A serological test is a way to tell if someone’s immune system has learned to create antibodies that fight a particular infection. In some cases of COVID-19 without severe symptoms, the serological test may be the only way to confirm that someone has immunity after the virus itself has already cleared out of their body.
The VirIntel COVID-19 Antibody Test is a qualitative in vitro diagnostic test for the detection of antibodies to SARS-Cov-2 in human serum samples. The test identifies individuals with an adaptive immune response to SARS-CoV-2, indicating recent or prior infection. Serological surveys are also used in epidemiological studies to determine the prevalence and spread rate of a disease within a population.
VirIntel's COVID-19 Antibody Test allows detection of IgG antibodies to two proteins of SARS-CoV-2 providing comprehensive data on the immune response to the infection:
The clinical performance of the VirIntel COVID-19 Antibody Test was assessed with specimens obtained from a general asymptomatic population of pre-epidemic individuals and specimens from donors recovered from COVID-19.
A total of 89 specimens collected prior to the outbreak of the COVID-19 pandemic were tested. Five of these specimens were HIV positive. The test results were considered positive if both RBD and N analysis results appeared above the respective thresholds. The study yielded no false positives results; thus, the specificity of the test was 100% (89/89).
A total of 31 specimens (COVID-19 Panels A-1 and A-2, Access Biologicals, LLC) from donors who were determined COVID-19-positive using a SARS-CoV-2 RT-PCR assay (TaqPath COVID-19 Combo kit, ThermoFisher Scientific) 4-8 weeks before the blood draw were used for the clinical sensitivity validation. The test results were considered positive if both RBD and N analysis results appeared above respective thresholds. The study yielded 2 false negative results; thus, the sensitivity of the test was 93.6% (29/31).
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