Increased confidence and efficiency with improved infectious disease diagnostics
For both the patient journey and laboratory efficiency, when diagnosing infectious diseases it is important to get it right and to get it right the first time. CLI caught up with Dr Gaiane Demirdjian, Director of Research & Development at Beckman Coulter Diagnostics, to find out more about how their new line of infectious disease assays does just that.
Please tell us about yourself – what is your experience with working in blood virus diagnostics?
I’m the Director of the Infectious Disease Research & Development Department at Beckman Coulter’s state-of-the-art facility in Marseille. I joined Beckman Coulter about 10 years ago, leveraging 23 years of expertise in biomarker development on automated analysers and a deep understanding of unmet medical needs and clinical and disease states, particularly infectious diseases.
Our expertise in infectious diseases is global. Thanks to our sites in Israel, Ireland, the United States, and France, work on our infectious disease portfolio has been a worldwide effort. Each centre of excellence has its own unique specialties that, combined, strengthen our portfolio.
The Marseille site, for the assay development, holds Blood Virus R&D and Clinical affairs led by more than 20 key experts with tremendous experience and expertise in the field: more than 50 associates dedicated to Blood Virus (BV) assay development on a new DxI 9000 Immunoassay Analyzer.
With the development of immunoassays having begun in 1985, Marseille has since expanded to seven development teams working to deliver the BV portfolio, including the full menu of Hepatitis B, C and A assays and the HIV Ag/Ab Combo assay. The site also specializes in the development of monoclonal antibodies, purification, conjugate synthesis, and process characterization.
Illustration of HIV viral particles (AdobeStock)
What makes the diagnosis of BV infections different from the diagnosis of diseases caused by other infectious agents?
Firstly, testing for infectious disease screening or diagnosis differs from standard immunoassay testing, and from a health perspective the implications for the patient can be life-changing.
As such, laboratories are requesting reliable, highly sensitive tests from their vendors that can provide clear answers and facilitate the implementation of recommended testing algorithms
to streamline patient pathways.
Beckman Coulter provides full care support across a core laboratory – from initial health symptoms all the way to diagnosis and ongoing treatment, including:
• screening: helping to identify health issues with highly sensitive assays;
• diagnosis: helping to confirm patient diagnoses with high-quality results;
• classification: helping to select therapies and deliver care with confidence; and
• monitoring: helping to monitor disease status.
We can achieve this thanks to our portfolio of innovative solutions in immunoassay, hematology, chemistry, microbiology and urinalysis, and are able to deliver quality results more efficiently thanks to our solutions being powered by automation and clinical informatics.
Why is there a need to develop new assays for hepatitis?
Diagnostic tests for infectious diseases such as hepatitis and HIV must continually advance to address both the evolving nature of viruses and the increasing efficiency and quality requirements of laboratories.
One major challenge with the detection of hepatitis B surface antigen (HBsAg) is the increasing number of HBsAg mutants that arise – in part due to the expansion of vaccination. The diagnostic accuracy of immunoassays will be impaired if key mutants are not detectable. During the development of the Access HBsAg and HBsAg Confirmatory assays, Beckman Coulter successfully detected all mutants tested, ensuring the high reliability of the assay on a large panel of the latest HBsAg variants.
Additionally, repeat testing can be a drain on laboratory resources; thus, it is important for laboratories to be able to trust the initial results obtained with HBsAg. New features such as Beckman Coulter’s high positive algorithm, which eliminates the need for repeat testing if the sample-to-cut-off ratio exceeds a specified value, can help drive a more efficient diagnostic process. Using the high positive algorithm, 96.9% of HBsAg positive samples could be reported as positive without any additional repeat or confirmation testing. Reducing repeat testing for HBsAg helps streamline workflows, saves time, and contributes to an overall cost-effective and patient-centric testing approach for laboratories.
For several years now, fourth generation HIV assays (which simultaneously detect HIV-1 p24 antigen and HIV-1/2 antibodies) have been routinely used to support the detection of early HIV infection. There is a growing need not just for simultaneous detection but also for the differentiation of the antigen and antibodies. Sub-results analysis, particularly for the antigen, could facilitate early detection of acute HIV infection. The Access HIV Ag/Ab Combo assay allows for simultaneous qualitative detection and differentiation of HIV-1 p24 antigen and HIV-1/2 antibodies and has demonstrated superior seroconversion sensitivity compared to other widely used immunoassays.
What is Beckman Coulter doing to meet the laboratory needs for reliability and highly sensitive tests and how will these developments aid the diagnostic process?
Improvements in analytical sensitivity support improvements in diagnostic accuracy.
The introduction to the market of the DxI 9000 Analyzer has brought several technological advances, including optimized low-volume pipetting capabilities and a new substrate (Lumi-Phos PRO). These features, in conjunction with optimized assay formulation, improve analytical detection capabilities and support excellent discrimination of non-reactive samples from cut-offs, thus enhancing clinical sensitivity and specificity To further improve reproducibility, the DxI 9000 Analyzer features a dedicated sample precise pipettor to pipette volumes as low as 2 μL with exquisite precision, <2% CV. Precise and accurate delivery of patient samples is a critical step in obtaining accurate test results. PrecisionVision Technology, a novel, patented machine vision technology, ensures that these deliveries are correct for every single test.
What other factors contribute to improvements in the assays?
One major factor is the quality of the raw materials used in the assays, as high-quality raw materials contribute to increased sensitivity in immunoassays.
Well-characterized antibodies and antigens with minimal cross-reactivity ensure the ability of the assay to detect analytes at low concentrations, enhancing its overall sensitivity and diagnostic utility.
As a scientist designing the assay, I acknowledge that sensitivity relies on the quality of antibodies and antigens. The quality of our raw materials helps us to develop solutions that improve both efficiency and confidence for our customers. Because we control the raw material production process, we can tailor each protein to meet the specific needs of each assay. This helps us to ensure the highest quality results, and also helps us to support a strong, reliable supply chain. Additionally, the choice of substrates and detection systems contributes to signal amplification, enhancing the immunoassay’s overall sensitivity.
The author
Gaiane Demirdjian PhD
Director of Research & Development
Beckman Coulter Diagnostics,
13276 Marseille, France
Email: EUPublicRelations@beckman.com
For further information see: https://www.beckmancoulter.com/en/solutions/idbv-solutions
