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ID-PaGIA Heparin/PF4 Antibody Test (Kit)
ID-PaGIA Heparin/PF4 Antibody Test

Name
ID-PaGIA Heparin/PF4 Antibody Test (Kit)

Description
Rapid test for the exclusion of heparin induced thrombocytopenia (HIT).
(Id-n°: 45580)

Configuration
Reagent 1:
Red polystyrene particles coated with human platelet factor 4 and heparin.

Reagent 2:
Gel card with anti-human-IgG.

Negative and positive controls.

Principle
Gel agglutination assay for antibodies directed against the complex of platelet factor 4 (PF4) and heparin.

Serum is incubated with the specific particles. After centrifugation through the gel, particles carrying antibodies against heparin/PF4, are either retarded on top or within the gel matrix.

Positive results confirm the presence of antibodies directed against Heparin/PF4.
A negative result has a very high negative predictive value for ruling out HIT*.

Test characteristics:
• very rapid: result in less than 20 min (including 10 min centrifugation)
• very simple procedure
• very reliable performance*
• economical: unused microtubes in the card can be used at a later time (if the aluminium seal is intact)

*Pouplard C, et al..Prospective evaluation of the '4Ts' score and particle gel immunoassay specific to heparin/PF4 for the diagnosis of heparin-induced thrombocytopenia..J Thromb Haemost. 2007;5:1373-9.
Eichler P, et al. The new ID-Heparin/PF4 antibody test for rapid detection of heparin-induced antibodies in comparison with functional and antigenic assays.Br J Haematol. 2002;116:887-91., Gemmel R et al.Evaluation of the DiaMed Heparin/PF4 test for HIT. J Thrombosis Haem,ostasis 2005;3 (Suppl.1), Abstract P2100; Schenk et al;.IgG classification of anti-PF4/heparin antibodies to identify patients with heparin-induced thrombocytopenia during mechanical circulatory support. J Thromb Haemost. 2007;5:235-41.



Diag. appl.
Antibodies against PF4/heparin are involved in the pathogenesis of HIT. However, not all antibodies with this specificity are pathogenic. Therefore a positive test result in an immunoassay such as PaGIA (or ELISA) should be taken with caution and probably also functional assays should be considered as well.

On the other hand the absence of antibodies makes HIT very unlikely. Several papers have reported a high negative predictive value of the PaGIA test (see above for references).

For the complex situation of HIT also very close collaboration between laboratory and clinic is essential for therapeutic decisions. Patients with suspected HIT require immediate anticoagulation with drugs such as direct thrombin inhibitors (hirudin, agathroban, bivalirudin), or danaparoid. These drugs are much more expensive than heparin and are more difficult to handle, especially because there is no antidote available. Therefore overdosing may induce a bleeding risk. Therefore a rapid ruling out of HIT is beneficial for making the right therapeutic decisions.


Pkg. size
Profiles or single test
REF
ID-PaGIA Heparin/PF4 Antibody Test (Kit)
18 Tests

including:
1 x 3 ID-Cards
1 x 1 mL Particles
1 x 0.2 mL Positive control
1 x 0.2 mL Negative control
050021