OPTI SARS-CoV-2/Influenza A/B RT-PCR Test
OPTI Medical Systems has obtained CE marking for its OPTI SARS-CoV-2/Influenza A/B RT-PCR Test for identification and differentiation of SARS-CoV-2, influenza A, and influenza B RNA. The test is available in countries accepting the CE mark.
This respiratory panel distinguishes between SARS-CoV-2 and influenza A and B extracted from nasopharyngeal swabs. Use of this test is ideal for identifying the cause of symptoms during influenza season.
The OPTI SARS-COV-2/Influenza A/B RT-PCR Test delivers highly accurate results with high sensitivity (LoD ≤3 copies/μl). Results are available as fast as 2 hours, including RNA extraction. The test detects new SARS-CoV-2 variants of concern (UK B.1.1.7, Brazil P.1, and South Africa B.1.351) based on the sequences submitted to the GISAID database.
IDEXX Laboratories, the parent of OPTI Medical Systems, has extensive expertise in PCR test development and manufacturing.
OPTI DNA/RNA Magnetic Bead Kit
The OPTI DNA/RNA Magnetic Bead Kit is intended for extracting RNA from respiratory samples for subsequent analysis with the OPTI SARS-CoV-2/Influenza A/B RT-PCR Test. The extraction kit requires minimum hands-on time (less than 15 minutes) when used on automated magnetic separators, such as Kingfisher™ purification systems, for high-throughput sample processing. The optional manual protocol minimizes instrument investments.
This CE mark certification represents OPTI Medical Systems’ assurance that its test complies with the European Union’s In Vitro Diagnostic Medical Devices Directive, which applies to products that are manufactured in or designed to be sold in the European Economic Area* and Switzerland.
This test has not been reviewed by the FDA.
*The European Economic Area includes the European Union (Austria, Belgium, Bulgaria, Croatia, Republic of Cyprus, Czech Republic, Denmark, Estonia, Finland, France, Germany, Greece, Hungary, Ireland, Italy, Latvia, Lithuania, Luxembourg, Malta, Netherlands, Poland, Portugal, Romania, Slovakia, Slovenia, Spain, and Sweden) and the following countries: Iceland, Liechtenstein, Norway, and United Kingdom.