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ZYMUTEST™ HIA IgG

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ZYMUTEST™ HIA IgG (RK040A) is an Enzyme Immuno-assay to measure Heparin-dependent antibodies of the IgG isotype in human plasma or serum. Manufactured by HYPHEN BioMed.

Product Brand:
Product Code: RK040A
Description

Enzyme Immuno-assay designed for measuring heparin-dependent antibodies of the IgG isotype, in human plasma. 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.

Recent anecdotal evidence suggests a link between a prothrombotic state and people who have recently received a Covid vaccination. These prothrombotic states are being referred to as VATTS (vaccine-associated thrombosis/thrombocytopenia syndrome) or VIPIT (vaccine inducted prothrombotic immune thrombocytopenia). As these patients present with thrombocytopenia the diagnosis of HIT can be difficult. The ZYMUTEST™ HIA IgG ELISA has been shown to be one of the most reliable tests in identifying these individuals. Because of the design of the ZYMUTEST™ HIA IgG ELISA which uses protamine sulphate to bind the heparin and platelet factors to the micro-titre wells only patient antibodies that cause thrombocytopenia induced by heparin are detected, i.e. true hit.

ZYMUTEST™ HIA has a proven performance of many years and complies with the ISTH guidelines on HIT confirmation assays. The kits are complete with positive and negative controls, platelet lysate, wash buffer and 8 well strips. Offered in 2 formats either 12×8 wells or 4×8 wells both kits can be used for individual patient testing as the 8 well strip format can manage samples and controls thus minimising any wastage.

Overview

  • CE marked kits compliant with ISTH guidelines on HIT testing
  • IgG specific is one of the assays of choice for HIT confirmation
  • Complete kits constructed for ease of use and economy
  • 96 well and 32 well presentations for all laboratory sizes
  • Manufactured to enhance binding of true HIT IgG antibodies
  • Tried and tested kits available now

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.

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.
Product Specification
Specification Type
Specification Value
Product Range
Product Code
RK040A
Product Name
ZYMUTEST™ HIA IgG
Product Category
Product Brand
Product Analyte or Application
Product Size
Kit of 96 tests
Product Storage
2°C to 8°C
Product IVD Registration Status
510(k),CE-Mark - Professional Use
Product Documents

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