Diazyme Laboratories has recently announced that it has made two serological tests available for coronavirus (SARS-CoV-2), called DZ-Lite SARS-CoV-2 IgM and SARS-CoV-2 IgG CLIA test kits. Both the Diazyme IgM and IgG tests have been run on a completely automated, chemiluminescence analyzer called Diazyme DZ-Lite 3000 Plus. The notification of the serological test done by Diazyme has been listed on the EUA website of the FDA under the header- FAQs on Diagnostic Testing for SARS -CoV-2.
Diazyme Laboratories’ Managing Director, Dr. Chong Yuan stated that the company followed the Emergency Use Notification process of the FDA to help make the tests available. The process had been given in the Policy for Diagnostic Tests for Coronavirus Disease, introduced by the FDA during the time of Public Health Emergency on March 16, 2020.
Dr. Chong thanked the FDA for giving an immediate response to the company’s requests as well as its guidance in helping make extra tests available to fight the ongoing coronavirus outbreak. As per the research, after getting infected with SARS-CoV-2, the viral antigens tend to stimulate the immune systems of the body to be able to produce antibodies. These antibodies can be detected with the company’s IgG and IgM tests.
Dr. Chong further added that the completely automated serological tests that the company offers show high sensitivity, clinical agreement and specificity with the samples that are confirmed with the standard method of nucleic acid testing (RT-qPCR).
For the record, Diazyme Laboratories, Inc., is essentially a Life Science Affiliate of General Atomics that is located in Poway, California. Diazyme is involved in the development of diagnostic reagents by using its proprietary enzyme as well as its immunoassay technologies that are run on the chemiluminescence instruments and automated chemistry analyzers in different user-friendly formats. Diazyme is a medical device manufacturer that has been certified ISO 13485 and cGMP.