The OPTI® Rapid Lysis Buffer is used for sample preparation prior to the OPTI® SARS-CoV-2 RT-PCR Test.
The OPTI® SARS-CoV-2 RT-PCR Test has received FDA Emergency Use Authorization and CE-IVD for sample handling using the OPTI® Rapid Lysis Buffer. The OPTI Rapid Lysis Buffer protocol eliminates the need for magnetic bead or spin column extraction and prepares the samples for PCR testing using a simple heating protocol. This protocol has shown a diagnostic sensitivity and specificity of 100% when compared to magnetic bead extraction.
The OPTI SARS-CoV-2 RT-PCR Test is authorized for use by high-complexity labs and has been verified to detect all SARS-CoV-2 variants of concern. It uses an internal sample control targeting human RNase P and minimizes impact of viral mutation with detection of two targets in the N region of SARS-CoV-2. Manufacturing of the assay and the sample preparation buffer takes place at IDEXX's state-of-the-art PCR production facilities in Montpellier, France, along with other PCR products for COVID-19.
About OPTI Medical: Roswell, Georgia-based OPTI Medical Systems, a subsidiary of IDEXX Laboratories, specializes in the design and manufacturing of point-of-care and laboratory diagnostic solutions. OPTI Medical Systems leverages advanced technologies to develop reliable, cost-effective products that combine accuracy with convenience, ease of use, and clinical flexibility to support infectious disease diagnostics as well as point-of-care blood gas and electrolyte analysis using optical fluorescence technology.
RSS