COVID-19 New & Noteworthy


July/August 2020 - Vol. 9 No. 7 - Page #23

As hospitals and health systems across the United States manage the effects of the COVID-19 pandemic, the US Food and Drug Administration continues to grant Emergency Use Authorization (EUA) for a growing number of tests and related products.* This month’s special COVID-19-related New & Noteworthy section features a sampling of diagnostic testing systems and other helpful tools that have been granted an EUA as of this issue’s press date. It is important for our readers to note that FDA EUA status is subject to change at any time; before moving forward with any new testing system, laboratorians are encouraged to stay abreast of the latest developments via the link below.

Per the FDA, these tests are only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostic tests for detection and/or diagnosis of COVID-19 under Section 564(b)(1) of the Act, 21 U.S.C. § 360bbb-3(b)(1), unless the authorization is terminated or revoked sooner.

*www.fda.gov/medical-devices/emergency-situations-medical-devices/emergency-use-authorizations#covid19ivd


Hydrogen Peroxide Decontamination Services

The FDA has issued an EUA to Technical Safety Services (TSS) for the use of vaporized hydrogen peroxide (HP) to decontaminate compatible N95 respirators for reuse by health care personnel. TSS has engineered and customized a scalable decontamination system for this process; all decontamination cycles will occur onsite or in a preferred central location with the ability to process up to 5000 masks per cycle in each CS-20 system. Two cycles per day can be run with each system and the method is fully validated to consistently deliver a 6-log reduction in bioburden based on a minimum dosage of HP per disinfection cycle. Decontamination will allow these important devices to be reused by health care personnel during the COVID-19 pandemic and beyond, and a chain of custody and flow path has been created for each hospital to ensure a safely managed process. TSS will work with each organization to ensure they comply with local and national regulatory standards.

Technical Safety Services, Inc (TSS)


Access SARS-CoV-2 IgG Antibody Test

Beckman Coulter Diagnostics announces that its COVID-19 antibody test, Access SARS-CoV-2 IgG, has received an EUA from the US FDA. The assay detects immunoglobulin G (IgG) antibodies (associated with lasting immunity) with 99.6% specificity and 100% sensitivity. In an independent study, 100% specificity and 100% sensitivity rates were found. The test identifies convalescence plasma donors, whose donations can be banked to treat critically ill patients until a vaccine becomes available. In addition, the test detects antibodies to the receptor-binding domain of the spike protein on the novel coronavirus that are thought to be neutralizing antibodies that could block future infection.

Beckman Coulter Diagnostics


SARS-CoV-2 Total Antibody Test

Siemens Healthineers announces that the US FDA has issued an EUA for its laboratory-based total antibody test—SARS-CoV-2 Total (COV2T)—to detect the presence of SARS-CoV-2 antibodies including IgM and IgG in blood. Test data has demonstrated 100% sensitivity and 99.8% specificity. The total antibody test allows for identification of patients who have developed an adaptive immune response, which indicates recent infection or prior exposure. The COV2T test is available on the Atellica IM immunoassay analyzers, which can run up to 440 tests per hour and enable results in 10 minutes, and the ADVIA Centaur XP and XPT analyzers, which can test up to 240 samples per hour with results in 18 minutes.

Siemens Healthineers


Mask Decontamination

EuroBio Concept (EBC), a manufacturer of restricted access barrier systems (RABS), produces a unit that provides an H2O2 vapor decontamination cycle for added protection. This H2O2 decontamination process can be used for masks or other equipment. For decontamination, EBC is able to obtain 99.9999% elimination of pathogens with a 6-log kill and 0 ppm residue with 35% H2O2 vapor after one cycle of 4 hours for approximately 300 masks. The system makes it possible to run three cycles daily to decontaminate approximately 1000 masks per 24 hours. The system uses a four-step process, including preparation, gassing, contact/dwell time, and aeration (using catalytic conversion to safely convert the H2O2 to water vapor and oxygen). The unit is designed for easy installation by non-technical personnel. It comes with an installation manual and a training video is offered.

EuroBio Concept (EBC)


Sample Collection Kit with Novel Viral Transport Media

EKF Diagnostics is supplying a novel, patented sample collection device which allows
COVID-19 samples to be rapidly inactivated in the collection tube, avoiding contamination and preserving RNA without need for refrigeration. The PrimeStore MTM (molecular transport medium) sample collection kit includes an FDA-cleared microbial nucleic acid storage and stabilization device that deactivates viruses, bacteria, fungi, and mycobacterium tuberculosis, enabling safe sample handling and transport, and eliminating the risk of infection during transport and within laboratories. In addition to removing the need for cold chain storage of samples, RNA and DNA are preserved ready for safe testing immediately on arrival in the laboratory and without the need for containment.

EKF Diagnostics & Longhorn Vaccines and Diagnostics

 

COVID-19 IgG/IgM Rapid Test Cassette

Menarini Silicon Biosystems has signed a non-exclusive distribution agreement for a rapid antibody detection kit manufactured by Healgen Scientific. The COVID-19 IgG/IgM Rapid Test Cassette is now available for use in the US under an FDA EUA. The test detects two types of antibodies, IgG and IgM, in just 10 minutes. To use the test, health care workers place a small sample of serum or plasma or one drop of blood on a test cassette. Molecules in the test kit bind to any antibodies specific to the virus. If antibodies are present, a positive result will appear in the cartridge. Currently, the test is authorized for use in laboratories certified to perform moderate or high complexity tests.

Menarini Silicon Biosystems & Healgen Scientific


COVID-19 Saliva Test

The US FDA has granted an EUA to Phosphorus, Inc for its COVID-19 saliva test that features at-home sample collection. The test is available for ordering online, as well as through partnerships between employers and health care providers with the goal of safely resuming operations. Using a saliva-based collection method can be simpler and less intrusive than the prevalent swab-based methods. This ease-of-use is a key characteristic to enabling the widespread and repetitive testing protocols proposed by experts to contain the COVID-19 pandemic.

Phosphorus, Inc

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