AcroMetrix Announces European Launch of OptiQual® Enterovirus Controls
Alkmaar, The Netherlands, 03 Apr 2008
AcroMetrix announced today the launch of the OptiQual® Enterovirus Low Positive and Negative Controls in anticipation of the Enterovirus testing season. The OptiQual Enterovirus Low Positive Control is the first ready-to-use external run control intended for use in assessing the performance of nucleic acid test procedures for the qualitative determination of Enterovirus RNA. This product was released as a CE IVD product under the European Directive on In Vitro Diagnostics Medical Devices.
Most nucleic acid procedures that are performed in hospital laboratories are designed to aid in the detection of EV-associated meningitis. About 90% of all viral meningitis cases involve enteroviruses. Accurate diagnosis using a controlled assay for enterovirus reduces unnecessary treatment.
“The OptiQual Enterovirus Controls are the first CE Marked, standardised control for Enterovirus testing.” said Douglas Lunderville, Marketing Manager, AcroMetrix Europe, “We are excited to provide this unique solution to the Enterovirus testing laboratory.”
The OptiQual Enterovirus Low Positive Control is calibrated against a standard set at 100 EVU/mL (Enterovirus Units per millilitre) in accordance with the ISO 17511 standard. The establishment of the EVU allows for the standardised comparison of test results across laboratories, assays, and manufacturers performing Enterovirus testing.
About AcroMetrix
AcroMetrix, with facilities in Benicia, California and Alkmaar, The Netherlands, provides a comprehensive line of molecular and serological diagnostic quality control products that assist laboratories in meeting current regulations regarding quality. AcroMetrix maintains this leadership role by consistently developing innovative standards, external run controls, and validation kits for molecular and serological testing in clinical diagnostics and blood screening laboratories. For more information on AcroMetrix please visit the company web site at http://www.acrometrix.com.
Contact
Douglas Lunderville, +31 72 527 2782 or