ZYMUTEST™ HIA IgG — IgG Heparin-PF4 Antibody ELISA for HIT
Processing...

ZYMUTEST™ HIA IgG — IgG Heparin-PF4 Antibody ELISA for HIT

Code: ARK040A
Manufacturer’s Part Number: RK040A
Product size: Kit of 96 tests
Clearance: 510(k)
Price: $999.00
Qty
 

Product Description

ELISA for detection and quantification of IgG heparin-PF4 antibodies (anti-heparin/platelet factor 4 complexes) in human plasma or serum. CE-IVD / 510(k).

IgG isotype antibodies are most strongly associated with the clinical diagnosis of heparin-induced thrombocytopenia (HIT) and HIT with thrombosis (HITT). The IgG-specific assay offers higher clinical specificity than pan-isotype assays. For patients with suspected HIT after 5–10 days of heparin exposure.

  • IgG-specific — highest specificity for clinically significant HIT
  • 96-test plate format
  • CE-IVD and 510(k) cleared
  • For maximum sensitivity, pair with ZYMUTEST™ HIA IgGAM (RK040D) for initial screening

Product Characteristics

  • Total Assay Time: 2 hr 15 min
  • Cut Off: A450 > 0.30
  • Dynamic Range: A450 up to 3.0
  • Intra-Assay CV: 4 to 6%
  • Inter-Assay CV: 5 to 8%

Product Components

  • Micro ELISA Plate (12 strips of 8 wells)
  • 2x HIA Sample Diluent.
  • 3x HIA IgG Positive Control.
  • 3x Negative Control.
  • 3x Platelet Lysate.
  • 3x Anti-IgG (Fcγ)-HRP IC.
  • 1x Conjugate Diluent.
  • 1x Wash Solution.
  • 1x TMB.
  • 1 x 0.45M Sulfuric Acid.
  • Video of Product Components
    (Video can be viewed with Flash Plugin)
  

Product Applications

Clinical suspicion of HIT during heparin therapy.

Heparin-dependent antibodies of the IgG isotype are those strongly associated with the clinical diagnosis of HIT. The ZYMUTEST™ HIA IgG assay offers then a better specificity for the clinical complication of HIT, but it has less sensitivity as cases associated with only IgM and/or IgA isotypes are missed.

Instructions For Use

Material Safety Data Sheet (MSDS)

Data Sheet/Technical Data

Certificate of Analysis (COA)

Other Documents