Performance Characteristics
- Entire test performed in-house
Controlled studies of potentially interfering substances showed no interference to each substance listed at the indicated concentration - Biotin 3500 ng/mL, Triglycerides 3000 mg/dL, Hemoglobin 1000 mg/dL, Unconjugated bilirubin 40 mg/dL, Conjugated bilirubin 40 mg/dL, Cholesterol total 500 mg/dL, Acetaminophen 500 mg/mL, Ibuprofen 500 mg/mL, Total Protein (high) ≥ 120 g/L, Total Protein (low) ≤ 60 g/L, Total IgM 5.5 mg/dL. For studies of potential interference from cross-reactivity to antibodies to other viruses that may cause symptoms similar to SARS-CoV-2 infection, other organisms that may cause infectious diseases, as well as from other conditions that may result from atypical immune system activity, samples for the evaluation were collected before October 2019, prior to the SARS-CoV-2 pandemic. 3 specimens out of 180 assessed specimens resulted Positive with the LIAISON® SARS -CoV-2 IgM assay. For measurement of precision, a five-day study was performed by using a coded panel of 6 serum samples prepared by either spiking or diluting samples as necessary to obtain negative, low positive and moderate positive samples. Kit Controls sets were also included in the study. The panel samples and kit controls were tested with the LIAISON® SARS-CoV-2 IgM assay in 6 replicates per run, 3 runs per day for 5 operating days on one LIAISON® XL Analyzer, on 1 kit lot. 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. 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. 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. 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
- Not Applicable
