DiaSorin LIAISON® SARS-CoV-2 IgM
- 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.: GTR000593430.1
- Last updated: 2021-07-21
- Annual Review past due read more
- Test version history
- 593430.1, 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 IgM
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. Blood should be collected aseptically by venipuncture and the serum or plasma separated from clot, red cells or gel separator carefully following the tube manufacturers’ instructions and according to good laboratory practices. Specimens may be shipped on dry ice (frozen), on wet ice (for 2-8 C), following the sample storage limitations described below. Uncontrolled transport conditions (in terms of temperature and time) may 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.Sensitivity: 268 samples were collected over the course of time from 223 European patients. The group included patients hospitalized with moderate symptoms, patients admitted to the ICU with severe symptoms, and patients not hospitalized without or with mild symptoms. with SARS-CoV-2 was confirmed by RT-PCR test at the time of the diagnosis. Samples were tested at the time of admission and thereafter up to 30 days. Results are shown as days from diagnosis (percent samples tested; 95% CI - Positive Percent Agreement with PCR Comparator): ≤ 7 days (64.8%; 55.3% - 73.2%), 8-14 days (91.5%; 80.1% - 96.6%), 15 – 30 days (94.0%; 88.1% - 97.1%). Negative percent agreement (NPA): 2473 presumed SARS-CoV-2 negative samples collected before the COVID-19 outbreak from a European laboratory routine (n=1072), a US laboratory routine (n=400) and European blood donors (n= 1001) were tested resulting in an NPA of 99.3% (2455 / 2473, 95% CI: 98.9% – 99.5%).
Citations
Not provided
Comments about the test interpretation (e.g. clinical implication of test results)
The analyzer automatically calculates SARS-CoV-2 IgM antibody concentrations expressed as an Index value and grades the results. Assay range: 0 – no limit. Negative result - A result below the 1.1 Index may indicate the absence or level of IgM antibodies to SARS-CoV-2 below the threshold. The test could score negative in patients during the incubation period and in the early stages of infection. Positive result - A result above or equal to the 1.1 Index generally indicates the presence of IgM 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.