Performance Characteristics
- Entire test performed in-house
Controlled studies of potentially interfering substances showed no interference at the following concentrations - Triglycerides 3000 mg/dL, Hemoglobin 1000 mg/dL, Unconjugated bilirubin 40 mg/dL, Conjugated bilirubin 40 mg/dL, Cholesterol total 400 mg/dL, Acetaminophen 500 mg/mL, Ibuprofen 500 mg/mL. The LIAISON® SARS-CoV-2 S1/S2 IgG assay demonstrated up to a 16% negative Bias in SARS-CoV-2 IgG positive specimens with biotin concentrations of 3500 ng/mL. For studies of potential cross-reactivity to antibodies to other viruses that may cause symptoms similar to SARS-CoV-2 infection and other organisms that may cause infectious diseases, as well as to other conditions that may result in atypical immune system activity, samples were collected before October 2019, prior to the SARS-CoV-2 pandemic. Three (3) specimens out of 168 assessed specimens resulted positive. A five day precision study was performed by using a coded panel of 6 plasma samples prepared by either spiking or diluting samples as necessary to obtain negative, low positive and moderate positive samples. Kit Controls were also included in the study. The panel samples and kit controls were tested with LIAISON® SARS-CoV-2 S1/S2 IgG assay in 6 replicates per run, 3 runs per day for five operating days on one LIAISON® XL Analyzer. The CLSI document EP5-A3 was consulted in the preparation of the testing protocol.
Bacterial contamination or heat inactivation of the specimens may affect the test results. Specimens from patients receiving therapeutic doses of Biotin (Vitamin H, B7 or B8) may interfere in immunoassays based on biotinylated reagents. Interference was not observed testing Biotin serum concentration up to 3500 ng/mL with LIAISON® SARS-CoV-2 S1/S2 IgG assay (The LIAISON® SARS-CoV-2 S1/S2 IgG assay demonstrated up to a 16% negative Bias in SARS-CoV-2 IgG positive specimens with biotin concentrations of 3500 ng/mL). Detection of IgG antibodies against SARS-CoV-2 at present is not yet established to determine long term immunity to the virus or to protect the patient against re-infection by the virus. The results obtained with this test should only be interpreted in conjunction with clinical findings, and the results from other laboratory tests and evaluations. This is especially important if the patient has had recent exposure to COVID-19, or clinical presentation indicates that COVID-19 is likely and diagnostic tests for other causes of illness (e.g., other respiratory illness) are negative. In this case, direct testing for the SARS-CoV-2 virus (e.g. PCR testing) should be considered. 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
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.
