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.* Following on last month’s special COVID-related New & Noteworthy section, this month’s feature comprises a sampling of additional diagnostic testing systems that have been granted an EUA as of this issue’s press date.
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.
The Elecsys Anti-SARS-CoV-2 immunoassay from Roche Diagnostics is an in vitro test that uses serum and plasma as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Hospitals and reference laboratories can run the test on Roche’s cobas e411, e601, e602, and e801 analyzers. These fully automated systems provide test results in approximately 18 minutes. Clinical data for this total antibody test includes 99.81% specificity achieved through the testing of 5272 samples; no cross reactivity was found in 80 samples from individuals with past infection to the common cold and other coronaviruses. The test also shows 100% sensitivity at greater than 14 days after PCR confirmation.
The Anti-SARS-CoV-2 Rapid Test from Hardy Diagnostics is an immunoassay intended for qualitative detection and differentiation of IgM and IgG antibodies to SARS-CoV-2 in human plasma or serum. Through a partnership with Autobio Diagnostics, Hardy Diagnostics is delivering this rapid test in the United States. Requiring no special equipment or special expertise or training to implement, the Anti-SARS-CoV-2 Rapid Test offers a turnaround time of 15 minutes. This lateral flow immunoassay is intended to be used with anticoagulated blood (Heparin/EDTA/sodium citrate) or serum from individuals with signs and symptoms of COVID-19 infection. The test is also intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Follow-up testing with a molecular diagnostic test should be considered to confirm infection status.
The Rheonix COVID-19 MDx Assay is a fully automated test that enables detection of SARS-CoV-2 directly from respiratory samples. The test is designed to operate on the Rheonix Encompass MDx workstation and facilitates same-day test results for small- and medium-throughput laboratories. A sample-to-answer test, it requires no technician involvement after loading the samples onto the workstation. The system enables cost-effective on-site testing at distributed locations, thus allowing for more rapid decisions regarding isolation and treatment of infected patients. The system requires minimal training and can be quickly installed.
The Aries SARS-CoV-2 Assay from Luminex runs on the Aries System, an FDA-cleared, sample-to-answer, automated, on-demand molecular diagnostic platform. The system is capable of running up to 144 tests per day, requiring no special training and minimal human interaction. The assay will allow hospital professionals to determine the appropriate course of treatment for patients suspected of having COVID-19 within approximately 2 hours.
The Platelia SARS-CoV-2 Total Ab assay from Bio-Rad is now available for the detection of total antibodies (IgM, IgA, and IgG) to SARS-CoV-2. This blood-based immunoassay, designed for in vitro diagnostic testing, can test for all three antibodies in a single assay to help identify individuals who have developed antibodies against SARS-CoV-2. The assay will help clinicians diagnose recent or prior infection with SARS-CoV-2 by identifying individuals with an adaptive immune response to the virus. Through clinical evaluation, the assay has demonstrated specificity of more than 99% and sensitivity of 98%. No cross-reactivity (false positive results) were observed in specimens from patients with antibodies to non-SARS coronaviruses or other medical conditions.
Bio-Rad Laboratories, Inc
The Lyra Direct SARS-CoV-2 Assay from Quidel removes the RNA extraction processing step, helping to ease supply bottlenecks. The assay uses a reformulated buffer that replaces the extraction step with a 10-minute heat step, saving approximately 50 minutes in total processing time. The assay retains its versatility, in that it is still capable of running on any of six thermocyclers (Applied Biosystems 7500 Standard, Applied Biosystems 7500 Fast, Bio-Rad CFX96 Touch, Qiagen Rotor-Gene Q, Roche LightCycler 480, and Thermo Fisher QuantStudio 7 Pro).
The Digital PCR and qPCR COVID-19 test kits from Gnomegen LLC will be distributed in North America by Todos Medical. Gnomegen previously received EUAs for its digital PCR detection kit and its qPCR detection kit, and the company has completed validation testing for the its qPCR reagents. Todos expects that its CLIA lab partner will be able to process up to 2000 tests per day with existing equipment, and can ramp up to 7000 tests per day in the coming months.
Todos Medical, Ltd
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