International symposium for leading virologists provides European launchpad for new range of infectious disease assays
An international symposium on infectious disease testing staged recently by Bayer HealthCare diagnostics division gave leading European virologists a unique opportunity to discuss current trends and learn about the company's newly launched range of infectious disease immunoassays.
This assay range, comprising methods for rubella, toxoplasmosis, hepatitis B, hepatitis C and HIV as well as antibiotic assays is designed for use on Bayer's Advia Centaur immunoassay system, providing virology and microbiology laboratories with a total solution for high throughput automated viral serology.
Launch of these assays is the latest product of the company's long history of collaboration with microbiologists, spanning 75 years.
The two-day symposium, entitled 'Advances in infectious disease testing', was a CPD-accredited scientific event held at Bayer's global corporate headquarters at Leverkusen, Germany.
It was attended by some 250 delegates from laboratories across Europe, including representatives from the regional virus laboratories and teaching hospitals, as well as several other UK and Ireland hospital laboratories.
Professor Michael Roggendorf from Essen University Hospital, Germany, gave a presentation highlighting the diagnostic importance of the new assays.
He explained how they enable a differential diagnosis to be made between acute and chronic infection and allow the early signs of seroconversion to be identified.
He explained some of the clinical issues that can occur when assays do not meet performance specifications and outlined his own personal wishlist for hepatitis B and C assays.
Bayer's Robert Dwyer answered many questions from the audience regarding development of the assays.
Coining the phrase "wash away your problems" with regard to the wash steps included in the assay architecture, he particularly highlighted the high delta value of the new hepatitis C assay which eliminates concerns about false positive results.
Considerable interest was expressed in the results of parallel evaluation studies carried out in the laboratories of Fondation Merieux in France to assess the new hepatitis B and C assays.
Delegates learned that excellent results had been obtained in terms of the assays' high sensitivity and specificity, based on evaluation data resulting from over 28,000 tests.
Paul Taylor, consultant clinical scientist in the department of virology at St Mary's Hospital, London, described how automation of serology testing using the Advia Centaur allows substantial testing volumes to be processed at high speed.
He stated that this is particularly useful when dealing with the increasing workloads generated by increased hepatitis and HIV screening as has been recommended for pregnant women.
Jim Hughes, senior vice president of manufacturing at Walpole, addressed delegates on the application of quality systems to virology testing, describing the state-of-the-art facilities used for manufacture of the assays and the company's excellent compliance record.
The manufacturing facility produces 350 million tests per year, and is subject to regular Federal Drug Administration (FDA) and Lloyds Register Quality Assurance (LRQA) inspections.
Patient panels are utilised for quality control purposes, with samples from 100 negative patients being utilised for QC testing of all infectious disease assay batches.
For many delegates, this symposium was their first introduction to Bayer HealthCare, a subgroup of Bayer which combines the global activities of the company's animal health, biological products, consumer care, diagnostics and pharmaceuticals divisions.
