Creative Diagnostics advances IgM diagnostic testing with human hybrid monoclonal antibodies
Creative Diagnostics has launched a comprehensive range of human hybrid IgM control monoclonal antibodies designed to overcome critical challenges in diagnostic assay development. The new product line addresses the persistent difficulty of sourcing reliable IgM-positive control materials for infectious disease testing across multiple pathogens including CMV, HSV, measles, mumps, rubella, and varicella-zoster virus.
Innovative solution to IgM testing challenges
The breakthrough addresses a fundamental problem in diagnostic development. “Sourcing these sera can be complex and time-consuming, and it can sometimes be impossible to find suitable materials,” the company notes. IgM antibodies present particular challenges because “IgM levels fluctuate during an immune response” and each disease exhibits “unique variations in IgM levels and characteristics.”
Traditional approaches rely on characterized disease state sera – samples from infected individuals – which serve as critical reference materials for test validation. These materials ensure diagnostic tests meet regulatory requirements for sensitivity, reproducibility, and accuracy whilst functioning as calibration standards and quality control tools.
Advanced manufacturing approach delivers consistency
Creative Diagnostics’ solution employs transgenic mice expressing human IgM heavy chain constant regions to produce the monoclonal antibodies. The manufacturing process concentrates these antibodies and incorporates them into an “IgG-removed and defatted human serum matrix to ensure the final product closely resembles IgM-positive human plasma in the natural disease state.”
Rigorous validation demonstrates that these hybrid materials “behave in an almost identical manner to their natural counterparts” in both ELISA and bead-based applications, providing laboratory scientists with reliable alternatives to difficult-to-source natural sera.
Comprehensive pathogen coverage enhances laboratory capabilities
The product portfolio includes specific antibodies for major infectious diseases. The Anti-CMV monoclonal antibody (DMAB-CLS25048) targets cytomegalovirus, which ranges “from asymptomatic to severe end-organ dysfunction in immunocompromised patients.” Similarly, the Anti-HSV-1/2 monoclonal antibody (DMAB-CLS25049) addresses herpes simplex virus testing needs for this “common infection that causes painful blisters or sores.”
Additional products cover measles virus (MeV), mumps virus (MuV), rubella virus (RuV), Mycoplasma pneumoniae, Toxoplasma gondii, and varicella-zoster virus, providing comprehensive infectious disease testing support.
Quality assurance meets regulatory standards
Manufactured under ISO 13485 standards, the antibodies deliver “exceptional quality and reproducibility” with consistent lot-to-lot performance. This quality framework enables laboratory researchers to “enhance the accuracy and reliability of their diagnostic tests” whilst providing what Creative Diagnostics describes as a “stable, high-performance, and ethically sourced supply of control materials.”
The development represents a significant advancement in diagnostic assay standardisation, offering clinical laboratories reliable alternatives to the traditional challenges of sourcing appropriate IgM control materials for infectious disease testing.
For more information, visit: https://www.creative-diagnostics.com/new-human-hybrid-igm-control-monoclonal-antibody.htm
Digital issue: Please click here for more information
