At Creative Biolabs, in vitro diagnostic (IVD) kit or assay development services are backed by years of experience and over a hundred immunoassay kits that have been developed, manufactured, and distributed to countries across the globe. We have scientists that are expert in the development of immunoassays of different formats. Whether you are developing an ELISA/EIA or immunohistochemistry, western blot or lateral flow assay, our IVD products are differentiated from high-performance formulations that provide a quicker path to commercialization. With our reliable newly developed antibodies and antigens, and state-of-the-art facilities, we can develop the most sensitive, reproducible immunoassays and immunodiagnostic kits in the world.

IVD Kit Development

ELISA

Enzyme-Linked Immuno Sorbent Assay (ELISA) kits are widely used for the in vitro quantitative measurement of different disease biomarkers in human serum, urine or stool samples. The principle of ELISA is the binding of a labeled specific antibody to the target antigen, which is also called analyte. The enzyme (or other labels) can react with the substrates, producing detectable signals. Based on different signal detection methods, ELISAs Colorimetric ELISA, Chemiluminescent ELISA, Electrochemiluminescence, Immuno-PCR, and so on, Creative Biolabs helps our clients develop different ELISA assays formats, including sandwich and competitive assays.

IVD Kit Development

RadioImmunoAssay (RIA)

A RIA is an immunoassay that uses radiolabeled (3H, 125I, and 14C) molecules in a stepwise formation of immune complexes. The radioactivity of the molecules can be measured to analyze and quantitate small molecules, peptides, and proteins in biological samples. It is an old assay technique but it is still widely used and continues to offer distinct advantages in terms of simplicity and sensitivity.

Lateral-Flow Immunochromatographic Assay (LFIA)

LFIA is a simple and rapid diagnostic device used to confirm the presence or absence of a target analyte (e.g., pathogens or biomarkers in humans or animals, contaminants) in the sample matrix. Lateral flow tests are widely used in human health for point of care testing. Creative Biolabs develops lateral flow assays with different labels (e.g., gold, magnetic beads, colored latex nanoparticles).

Latex particle-enhanced Turbidimetric Immunoassay (LETIA)

LETIA is an accurate and stable assay commonly used to quantify serum protein in a homogenous system. In LETIA, antibodies are covalently attached to polymer latex microspheres with antigen binding sites exposed. The turbidity of the solution is changed when the antibody-microsphere-antigen complex is formed and the absorbance at a specific range is correlated to antigen concentration. This assay does not require specific instruments, merely a general automated analyzer, and have the advantages of decreased operating time and reduced costs together with an overall integration with other clinical chemistry analyses.

IVD Kit Development

Western Blot

The western blot method is composed of a gel electrophoresis to separate native proteins, followed by an electrophoretic transfer onto a membrane and an immunostaining procedure to visualize a certain protein on the blot membrane. The HIV test, for example, employs a western blot assay to detect anti-HIV antibody in human serum. Generally, HIV viral antigens are transferred onto test strips for detection of specific antibodies. This assay is sensitive, reliable, and easy to run.

IVD Kit Development


Immunohistochemistry

Immunohistochemical staining is widely used in the diagnosis of abnormal cells such as tumors. It exploits the principle of antibodies binding specifically to antigens in biological tissues. The visualization of the interaction can be accomplished by using different antibody conjugates, such as enzymes and fluorophores.

Flow Cytometry

Flow cytometry is a technology that is used to analyze the physical and chemical characteristics of particles in a fluid as it passes through at least one laser. Cell components are fluorescently labeled and then excited by the laser to emit light at varying wavelengths. Specific antibodies for flow cytometry can be produced targeting cell surface antigens.

Microplate Coating

Creative Biolabs offers a wide range of microplate coating services including poly-D-lysine, collagen, streptavidin coating, antibody coating, and other coatings on request. We offer plates of different sizes and formats. Moreover, we work side-by-side with our clients to select the right coating surfaces and coating process designs.

The technical team at Creative Biolabs is highly skilled in IVD kit development. Using novel techniques and formulations, they are often able to overcome obstacles in development and build robust, reproducible assays for our clients. If you are interested in any of our services or have a specific assay that you want to develop, please contact us and we would be happy to help. Our knowledgeable team will be able to provide you with a highly competitive quote with realistic turnaround times.



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45-1 Ramsey Road, Shirley, NY 11967, USA
Tel: 1-631-381-2994
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