How are plasma and serum controls helping progress allergy, autoimmune and infectious disease diagnostics

Diagnosing conditions such as infectious diseases, autoimmune disorders, and allergies demands diagnostic assays with exceptional sensitivity, specificity, and reproducibility. At the core of many of these assays are two critical biological materials—human plasma and serum.

The development and validation of diagnostic assays requires plasma and serum for the manufacture of controls and calibrators. These matrices help maintain assay consistency across batches over time, thereby supporting regulatory compliance and accurate diagnosis. To understand this better, we will discuss how Biosynth’s plasma and serum support key diagnostic areas and drive innovation in assay development.

IgE Serum and Plasma Controls in Allergy Diagnostics

Allergic diseases are increasing, making the accurate diagnosis of causative allergens critical so that patients can avoid triggers. Several allergy diagnostics exist:

Skin prick test – the skin is lightly scratched, and a solution of a potential allergen (e.g., pollen, pet dander, dust mites, foods) are applied. The area of skin is then examined for a reaction. While this test is painless and has minimal side effects, it is less reliable with food allergens. The results are also difficult to interpret in patients with dermatographism or eczema.

ELISA – measures serum allergen-specific IgE concentrations, using an anti-IgE capture antibody. This method has reasonable specificity, is safe, and is successful for patients with skin conditions.

IgE Controls and Calibrators

For the calibration and validation of allergy tests, myeloma IgE serum has been the raw material of choice. However, locating this natural product can be challenging, and companies are often forced to hold large volumes in stock or face potential out-of-stock situations.

Compared to native myeloma plasma, Biosynth’s cell culture-derived IgE product is derived from a human myeloma cell line, ensuring lot-to-lot consistency without relying on a donor and the associated concerns that can accompany natural products. Contact us for more information.

Autoimmune Disease Serum and Plasma

Autoimmune diseases occur when the immune system, i.e., autoantibodies, mistakenly targets the body’s own cells, leading to chronic inflammation and tissue damage. Early and accurate diagnosis is crucial, as delays in treatment can cause serious complications. In autoimmune disease diagnostics, serum and plasma samples that closely mimic those from real patients serve as positive controls in the development and validation of assays that detect autoantibodies and other disease markers with high sensitivity and specificity.

Anti-Nuclear Antibodies

Anti-nuclear antibodies (ANA) are autoantibodies that target components of the nucleus of cells. Their presence is significant in diagnosing autoimmune diseases, particularly systemic lupus erythematosus (SLE), where ANA is positive in >95% of cases. Other autoimmune disorders with positive ANA include sjögren’s syndrome, systemic sclerosis (scleroderma), mixed connective tissue disease (MCTD), polymyositis/dermatomyositis, rheumatoid arthritis (RA), and autoimmune hepatitis.

Several laboratory methods can screen for ANA, each with varying sensitivity, specificity, and clinical relevance.

Indirect immunofluorescence (IFA) - patient serum is incubated with human epithelial cells, and if ANA are present, they bind to the cell nuclei. A fluorescent-labeled antibody is added, and fluorescence patterns are analyzed under a microscope. Titers of ANA are measured, and ANA patterns in immunofluorescence can diagnose specific diseases for example:

· Homogeneous Pattern - SLE, drug-induced lupus

· Speckled Pattern - SLE, Sjögren’s, MCTD

· Centromere Pattern - Limited scleroderma (CREST syndrome)

· Nucleolar Pattern - Systemic sclerosis

Figure 1: Anti-nuclear antibody patterns in patients with SLE. Image taken and adapted from Al-Mughales, 2022

Although immunofluorescence is sensitive and widely used, interpretation of specific ANA patterns is subjective and requires trained personnel. Quantitative methods like ELISAs can be used to overcome such issues.   

ELISA – patient serum containing ANA binds to purified nuclear antigens coated on a plate, triggering a color reaction. Automated ELISAs can test multiple samples at once and reduce the risk of human error. But, compared to IFA it has lower sensitivity and cannot differentiate between specific ANA patterns. Therefore, there is still a need for innovation in diagnostics that addresses these inherent limitations of the current methods.

To support our customer developing autoimmune disease diagnostic tests, Biosynth has a range of ANA biofluid products:

Other autoimmune diseases Biosynth’s plasma and serum products are serving:

Infectious Disease

Bordetella Pertussis

Bordetella pertussis is a gram-negative, aerobic, coccobacillus bacterium that is the primary cause of whooping cough. Early diagnosis is crucial to prevent the spread of the disease, but it can be challenging due to its similarity with other respiratory infections. Therefore, patient diagnosis often relies on laboratory tests like PCR, culture tests, and serology, all of which have their advantages and limitations.

For the development of accurate serology assays with reduced variability, Biosynth has a range of specialized Bordetella pertussis serum and plasma products:

Infectious disease reagents is one of Biosynth’s specialities, demonstrated by the extensive portfolio of biospecimens for globally relevant pathogens:

Why Biosynth for Your Serum and Plasma?

Biosynth’s specialized human plasma and serum cover a variety of clinically relevant biomarkers to help our customers develop the next state-of-the-art diagnostic assay.

· We are the largest provider of bulk disease state plasma for controls in Europe

· Our serum and plasma are perfect for developing and trouble-shooting new diagnostic assays.

· We are flexible and can provide various quantities, purities, treatment, and filtration levels.

· Biosynth’s human serum calibrators and controls allow operators to achieve specific, replicable results every time.

Download our flyer for a comprehensive overview of all of our plasma and serum products.

Whether you are developing a new diagnostic assay or on the cusp of discovering a novel biomarker Biosynth’s specialized biospecimens are here to serve a variety of diagnostic research areas.

Browse our human serum and plasma products today or check out our range of animal serum products.

For more on how serum and plasma play a significant role in the development of clinical and veterinary diagnostics, download our white paper.

Additional Plasma and Serum Products of Interest

Biosynth’s collection of Myeloma Plasma

Additional Plasma and Serum Products of Interest