New Tests for Diagnosis of Borreliosis Approved for Use as CE IVD Products
Additional CE certified tests from PROGEN / Multimetrix for a two-step diagnostic of Lyme Borreliosis are approved for laboratory diagnosis.
PROGEN Biotechnik / Multimetrix are supplementing their multiplex product line and offer now new additional CE marked tests for the laboratory diagnosis of Lyme borreliosis. The requirements for the diagnosis of Lyme borreliosis established by the National Reference Centre for Lyme borreliosis stipulate a two-step diagnostic procedure. Now the PROGEN / Multimetrix Luminex-based tests can implement these requirements. In addition to our confirmation assays (Borrelia IgM and IgG) new Borrelia Screening IgG and IgM Tests are now available for the first step of the diagnostic procedure.
These tests allow for an automated, quantitative and sensitive detection of specific IgM and IgG antibodies in human samples. Also, in cases of suspected Lyme neuroborreliosis the Borrelia IgG and IgM Test as well as the Screening IgG Test are applicable for the detection of specific antibodies in cerebrospinal fluid.
The PROGEN / Multimetrix multiplex tests for the laboratory diagnosis of Lyme borreliosis are a cost-effective alternative to conventional tests and offer an improved diagnostic reliability for both levels of the diagnostic procedure.
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PROGEN Biotechnik GmbH, located in Heidelberg, Germany, (www.progen.de) is EN ISO 13485:2007 certified and a manufacturer of in vitro diagnostics (Borreliosis, Hanta-Virus, FSME) and research products (antibodies, polypeptides, AAV, hyperphage) as well as specialist for the manufacturing of multiplex assays in bead-technology used for the Luminex® platform. The company is main shareholder of Multimetrix GmbH based in Regensburg, Germany (www.multimetrix.com). PROGEN is a member of the VDGH, a German association of diagnostic manufacturers.