IVD Antibody & Immunoassay Development Services for Inflammatory Bowel Disease Biomarkers

Creative Biolabs has extensive experience in the in vitro diagnostic (IVD) antibody as well as diagnostic test/assay development targeting a wide range of biomarkers of different diseases. Especially, here we introduce the biomarkers and antibody/immunoassay development services for inflammatory bowel disease (IBD).

Introduction to IBD

IBDs, mainly consisting of Crohn’s disease (CD) and ulcerative colitis (UC), are lifelong, chronic intestinal disorders, which are characterized by periods of remission and recurrent relapse. These gastrointestinal disorders can manifest with various symptoms, such as diarrhea, pain, and bleeding in individuals of any age, affecting the physical, psychological, familial, and social aspects of life. At present, the specific cause of IBD is unknown, but the hypothesis describing IBD as a result of the interaction of environmental and genetic factors is most accepted. Detecting the presence of IBD is critical in the assessment of individuals presenting with symptoms suggestive of this disease. Discerning which patients require further investigations to establish a diagnosis is important to ensure timely diagnosis and medications. Besides, disease monitoring in the ongoing management following therapeutic intervention and prediction of disease relapse after medication are also important.

Diagnostic Tools of IBD

Diagnosis of IBD has so far relied on a combination of clinical evaluation (symptoms), radiology and endoscopy, in conjunction with histological examinations and imaging techniques. These diagnostic tools are time-consuming, costly, invasive, and/or not necessarily objective. Blood tests that provide an indirect measurement of disease activity have been developed through the detection of biomarkers such as C-reactive protein (CRP) and erythrocyte sedimentation rate (ESR). These tests are now commonly used but have insufficient sensitivity and specificity for intestinal inflammation. Studies have concentrated on the discovery of more reliable and specific biomarkers in both blood and stool samples.

Serological markers including p-ANCA, ASCA, CBir1, anti-I2, anti-OmpC, ALCA, ACCA, AMCA, anti-L, and anti-C, have been discovered to correlate with IBD. Stool markers have also emerged as new diagnostic tools to detect intestinal inflammation, such as calprotectin and lactoferrin.

Fecal markers of intestinal inflammation. Fig.1 Fecal markers of intestinal inflammation. (Däbritz, 2014)

IVD Antibody & Immunoassay Development Services Provided by Creative Biolabs

Non-invasive diagnostic tests based on the measurement of disease markers or infectious pathogens in easily obtained biological samples with IVD immunoassays are of great importance in the diagnosis of IBD. These IVD immunoassays use antibodies/antigens that are specific for the analyte and generate quantitative or qualitative information in a sensitive and rapid manner. Different signal detection methods have been developed, which results in the emergence of a broad array of immunoassay platforms, including ELISA (enzyme-linked immune-sorbent assay), LFIA (lateral flow immunoassay), CLIA (chemiluminescent immunoassay), IHC (immunohistochemistry), etc.

The development of biomarker-specific IVD immunoassays is a time-consuming, resource-intensive effort. Particularly, the use of high-quality elements, antibodies, and antigens, is of great importance to achieve high sensitivity and accuracy. Creative Biolabs has built a versatile IVD platform to provide custom IVD antibody development services for a broad range of disease biomarkers. Besides, we also help our clients with contract research in immunoassay design, critical raw material sourcing, component formulation, assay optimization & validation, and kit production. For more information please click the links below:

Workflow for production of an Immunoassay

For IBD, we focus on various biomarkers including but not limited to:

Features of Our Services

  • Our repertoire includes both established and novel biomarkers
  • A specialized technical team and abundant experience in antibody/immunoassay development
  • State-of-the-art techniques and short turnaround time
  • Services are tailored to meet the needs of our valued IVD clients

Please feel free to contact us for more information and a quote.

References

  1. Däbritz, J., (2014). "Diagnostic utility of faecal biomarkers in patients with irritable bowel syndrome." World journal of gastroenterology: WJG, 20(2), 363.
  2. Beniwal, P., (2010). "The status of diagnostic markers for inflammatory bowel disease." Current gastroenterology reports, 12(6), 479-484.

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