By itself, a positive result on this ELISA test is relatively non-specific for a clinical diagnosis of heparin-associated antibody syndrome (HIT) (frequent false-positives) and a negative result does not exclude a diagnosis of HIT if the clinical suspicion remains high (occasional false-negatives). Results should be used in conjunction with clinical findings, platelet counts and other laboratory results.
For a clinical scoring system to assess pretest probability of HIT and other guidance for diagnosing HIT, refer to the Heparin-Associated Antibody Syndrome topic at arupconsult.com.
Compliance Statement B
: 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, FDA clearance or approval is not currently required for clinical use. The results are not intended to be used as the sole means for clinical diagnosis or patient management decisions.