COVID-19 vaccination elicits antibodies against the SARS-CoV-2 proteins including nucleocapsid and spike. Serological tests which detect antibodies to this spike protein can be used as an aid in the diagnosis of SARS-CoV-2 infection in conjunction with clinical presentation and other laboratory tests.
The assay is also to be used as an aid in evaluating the immune status of infected individuals and to monitor antibody response in individuals that have received the COVID-19 vaccine.
The host immune system reacts to COVID-19 disease by producing SARS-CoV-2 specific antibodies. These antibodies appear in serum or plasma of infected individuals after the detection of viral ribonucleic acid (RNA) in swabs and are detectable 3-14 days after the onset of symptoms. SARS-CoV-2 specific IgG antibodies are detectable in COVID-19 patients during the symptomatic phase of the disease and after viral RNA is no longer detectable. The sensitivity of combining RNA with antibody results for the diagnosis of COVID-19 infection has been reported to be > 99%. The persistence of IgG antibodies allows identification of individuals who have been vaccinated against SARS-CoV-2, or those who were infected in the past, recovered from the illness, and developed a degree of immunity to the disease.
The SARS-CoV-2 anti-spike IgG assay quantifies the concentration of SARS-CoV-2 IgG in the blood of individuals who have been infected with, or are vaccinated against COVID-19, giving results in the form of Arbitrary Units / Millilitre (AU/ml). Higher titre antibody responses have been observed in patients with more severe illness as compared with mildly symptomatic or asymptomatic individuals. Research is ongoing to establish the extent to which IgG antibodies to SARS-CoV-2 confer immunity to infection.
SARS-CoV-2 antibody tests are not used to diagnose current or active infection.
5mL venous serum or plasma.
Enfer Medical offers the chemiluminescent microparticle immunoassay (CMIA) technology for the qualitative and quantitative determination of IgG antibodies in serum and plasma. The antibodies are specific to the receptor-binding domain (RBD) of the S1 subunit of the spike protein of the SARS-CoV-2 virus. This test is CE-IVD certified.
For clients using the Enfer Medical Client Portal, the Enfer Medical Patient Request Form (PRF) will be generated when you have completed your “Test Request” within the portal linked below.
Please note that samples suspected of containing high risk pathogens such as Mycobacterium tuberculosis should be clearly identified on the form and packed separately from other samples.
Results are available next working day.
This assay is available seven days a week.
The packaging/preparation of samples for delivery to the laboratory are required to be in adherence to all national regulations for the safe transport of biological materials. HSE guidance can be reviewed HERE.
There are specific packaging instructions and labelling requirements requiring triple packaging including:
Further information on the packaging/preparation of samples for delivery to the laboratory is contained within the Enfer Medical Laboratory User Manual which clients are provided with.
Samples must be tested within 4 hours of collection if stored at room temperature. Samples must be tested within 4 days of collection if stored at 2-8°C.
In addition to the packaging of samples, the transport/delivery of clinical samples to the laboratory is required to be in adherence to all national regulations for the safe transport of biological materials. Enfer Medical provides a fully compliant logistics service, aligned with clients’ testing requirements.
Prompt transport of specimens:
To ensure prompt testing of samples and release of results within the published test turnaround times, samples should arrive to the laboratory by 18:00. Test turnaround time is measured from receipt of the sample at the laboratory until the time the authorised results are reported to users.
In rare cases specimens may not be suitable for testing on arrival to the laboratory. In that case the sample will be rejected at the receipt stage and the service user will be notified immediately and an explanation as to why the sample could not be processed will be provided. Reasons why samples cannot be processed include but are not limited to:
Following receipt at the Laboratory, results should be available on the next working day and will be reported to the referring clinician via the Enfer Medical Client Portal or in a format agreed with clients.
Established clients can login to the portal using the link above.
