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Docket #: S16-414

ISAP- a PCR-based method for isotype-specific antibody detection

Stanford researchers have developed a PCR-based method that detects disease-relevant, isotype-specific antibodies and can be used to diagnose allergy. Allergy is a prevalent immune hypersensitivity disease that affects more than 20% of the US population. Current methods for diagnosing and monitoring allergy patients may be inappropriate for children, require large amounts of sample and/or are expensive. To overcome these limitations and provide a sensitive, specific, and cost-efficient diagnostic tool the inventors have developed the ISAP (Isotype-Specific Agglutination-PCR) assay.

ISAP is a PCR-based method for detecting antigen-binding antibodies of a specific isotype. Using only a small amount of sample, the assay can detect the isotype of antibodies against a particular allergen to allow deep investigation of the immunoglobulin response. ISAP can be coupled with other PCR-based methods into a single multiplexed assay to detect total IgE, specific IgE, specific IgG4 and total anti-allergen antibodies providing a comprehensive picture of the immune response. This technique offers a more sensitive, specific and cost-effective method for better allergy testing in labs and clinics.

Stage of research
Using mouse models of peanut allergy, the inventors have shown this method is more sensitive than ELISA-based methods and at least as effective as the gold standard ImmunoCAP platform, while having key advantages including cost-effectiveness and reduced sample consumption. Optimization of the method for clinical use is ongoing.

Applications

  • Allergy diagnostic- including peanut allergy
  • Monitor disease-relevant antibodies associated with autoimmune diseases, infection or inflammation for better disease management

Advantages

  • PCR-based allergy detection assay
  • Enhanced sensitivity and specificity- more sensitive than ELISA-based methods
  • Low sample consumption- uses small amount of sample as compared to ImmunoCAP assays
    • Better for pediatric patients
  • Low assay cost
  • Simple work flow
  • Does not require specialized equipment- uses standard qPCR instruments
  • Establishes a complete view of the allergic response- allows multiplex detection of diverse allergic information
  • Compatible with serum or whole blood samples

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