Creative Diagnostics Launches Human Hybrid IgM Control Monoclonal Antibodies to Accelerate Diagnostic Assay Development

Creative Diagnostics releases its new Human Hybrid IgM Control Monoclonal Antibodies for research applications.

NEW YORK, NY, UNITED STATES, June 23, 2025 /EINPresswire.com/ -- Creative Diagnostics, a leading manufacturer and supplier of antibodies, antigens and assay kits, has announced release of its new line of Human Hybrid IgM Control Monoclonal Antibodies for research applications, covering a range of diseases such as CMV, HSV, MeV, MuV, RuV, and VZV.

Characteristic disease state sera are serum samples derived from individuals with specific conditions or diseases. These sera are valuable for many aspects of diagnostics, especially for developing and validating diagnostic tests. For instance, characterized disease state sera ensure that diagnostic tests can reliably and accurately identify individuals with a specific disease while meeting regulatory parameters such as sensitivity, reproducibility, and accuracy. They can also be used as optimization tools, calibration standards, reference materials, and quality control tools.

However, sourcing these sera can be complex and time-consuming, and it can sometimes be impossible to find suitable materials. This is especially true of IgM sera because IgM levels fluctuate during an immune response. Additionally, each disease type has unique variations in IgM levels and characteristics, so expert knowledge is required beforehand.

To address these challenges, Creative Diagnostics has introduced an alternative to hard-to-find human disease state IgM plasma. These human hybrid IgM control Mab materials cover a wide range of diseases, including CMV, HSV, MeV, MuV, RuV, M. pneumoniae, T. gondii, and VZV. The monoclonal antibodies are produced in transgenic mice that express the human IgM heavy chain constant region. The antibodies are then concentrated and added to 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 testing in ELISA and bead-based applications has shown that the products behave in an almost identical manner to their natural counterparts.

For example, Creative Diagnostics offers Anti-CMV monoclonal antibody (DMAB-CLS25048) to formulate calibrators and controls for CMV IgM assays. Cytomegalovirus (CMV) is widespread, with manifestations ranging from asymptomatic to severe end-organ dysfunction in immunocompromised patients with congenital CMV disease. In addition, Creative Diagnostics provides the Anti-HSV-1/2 monoclonal antibody(DMAB-CLS25049) to prepare calibrators and controls for the HSV-1/2 IgM assay. Herpes simplex virus (HSV), also known as herpes, is a common infection that causes painful blisters or sores. It spreads primarily through skin-to-skin contact, and it is treatable but not curable.

Manufactured under ISO 13485 standards, this new portfolio of antibodies can ensure exceptional quality and reproducibility. Their lot-to-lot consistency and performance will empower laboratory researchers to enhance the accuracy and reliability of their diagnostic tests. Creative Diagnostics can now provide clients a stable, high-performance, and ethically sourced supply of control materials.

For more information about the Human Hybrid IgM Control Monoclonal Antibodies or other other research tools, please visit https://www.creative-diagnostics.com/new-human-hybrid-igm-control-monoclonal-antibody.htm.

About Creative Diagnostics

Creative Diagnostics is a leading manufacturer and supplier of antibodies, viral antigens, innovative diagnostic components, and critical assay reagents. In addition to providing contract R&D and biologic manufacturing services for diagnostic manufacturers along with GMP biologics manufacturing for the biopharmaceutical market, the company aims to continue to act as a trusted source for all researchers' assay development and manufacturing needs.

Thomas Schmitt
Creative Diagnostics
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