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GTR Home > > DiaSorin LIAISON® SARS-CoV-2 IgM

Overview

Test name

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DiaSorin LIAISON® SARS-CoV-2 IgM

Purpose of the test

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This is a clinical microbial test intended for Help: Screening

Condition

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How to order

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Order URL Help: https://makoexchangedev.com/covid19-ereq/

Specimen source

Plasma
Serum

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

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Serology
OAntibody assay
Chemiluminescent Immunoassay (CIA)
  • LIAISON® XL Analyzer (DiaSorin, Inc.)

Summary of what is tested

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Clinical utility

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Not provided

Clinical validity

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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.

Clinical resources

Practice guidelines

  • NICE, 2022
    UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19

Consumer resources

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.