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GTR Home > > DiaSorin LIAISON® SARS-CoV-2 S1/S2 IgG Test

Indication

This is a clinical microbial test intended for Help: Screening

Clinical summary

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An acute infection of the respiratory tract that is caused by the severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2). Based on currently available information, SARS-CoV-2 is thought to mainly spread from person to person through respiratory droplets. Typically, there is a two- to 14-day incubation period and infected persons can present with no symptoms or mild to severe fever, dry cough, fatigue, and difficulty breathing. Dysgeusia, anosmia, and gastrointestinal and flu-like symptoms have also been reported. Older adults and persons of any age who have serious underlying medical conditions may be of higher risk for severe illness, including secondary infections, respiratory failure, and multi-organ dysfunction. [from NCI]

Conditions tested

Target population

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The test is intended for use as an aid in identifying individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection.

Citations

Not provided

Clinical validity

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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

Clinical utility

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Clinical resources

Practice guidelines

  • NICE, 2024
    UK NICE Guideline NG191, COVID-19 rapid guideline: managing COVID-19, 2024

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.