Utility of COVID-19 antigen testing in the emergency department.

BACKGROUND: The BinaxNOW coronavirus disease 2019 (COVID-19) Ag Card test (Abbott Diagnostics Scarborough, Inc.) is a lateral flow immunochromatographic point-of-care test for the qualitative detection of severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) nucleocapsid protein antigen. It provides results from nasal swabs in 15 minutes. Our purpose was to determine its sensitivity and specificity for a COVID-19 diagnosis. METHODS: Eligible patients had symptoms of COVID-19 or suspected exposure. After consent, 2 nasal swabs were collected; 1 was tested using the Abbott RealTime SARS-CoV-2 (ie, the gold standard polymerase chain reaction test) and the second run on the BinaxNOW point of care platform by emergency department staff. RESULTS: From July 20 to October 28, 2020, 767 patients were enrolled, of which 735 had evaluable samples. Their mean (SD) age was 46.8 (16.6) years, and 422 (57.4%) were women. A total of 623 (84.8%) patients had COVID-19 symptoms, most commonly shortness of breath (n = 404; 55.0%), cough (n = 314; 42.7%), and fever (n = 253; 34.4%). Although 460 (62.6%) had symptoms ≤7 days, the mean (SD) time since symptom onset was 8.1 (14.0) days. Positive tests occurred in 173 (23.5%) and 141 (19.2%) with the gold standard versus BinaxNOW test, respectively. Those with symptoms >2 weeks had a positive test rate roughly half of those with earlier presentations. In patients with symptoms ≤7 days, the sensitivity, specificity, and negative and positive predictive values for the BinaxNOW test were 84.6%, 98.5%, 94.9%, and 95.2%, respectively. CONCLUSIONS: The BinaxNOW point-of-care test has good sensitivity and excellent specificity for the detection of COVID-19. We recommend using the BinasNOW for patients with symptoms up to 2 weeks.

Characterization of Exhaled Particle Deposition and Ventilation in an Indoor Setting

Exhalation of infectious micrometer-sized particles has been strongly implicated in respiratory infection spread. An important fundamental question is then the fate of infectious exhaled particles in indoor spaces, i.e., whether they will remain suspended in an aerosol until ventilation leads to their clearance or whether they will deposit, and if so, on what surfaces in an indoor space. We investigated the interplay between deposition and ventilation using model experiments with a breathing simulator manikin in an office environment. The breathing simulator utilized physiologically correct exhalation and inhalation breathing waveforms as well as an anatomically correct manikin. The simulator output fluorescein-doped particles with a volume distribution spanning the 1-3 um range. The office environment was a 344 m3 room equipped with desks. Four different test conditions were created by changing the simulator location and via different air change rates and MERV ratings of filters in the HVAC system. We found that the rate of ventilation exceeds the rate of deposition on all surfaces (quantified by Stanton numbers, which were below unity) with several important exceptions: (1) surfaces close to (within 2 m) the simulator;and (2) non-passive surface exteriors (return grilles and diffusers). A detectable decrease in Stanton number with distance suggests that the room environment cannot be approximated as truly well-mixed. The finding of enhanced deposition on non-passive surfaces at all distances from the room highlights that infectious particles may preferentially deposit on such surfaces in indoor spaces. Finally, while our results highlight particular surfaces with enhanced deposition, our results confirm the importance of ventilation in a room as a means to reduce infectious aerosol particle concentrations, as in large part the clearance for particles appears to occur by ventilation.

Single-pass wind tunnel testing for recirculating virus aerosol control technologies

A number of recirculating flow aerosol control technologies have been commercialized to mitigate aerosol-transmitted virus infections. Many of these technologies incorporate filters for particle collection and some may also incorporate technologies for virus inactivation. Given the wide variety of commercially available aerosol control technologies to consumers, it is extremely important to develop standardized methods to characterize their performance in bioaerosol removal and inactivation, such that technologies can be compared on an “equivalent-test” basis. However, no standard procedures have been established to evaluate the effectiveness of bioaerosol removal and inactivation in recirculating aerosol control technologies. We propose the use of a single-pass tunnel to assess the performance of bioaerosol control technologies, as single-pass wind tunnels can be sealed with well-controlled velocity and particle concentration profiles. Here, we specifically describe the construction of a single-pass wind tunnel and apply it to three recirculating aerosol control technologies, incorporating UV-C sources, filters, and electrostatic precipitators, respectively. We utilize a porcine respiratory coronavirus (PRCV) challenge aerosol, generated via pneumatic nebulization of a high titer (∼107 TCID50 mL−1) viral suspension. Following guidelines similar to those used in the ANSI/ASHRAE Standard 52-2 test procedure for HVAC filters, in single-pass wind tunnel tests, velocity uniformity and particle uniformity are first monitored across the cross-section of the tunnel. The size distribution of viable particles is additionally determined in advance of tests by the collection of particles in the wind tunnel using a cascade impactor, with both RT-qPCR and titration used to quantify viruses collected on each impaction stage. We show that the viable particle size distribution follows the volumetric size distribution of the nebulized virus-laden suspension, and that this distribution can be tuned to be similar in shape to the observed distribution of aerosol from human respiratory activities. Following tunnel and virus aerosol characterization, for each tested technology, using triplicate tests, the single-pass log reduction based on RT-qPCR and viable virus titration is determined by simultaneously collecting virus aerosol particles upstream and downstream of the control technology. The tested technologies in this study have titration-based single-pass log reductions in the 1.5–4.0 range. Overall, design and testing suggest that the single-pass wind tunnel approach is a tractable method to examine the efficacy of aerosol control technologies in removing and inactivating viruses in aerosols, and suggest that such technologies should be described by their single-pass log reduction and operating flow rate, with the test virus size distribution reported alongside test results. In addition, we examine the limits of detection in single-pass wind tunnel tests in comparison to chamber tests, and in doing so find that for most control technologies, the wind tunnel test will yield higher concentrations downstream or during sampling, and hence clearer results for the log reduction.

Localized and Whole-Room Effects of Portable Air Filtration Units on Aerosol Particle Deposition and Concentration in a Classroom Environment

In indoor environments with limited ventilation, recirculating portable air filtration (PAF) units may reduce COVID-19 infection risk via not only the direct aerosol route (i.e., inhalation) but also via an indirect aerosol route (i.e., contact with the surface where aerosol particles deposited). We systematically investigated the impact of PAF units in a mock classroom, as a supplement to background ventilation, on localized and whole-room surface deposition and particle concentration. Fluorescently tagged particles with a volumetric mean diameter near 2 μm were continuously introduced into the classroom environment via a breathing simulator with a prescribed inhalation–exhalation waveform. Deposition velocities were inferred on >50 horizontal and vertical surfaces throughout the classroom, while aerosol concentrations were spatially monitored via optical particle spectrometry. Results revealed a particle decay rate consistent with expectations based upon the reported clean air delivery rates of the PAF units. Additionally, the PAF units reduced peak concentrations by a factor of around 2.5 compared to the highest concentrations observed and led to a statistically significant reduction in deposition velocities for horizontal surfaces >2.5 m from the aerosol source. Our results not only confirm that PAF units can reduce particle concentrations but also demonstrate that they may lead to reduced particle deposition throughout an indoor environment when properly positioned with respect to the location of the particle source(s) within the room (e.g., where the largest group of students sit) and the predominant air distribution profile of the room.

Evidence-based aerosol clearance times in a healthcare environment.

BACKGROUND: As researchers race to understand the nature of COVID-19 transmission, healthcare institutions must treat COVID-19 patients while also safeguarding the health of staff and other patients. One aspect of this process involves mitigating aerosol transmission of the SARS-CoV2 virus. The U.S. Centers for Disease Control and Prevention (CDC) provides general guidance on airborne contaminant removal, but directly measuring aerosol clearance in clinical rooms provides empirical evidence to guide clinical procedure. AIM: We present a risk-assessment approach to empirically measuring and certifying the aerosol clearance time (ACT) in operating and procedure rooms to improve hospital efficiency while also mitigating the risk of nosocomial infection. METHODS: Rooms were clustered based on physical and procedural parameters. Sample rooms from each cluster were randomly selected and tested by challenging the room with aerosol and monitoring aerosolized particle concentration until 99.9% clearance was achieved. Data quality was analysed and aerosol clearance times for each cluster were determined. FINDINGS: Of the 521 operating and procedure rooms considered, 449 (86%) were issued a decrease in clearance time relative to CDC guidance, 32 (6%) had their clearance times increased, and 40 (8%) remained at guidance. The average clearance time change of all rooms assessed was a net reduction of 27.8%. CONCLUSION: The process described here balances the need for high-quality, repeatable data with the burden of testing in a functioning clinical setting. Implementation of this approach resulted in a reduction in clearance times for most clinical rooms, thereby improving hospital efficiency while also safeguarding patients and staff.

Greater than 3-Log Reduction in Viable Coronavirus Aerosol Concentration in Ducted Ultraviolet-C (UV-C) Systems.

Control technologies to inactivate airborne viruses effectively are needed during the ongoing SARS-CoV-2 pandemic, and to guard against airborne transmitted diseases. We demonstrate that sealed UV-C flow reactors operating with fluences near 253 ± 1 nm of 13.9-49.6 mJ cm-2 efficiently inactivate coronaviruses in an aerosol. For measurements, porcine respiratory coronavirus (PRCV) was nebulized in a custom-built, 3.86 m wind tunnel housed in a biosafety level class II facility. The single pass log10 reduction of active coronavirus was in excess of 2.2 at a flow rate of 2439 L min-1 (13.9 mJ cm-2) and in excess of 3.7 (99.98% removal efficiency) at 684 L min-1 (49.6 mJ cm-2). Because virus titers resulting from sampling downstream of the UV-C reactor were below the limit of detection, the true log reduction is likely even higher than measured. Comparison of virus titration results to reverse transcriptase quantitative PCR and measurement of fluorescein concentrations (doped into the nebulized aerosol) reveals that the reduction in viable PRCV is primarily due to UV-C based inactivation, as opposed to physical collection of virus. The results confirm that UV-C flow reactors can efficiently inactivate coronaviruses through incorporation into HVAC ducts or recirculating air purifiers.

Combined Effects of Masking and Distance on Aerosol Exposure Potential.

OBJECTIVE: To quantify the efficacy of masking and "social distancing" on the transmission of airborne particles from a phantom aerosol source (simulating an infected individual) to a nearby target (simulating a healthy bystander) in a well-controlled setting. METHODS: An aerosol was created using monodisperse polystyrene latex beads in place of infectious respiratory secretions. Detection was by aerodynamic particle spectrometry. Both reusable cloth masks and disposable paper masks were studied. Transmission was simulated indoors during a 3-minute interval to eliminate the effect of variable ventilation rate on aerosol exposure. The study commenced on September 16, 2020, and concluded on December 15, 2020. RESULTS: Compared with a baseline of 1-foot separation with no masks employed, particle count was reduced by 84% at 3 feet of separation and 97% at 6 feet. A modest decrease in particle count was observed when only the receiver was masked. The most substantial exposure reduction occurred when the aerosol source was masked (or both parties were masked). When both the source and target were masked, particle count was reduced by more than 99.5% of baseline, regardless of separation distance or which type of mask was employed. CONCLUSION: These results support the principle of layered protection to mitigate transmission of SARS-CoV-2, the virus causing COVID-19, and other respiratory viruses and emphasize the importance of controlling the spread of aerosol at its source. The combination of masking and distancing reduced the exposure to exhaled particulates more than any individual measure. Combined measures remain the most effective way to combat the spread of respiratory infection.

Wind tunnel-based testing of a photoelectrochemical oxidative filter-based air purification unit in coronavirus and influenza aerosol removal and inactivation.

Recirculating air purification technologies are employed as potential means of reducing exposure to aerosol particles and airborne viruses. Toward improved testing of recirculating air purification units, we developed and applied a medium-scale single-pass wind tunnel test to examine the size-dependent collection of particles and the collection and inactivation of viable bovine coronavirus (BCoV, a betacoronavirus), porcine respiratory coronavirus (PRCV, an alphacoronavirus), and influenza A virus (IAV), by a commercial air purification unit. The tested unit, the Molekule Air Mini, incorporates a MERV 16 filter as well as a photoelectrochemical oxidating layer. It was found to have a collection efficiency above 95.8% for all tested particle diameters and flow rates, with collection efficiencies above 99% for supermicrometer particles with the minimum collection efficiency for particles smaller than 100 nm. For all three tested viruses, the physical tracer-based log reduction was near 2.0 (99% removal). Conversely, the viable virus log reductions were found to be near 4.0 for IAV, 3.0 for BCoV, and 2.5 for PRCV, suggesting additional inactivation in a virus family- and genus-specific manner. In total, this work describes a suite of test methods which can be used to rigorously evaluate the efficacy of recirculating air purification technologies.

Aerosol Generation from the Respiratory Tract with Various Modes of Oxygen Delivery.

Rationale: Aerosol generation with modes of oxygen therapy such as high-flow nasal cannula and noninvasive positive-pressure ventilation is a concern for healthcare workers during the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) pandemic. The amount of aerosol generation from the respiratory tract with these various oxygen modalities is unknown.Objectives: To measure the size and number concentration of particles and droplets generated from the respiratory tract of humans exposed to various oxygen delivery modalities.Methods: Ten healthy participants with no active pulmonary disease were enrolled. Oxygen modalities tested included nonhumidified nasal cannula, face mask, heated and humidified high-flow nasal cannula, and noninvasive positive-pressure ventilation. Aerosol generation was measured with each oxygen mode while participants performed maneuvers of normal breathing, talking, deep breathing, and coughing. Testing was conducted in a negative-pressure room. Particles with a diameter between 0.37 and 20 µm were measured using an aerodynamic particle spectrometer.Measurements and Main Results: Median particle concentration ranged from 0.041 to 0.168 particles/cm3. Median diameter ranged from 1.01 to 1.53 µm. Cough significantly increased the number of particles measured. Measured aerosol concentration did not significantly increase with the use of either humidified high-flow nasal cannula or noninvasive positive-pressure ventilation. This was the case during normal breathing, talking, deep breathing, and coughing.Conclusions: Oxygen delivery modalities of humidified high-flow nasal cannula and noninvasive positive-pressure ventilation do not increase aerosol generation from the respiratory tract in healthy human participants with no active pulmonary disease measured in a negative-pressure room.

Design and evaluation of a portable negative pressure hood with HEPA filtration to protect health care workers treating patients with transmissible respiratory infections.

BACKGROUND: To mitigate potential exposure of healthcare workers (HCWs) to SARS-CoV-2 via aerosol routes, we have developed a portable hood which not only creates a barrier between HCW and patient, but also utilizes negative pressure with filtration of aerosols by a high-efficiency particulate air filter. MATERIAL AND METHODS: The hood has iris-port openings for access to the patient, and an opening large enough for a patient's head and upper torso. The top of the hood is a high-efficiency particulate air filter connected to a blower to apply negative pressure. We determined the aerosol penetration from outside to inside in laboratory experiments. RESULTS: The penetration of particles from within the hood to the breathing zones of HCWs outside the hood was near 10-4 (0.01%) in the 200-400 nm size range, and near 10-3 (0.1%) for smaller particles. Penetration values for particles in the 500 nm-5 µm range were below 10-2 (1%). Fluorometric analysis of deposited fluorescein particles on the personal protective equipment of an HCW revealed that negative pressure reduces particle deposition both outside and inside the hood. CONCLUSIONS: We find that negative pressure hoods can be effective controls to mitigate aerosol exposure to HCWs, while simultaneously allowing access to patients.