News Archive

6/19/2000
Study on Accuracy, Reliability of In Vitro Allergy Tests Demonstrates That Pharmacia CAP System™ Performs ‘Close to Ideal Standard’
OLATHE, Kan. (June 19, 2000) - In a major study of the precision and accuracy of commercial laboratory tests to assess patients' levels of immunoglobulin E (IgE), the protein responsible for allergic reactions to allergens such as cat dander or ragweed, researchers have identified only one in vitro test, Pharmacia CAP System™, that performed well when compared with the ideal assay. The study was published in this month's issue of the Journal of Allergy and Clinical Immunology. Because of discrepancies in traditional in vitro tests, including the older RAST (radioallergosorbent test) method, allergy specialists have been slow to accept in vitro testing as a valid allergy diagnostic. This study demonstrates that one in vitro test method is clearly superior to the others, providing a reliable and accurate result.

"The results of our study, 'Analytical Precision and Accuracy of Commercial Immunoassays for Specific IgE: Establishing a Standard,' clearly show that data from different in vitro assay systems are not interchangeable," said lead investigator P. Brock Williams, Ph.D., director of research, IBT Reference Laboratory, Lexena, Kan. In in vitro testing, a blood sample is taken from the patient and sent to a laboratory where it is analyzed for IgE to different allergens, providing evidence that a specific allergy exists. "As new allergy treatments are being developed that rely on accurate measurement of IgE, broader use of laboratory or in vitro methods for assessing allergen susceptibility will depend upon the reliability of the tests themselves," added Dr. Williams. According to the study, of the in vitro tests analyzed, "Only Pharmacia CAP System was capable of measuring specific IgE antibodies over a large range with precision and accuracy for the allergens studied."

In the study, sera were diluted and measured into blindly coded vials. These were then shipped to six laboratories using five different testing methodologies on three separate occasions. These included: Allergy Testing Laboratories, using a modified RAST method (A-RAST); Allercare, using Diagnostic Products Corporation's AlaSTAT (A-STAT) test; Commonwealth Medical Laboratory, using a Hycor Biomedical modified RAST test; Laboratory Corporation of America, using a modified Hycor Biomedical RAST test (L-RAST); IBT Reference Laboratory, using Pharmacia CAP System; and Smith Kline Beecham Clinical Laboratories, using Pharmacia CAP System.

The serum samples were tested for 17 common allergens - including cat dander, Bermuda grass, timothy grass, white oak, short and giant ragweed and several common molds and yeasts. Individual laboratory reports were forwarded to an independent statistical team, who broke the code and analyzed the findings. Results from only two laboratories - the two using Pharmacia CAP System - did not differ significantly from the ideal expected results. Results from the diluted samples revealed not only a significant difference between laboratories and methods, but also significant differences for the same allergens.

New therapies, such as monoclonal antibodies against IgE, are administered in part based on the patient's IgE levels. To use these new agents effectively, accurate tests must be available. The authors of the study support the use of Pharmacia CAP System as "a current standard for quantitative measurements of specific IgE antibodies." The U.S. Food and Drug Administration (FDA) recently cleared Pharmacia & Upjohn Diagnostics, a division of Pharmacia Corporation, to market 30 new allergens using the ImmunoCAP Specific IgE Blood Test. This brings the total FDA-cleared tests for allergens using the ImmunoCAP Specific IgE Blood Test to 316, and Pharmacia & Upjohn Diagnostics continues to lead in FDA clearances for allergens. ImmunoCAP, already the broadest line of laboratory tests for allergy, may now be used to test for even more allergens by offering physicians a safe, accurate, effective and reliable alternative to other testing.

Physicians interested in learning how to order allergy testing using the ImmunoCAP Specific IgE Blood Test may call 1-877-862-4947.

Pharmacia & Upjohn Diagnostics, a division of Pharmacia Corporation, is headquartered in Uppsala, Sweden, and is a world leader in in vitro diagnostic research and product innovation. Pharmacia & Upjohn Diagnostics' U.S. operations are based in Kalamazoo, Mich.

Pharmacia Corporation (NYSE:PHA) is a leading global pharmaceutical company created through the merger of Pharmacia & Upjohn with Monsanto Company and its G.D. Searle unit. Pharmacia has a broad product portfolio, a robust pipeline of new medicines, and an annual investment of more than $2 billion in pharmaceutical research and development.

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