.8%-12.3%).

Conclusion
We did not identify any COVID-19-positive asymptomatic hospital employees who passed screening measures. This suggests very low risk of nosocomial transmission to other employees, patients, and families. Along with low community prevalence and capture of COVID-19-positive symptomatic employees, we could confidently advise staff that universal surgical masking and eye protection were likely adequate to prevent significant exposure.

Disclosures
All Authors: No reported disclosures
466. SARS-CoV-2 Diagnosis And Point Prevalence in a Non-Cohorted Tertiary Care Center
Authors: Schrank Spencer , McAleese Katherine , Spence Amanda B , Natarajan Madhuri , Timpone Joseph , Chang Joseph , Balba Gayle p , Kumar Princy 
Published: January 2021

Abstract

Background
The CDC recommends testing for SARS-CoV-2 in patients who present with symptoms consistent with COVID-19 and to cohort hospitalized patients diagnosed with COVID-19. Up to 35% of persons infected with SARS-CoV-2 are asymptomatic; however, no recommendations exist for universal testing in hospitalized patients. We assessed the point prevalence of SARS-CoV-2 infection amongst hospitalized patients at a tertiary care center during a time when there was a regional surge of cases.

Methods
Nasopharyngeal SARS-CoV-2 PCR testing was performed on inpatients at Georgetown University Hospital on 4/27/20, excluding those who were SARS-CoV-2 positive, tested within 72 hours or admitted to pediatric, psychiatric, labor & delivery or ICUs. Patients within the hospital were not cohorted based on COVID-19 status. Patient demographics and comorbidities were obtained from the EMR and analyzed for significance based on SARS-CoV-2 status.

Results
Hospital census on the testing date was 297; 204/297(68.7%) met inclusion criteria; 78/297(26.3%) were known COVID-19 patients. Within the study group 78/204 (38.2%) had known COVID-19, 21/204 (10.3%) were PUIs (4 of whom tested positive), 31/204 (15.1%) tested negative for COVID-19 within 72 hours and 74/204 (36.3%) met criteria for testing. The median age was 62 years (IQR, 53 to 70), 59%(n=122) were male, 56%(n= 115) were Black, and 90%(n=185) had at least one co-morbidity. 0/74 of those tested on 4/27/20 were positive for SARS-CoV-2, and none were diagnosed with COVID-19 within 28 days. In adjusted analyses, patients who were hospitalized for COVID-19 were more likely to be Black(OR=10.53 95% CI 3.02, 36.68, p=0.0002); male(OR=3.27 95% CI 1.26, 8.47, p=0.0143); reside in group/nursing homes(OR= 11.78 95%CI 3.03, 45.76, p=0.0004); have a history of prior stroke(OR= 6.25 95%CI 1.49, 26.12, p=0.012); but less likely to smoke(OR=0.10 95%CI 0.02, 0.48, p=0.0039), or have active malignancy (OR= 0.11 95%CI 0.01, 0.73, p=0.0223).

Conclusion
The use of CDC testing criteria for PUIs were successful in identifying COVID-19 patients and limiting the need for routine testing in all hospitalized patients during a time when access to testing was limited. Nosocomial transmission did not occur in our institution despite a lack of cohorting.

Disclosures
Princy Kumar, MD, Gilead Sciences Inc. (Scientific Research Study Investigator)
468. Specimen pooling conserves additional testing resources when patients’ infection status is correlated: A simulation study
Authors: Rewley Jeffrey 
Published: January 2021

Abstract

Background
In the early stages of a novel pandemic, testing is simultaneously in high need but low supply, making efficient use of tests of paramount importance. One approach to improve the efficiency of tests is to mix samples from multiple individuals, only testing individuals when the pooled sample returns a positive.

Methods
I build on current models which assume patients’ sero-status is independent by allowing for correlation betweenconsecutive tests (e.g. if a family were all infected and were all tested together). In this model, I simulate 10,000 patients being tested in sequence, with population sero-prevalence ranging from 1% to 25%, using batch sizes from 3 to 10, and assuming the increased probability of consecutive infections ranged from 0% to 50%.

Results
I find that as the likelihood of consecutive infected patients increases, the efficiency of specimen pooling increases. As well, the optimal size of the batch increases in the presence of clustered sequences of infected patients.
Heat map indicating the manner in which the number of tests needed is reduced as population prevalence and correlation between cases changes. Red indicates that there is no reduction in the number of tests, and blue indicates a near 100% reduction in the number of tests, with intermediate colors indicating intermediate fractions.

Conclusion
This analysis indicates further improvements in specimen pooling efficiency can begained by taking advantage of the pattern of patient testing.

Disclosures
Jeffrey Rewley, PhD, MS, American Board of Internal Medicine (Employee)
469. Temporal, Spatial, and Demographic Relationships of SARS-COV-2 Gene Target Cycle Thresholds
Authors: Reno Lisa , Newhart Donna , Clifford Robert , Bress Jonathan , Yu Stephanie , Hanna John J , Walsh Edward E , Lesho Emil P 
Published: January 2021

Abstract

Background
The optimum duration of isolation precautions (IP) for SARS-COV-2-infected individuals is uncertain. Most healthcare facilities must rely on surrogates of infectivity such as illness duration or nucleic acid amplification (NA). The availability of NA remains limited in many locations, requiring laboratories to alternate platforms to provide uninterrupted support. Regulatory-driven repeat testing further stresses scarce resources. A target gene cycle threshold (Ct) of 24 has been shown to correlate with culture negativity. We sought to evaluate temporal, spatial, and demographic relationships of SARS-COV-2 Ct that could inform local infection control efforts and testing policy.

Methods
From 03-14-20 to 06-01-20, nasopharyngeal swabs from inpatients were prospectively tested weekly on an emergency-use authorized laboratory developed assay, or 1 of 3 commercial platforms targeting the RNA-dependent RNA polymerase, N, ORF1ab, S, and/or PanSARS-E genes. A regional COVID-19 registry was also queried.

Results
70 inpatients were prospectively evaluated (Table). Mean time to negative was 28.5 days from symptom onset (SO) and 24.1 days from initial test. Initial Ct values were significantly lower compared to those on week 3 (Figure 1). 3.3%, 8.9%, 31.3% and 50.0% tested negative at weeks 1,2,3, and 4 respectively. Trajectories did not differ by race, gender or comorbidity. 13% had isolation precautions (IP) discontinued during admission (mean time to discontinuation 15.8 days; range 12–40). None were linked to new transmissions. 20% reverted to positive after being negative. 0% of a growing number of patients across our health system (27 at time of submission), who have had IP discontinued, were linked to new infections. Data from 180 consecutive patients were available for retrospective evaluation. Mean Ct did not differ between treated-and-released (23.0) and admitted patients (22.6), nor between ward (23.1) and intensive care unit patients (20.2) (all p &gt; 0.4).
Table

Figure 1

Conclusion
Linear regression revealed that a Ct of 24 and negative Ct value will occur 8.8 and 36 days after SO (Figure 2). These findings are consistent with smaller cohorts, and they add to the growing body of evidence that test-driven approaches for maintenance of IP or patient disposition should be reconsidered.
Figure 2

Disclosures
All Authors: No reported disclosures
476. Gilead Sciences’ Commitment to the COVID-19 Pandemic
Authors: Lee EunYoung , Osinusi Anu , Chokkalingam Anand , Brainard Diana M , Tran Tram , Dau Lauren , Ferrinho Diogo , Wang ChenYu , Juneja Kavita 
Published: January 2021

Abstract

Background
COVID-19 has spread rapidly: from the first case in Dec 2019, the declaration of a global pandemic in Mar 2020, to Jun 18, 2020 with &gt;8 M confirmed cases and &gt;400,000 deaths worldwide. Throughout this rapid spread, Gilead has focused on contributing antiviral expertise and resources to help patients (pts) and communities fighting COVID-19

Methods
Gilead is supporting the efforts of governments, partnering with professionals, and community-based org., and collaborating with healthcare providers to accelerate research and access to remdesivir (RDV), the first medicine with demonstrated efficacy in treatment of COVID-19. This is a review of the programs initiated in RDV research, access, research grants and collaborative education

Results
In Jan 2020 Gilead began working with government and regulatory authorities to make RDV accessible to pts globally through the compassionate use and expanded access programs. These programs has treated &gt;2000 COVID-19 pts. By Feb 2020, several phase 3 randomized trials on RDV were initiated. Based on trials completed and published data (n= &gt;2000), RDV was granted emergency use authorization in the US on May 1, 2020 with full approval in 5 countries thereafter and several under review elsewhere. Collectively there will be &gt;12,000 pts enrolled in RDV clinical programs by Dec 2020.
Increasing manufacturing of RDV began at-risk in Jan 2020. By May 2020 Gilead has decreased production time, increased supply and committed to donating all its 1.5 M doses. Under the licensing agreements with generic drug manufacturers, RDV will be available in 127 countries upon approval.
Gilead has committed to supporting research grants to enhance the understanding of the clinical course and outcomes in vulnerable population, long-term sequelae, and evaluate real world safety and effectiveness of COVID-19 therapies.
Finally, Gilead has provided corporate grants to support the efforts of community-based orgs and public health entities to expand education on COVID-19

Conclusion
Gilead has initiated a global, multifaceted rapid response that reflects the unprecedented emergency posed by SARS-COV-2. This includes increasing RDV production, access, timely initiation of phase 3 RDV trials, and establishment of grants programs for community projects, research and education

Disclosures
EunYoung Lee, PharmD, Gilead Sciences (Employee) Anu Osinusi, MD, Gilead Sciences (Employee) Anand Chokkalingam, PhD, Gilead Sciences (Employee) Diana M. Brainard, MD, Gilead Sciences (Employee) Tram Tran, MD, Gilead Sciences (Employee) Lauren Dau, PharmD, Gilead Sciences (Employee) Diogo Ferrinho, PharmD, Gilead Sciences (Employee) ChenYu Wang, PhD, Gilead Sciences (Employee) Kavita Juneja, MD, Gilead Sciences (Employee)Gilead Sciences (Employee)
477. Implementing a Follow-up Call Program for Ambulatory patients with COVID-19 in a Tertiary Center in Mexico City
Authors: Pinto Yamile G Serrano , Crabtree-Ramírez Brenda , Ortiz Cristian E Espejo , Hernández-Alemon Aldo , Iruegas-Núñez David A , Hernández-Martínez Ingrid V , Gómez-Islas Valeria E , Oropeza-Viveros Dulce M , Castro Gómez Sandra Erika , Esquinca-González Alexia , García-Fong Kevin R , Gómez-Vázquez Eduardo , Arias-Delgado Karen A , Guerrero-Torres Lorena , Lopez Iñiguez Alvaro 
Published: January 2021

Abstract

Background
The Instituto Nacional de Ciencias Médicas y Nutrición Salvador Zubirán is a teaching hospital which was converted into a Coronavirus disease 2019 (COVID-19) designated hospital on mid-March 2020. In Mexico City, the COVID-19 peak started in mid-April 2020. A considerable proportion of those diagnosed with SARS-CoV-2 infection were treated by ambulatory care. We aimed to describe the clinical characteristics at diagnosis of ambulatory patients diagnosed with COVID-19, their willingness to donate plasma and their clinical outcomes at one month of the follow-up call program implementation.

Methods
A call strategy follow-up program (FUP) was established on April 19, 2020. All ambulatory patients received at least 3 calls every 48–72 hours, followed by 2 weekly calls. A team of voluntary medical students, general practitioners, fellows, and medical specialists was assembled for this purpose. Signs of alarm (fever &gt;72 hours, shortness of breath, respiratory insufficiency) and other clinical signs were collected on every call. Willingness to donate plasma and possibility of a correct home isolation were also addressed.

Results
From April 19 to May 18, 2020, a total of 360 patients tested positive for SARS-CoV2, of whom 350 were followed. Their median age was 44 years (33–51), and 55% were female. 145 (41%) had completed all FUP calls and 194 (55%) referred to be asymptomatic in their last call. We identified 8 patients with signs of alarm during the calls, and 2 of them required hospitalization. During the FUP, 66% referred fatigue that limited their activities, 56% anosmia or dysgeusia, 32% headache, and 22% diarrhea. 90% were capable to properly isolate in their homes. Willingness to donate plasma was assessed in 89 patients, of whom, 75 (84%) manifested their willingness to donate.

Conclusion
Ambulatory follow-up is feasible and effective to identify those in need of hospitalization. Remarkably, half of the ambulatory patients had no comorbidities and presented anosmia/dysgeusia as the most frequent symptoms during follow-up. Willingness to donate plasma was high in this cohort.

Disclosures
All Authors: No reported disclosures
481. Epidemic – Pandemic Impacts Inventory (EPII) Survey Results for Persons Living with HIV in Chicago’s West and Southwest Communities
Authors: Hunt Bijou R , Anderson Rachel , Sinha Paarul , Cetrone Hollyn , Glick Nancy 
Published: January 2021

Abstract

Background
The rapid spread of COVID-19 in recent months has caused local and regional governments to enact protective measures that have hindered economies and imposed demanding restrictions on daily life. Households may be experiencing physical, psychological, social, and economic challenges due to these preventative measures. Populations with fewer resources and/or pre-existing conditions may be at higher risk for these negative, life-altering effects. Therefore, we investigated COVID-19 impact on daily life among persons living with HIV (PLH) in Chicago’s under-resourced, largely minority, west and southwest side communities.

Methods
We modified the EPII, a survey designed to measure pandemic disease impact over nine domains of life, to assess how COVID-19 affected PLH receiving outpatient HIV care. From 5/11–29/2020, participants (n=49) completed the survey online or over the phone and received a $10 grocery gift card. We present the proportion of respondents who reported that they or any household member was impacted by select survey items.

Results
More than half of respondents reported a household member getting laid off and/or furloughed (63%), increased mental health (45%) or sleep problems (51%), less physical activity (61%), and increased screen time (82%); 45% were unable to pay important bills. Positive changes included eating healthier foods (53%), more time for enjoyable activities (63%), more quality time with friends or family (65%), and paying more attention to personal health (76%). We observed differences by gender, age, and race/ethnicity over all domains (Table 1). Finally, 80% of those who participated in telehealth services were satisfied with their experience.
Table 1.

Conclusion
Overall, respondents struggled with employment, emotional and physical health effects of COVID-19, yet also experienced aspects of positive life change. In the future, these results should be compared with results from a general population to determine whether PLH are disproportionately burdened. Regardless, COVID-19 has negatively impacted daily life for everyone, including PLH, and these individuals may need additional resources compared to their less resource-challenged counterparts.

Disclosures
All Authors: No reported disclosures