DiaSorin LIAISON® SARS-CoV-2 S1/S2 IgG Test
- GTR Test IDHelpEach Test is a specific, orderable test from a particular laboratory, and is assigned a unique GTR accession number. The format is GTR00000001.1, with a leading prefix 'GTR' followed by 8 digits, a period, then 1 or more digits representing the version. When a laboratory updates a registered test, a new version number is assigned.: GTR000593429.1
- Last updated: 2021-07-21
- Annual Review past due read more
- Test version history
- 593429.1, last updated: 2021-07-21
Clinical microbial testHelpIn the U.S., clinical tests must be performed under CLIA certification. When a lab uses the same methods for a test in both clinical and research settings, the test appears as two separate GTR records. for COVID-19
Offered by Mako Medical Laboratories
Overview
Test name
HelpThe name the laboratory assigns the test. Used as the default title of the page specific to the test.DiaSorin LIAISON® SARS-CoV-2 S1/S2 IgG Test
This is a clinical microbial test intended for HelpPurposes or indications for the test. Lab-provided.: Screening
Click Indication tab for more information.
Order URL HelpLink to the laboratory webpage with information about how to order this test. Please note that clicking on this link will open a new tab in your internet browser.: https://makoexchangedev.com/covid19-ereq/
Specimen source
Sample requirements
Either human serum or plasma may be used. The anticoagulants sodium heparin, lithium heparin, and potassium EDTA may be used with this assay. Follow the tube manufacturers’ instructions carefully when using collection containers. Blood should be collected aseptically by venipuncture and the serum or plasma separated from clot, red cells, or gel separator, after centrifugation. Before shipping specimens, serum or plasma specimens should be removed from clot, red cells, or gel separator. Specimens may be shipped in dry ice (frozen), in wet ice (2-8 C) or at room temperature (20-25 C); if the assay is performed within seven days of sample collection, the samples removed from red cells, clot or gel separator may be kept at 2-8 C; otherwise they should be aliquoted and stored deep-frozen (–20 C or below). Uncontrolled transport conditions (in terms of temperature and time) can cause inaccurate analytical results.Methodology
HelpThe assay's major method category (biochemical, cytogenetic or molecular genetics); method category (i.e. enzyme assay, chromosome breakage studies, targeted mutation analysis); methodology (i.e. the name of the method used) and instruments used when performing this test.- Serology
- OAntibody assay
- Chemiluminescent Immunoassay (CIA)
- LIAISON® XL Analyzer (DiaSorin, Inc.)
Not provided
Clinical validity
HelpHow consistently and accurately the test detects or predicts the intermediate or final outcomes of interest. Lab-provided.Clinical sensitivity: Total IgG positive results from 76 patients SARS-CoV-2 PCR positive from 3 hospitals shown as days from diagnosis (percent samples tested; 95% CI - Positive Percent Agreement with PCR Comparator): ≤ 5 days (25%; 14.57% - 39.44%), 6-14 days (89.80%; 78.24% - 95.56%), ≥15 days (97.56%; 87.40% - 99.57%). Clinical specificity: Presumed SARS-CoV-2 negative samples (n=1090) collected prior to COVID-19 were tested; 1082 out of 1090 were negative resulting in 99.3% clinical specificity (95% CI: 98.6 – 99.6%).
Citations
Not provided
Comments about the test interpretation (e.g. clinical implication of test results)
The analyzer automatically calculates SARS-CoV-2 S1/S2 IgG antibody concentrations expressed as arbitrary units (AU/mL) and grades the results. Assay range. Up to 400 AU/mL. A negative result (< 15.0 AU/mL) may indicate absence or level of IgG antibodies to SARS-CoV-2 below the limit of detection of this test. A negative result can also be seen in samples taken during an acute infection prior to IgG seroconversion. A positive result (≥ 15.0) indicates the presence of IgG antibodies to SARS-CoV-2 and generally indicates exposure to SARS-CoV-2. Test results are reported qualitatively as positive or negative. However, diagnosis of SARS-CoV-2 infection should not be established on the basis of a single test result, but should be determined in conjunction with clinical findings, patient history, and always in association with medical judgment.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.