ZYMUTESTâ„¢ HIA IgG
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ZYMUTESTâ„¢ HIA IgG

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

For In Vitro Diagnostic Use.

ZYMUTEST™ HIA IgG is an ELISA for detecting IgG antibodies against Platelet Factor 4 (PF4)/heparin complexes in human plasma or serum. IgG-specific assay provides higher specificity for clinically significant (pathogenic) HIT antibodies compared to polyspecific IgGAM screening. For diagnosis and risk assessment of Heparin-Induced Thrombocytopenia (HIT) and HIT with Thrombosis (HITT). Use in conjunction with clinical scoring (4Ts score) and functional assays (SRA, HIPA) for definitive HIT diagnosis. FDA 510(k) cleared. CE-IVD. 96-test microplate.

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
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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 ZYMUTESTâ„¢ 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