Siemens Healthineers has launched a COVID-19 test in Europe that can measure the levels of neutralising antibodies in the blood.
The SARS-CoV-2 IgG Antibody Test (sCOVG) has the ability to detect neutralising antibodies and reports quantitative results, measuring the levels present in a person’s blood sample.
Healthineers announced today that the sCOVG test has now achieved a CE mark, meaning that it can be marketed in the EU.
The medical technology company also announced that it has submitted an emergency use authorisation (EUA) application for the test to the US Food and Drug Administration (FDA).
Neutralising antibody levels are an important indicator of immune response to infectious diseases, including COVID-19. This type of antibody is capable of neutralisation, ie, the process of blocking the virus from infecting more cells.
Healthineers added in a statement that the sCOVG test could help to understand the effectiveness of COVID-19 vaccines, some of which could soon score regulatory approval.
By measuring neutralising antibody levels, the test could give an indication of the level of immunity that is provided by a vaccine for the SARS-CoV-2 virus, which causes COVID-19.
“Healthcare providers can feel confident that our test will help them determine whether a patient’s immune system is producing the right antibodies to stop or prevent COVID-19 infection,” said Deepak Nath, president of laboratory diagnostics at Siemens Healthineers.
In July, Healthineer’s SARS-CoV-2 Total (COV2T) test proved the most effective out of four COVID-19 antibody tests evaluated in a comparative study conducted by Public Health England and Oxford University.
Aside from the COV2T test, the researchers evaluated Abbott’s SARS-CoV-2 Immunoassay, DiaSorin’s LIAISON SARSCoV-2 S1/S2 IgG and Roche’s Elecsys Anti-SARS-CoV-2.
For each test, the researchers calculated the sensitivity and specificity values, which were then compared to the performance target set by the UK Medicines and Healthcare products Regulatory Agency (MHRA) of 98% across both criteria.
The Healthineers test came out on top, with a sensitivity value of 98.1% and a specificity value of 99.9%, proving more effective than the assays from Abbott, Roche and Diasorin.
It was also the only test to meet the target set by the MHRA across both specificity and sensitivity values, with the other three tests only meeting the specificity targets.