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Background In the setting of the global pandemic due to COVID-19, high-risk patients with mild to moderate disease were identified as a group who would benefit from COVID-19 monoclonal antibody (mAB) treatment to mitigate progression to severe disease or hospitalization. The U.S. Food and Drug Administration (FDA), under Emergency Use Authorizations (EUA) approved multiple COVID-19 mAB therapies with specific criteria for eligibility of candidates, documentation of discussion with patients, and reporting of all errors and serious adverse events. Methods A cross discipline working group implemented a mAB clinic at complexity level 1a VA Medical Center in metropolitan Washington, D.C. through collaboration of personnel committed to patient care. The team successfully persuaded hospital leadership to provide space and leveraged technologies for rapid communication and dissemination of education. A stewardship driven medical center wide surveillance system rapidly identified outpatients for screening; primary care and ED providers were engaged through various electronic methods of education, including email, web-based team communication, intranet webpages and other electronic modalities. Within the EMR, an order panel was implemented to assure that the key requirements of the EUA were met and the provider was guided to the appropriate mAB, nursing, and PRN rescue medication orders. Results Of over 17,000 COVID-PCR tests were performed at our medical center, 198 outpatients were screened and 16 received COVID-19 mAB infusions between January 2, 2021 to May 31, 2021. One patient experienced a reaction requiring the infusion to be stopped and supportive medications to be administered; there were no long-term sequalae reported as a result of this event. Conclusion A multidisciplinary collaboration is well suited to implement innovative processes and policies for novel therapies in the middle of a pandemic. An agile workflow, regular communications between members of the workgroup, and commitment of institutional leadership helped facilitate the changes necessary to provide our patients the opportunity to receive potentially life-saving therapies. Disclosures All Authors: No reported disclosures

Electrospray ionization mass spectrometry (ESI-MS) analysis of reverse transcription (RT)-PCR amplicons from human respiratory samples allows for broad pathogen identification approximately 8 h after collection. We investigated the performance characteristics of a high-throughput RT-PCR-coupled ESI-MS assay for distinguishing biothreat (BT) agents from common bacterial, fungal, and viral respiratory pathogens in bronchoalveolar lavage (BAL) fluid specimens from subjects with suspected respiratory infections. In a retrospective case series, 202 BAL fluid specimens were collected at the Johns Hopkins Hospital between August 2010 and February 2011 from patients with suspected acute respiratory infections. Samples were processed using standard bacterial, viral, and fungal testing in the clinical microbiology laboratory as part of routine care and then were blindly spiked with either water or nucleic acids from BT organisms ( Bacillus anthracis , Yersinia pestis , Francisella tularensis , Brucella spp., Burkholderia spp., and Rickettsia prowazekii ) and tested by RT-PCR–ESI-MS. The sensitivities and specificities of RT-PCR–ESI-MS versus standard clinical methods were as follows: for mock BT DNA, 98.5% sensitivity (95% confidence interval [CI], 94.2 to 99.7%) and 100% specificity (95% CI, 93.1 to 100.0%); for bacterial pathogens, 81.8% sensitivity (95% CI, 74.3 to 87.6%) and 73.6% specificity (95% CI, 64.2 to 81.4%); for viral pathogens, 93.3% sensitivity (95% CI, 66.0 to 99.7%) and 97.3% specificity (95% CI, 89.7 to 99.5%); for fungal pathogens, 42.6% sensitivity (95% CI, 29.5 to 56.7%) and 97.8% specificity (95% CI, 91.8 to 99.6%). Our data suggest that RT-PCR–ESI-MS is a useful adjunct to standard culture protocols for rapid detection of both BT and common respiratory pathogens; further study is required for assay validation, especially for fungal detection, and potential implementation.

Spontaneous bacterial peritonitis (SBP) can be a severe complication occurring in patients with cirrhosis and ascites, with associated mortality often as high as 40%. Traditional diagnostics for SBP rely on culture techniques for proper diagnosis, although recent reports suggest that the presence of bacterial DNA in peritoneal fluid in patients with cirrhosis and ascites is an indicator of SBP. A previously published broad-range PCR (16S PCR) coupled with high-resolution melt analysis (HRMA) was compared with standard culture techniques for diagnosis of SBP in 106 peritoneal fluid samples from patients with suspected SBP. The sensitivity and specificity for 16S PCR for detecting eubacterial DNA compared with those of standard culture techniques were 100% (17/17) and 91.5% (85/89), respectively. Overall, HRMA concordance with species identification was 70.6% (12/17), although the 5 samples that were discordant at the species level were SBP resulting from a polymicrobial infection, and species-level identification for polymicrobial infections is outside the capability of HRMA. Both the broad-range 16S PCR and HRMA analysis provide useful diagnostic adjunctive assays for clinicians in detecting and identifying pathogens responsible for SBP.

Current culture and phenotypic protocols for diagnosing Salmonella infections can be time-consuming. Here, we describe the application of a 16S rRNA PCR coupled to high-resolution melt analysis (HRMA) for species and serotype identification within 6 h of blood sample collection from a patient with Salmonella enterica serotype Enteritidis bacteremia.

Objective To identify and prioritize potential Emergency Department (ED) and hospital-based interventions which could mitigate the impact of crowding during patient surge from a widespread infectious respiratory disease outbreak and determine potential data sources that may be useful for triggering decisions to implement these high priority interventions. Design Expert panel utilizing Nominal Group Technique to identify and prioritize interventions, and in addition, determine appropriate "triggers" for implementation of the high priority interventions in the context of four different infectious respiratory disease scenarios that vary by patient volumes (high versus low) and illness severity (high versus low). Setting One day in-person conference held November, 2011. Participants Regional and national experts representing the fields of public health, disease surveillance, clinical medicine, ED operations, and hospital operations. Main outcome measure Prioritized list of potential interventions to reduce ED and hospital crowding, respectively. In addition, we created a prioritized list of potential data sources which could be useful to trigger interventions. Results High priority interventions to mitigate ED surge included standardizing admission and discharge criteria and instituting infection control measures. To mitigate hospital crowding, panelists prioritized mandatory vaccination and an algorithm for antiviral use. Data sources identified for triggering implementation of these interventions were most commonly ED and hospital utilization metrics. Conclusions We developed a prioritized list of potentially useful interventions to mitigate ED and hospital crowding in various outbreak scenarios. The data sources identified to "trigger" the implementation of these high priority interventions consist mainly of sources available at the local, institutional level.

A comparison study was performed between the PLEX-ID and the CDC RT-PCR method for the detection and identification of Influenza A viruses using nasopharyngeal samples (N = 75) collected between January and May 2011. Overall agreement was 89.3% (67/75 kappa = 0.57 95% CI 0.3–0.89). Positive percent agreement was 92.3% (60/65); negative percent agreement was 70% (7/10). H1N1 pdm09 identified: 42.6% (32/75) and 54.7% (41/75) by PLEX-ID and CDC RT-PCR, respectively. H3N2 identified: 29.3% (22/75) and 32% (24/75) of samples by PLEX-ID and CDC RT-PCR, respectively. Negatives identified: 16% (12/75) and 13.3% (10/75), by PLEX-ID and CDC RT-PCR respectively. For influenza viruses identified as H1N1 pdm09, Influenza A virus A/NEW YORK/15/2009(H1N1 pdm09) was the most prevalent genotype at 50% (16/32), followed by A/CALIFORNIA/05/2009(H1N1 pdm09) at 18.2% (6/32). Updated assay plates containing additional primers designed for H1N1 pdm09 HA and NA genes were utilized for this evaluation. Among H1N1 pdm09 samples, the HA gene was conserved in 96.9% (31/32) of samples. The NA gene was conserved in 96.9% (31/32).

Detection of pathogens in bloodstream infections is important for directing antimicrobial treatment, but current culture-based approaches can be problematic. Broad-range PCR assays which target conserved genomic motifs for postamplification amplicon analysis permit detection of sepsis-causing pathogens. Comparison of different broad-range assays is important for informing future implementation strategies. In this study, we compared positive-blood-culture bottles processed by PCR coupled to high-resolution melting curve analysis (PCR/HRMA) and PCR coupled to electrospray ionization-mass spectrometry (PCR/ESI-MS) to microbiology culture results. Genus-level concordance was 90% (confidence interval [CI], 80 to 96%) for PCR/HRMA and 94% (CI, 85 to 98%) for PCR/ESI-MS. Species-level concordance was 90% (CI, 80 to 96%) for PCR/HRMA and 86% (CI, 75 to 93%) for PCR/ESI-MS. Unlike PCR/HRMA, PCR/ESI-MS was able to resolve polymicrobial samples. Our results demonstrated that the two assays have similar overall concordance rates but may have different roles as potential adjunctive tests with standard blood culture, since each method has different capabilities, advantages, and disadvantages.

Background The emergence of the pandemic H1N1 influenza strain in 2009 reinforced the need for improved influenza surveillance efforts. A previously described influenza typing assay that utilizes RT-PCR coupled to electro-spray ionization mass spectrometry (ESI-MS) played an early role in the discovery of the pandemic H1N1 influenza strain, and has potential application for monitoring viral genetic diversity in ongoing influenza surveillance efforts. Objectives To determine the analytical sensitivity of RT-PCR/ESI-MS influenza typing assay for identifying the pandemic H1N1 strain and describe its ability to assess viral genetic diversity. Study design Two sets of pandemic H1N1 samples, 190 collected between April and June of 2009, and 69 collected between October 2009 and January 2010, were processed by the RT-PCR/ESI-MS influenza typing assay, and the spectral results were compared to reference laboratory results and historical sequencing data from the Nucleotide Database of the National Center for Biotechnology Information (NCBI). Results Strain typing concordance with reference standard testing was 100% in both sample sets, and the assay demonstrated a significant increase in influenza genetic diversity, from 10.5% non-wildtype genotypes in early samples to 69.9% in late samples (P