ZYMUTEST™ HIA IgGAM

ZYMUTEST™ HIA IgGAM

Code: ARK040D-CAN

Manufacturer’s Part Number: RK040D

Product size: Kit of 96 tests

Clearance: CE / HCL

Price: $956.00

Product Description

In EU: This Product is CE Marked.

Health Canada Licensed.

ZYMUTEST� HIA IgGAM is a polyspecific ELISA detecting all anti-PF4/heparin antibody isotypes (IgG + IgA + IgM) in plasma or serum. High-sensitivity screening test � captures all anti-PF4 antibodies for maximum negative predictive value. If positive, reflex to IgG-specific (ARK040A) for improved specificity. FDA 510(k) cleared. CE-IVD. 96-test microplate.

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 to 6%

Inter-Assay CV: 5 to 8%

Product Components

Micro ELISA Plate (12 strips of 8 wells)

2x HIA Sample Diluent.

3x HIA IgGAM Positive Control.

3x Negative Control.

3x Platelet Lysate.

3x Anti-IgG (Fcγ)-IgM (µ)-IgA(α)-HRP IC

1x Conjugate Diluent.

1x Wash Solution.

1x TMB.

1 x 0.45M Sulfuric Acid.

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Product Applications

Assessment of the risk to develop HIT/HITT, in patients treated with heparins (Unfractionated or LMWH): presence of antibodies is a risk indicator for development of HIT/HITT.

Clinical suspicion of HIT during heparin therapy.