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Test Code LAB5387 Heparin-PF4 IgG Antibody, Serum

Important Note

Mayo code is HITIG

Useful For

Detection of IgG antibodies directed against heparin/platelet factor 4 complexes that are implicated in the pathogenesis of immune-mediated type II heparin-induced thrombocytopenia, spontaneous heparin platelet-factor 4 IgG antibody, and thrombocytopenia and thrombosis occurring after SARS-CoV2 adenovirus vector vaccine

Reporting Name

Heparin-PF4 IgG Ab (HIT), S

Specimen Type

Serum Red


Specimen Required


Patient Preparation: Fasting is preferred but not required

Collection Container/Tube: Red top

Submission Container/Tube: Plastic vial

Specimen Volume: 1 mL

Collection Instructions: Centrifuge and aliquot serum into a plastic vial.

Specimen Stability Information: Frozen (preferred) 2 years/Refrigerate 7 days


Specimen Minimum Volume

0.5 mL

Specimen Stability Information

Specimen Type Temperature Time Special Container
Serum Red Frozen (preferred)
  Refrigerated  7 days

Reject Due To

Gross hemolysis Reject
Gross lipemia Reject

Reference Values

HIT ELISA:

<0.400

 

HIT Interpretation:

Negative

Supportive Data

The IgG human platelet factor 4 (H/PF4) enzyme-linked immunosorbent assay (ELISA) was compared with both the IgGAM H/PF4 ELISA (GTI Immucor) and the heparin-dependent platelet serotonin release assay (SRA) (Quest Diagnostics and Wisconsin Blood Center) in 208 patients. Assuming the SRA as the gold standard, the data were analyzed to determine the sensitivity of the ELISA assays for a positive SRA. Of the 208 patients tested, 49 had a positive SRA. With the IgGAM H/PF4 ELISA, 47/49 were positive (sensitivity 96%); with the IgG H/PF4 ELISA, 45 were positive (sensitivity 92%). Of those that tested negative with the SRA (n=159), 67 (42%) tested positive with the IgGAM H/PF4 ELISA, 37 (23%) tested positive with the IgG H/PF4 ELISA. (Mayo validation data)

 

In order to determine possible cross-reactivity between the target antigen and antibodies other than heparin-associated antibodies, 68 samples containing a variety of antibodies that included known antibodies to platelet alloantigens, platelet autoantibodies, antibodies to HLA class I and antirheumatoid factor were tested in this assay and none were found to cross react with the target antigen immobilized in the microwells.

Day(s) Performed

Monday through Sunday

Report Available

1 to 3 days

Specimen Retention Time

7 days

Performing Laboratory

Mayo Clinic Laboratories in Rochester

CPT Code Information

86022

LOINC Code Information

Test ID Test Order Name Order LOINC Value
HITIG Heparin-PF4 IgG Ab (HIT), S 73818-7

 

Result ID Test Result Name Result LOINC Value
46915 HIT ELISA 73818-7
21468 Heparin Inhibition 73817-9
21469 HIT Interpretation 73819-5
21470 HIT Comment 73816-1