RESUMEN
INTRODUCTION: The COVID-19 pandemic has created a high demand on personal protective equipment, including disposable N95 masks. Given the need for mask reuse, we tested the feasibility of vaporized hydrogen peroxide (VHP), ultraviolet light (UV), and ethanol decontamination strategies on N95 mask integrity and the ability to remove the infectious potential of SARS-CoV-2. METHODS: Disposable N95 masks, including medical grade (1860, 1870+) and industrial grade (8511) masks, were treated by VHP, UV, and ethanol decontamination. Mask degradation was tested using a quantitative respirator fit testing. Pooled clinical samples of SARS-CoV-2 were applied to mask samples, treated, and then either sent immediately for real-time reverse transcriptase-polymerase chain reaction (RT-PCR) or incubated with Vero E6 cells to assess for virucidal effect. RESULTS: Both ethanol and UV decontamination showed functional degradation to different degrees while VHP treatment showed no significant change after two treatments. We also report a single SARS-CoV-2 virucidal experiment using Vero E6 cell infection in which only ethanol treatment eliminated detectable SARS-CoV-2 RNA. CONCLUSIONS: We hope our data will guide further research for evidenced-based decisions for disposable N95 mask reuse and help protect caregivers from SARS-CoV-2 and other pathogens.
RESUMEN
BACKGROUND: The use of quantitative HIV-1 RNA assays is part of the standard of care for the management of HIV-1-infected individuals. OBJECTIVE: The Bayer VERSANT HIV-1 RNA 3.0 Assay (bDNA) was evaluated for reproducibility, linearity, limits of detection and quantitation, effects of potentially interfering substances and conditions, effects of plasma collection and handling conditions, clinical sensitivity and specificity, and biologic variability. STUDY DESIGN: Anti-HIV-1-positive specimens, patient specimens containing potentially interfering substances, and anti-HIV-negative specimens were collected from several HIV clinics, blood centers, or commercial companies across the United States. Specimen panels used to evaluate nonclinical performance of the assay were prepared at Bayer Diagnostics. Bayer Assay Development personnel performed 2 of the nonclinical studies-effect of freeze-thaw cycles using 'spiked' HIV-1 RNA-positive samples and effect of other disease organisms. All other studies were conducted at 7 external sites. In some of the studies performed, specimens were tested in parallel with the Roche AMPLICOR HIV-1 MONITOR version 1.0 PCR Test. RESULTS/CONCLUSIONS: The results of these studies showed that the Bayer Assay has excellent reproducibility, a broad linear range (75-500,000 HIV-1 RNA copies/ml), throughput of 168 patient results per two-plate run in a 22-h period, and few limitations for use. Because this test is designed for use only in individuals who are known to be HIV-1-positive, the clinical specificity of 97.6% is adequate for its intended use. These characteristics make it an attractive method for general laboratory use of monitoring HIV-1-infected patients.
