OPTI SARS-CoV-2
Total Antibody Test Kit
The OPTI SARS-CoV-2 Total Antibody Test Kit 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 kit 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.
- Relies on technical support from a market leader in ELISA testing.
- Detects total antibodies for broad sensitivity.
- Makes lab setup easy when ELISA readers and washers are utilized for a complete testing solution.
Performance
Performance of the OPTI-SARS COV-2 Total Antibody Test Kit 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.
Notes
- This test kit has not been reviewed by the FDA.
- 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.