Recommend that treatment decisions be based on the result of the B. pertussis
IgM immunoblot test instead of the ELISA test. B. pertussis
IgM test by ELISA may produce false-positive results.
Compliance Statement A
: For laboratory developed tests using a manufacturer labeled ASR as the reagent providing the specificity of the assay.
Analyte Specific Reagent. This test was developed and its performance characteristics determined by ARUP Laboratories. The U. S. Food and Drug Administration has not approved or cleared this test; however, the FDA has determined that such clearance or approval is not necessary.