New Clinical Diagnostic Solutions for Allergy and Autoimmune Testing On Display at AACC

Clinical laboratories performing immunodiagnostic testing now have a wider array of solutions to aid in the diagnosis of allergy and autoimmune diseases. The Phadia™ 2500E Laboratory System, ImmunoCAP™ Allergen Components (currently under FDA review) for Hazelnut, Walnut, and Cashew Nut, and EliA™ PR3s, MPOs and GBM Assays (recently FDA Cleared) make their debut at the American Association for Clinical Chemistry Annual Meeting & Clinical Lab Expo, Booth 3135 at the Georgia World Congress Center, Atlanta, GA.

Designed to deliver accurate and reproducible test results in allergy and autoimmunity diagnostics, the family of Phadia instruments from Thermo Fisher Scientific now includes the Phadia 2500E Laboratory System, designed specifically for laboratories meeting very high demands. Phadia Laboratory Systems are fully automated instruments for running assays that detect and quantitatively determine clinically relevant antibodies in the blood. The Phadia 2500E helps labs manage a very high volume of tests by incorporating two process lines configurable for allergy and autoimmunity testing, delivering 10,000 – 25,000 results per week.

The types of allergens that can be detected by Phadia Laboratory Systems have also been expanded to include new ImmunoCAP Allergen Components for Hazelnut, Walnut, and Cashew Nut (pending FDA Clearance) to aid in the diagnosis of potentially life-threatening nut allergies. Unlike skin scratch testing, the Phadia Laboratory Systems rely on Component Resolved Diagnostics, an in vitro approach that quantifies Immunoglobulin E (IgE) antibodies contained within a patient’s blood sample that recognize sensitization to protein level components of selected whole allergens.

There will soon be available:

• Two new ImmunoCAP Allergen Components for walnut proteins (ImmunoCAP Allergen Components Jug r 1 and Jug r 3). IgE antibodies to walnut storage protein Jug r 1 are suggestive of a primary walnut allergy, while antibodies to Jug r 3, a lipid transfer protein (LTP), are suggestive of cross-reactivity with other LTP-containing foods.

• The ImmunoCAP Cashew Nut Allergen Component (Ana o 3), a storage protein that is highly abundant in cashew nuts and associated with species specific cashew allergy.

• In addition, two new ImmunoCAP Hazelnut Allergen Components (Cor a 9 and Cor a 14), make for a total of four important hazelnut protein components that can help the clinician differentiate between a primary hazelnut allergy and cross-reactivity to tree pollens and fruits.

New immunoassays for autoimmune disorders are also available for use on the Phadia Laboratory Systems and have received FDA 510(k) clearance. The EliA PR3s, EliA MPOs and EliA GBM Assays are highly specific and quantitative assays to measure autoantibodies as an aid in the diagnosis of ANCA Associated Vasculitis (AAV), Goodpasture Syndrome, and associated diseases. These disorders are autoimmune disorders typically resulting in kidney swelling and malfunction. AAV is associated with autoantibodies to human proteins PR3 and MPO, while Goodpasture Syndrome patients exhibit autoantibodies to GBM. Since patients with these diseases often exhibit similar symptoms, it is important to test for autoantibodies found in both diseases to properly diagnose and treat the patient.

“The Phadia Laboratory Systems provide reliable test results to clinicians to aid in the diagnosis of patients suffering from severe allergies and autoimmune disorders by testing for antibody sensitizations to specific proteins associated with each disease,” said Joseph Bernardo, president of immunodiagnostics for Thermo Fisher. “Thermo Fisher has continued to innovate to allow clinical laboratories to push the boundaries of productivity, as evidenced by the new Phadia 2500E, while also expanding the catalog of available tests for allergy and autoimmune disorders.”