Code: ARK041A
Manufacturer’s Part Number: RK041A
Product size: Kit of 32 tests

Price: $309.00


Product Description

In US: 510(k) Cleared for In Vitro Diagnostic Use for Plasma only.

Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma or serum, or in any biological fluid where these antibodies must be measured. This assay measures only the IgG isotype, reported as the most associated with the clinical complications of heparin dependent antibodies (HIT/HITT), allowing confirmation of the diagnosis of HIT/HITT or its clinical suspicion. However, some cases associated with only IgM and/or IgA isotypes can be missed.

This kit allows individual test as it offers a packaging for 4 individual 8 well strips along with controls.

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 (4 strips of 8 wells)
  • 2x HIA Sample Diluent
  • 4x HIA IgG Positive Control
  • 4x Negative Control
  • 4x Platelet Lysate
  • 4x Anti-IgG (Fcγ)-HRP IC
  • 1x Conjugate Diluent
  • 2x Wash Solution
  • 1x TMB
  • 1 x 0.45M Sulfuric Acid

Product Applications

Individual test.

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 Mono Strip 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)

Technical Data

Other Documents