Summary
Background. No data exist regarding the inter-laboratory reproducibility of the heparin-induced-platelet-activation
(HIPA) test, the most widely used functional assay in Germany for the detection of
heparin-induced thrombocytopenia (HIT) antibodies. Methods. Nine laboratories used an identical protocol to test eight different sera with the
HIPA test. Five laboratories also tested the sera with a platelet factor 4 (PF4)/heparin-complex
ELISA. Cross-reactivity with danaparoid-sodium was assessed using 0.2 aFXa units instead
of heparin in the HIPA test. Results. Two of nine laboratories had no discrepant HIPA test results. Four laboratories differed
in one sample, one reported two discrepant results, and two laboratories reported
more than two discrepant results. Cross-reactivity with danaparoid-sodium test results
differed among laboratories. PF4/heparin ELISA results were identical in all five
laboratories. Conclusion. The HIPA test requires strict quality control measures. Using both a sensitive functional
assay (HIPA test) and a PF4/heparin ELISA will allow detection of antibodies directed
to antigens other than PF4/heparin complexes as well as detection of IgM and IgA antibodies
with PF4/heparin specificity.