PRODUCT DESCRIPTION

In US: 510(k) Cleared for In Vitro Diagnostic Use for Plasma only. Enzyme immuno-assay designed for measuring globally all heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma. This assay is proposed as screening, as an early identification of heparin treated patients presenting a risk to develop HIT or HITT. This assay measures the whole of antibodies. It offers the highest sensitivity as all isotypes are detected. It is the preferred assay when an early detection of heparin dependent antibodies is required for assessing the development risk of HIT/HITT. This kit allows individual testing as it offers a packaging for 4 individual 8 well strips along with controls. This is an ON-DEMAND item which requires minimum order quantity and extended lead time. Please Contact Us for a quote.

Enzyme immuno-assay designed for measuring globally all heparin-dependent antibodies, whether the isotype is: IgG, IgM and IgA, in human plasma.

PRODUCT CHARACTERISTICS

Total Assay Time: 2 hr 15 min

Cut Off: A₄₅₀ ≥ 0.50

Dynamic Range: A₄₅₀ up to 3.0

Intra-Assay CV: 4 – 6%

Inter-Assay CV: 5 – 8%

PRODUCT COMPONENTS

Micro ELISA Plate (4 strips of 8 wells)

2x HIA Sample Diluent.

4 x HIA IgGAM Positive Control

4 x Negative Control

4 x Platelet Lysate

4 x Anti-IgG (Fcγ)-IgM (µ)-IgA(α)-HRP IC

1 x Conjugate Diluent

4x Wash Solution

1 x TMB

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PRODUCT APPLICATION