Revvity’s EUROIMMUN Secures CE Mark for Innovative Measles Antibody Test
Revvity, Inc. (NYSE: RVTY) has announced the launch of EUROIMMUN’s Anti-Measles Virus ELISA 2.0 (IgG), which has received the CE mark. This novel assay is designed to support both the diagnosis of measles virus infections and the determination of immune status against the virus. The newly developed test is the first in a series of assays EUROIMMUN is working on to expand its serological infection diagnostics portfolio. Notably, it has been validated for use with dried blood spots (DBS), in addition to the more conventional serum and plasma samples.
The introduction of the Anti-Measles Virus ELISA 2.0 (IgG) comes at a critical time as global measles cases continue to rise. Measles is a highly contagious viral disease that spreads through airborne transmission and can lead to severe complications, including pneumonia, encephalitis, and even death, particularly in young children and immunocompromised individuals. Public health organizations around the world have been working to enhance surveillance and prevention strategies, and access to accurate, reliable, and widely available diagnostic tests is a key component of these efforts.
Addressing the Need for Dried Blood Spot Testing in Measles Diagnostics
Traditionally, diagnosing measles or confirming immunity has required venous blood samples, which may pose challenges in certain settings. In contrast, the use of dried blood spots allows for a much simpler and less invasive method of sample collection. A few drops of capillary blood, typically obtained via a simple finger prick, are deposited onto a special paper card. Once dried, these samples can be sent to diagnostic laboratories for analysis, making the process more accessible for patients and healthcare providers alike.
The benefits of using dried blood spot testing extend beyond convenience. Since DBS samples are more stable than liquid blood samples, they can be transported and stored more easily, particularly in remote areas or regions where medical infrastructure is limited. This innovation makes serological testing for measles more feasible in epidemiological studies, mass immunization programs, and routine diagnostic settings.
Until now, no commercial assay was available for detecting anti-measles virus IgG antibodies using DBS samples. Laboratories that sought to use DBS had to conduct their own validation procedures, which could be both time-consuming and resource-intensive. With the launch of the Anti-Measles Virus ELISA 2.0 (IgG), EUROIMMUN is filling this critical gap by providing an In Vitro Diagnostic Regulation (IVDR)-compliant solution that is ready for immediate implementation.
“Because there was no commercial assay for detecting anti-measles virus IgG antibodies using a DBS sample, diagnostic laboratories have had to validate DBS on their own,” said Dr. Lars Komorowski, Chief Scientific Officer of EUROIMMUN. “Now we can fill this gap by offering an IVDR-compliant solution.”
Enhancing Global Surveillance and Immunization Strategies
The availability of the Anti-Measles Virus ELISA 2.0 (IgG) with DBS validation has important implications for public health efforts worldwide. As measles outbreaks continue to emerge in various regions, particularly in communities with low vaccination coverage, health authorities must be equipped with effective tools for monitoring immunity levels and identifying new cases.
The test can be used for various purposes, including:
- Surveillance and Outbreak Investigations: Health agencies can track immunity levels within populations, helping to identify gaps in vaccine coverage and respond more efficiently to outbreaks.
- Serological Surveys: Researchers can study immunity trends over time, assessing the impact of vaccination campaigns and natural infection rates.
- Routine Diagnostic Testing: Clinicians can confirm suspected measles cases, ensuring appropriate treatment and isolation measures are taken to prevent further transmission.
Additionally, the ability to use DBS samples in serological testing enhances accessibility for individuals who may not have easy access to traditional healthcare facilities. This is particularly valuable for:
- Children and Elderly Patients: Since venous blood draws can be distressing for pediatric and geriatric populations, the finger-prick method used for DBS collection is a more patient-friendly alternative.
- Remote and Underserved Communities: DBS collection does not require specialized personnel or immediate refrigeration, making it an ideal option for use in areas with limited healthcare infrastructure.
- Travelers and Migrant Populations: The portability and stability of DBS samples facilitate immune status assessments in transient populations, supporting broader public health initiatives.
Automation and Scalability in Measles Diagnostics
EUROIMMUN has also ensured that the Anti-Measles Virus ELISA 2.0 (IgG) is compatible with both manual and automated laboratory workflows. This flexibility allows laboratories to integrate the assay into existing diagnostic procedures efficiently. EUROIMMUN’s scalable solutions for DBS processing and ELISA testing make it easier for labs of all sizes to adopt the new technology and enhance their diagnostic capabilities.
The test’s compatibility with automation is particularly valuable for large-scale screening programs. High-throughput laboratories can process significant volumes of DBS or traditional blood samples quickly and efficiently, improving turnaround times for results and enabling more timely public health responses.
The Future of Serological Testing for Infectious Diseases
The launch of the Anti-Measles Virus ELISA 2.0 (IgG) marks an important milestone in the ongoing evolution of serological testing for infectious diseases. As EUROIMMUN continues to develop additional assays within its infection diagnostics portfolio, the integration of DBS validation may become a standard feature, enhancing accessibility and ease of use for a wide range of applications.
The growing interest in DBS testing extends beyond measles diagnostics. Many other infectious diseases could benefit from similar advancements, including rubella, varicella, and even emerging viral threats. The ability to test for immunity or active infections using a simple, non-invasive sample collection method could revolutionize disease surveillance and control efforts worldwide.
As EUROIMMUN advances its research and development efforts, the company remains committed to innovation and scientific excellence. By expanding its range of CE-marked assays and ensuring compliance with stringent regulatory standards, EUROIMMUN is positioned to play a leading role in the future of diagnostic testing.
