ABSTRACT
Background: SARS-CoV-2 antigen-based tests are well-calibrated to infectiousness and have a critical role to play in the COVID-19 public health response. We report the development and performance of a unique lateral flow immunoassay (LFA). Methods: Combinations of several monoclonal antibodies targeting multiple antigenic sites on the SARS-CoV-2 nucleocapsid protein (NP) were isolated, evaluated, and chosen for the development of a LFA termed CoV-SCAN (BioMedomics, Inc.). Clinical point-of-care studies in symptomatic and asymptomatic individuals were conducted to evaluate positive predictive agreement (PPA) and negative predictive agreement (NPA) with RT-PCR as comparator. Results: In laboratory testing, CoV-SCAN detected 14 recombinant N-proteins of SARS-CoV-2 variants with sensitivity in the range of 0.2-3.2 ng/mL, and 10 authentic SARS-CoV-2 variants with sensitivity in the range of 1.6-12.5 TCID50/swab. No cross reactivity was observed with other human coronaviruses or other respiratory pathogens. In clinical point-of-care testing on 148 individuals over age 2 with symptoms of ≤5 days, PPA was 87.2% (CI 95: 78.3-94.8%) and NPA was 100% (CI 95: 94.2-100%). In another 884 asymptomatic individuals, PPA was 85.7% (CI 95: 42.1-99.6%) and 99.7% (99.0-99.9%). Overall, CoV-SCAN detected over 97.2% of specimens with CT values <30 and 93.8% of nasal swab specimens with the Omicron variant, even within the first 2 days after symptom onset. Conclusions: The unique construction of CoV-SCAN using two pairs of monoclonal antibodies has resulted in a test with high performance that remains durable across multiple variants in both laboratory and clinical evaluations. CoV-SCAN should identify almost all individuals harboring infectious SARS-CoV-2. Summary: Unique construction of a point-of-care rapid antigen test using two pairs of monoclonal antibodies has led to good performance that remained durable across multiple variants in laboratory and clinical evaluations. Test should identify almost all individuals harboring infectious SARS-CoV-2.
ABSTRACT
The employment and utilization of advanced practice providers (APPs) in the emergency department has been steadily increasing. Physicians, physician assistants (PAs), and nurse practitioners (NPs) have vastly different requirements for admission to graduate programs, clinical exposure, and postgraduate training. It is important that as supervisory physicians, patients, hospital administrators, and lawmakers, we understand the differences to best create a collaborative, supportive, and educational framework within which PAs/NPs can work effectively as part of a care team. This paper reviews the trends, considerations, and challenges of an evolving clinician workforce in the specialty of emergency medicine (EM). Subsequently, the following parameters of APP training are examined and discussed: the divergence in physician, PA, and NP education and training; requirements of PA and NP degree programs; variation in clinical contact hours; degree-specific licensing and postgraduate EM certification; opportunities for specialty training; and the evolution and availability of residency programs for APPs. The descriptive review is followed by a discussion of contemporary and timely issues that impact EM and considerations brought forth by the expansion of APPs in EM such as the current drive to independent practice and the push for reimbursement parity. We review current position statements from pertinent professional organizations regarding PA and NP capabilities, responsibilities, and physician oversight as well as billing implications, care outcomes and medicolegal implications.
