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The test can be used in conjunction with other FDA-cleared Lyme enzyme immunoassays developed by GSD as part of a CDC-recommended modified two-tiered testing algorithm.
Eurofins said its new multiplex PCR kit could be impactful for countries looking to gain control of disease clusters triggered by SARS-CoV-2 variants.
The company also said that it had received EUA from the US Food and Drug Administration for a non-prescription version of its COVID-19 sample collection kit.
The company said that the test, which detects IgG antibodies against SARS-CoV-2, can be used to measure immune responses to the virus and vaccines.
The test, which was developed by researchers at the Cleveland Clinic and the University of Alabama, looks for RNA molecules in urine that indicate rejection.
News items for the in vitro diagnostics industry for the week of Jan. 25, 2021.
The company said that in the second half of 2020, its core business, excluding COVID-19 clinical reagents and testing revenues, remained resilient despite lockdowns.
The test provides results in 15 minutes from nasopharyngeal samples and has a sensitivity of nearly 93 percent and specificity of nearly 99 percent.
News items for the in vitro diagnostic industry for the week of Oct. 19, 2020.
The firm said that its core business, excluding COVID-19 clinical testing revenues, returned to positive organic growth in the quarter.