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 SARS-CoV-2 in samples from human serum and plasma. The test can be run manually or using automated plate washers.
A complete serology-based testing solution
- Reduces waiting time with results in 90 minutes.
- Limits the need for validation due to an extensive validation data report.
- Is supported by an experienced technical team.
- Detects total antibodies for broad sensitivity.
- Makes lab setup easy when ELISA readers and washers are utilized for a complete testing solution.
Performance of the OPTI SARS-COV-2 Total Antibody Test was validated extensively using a large sample set. Results demonstrated diagnostic sensitivity of 96.1% (n = 155) ≥ 15 days after symptom onset and 96.8% (n = 201) ≥ 15 days after PCR-positive result. The diagnostic specificity of the test was 98.0% (n = 405).
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.