bluuebunny/crossref_metadata_2025_split huggingface dataset:
398. Risk Factors Associated with Requiring Invasive Mechanical Ventilation in Patients with SARS-CoV-2 Infection: Experience in a Tertiary Care Hospital in Mexico City
Authors: Garibay-Vega Brian Ricardo , Castañeda-Mendez Paulo F , Castillo-Álvarez José Luis , Barragán-Reyes Armando , Bay-Sansores Daniela , Pulido-Enríquez Jessica Isabel , Cabrera-Ruiz Maria Lorena , Aguilar-Zapata Daniel , Reyes-Mar Javier , Soto-Ramírez Luis Enrique 
Published: January 2021

Abstract

Background
The clinical presentation of SARS-CoV-2 disease ranges from asymptomatic respiratory infection to acute respiratory distress syndrome. Risk factors upon hospital admission associated with the need for invasive mechanical ventilation are not well documented.

Methods
185 hospitalized patients with confirmed COVID-19 were enrolled in this study, and they were classified as patients who required invasive mechanical ventilation and patients who did not require it. Comorbidities such as diabetes, high blood pressure, obesity, chronic lung disease and immunodeficiency were recorded. Laboratory studies were requested upon admission such as C-reactive protein, leukocyte and lymphocyte levels, D-dimer, troponin, serum ferritin and procalcitonin.

Results
Of the patients who entered the study, 65 patients (35%) required invasive mechanical ventilation (IMV), while 120 (65%) did not require advanced airway management. Of the patients with invasive mechanical ventilation, age &gt; 65 years, male sex, obesity (BMI &gt; 30) and high blood pressure were the most frequent characteristics, presenting the latter two in 26% and 27% respectively. Regarding laboratory studies, the parameters most associated with the requirement for mechanical ventilation were a D-dimer (&gt; 1000) and troponin (&gt; 1), with 26% and 18%, respectively.

Conclusion
This study showed the high proportion of obesity, hypertension and advanced age among patients who required invasive mechanical ventilation associated with SARS-CoV2 infection. The presence of elevated D-dimer and troponin on admission are associated with more severe presentations and a requirement for invasive mechanical ventilation.

Disclosures
All Authors: No reported disclosures
399. Risk Factors for Mortality in COVID-19 Patients in a Community Teaching Hospital
Authors: Andrade Justin A , Muzykovsky Karina , Truong James 
Published: January 2021

Abstract

Background
As of May 2020, there were over 190,000 confirmed COVID-19 cases in New York City (NYC) with approximately 13,000 deaths. Previously published literature identified risk factors (advanced age, higher severity of illness and elevated d-dimer) for mortality in a cohort of patients from Wuhan, China and mechanical ventilation in a case series from NYC. Another case series from NYC evaluated clinical outcomes only. There are limited published studies assessing clinical characteristics, outcomes and risk factors for mortality in COVID-19 patients in NYC. The objective of this study was to assess the risk factors for mortality in patients with confirmed COVID-19 infections.

Methods
This study was a single center retrospective case-control at The Brooklyn Hospital Center, a 464-bed community teaching hospital. Adult patients with confirmed COVID-19 infection, who received at least 24 hours of COVID-19 therapy were included. Endpoints assessed were risk factors for mortality in COVID-19 patients, increase in QTc, renal failure or renal replacement therapy, ventricular fibrillation or ventricular tachycardia. Baseline characteristics between survivor and non-survivors were analyzed utilizing Mann-Whitney U test/two-tailed t-tests for continuous data and Chi-square/Fisher’s exact test for categorical data. Univariable and multivariable logistic regression analyses were conducted to identify the risk factors for in-hospital mortality.

Results
Two-hundred and eighty six patients were included in this analysis, of whom 97 (33.9%) were non-survivors and 189 (66.1%) patients were survivors. Diabetes and coronary artery disease were more common in non-survivors compared to survivors (p = 0.003 and p &lt; 0.001, respectively). Multivariable logistic regression showed higher in-hospital mortality in patients with advanced age (odds ratio 5.779, 95 % confidence interval 1.369–24.407), vasopressor initiation (OR 28.301, 95 % CI 3.307–242.176), and development of renal failure (OR 30.927, 95 % CI 1.871–511.201).

Conclusion
Risk factors associated with mortality for COVID-19 patients in a community teaching hospital include advanced age, vasopressor therapy, and development of renal failure.

Disclosures
All Authors: No reported disclosures
402. Spontaneous pneumothorax in COVID-19
Authors: Tariq Zain , Doeing Diana , Nauriyal Varidhi , Chaudhry Zohra Sarfraz , Shallal Anita , Bhargava Pallavi , Chen Anne , Ramesh Mayur , Herc Erica 
Published: January 2021

Abstract

Background
Pneumothorax has been reported with the use of positive pressure ventilation in COVID-19 pneumonia. Literature on spontaneous pneumothorax (PTX) in COVID-19 patients is scant. We present a case series of 7 patients with COVID-19 pneumonia, who developed spontaneous pneumothorax without prior mechanical ventilation.

Methods
A retrospective chart review of 7 cases was performed from two different hospitals in the US between 4/6/2020–5/15/2020. Hospitalized patients with confirmed COVID-19 by nasopharyngeal RT-PCR who developed spontaneous pneumothorax were included. Collected data included demographics, co-morbidities, inflammatory biomarkers, chest imaging and management strategies. Length of stay, transfer to intensive care unit and death were the assessed outcomes. A descriptive analysis was done.

Results
There were 3 patients from Henry Ford Health System, Michigan and 4 patients from Silver Cross Hospital, Illinois. Median age was 75 years and 6 out of 7 (85.7%) were males (Table 1). There were no co-morbidities associated with spontaneous pneumothorax except for one patient with COPD. None of the patients’ imaging prior to diagnosis of pneumothorax revealed any underlying blebs. Median time from symptom onset to diagnosis of pneumothorax was 17 days. One of the patients had tension pneumothorax, two had bilateral pneumothorax and three had pneumomediastinum (Figure 1). Four patients required chest tube placement, three required escalation to ICU, of which two died.
Table 1. Demographics and Clinical Characteristics of Patients with Spontaneous Pneumothorax

Figure 1. CT imaging before (left) and after (right) Spontaneous Pneumothorax

Conclusion
Spontaneous pneumothorax may be an unrecognized late complication of COVID-19 pneumonia. In hospitalized patients with acute respiratory decompensation, spontaneous pneumothorax should be considered as part of the differential diagnosis. Repeat chest imaging should be considered in these cases.

Disclosures
All Authors: No reported disclosures
405. Trend in blood culture results in Washington DC during and prior to Pandemic COVID-19
Authors: Klein Adam , Liappis Angelike P 
Published: January 2021

Abstract

Background
The rate of bacterial and/or fungal infections among COVID-19 cases is reportedly low. Antimicrobial Stewardship Programs (ASPs) provide continuous surveillance of blood cultures to secure appropriate choice and duration of therapy. Comparing to historic data, we characterize our ASP experience in bacteremic surveillance during the COVID-19 pandemic.

Methods
Consecutive blood cultures at the Washington DC VA Medical Center were captured in an ASP-driven decision support software system (TheraDoc, Premier/DSS Inc) between Jan 1st 2018-May 31st 2020. In the setting of an established ASP, the organism positive cultures were reviewed over the first five months (Jan-May) of each of the three years collected. Results of cultures were characterized as either pathogenic gram positive (MSSA/MRSA/Enterococci/PSSP/PRSP/Strep sp.), pathogenic aerobic and anaerobic gram negative organisms and a skin contaminant-category (GPRs/skin flora/CNS).

Results
Over 3 yrs, 528 patients had 1464 positive cultures from among 8727 admissions, 83638 inpatient-days. The proportion of pathogenic GP bacteria and pathogenic GN bacteria were not statistically significantly different 38% (2018) vs 37% (2019) vs 39% (2020) and 33%, 31%, 27% respectively. There was slight trend in the increase of pathogenic GP 9.6 vs 9.5 vs 11.7 per 1,000 inpatient days and skin contaminant-category with 12.0 vs 11.0 vs. 14.1 per 1,000 patient days from 2019 to 2020. We noted a dramatic shift in culture surveillance report during the peak COVID-infection rates (March-April), notable for several weeks of few to no culture positive results. When broken down by month, variability was noted (data not shown). COVID-19 infected patients represented 9.0% (7/78) of positive blood culture results in 2020 Jan-May, only 5.1% (4/78) were treated as non-contaminants and were related to indwelling catheters or urosepsis.

Conclusion
Overall and adjusted rates of the blood cultures sent during the pandemic months in 2020 were comparable to the comparative years. Surveillance revealed short term changes in patterns which may have reflected the pandemic induced changes to admissions. COVID-19 infected patients rarely experienced line and hospital acquired bactermia/fungemia, most during the recovery period.

Disclosures
All Authors: No reported disclosures
406. Utility of Tracheal Aspirates in Guiding Antibiotic Use in Mechanically Ventilated Patients with COVID-19
Authors: Shihadeh Katherine C , Hussain Cory , Deida Axel Vazquez , Neumeier Anna , Jenkins Timothy C 
Published: January 2021

Abstract

Background
In critically ill patients with COVID-19 it is difficult to determine the presence of bacterial co-infection. Many patients receive antibiotics until a bacterial infection can be ruled out. To minimize aerosolization of SARS-CoV-2, non-invasive sampling, such as endotracheal aspiration (ETA), is preferred over invasive techniques. The purpose of this study is to determine the diagnostic yield of ETA and effect of ETA on antibiotic management in patients with COVID-19.

Methods
This retrospective analysis included patients admitted to the intensive care unit (ICU) from March 1 to May 31, 2020 who tested positive for SARS-CoV-2. Patients who did not receive mechanical ventilation were excluded. Data were extracted from electronic medical records. When ETA was performed, records were manually reviewed to determine diagnostic yield and effect on antibiotic management. Diagnostic yield was defined as ETA result with a plausible respiratory pathogen in a quantity of moderate or many. Plausible respiratory pathogens exclude normal flora, yeast, coagulase-negative Staphylococcus sp and Enterococcus sp. The primary outcome is the frequency of initiation, change, no change, or discontinuation of antibiotics based on ETA results.

Results
124 patients with COVID-19 were admitted to the ICU; 76 met inclusion criteria. The average age was 58 years and 75% were male. Hispanic or Latino ethnicity made up the majority of the patient population (63%). Antibiotics were administered to 97% of patients for a median of 11 days of therapy (IQR 7, 21). There were 100 ETAs performed on 55 patients for a diagnostic yield of 21%. ETA led to a change in antibiotic management 47% of the time it was performed. Antibiotic changes include de-escalation (29), discontinuation (7), escalation (6), and initiation (5).

Conclusion
The diagnostic yield of ETA in mechanically ventilated patients with COVID-19 was low. Furthermore, ETA results led to a change in antibiotics less than half of the time. The use of ETA to diagnose bacterial co-infection and guide antibiotic therapy in patients with COVID-19 should be weighed against the risk of using a more invasive sampling technique vs the benefit of potential for increased diagnostic yield. Another conclusion may be to forgo ETA if the result is unlikely to change management.

Disclosures
All Authors: No reported disclosures
408. Evaluation of the negative predictive value of the SARS-CoV-2 PCR respiratory assays in asymptomatic children undergoing surgery
Authors: Rao Suchitra , Ambroggio Lilliam , Asturias Edwin J , Bajaj Lalit , Corrado Michelle , Inge Thomas , Jung Sarah , Morrissey Tyler , Osborne Christina M , Searns Justin B , Whitney Gina , Dominguez Samuel 
Published: January 2021

Abstract

Background
Universal pre-operative screening with SARS-CoV-2 PCR has been adopted by institutions to mitigate risk to healthcare workers (HCW) during aerosol-generating procedures such as intubation. However, there remains uncertainty regarding rates of false negative results and optimal sampling type. The objective was to determine the reliability of single, pre-operative SARS-CoV-2 testing from the nasopharynx in children undergoing general anesthesia.

Methods
Children &lt; 18 years of age who underwent intubation for a procedure received pre-operative testing 24–48 hours prior with a nasopharyngeal (NP) swab or wash, in conjunction with intra-operative nasal wash (NW) and tracheal aspirate (TA) sampling. All paired samples underwent testing using the Simplexa DiaSorin platform or a modified Centers for Disease Control assay. Cohen’s Kappa was used for interrater reliability of each sample result. McNemar’s Test was used to compare result proportions by sample type. Positive and negative predictive values (PPV, NPV) were calculated based on the intraoperative NW as the reference standard. Analyses were conducted using SAS (v 9.4).

Results
We collected full sample sets from 364 children from April 14 to May 15; 66% of pre-operative samples were NP swabs. The median age was 6 years (IQR 2,13), 55% were male, 68% were white and 41% of children had a high-risk comorbidity. Most surgeries were conducted by general surgery (23%), followed by orthopedics (19%). Only 2.5% of children had respiratory symptoms, and 4.8% had a documented fever within a week of the procedure. SARS-CoV-2 positive samples occurred in 4/364 (1%) of pre-operative samples, 8/363 (2.2%) of intra-operative samples, and 8/348 (2.3%) of TA samples. The pre-operative test had 100% PPV and 99% NPV, and the TA had 100% PPV and 98.6% NPV (Table 1). There was very good agreement (Figure) between pre- and intraoperative upper respiratory sampling, with a Kappa of 0.66, (95% CI 0.35–0.97). There was no statistical difference in results by sample type.
Table 1. Comparison of intra-operative and pre-operative nasopharyngeal sample results, test characteristics and test concordance

Table 2. Comparison of intra-operative nasopharyngeal and tracheal aspirate sample results, test characteristics and test concordance

Figure 1 Percent agreement between pre-operative and intra-operative samples

Conclusion
There is a high PPV and NPV of pre-operative SARS-CoV-2 PCR testing among children undergoing anesthesia. These data can help inform guidelines regarding appropriate precautions for HCW performing high risk procedures in asymptomatic pediatric patients.

Disclosures
Suchitra Rao, MD, BioFire (Grant/Research Support) Samuel Dominguez, MD, PhD, BioFire (Consultant, Research Grant or Support)
411. Application of a SARS-CoV-2-specific serologic assay for translational research and surveillance
Authors: Sherman Amy C , Smith Teresa C , Espinoza Daniel , Zhu Yerun , Howard-Anderson Jessica , Taibl Kaitlin R , Fairley Jessica K , Wu Henry M , Edupuganti Sri , Rouphael Nadine , Rouphael Nadine , Rodriguez-Morales Alfonso J , Ospina Jaime Cardona , Arias Juan Carlos Sepúlveda , Fridkin Scott , Collins Matthew H 
Published: January 2021

Abstract

Background
Sensitive and specific SARS-CoV-2 antibody diagnostics are urgently needed to estimate the seroprevalence of SARS-CoV-2 infection in both the general population and special risk groups. Moreover, validated serologic assays are critical to understanding immunity to SARS-CoV-2 infection over time and identifying correlates of protection.

Methods
An enzyme-linked immunosorbent assay (ELISA) protocol to detect antibodies (IgG) that bind the receptor-binding domain (RBD) of the SARS-CoV-2 spike protein was validated and ROC curve analysis performed by testing a large panel of pre-pandemic sera (n=162) and convalescent sera from RT-PCR-confirmed COVID-19 cases (n=60). We then applied this test in two cohorts: 1) Healthcare personnel (HCP) that were enrolled in a longitudinal surveillance cohort just after peak local transmission and 2) Mildly ill patients being tested for SARS-CoV-2 infection by RT-PCR from NP swabs in an ambulatory testing clinic.
Demographics of mildly symptomatic patients tested for SARS-CoV-2 with RT-PCR

Results
ROC curve analysis yielded an AUC of 0.9953, with a sensitivity and specificity at 91.67% and 99.38% at the optimal OD normalization threshold of 0.20. In 240 HCP surveilled at enrollment, 5.83% had positive IgG results. Of 19 symptomatic patients who presented to the ambulatory clinic, 5/19 had a positive PCR. In convalescence (13–74 days post symptom onset), 3 of those 5 were positive for IgG.
Validation of the SARS-CoV-2 RBD ELISA

ROC Curve Analysis

Conclusion
We demonstrated high sensitivity and specificity of the SARS-CoV-2 RBD ELISA. This simple assay is an efficient way to track seroconversion and duration of antibody responses to SARS-CoV-2 for different populations, particularly since RBD-binding antibodies have been shown to correlate with neutralization activity and may be useful to determine protective immunity following natural infection or vaccination. Ongoing work will assess variation in magnitude, character and duration of antibody responses in key populations and seek to maximize deployability of large-scale SARS-CoV-2 serology.

Disclosures
Jessica Howard-Anderson, MD, MSc, Antibacterial Resistance Leadership Group (ARLG) (Other Financial or Material Support, The ARLG fellowship provides salary support for ID fellowship and mentored research training) Nadine Rouphael, MD, Lilly (Grant/Research Support)Merck (Grant/Research Support)Pfizer (Grant/Research Support)Quidel (Grant/Research Support)Sanofi Pasteur (Grant/Research Support)
415. Clinical Impact of Molecular Point-of-Care Testing for COVID-19 in Adults Presenting to Hospital: A Prospective, Interventional, Non-Randomised, Controlled Study
Authors: Brendish Nathan J , Poole Stephen , Naidu Vasanth V , Mansbridge Christopher , Norton Nicholas , Wheeler Helen , Presland Laura , Ewings Sean , Kidd Stephen P , Cortes Nick , Clark Tristan William 
Published: January 2021

Abstract

Background
The management of the COVID-19 pandemic is hampered by the long delays associated with laboratory PCR testing. In hospitals this leads to poor patient flow and nosocomial transmission and so rapid, accurate diagnostic tests are urgently required. The aim of this study was to evaluate the clinical impact and real-world diagnostic accuracy of molecular point-of-care testing (mPOCT) for COVID-19 in hospital.

Methods
We performed a prospective, interventional, non-randomised, controlled study of mPOCT for COVID-19 in adults presenting to hospital with suspected COVID-19. Patients were tested using the QIAstat-Dx SARS-CoV-2 at the point-of-care with results delivered to clinical and infection control teams. Control patients were tested using the PHE Rdrp reference assay. The Primary outcome measure was time to result and secondary outcome measures included infection control outcomes and measures of diagnostic accuracy.

Results
Between 20th March and 29th April 2020 500 patients were tested by POCT and 555 controls, who were tested with laboratory PCR, were identified. Overall 33% were positive for SARS-CoV-2. Median time to results with POCT was 1.7 (1.6 to 1.9) hours versus 21.3 (16.0 to 27.9) hours in the control group (difference of 19.6 hours, 95%CI 19.0 to 20.3; p&lt; 0.0001). Median time to arrival in definitive clinical area (COVID-19 positive or negative ward) was 8.0 (6.0 to 15.0) hours in the POCT group versus 28.8 (23.5 to 38.9) hours in the control group, p&lt; 0.0001. Median time to enrolment into other COVID-19 clinical trials was 1.5 (1 to 3) days in the POCT versus 3.0 (2 to 5) days in the control group, p&lt; 0.0001. Sensitivity of the POCT was 99.4% and specificity was 98.3%. The sensitivity of the laboratory PHE reference RdRp assay was 87.2% and specificity was 98.9%.

Conclusion
mPOCT was associated with a large reduction in time to results and improvements in infection control measures and patient flow, compared with laboratory PCR. In addition, patients were recruited onto other clinical trials more rapidly with POCT. The QIAstat-Dx SARS-CoV-2 panel had high diagnostic accuracy for the detection of COVID-19 compared to laboratory PCR. Resources should be urgently made available to support the widespread implementation of mPOCT in hospitals, in preparation for the second wave.

Disclosures
Tristan William. Clark, BM MRCP DTM&H MD, BioFire Diagnostics (Other Financial or Material Support, Equiptment and consumables for the purposes of research)BioMerieux (Other Financial or Material Support, Equipment and consumables for the purposes of research)Qiagen (Other Financial or Material Support, Discounted Equipment and consumables for the purposes of research)
416. Comparative Analytical Assessment of PCR Mastermixes for Detection of SARS-CoV-2 using the CDC Diagnostic Test and the LightMix Modular Test on the cobas® z 480 Analyzer
Authors: Cagas Steven , McCune Stephen , Rodriguez Pedro , Hein Ray , Osiecki John , Robinson Nicole , McGowin Chris L 
Published: January 2021

Abstract

Background
The novel severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) is a betacoronavirus responsible for the ongoing global pandemic and associated respiratory disease. Rapid development and implementation of molecular diagnostic testing solutions has been imperative to meet the enormous and urgent public health needs, and remains a key component of the US emergency response. Nucleic acid amplification tests (NAATs), with emergency use authorization (EUA) by the FDA, have been subject to significant supply chain shortages. This study aims to comparatively assess several commercially available substitutive mastermix reagents for the CDC SARS-CoV-2 EUA test and the TIB Mol Biol LightMix Modular (RUO) test.

Methods
Positive control material included with each testing kit was used directly as DNA template for all manually assembled reactions and comparative evaluation. Additionally, these tests were evaluated similarly using the cobas omni Optimization kit, the first step in assessing suitability on the cobas® omni Utility Channel for high-volume user-defined molecular testing on the fully automated cobas® 6800/8800 Systems. All PCR was performed per the manufacturer’s instructions using the User Defined Workflow (UDF; open channel) on the cobas® z 480 analyzer.

Results
Robust amplification of the commercial control material was observed with each mastermix for all gene targets within the CDC and LightMix tests. Modest but significant (ANOVA, p&lt; 0.05) target-specific Ct-value impacts were observed among the mastermixes assessed in this study. Using the cobas® omni optimization kit, Ct values for each target within the CDC and LightMix tests were consistently and significantly lower (ANOVA, p&lt; 0.05) than the comparator mastermixes.

Conclusion
Each mastermix may be a useful alternative to the recommended mastermix for SARS-CoV-2 detection. Additionally, these findings suggest the CDC and LightMix tests may be adapted for fully-automated, high-throughput testing on the 6800/8800 Systems.

Disclosures
Steven Cagas, PhD, Roche Diagnostics Corp (Employee) Stephen McCune, BS, Roche Diagnostics Corp (Employee) Pedro Rodriguez, Ph.D, Roche Diagnostics Corp (Employee) Ray Hein, PhD, Roche Diagnostics Corp (Employee) John Osiecki, PhD, Roche Diagnostics Corp (Employee) Nicole Robinson, Ph.D, Roche Diagnostics Corp (Employee) Chris L. McGowin, PhD, Roche Diagnostics Corp (Employee)