Research & Development
MatMaCorp's COVID-19 2SF RNA Test Effective in Detecting Variants
26 February 2021 - - Data demonstrating the effectiveness of US-based molecular diagnostic systems developer MatMaCorp's (Materials and Machines Corp.) COVID-19 2SF RNA test in detecting variants associated with SARS-CoV-2, the virus causing COVID-19, the company said.

Preliminary evaluation by MatMaCorp indicated that the company's COVID-19 test is capable of detecting >99.5% of 3,801 coronavirus variants reported worldwide to date.

As new COVID-19 variants are rapidly spreading around the globe, diagnostic providers have had to prove that their tests can accurately identify new virus strains as they emerge.

This evaluation by MatMaCorp follows guidance issued by the US Food and Drug Administration recommending test developers to consider the potential for future viral genetic mutations when designing new tests and also conduct routine monitoring to evaluate the potential impact of new mutations on current tests.

MatMaCorp has not had to modify its COVID-19 2SF RNA test to ensure effectiveness against variants, because the test was developed specifically to identify a highly conserved gene within SARS-CoV-2.

To identify the virus, MatMaCorp's COVID-19 test employs 'padlock probes' small bits of DNA targeted with high specificity toward the RNA-dependent RNA polymerase gene, an essential gene for viral replication.

Notably, the RdRp gene has not accumulated significant changes in any of the COVID-19 strains so far identified and analyzed by MatMaCorp.

Bioinformatics analysis provided by Dr. Kalbfleisch showed that MatMaCorp's 2SF RNA test can detect 99.7% of isolates for B.1.1.7 (UK variant), 99.8% of isolates for B.1.1.28 (Brazil variant), 100% of isolates for B.1.351 (South Africa variant), and 100% of isolates for B.1.525 (emerging global variant).

MatmaCorp's test, performed on the company's Solas 8 portable detection system, was recently granted an EUA by the US FDA. It is classified as a high complexity test; the portable testing platform can rapidly perform multiple RT-PCR assays and has been validated by six independent locations across the country.

It currently supports testing in rural community hospitals, and the company is working on additional claims to expand the use of the platform.

In addition to the Solas 8 platform, the company is also diligently moving forward with the development of a hand-held real-time PCR device that is capable of detecting and quantitating DNA or RNA targets within one hour and providing cycle threshold values.

This new system is geared towards the global point-of-care market and is expected to be available later in 2021 for wider use in molecular diagnostic applications.

MatMaCorp (Materials and Machines Corp.) is a developer of comprehensive solutions for science, medicine, and agriculture.

By combining engineering, life science, and information technology, MatMaCorp has developed a portable, easy-to-use, and affordable suite of products to power human diagnostics, animal health, and agriculture applications, including food safety and breeding.

Commercially available tests include: A2, African swine fever, and bovine congestive heart failure.
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