OPTI SARS-CoV-2 Total Antibody Test
OPTI Medical Systems has obtained CE marking for its OPTI SARS-CoV-2 Total Antibody Test for detection of total antibodies against SARS-CoV-2.
The OPTI SARS-CoV-2 Total Antibody Test is an enzyme-linked immunosorbent assay (ELISA) that detects total antibodies (IgG, IgM, and IgA) against the receptor binding domain (RBD) of the spike (S) protein of SARS-CoV-2 in samples from human serum and plasma. Given that current vaccines have been developed to elicit antibodies against the receptor binding domain of the spike protein, this test is an excellent tool for assessing vaccine-elicited antibody uptake.
A complete serology-based testing solution
- Detects total antibodies for broad sensitivity.
- Suitable for assessing vaccine-elicited antibody uptake.
- Limits the need for validation due to an extensive validation data report.
- Supported by an experienced technical team.
- Reduces waiting time with results in 90 minutes.
- Makes lab setup easy when ELISA readers and washers are utilized for a complete testing solution.
The OPTI SARS-CoV-2 Total Antibody Test has been evaluated and compared against another ELISA for SARS-CoV-2 antibody detection at Iowa State University, USA. The test performed with 100% diagnostic sensitivity, 99.7% diagnostic specificity, and correctly identified all reference panel samples.
An internal study has demonstrated that the OPTI SARS-CoV-2 Total Antibody Test is an extremely sensitive test for evaluating antibody responses in people who have had one or both Moderna vaccinations. Similar results should be expected with other vaccines that use the RBD subunit of the spike protein.
IDEXX Laboratories, the parent of OPTI Medical Systems, has extensive expertise in ELISA development and manufacturing.
- The OPTI SARS-CoV-2 Total Antibody Test has obtained CE marking. 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.
- The OPTI SARS-CoV-2 Total Antibody Test has not been authorized for emergency use by the Food and Drug Administration.
- Negative results do not preclude acute SARS-CoV-2 infection. If acute infection is suspected, direct testing for SARS-CoV-2 is necessary.
- Results from antibody testing should not be used to diagnose or exclude acute SARS-CoV-2 infection.
- Positive results may be due to past or present infection with non-SARS-CoV-2 coronavirus strains, such as coronavirus HKU1, NL63, OC43, or 229E.
*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.