The objective of the test SteriLumen conducted in partnership with MRIGlobal was to demonstrate that Airocide devices could eliminate and neutralize infectious SARS-CoV-2. MRIGlobal is a Biosafety Level 3 Laboratory located in Kansas City, MO.
The experimental phase of this project was initiated by MRIGlobal on July 27,2021 and concluded on August 1, 2021. The experimenters were Rick Tuttle and Kristy Solocinski. They were assisted by Jacob Wilkinson. The project was managed by William Sosna.
The standard for all COVID related work performed by MRIGlobal falls under Emergency Use Authorization (EUA). Therefore, COVID related studies by MRIGLobal are not strictly speaking in compliance with FDA Good Laboratory Practice Regulations (21 CFR 58) or EPA Good Laboratory Practice Regulations (40 CFR 160). This was disclosed within the report presented by MRI Global. The test was performed according to MRIGlobal Standard Operating Procedures which includes redundant personnel oversight and quality review of all data. The Quality Assurance (QA) group is independent. Also, all MRIGlobal work is routinely reviewed by the FDA, EPA, and USDA. All study records are stored securely at MRIGlobal.
The device used to demonstrate the ability of the Airocide product line to eliminate and neutralize infectious SARS-CoV-2 was the HD-1200 model. The HD-1200 contains both a MERV-13 filter stage and a Photocatalytic Oxidation (PCO) stage in its standard form. The two stages are intended to cover as wide a spectrum of indoor air quality issues as possible. MRIGlobal was provided with two HD-1200 devices. One was in the standard form with both stages. The other had the MERV-13 filter removed. SteriLumen wished to see how the standard two-stage form of the device, and PCO stage alone would perform in eliminating and neutralizing SARS-CoV-2. The reason for the PCO alone analysis is because many Airocide devices sold by SteriLumen have only the PCO stage. So, SteriLumen wished to confirm the efficacy of those devices in eliminating and neutralizing infectious SARS-CoV-2.
Each of the two HD-1200 units submitted to MRIGlobal by SteriLumen were tested independently for efficacy in aerosol removal/deactivation of infectious SARS-CoV-2. These tests were performed in a Class 3 Biological safety cabinet. The specific isolate used in this test was SARS-CoV-2 Washington State Isolate Strain (USA-WAI/2020).
The conclusions of the test were that the HD-1200 with both the filter stage and PCO stage removed 99.94% of the aerosolized SARS-CoV-2 virus within 5 minutes and 30 seconds of operation. The HD-1200 with PCO only removed 99.05% of the aerosolized SARS-CoV-2 between 20 and 30 minutes of operation.