SARS-CoV-2

COVID-19 Diagnostics, available at BMD

SARS-CoV-2 (Severe Acute Respiratory Syndrome Coronavirus 2) is a new pathogen that emerged in the Chinese province of Hubei in December 2019 and spread worldwide in the following months having been declared pandemic in March 2020. Coronaviruses are enveloped, positive‐sense, and single‐stranded RNA viruses. SARS-CoV-2 shows great genetic homology with SARS-CoV and other SARS-like bat coronaviruses.

According to EU recommendations, timely and accurate COVID-19 laboratory testing is an essential part of the management of COVID-19 for slowing down the pandemic, supporting decisions on infection control strategies and patient management at healthcare facilities, and detecting asymptomatic cases that could spread the virus further if not isolated.

SARS-CoV-2 can be diagnosed in the laboratory by direct methods to antigen and nucleic acid detection or by serological test to measure the presence of IgM and IgA or IgG antibodies. The spike protein and the nucleoprotein have been suggested as the main targets for the measurement of antibody responses.

Our proposal:

MOLECULAR ASSAYS

SARS-CoV-2 detection kit

IMMUNOASSAYS

COVID-19 IgG, IgA/M rapid test, ELISA and CLIA

QC & EQA

Third party quality controls for PCR, CLIA, Elisa, IFA, Immunoblot and Lateral-flow (rapid) tests