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Patent-Pending ELISA Test

The ELISA test measures simultaneously both IgG and Immune Complexes (Type II and III reactions) providing the physician a more complete picture of the allergic process when compared to tests that measure IgG alone. Unlike all other tests, which measure only IgG, the ELISA test employs a unique patent-pending process to measure both IgG and Immune Complexes.

Our patent-pending process allows us to measure the presence of allergen-specific immunoglobulins IgG and immune complex in patient's serum. This results in a more sensitive test which will uncover more accurately delayed allergic reactions. Immune complexes are indicative of allergic reactions. C3b is the common junction of all three complement pathways and must be measured to provide the complete picture of types II, III, and IV reactions. Immune complexes are missed with a straight complete IgG (IgG 1-4) test measuring only these antibodies alone. Therefore, the test is a qualitative assay measuring immunoglobulins and the complement cascade to food antigens (allergens) in serum.

Additionally, the ELISA test differs very significantly from all others. Briefly, ELISA 96 well plate is coated with 44 different allergens (allergen is a food, food additive or dye causing allergies) in duplicate arranged in a micro titer array. Scientific research-centers will always do ELISA testing this way. To find the high, low and mid point on each plate we establish a three-point standard curve. When this is done, we establish a true standard calibration curve that validates the accuracy of each of the readings we obtained and verify each antigen test result. The standard curve allows the assay to be standardized to ensure accuracy from run-to-run reproducibility. Using this method a physician can state with 95% accuracy that a patient has a positive or negative reaction against a particular food.

Distinct Advantages of the ELISA Test:

  • Qualitative : The kits employ a standard curve with precise amounts of antibody to calibrate the reactivity of each sample and to standardize each run.
  • Standard Curve : r ≥ 0.95 by linear regression
  • Statistical Analysis : 95% confidence limits for true positives or true negatives
  • Specificity : Human IgG heavy chain all isotypes (IgG 1, 2, 3, 4) and Immune Complexes. The conjugate does not cross react with other classes of antibody or Kappa or Lambda light chains.
  • Micro Arrays : Food antigens are plated in duplicate using automated workstations that ensure coating accurate volumes and the correct placement of the antigens.

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