SARS-CoV-2 (COVID-19) antibodies

6 liquid samples (minumum 0,3 ml) of human plasma.

4 surveys per year. This program is not accredited according to DIN EN ISO/IEC 17043:2010.

Analytical parameters

anti-SARS-CoV-2 IgA, anti-SARS-CoV-2 IgG, anti-SARS-CoV-2 IgM, anti-SARS-CoV-2 total antibodies

In the current epidemiological situation, serological analysis of SARS-CoV-2 (COVID-19) is becoming increasingly important. As a supplement to direct detection of the pathogen by NAT/PCR, antibody tests can provide valuable information on whether patients/persons have already had contact with the SARS-CoV-2 pathogen resulting in an immune response by their body. This is particularly relevant for persons from the risk group or for personnel in critical areas (hospitals, nursing, medical practices, schools, police etc.).

With the increasing availability of newly developed tests for the detection of antibodies against SARS-CoV-2 (COVID-19), ESfEQA introduces a new EQA program for medical laboratories to support them in the quality assurance of the serological diagnostics of SARS-CoV-2 (COVID-19). Since the development and approval of the tests in this special situation had to take place under accelerated conditions, the findings from this EQA program are particularly important for the laboratories to assess to the diagnostic sensitivity and specificity of the various tests in routine testing.

For survey samples challenging the sensitivity of the different assays we use sample material from patients who have undergone a SARS-CoV-2 infection. In the evaluation report we will provide clinical information about the donors, such as, if applicable, date of onset of symptoms, date of positive PCR result, date of negative PCR result, date of plasma donation.For survey samples challenging the specificity of the analytical system we will use donor material from 2019 and previous years.