Menarini Silicon Biosystems begins distribution of rapid COVID-19 antibody test in North America

Menarini Silicon Biosystems, a pioneer of liquid biopsy and rare cell technologies, has announced that it has signed a non-exclusive distribution agreement to begin selling a rapid antibody detection kit that can help determine if someone has been previously infected with the novel coronavirus, SARS-CoV-2.

Manufactured by Healgen Scientific, LLC, the COVID-19 IgG/IgM Rapid Test Cassette* is now available for use in the U.S. under the Food & Drug Administration's (FDA) emergency access mechanism known as an Emergency Use Authorization (EUA). The test is also available in Europe through A. Menarini Diagnostics, the European diagnostics division of The Menarini Group.

"We are proud to utilize our distribution channels, both in the U.S. and abroad, to increase access to technology that will provide clinicians and public health experts with more information to address this global health crisis," said Fabio Piazzalunga, President of Menarini Silicon Biosystems.

When a person is exposed to SARS-CoV-2, their immune system responds by producing antibodies to fight the virus—and those antibodies can be detected in the blood for months after recovery. A positive antibody test, also known as a serological assay, indicates that a person has likely been infected with SARS-CoV-2 at some point in the past, even if they had no symptoms. An antibody test cannot diagnose a current infection.

Healgen's COVID-19 IgG/IgM Rapid Test Cassette detects two types of antibodies, immunoglobulin G (IgG) and immunoglobulin M (IgM), in just 10 minutes. To use the test, healthcare 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."

Antibody tests that have EUA are preferred for public health and clinical use since their test performance data have been reviewed by FDA. Healgen's test offers rapid results with high sensitivity and accuracy. In testing at two sites in China from January to March 2020, the test correctly identified with a 96.7% positive percent agreement the positive samples containing either IgG or IgM antibodies compared to RT-PCR (reverse transcription–polymerase chain reaction) and had a 97.0% negative percent agreement of the negative samples compared to RT-PCR.

Recommendations on the use of COVID-19 antibody tests are changing rapidly as new information becomes available. While researchers currently agree there is not enough evidence to conclude that the presence of antibodies indicates immunity to the virus, these tests are expected to play a crucial role in understanding the virus's spread and identifying groups at higher risk for infection. The Centers for Disease Control (CDC) regularly updates its guidance on Using Antibody Tests for COVID-19 as new data emerge.

Healgen Scientific, LLC, (Houston, TX), is a wholly owned subsidiary of Zhejiang Orient Gene Biotech Co., Ltd, based in China.

*This test has not been FDA cleared or approved. This test has been authorized by FDA under an EUA for use by authorized laboratories. This test has been authorized only for the presence of IgM and IgG antibodies against SARS-CoV-2, not for any other viruses or pathogens. This test is only authorized for the duration of the declaration that circumstances exist justifying the authorization of emergency use of in vitro diagnostics 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.

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