BIVDA offers testing progress update following Roche approval

The British In Vitro Diagnostics Association (BIVDA) has said it is delighted to see IVD making headlines following the approval of Roche Diagnostics’ COVID-19 antibody test by Public Health England.

The IVD industry has been working over the past few months to develop and manufacture tests and reagents for healthcare systems around the world. Initially this was focussed on tests to detect actively infected individuals mostly using PCR technology from swab samples. The focus has now moved to laboratory-based tests for antibody in blood, while companies are also continuing to refine and improve the lateral flow technology which would allow for antibody testing from a finger prick of blood.

Commenting on the progress made so far, BIVDA chief executive Doris-Ann Williams said: “The government are in the process of revising their testing strategy to cover the next 9-12 months and the IVD industry will continue to support in any way possible but there are questions within the BIVDA membership over apparent pre-selection of laboratory antibody tests from a small number of companies when others with CE marked tests have not been selected for evaluation by Public Health England.”

A number of other companies who have had CE marked kits available for a longer period are still undergoing evaluation.

Roche’s Elecsys Anti-SARS-CoV-2 antibody test has a specificity greater than 99.8% and 100% sensitivity (14 Days post-PCR confirmation) and can help assess patients’ immune response to the virus. As more is understood about immunity to SARS-CoV-2, the test may help to assess who has built up immunity to the virus.

Through a blood sample, the test, which is based on an in-solution double-antigen sandwich format, can detect antibodies to the new coronavirus causing COVID-19, which could signal whether a person has already been infected and potentially developed immunity to the virus. Based on the measurement of a total of 5,272 samples, the Elecsys Anti-SARS-CoV-2 assay has 99.81% specificity and shows no cross-reactivity to the four human coronaviruses causing common cold. This means it can lower the chance of false positives due to the detection of similar antibodies that may be present in an individual, but are specific for coronaviruses other than SARS-CoV-2. Elecsys Anti-SARS-CoV-2 detected antibodies with 100% sensitivity in samples taken 14 days after a PCR-confirmed infection.

After the test received CE marking earlier on this month, Geoff Twist, managing director of Roche Diagnostics UK & Ireland, said: “Reliable antibody testing is the crucial next step in helping us to understand the spread of the virus and to provide much-needed reassurance to our valued key workers, enabling them to continue providing their vital support.

“More than ever, it is critical that industry works in collaboration with the NHS to help alleviate pressures and provide a solution, and we are extremely proud to be able to deliver our high quality antibody test, which will lead to greater confidence as we move into the next phase.

“We will continue to work closely with the NHS, public health bodies and the UK government to enable the roll out of the test across the UK.”