Performance Characteristics
- Entire test performed in-house
Specificity: 99.33%; Sensitivity: 98%
1. This test should not be used to diagnose or exclude acute SARS-CoV-2 infection. Direct testing for SARS-CoV-2 should be performed if acute infection is suspected.
2. It is not known at this time if the presence of antibodies to SARS-CoV-2 confers immunity to reinfection.
3. Negative results do not rule out SARS-CoV-2 infection, particularly in those who have been in contact with the virus. Follow-up testing with a molecular diagnostic should be considered to rule out infection in these individuals.
4. The detection of anti-SARS-CoV-2 antibodies is dependent on the presence of the analyte in the specimen. A negative or non-reactive result can occur if the quantity of antibodies for the SARS-CoV-2 virus present in the specimen is below the detection limit of the assay. During the acute infection phase and/or for immunosuppressed patients, anti-SARS-CoV-2 antibodies might not be detectable. Thus, a negative result does not preclude or rule out COVID-19 infection.
5. A positive result may not indicate previous SARS-CoV-2 infection. Consider other information including clinical history and local disease prevalence, in assessing the need for a second but different serology test to confirm an immune response.
6. The results obtained with this test should only be interpreted in conjunction with clinical findings, and the results from other laboratory tests and evaluations.
7. Performance characteristics of Platelia SARS-CoV-2 Total Ab have not been evaluated with serum or plasma specimens originating from new-borns or pediatric patients.
8. Platelia SARS-CoV-2 Total Ab can detect total antibodies specific to SARS-CoV-1 and to SARS-CoV-2, and cross-reaction is possible with MERS-CoV.
9. This test should not be used for screening of donated blood.
Proficiency Testing (PT)
- Is proficiency testing performed for this test?
HelpWhether the test undergoes periodic internal or external evaluation of the accuracy of test results. Lab-provided.
- No
- FDA Category Designation
- EUA - Emergency Use Authorization
- NYS CLEP test approval #
- 8680
- Status
- Approved
IMPORTANT NOTE: NIH does not independently verify information submitted to the GTR; it relies on submitters to provide information that is accurate and not misleading. NIH makes no endorsements of tests or laboratories listed in the GTR. GTR is not a substitute for medical advice. Patients and consumers with specific questions about a genetic test should contact a health care provider or a genetics professional.
