Bio-Shield 2019-nCoV Total Ig | Excellent sensitivity & specificity

5/2020

Bio-Shield 2019-nCoV Total Ig demonstrated excellent sensitivity & specificity in the latest clinical performance study conducted in the reference for SARS-CoV-2 laboratory of Aristotle University of Thessaloniki

ProGnosis Biotech has recently developed three ELISA kits for the determination of antibodies against SARS-CoV-2. These tests are a truly reliable diagnostic tool that determines individuals’ exposure to the virus providing comprehensive answers regarding infection rates and potential immunity. Our company’s antibody tests are demonstrating highly accurate results as proven by recent evaluation studies.

On the 5th of May 2020, at the second Department of Microbiology, School of Medicine, of the Aristotle University of Thessaloniki, which serves as one of the official Reference Laboratories for SARS-CoV-2 in Greece, took place the latest performance study of our company’s ELISA antibody tests. The study aimed to evaluate the sensitivity and the specificity of the ELISA kit, Bio-Shield 2019-nCoV Total Immunoglobulins which determines the IgA, IgM, IgG antibodies against SARS-CoV-2.

For the evaluation, 76 positive and 86 negative samples were examined (162 in total). The positive samples had been priorly confirmed by RT-PCR in several reference laboratories of Northern Greece, while the negative ones had been collected prior to the pandemic.

The Bio-Shield 2019-nCoV Total demonstrated excellent results in terms of sensitivity and specificity (98,68% and 100% respectively), for the total number of antibodies against the SARS-CoV-2. Additionally, for samples that were collected after the first 7 days from the onset of the symptoms, both their sensitivity and specificity reached  100%.

ProGnosis Biotech has also developed the Bio-Shield 2019-nCoV IgG that specifically determines the IgG antibodies against SARS-CoV-2, as well as the Bio-Shield 2019-nCoV IgM which determines the IgM antibodies. The three ELISA antibody tests can be used by any research and medical laboratory and they are compatible with automated ELISA systems. These tests enable more reliable estimates of SARSCoV-2 prevalence and they offer valuable insights for epidemiological studies while they are useful for the evaluation of asymptomatic individuals.