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. Opti Medical’s SARS-CoV-2 PCR Test was originally authorized by the FDA in March 2020.
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. The OPTI Rapid Lysis Buffer has shown a diagnostic sensitivity and specificity of 100 % when compared to magnetic bead extraction.
The PCR testing workflow for SARS-CoV-2 from OPTI Medical comes with the following benefits:
- High sensitivity and specificity as proven by internal and external validations
- Extraction-free sample handling with savings in instruments, reagents, and consumables
- Increased workflow efficiencies and sample throughput
- Simplified workflow with less lab space and minimum training requirements
Free trial kits are available by contacting Opti Medical at [email protected].