ZYMUTEST™ HIA IgGAM — Pan-Isotype HIT Screening ELISA (IgG/IgA/IgM)

ZYMUTEST™ HIA IgGAM — Pan-Isotype HIT Screening ELISA (IgG/IgA/IgM)

Code: ARK040D-CAN

Manufacturer’s Part Number: RK040D

Product size: Kit of 96 tests

Clearance: CE / HCL

Price: $956.00

Product Description

Pan-isotype ELISA for detection of heparin-PF4 antibodies of all isotypes (IgG, IgA, IgM) in plasma or serum. Maximum sensitivity HIT screening. CE-IVD / 510(k).

Detects all antibody isotypes responsible for HIT/HITT, including IgA/IgM-only cases that would be missed by IgG-specific assays. Positive results should be followed with ZYMUTEST™ HIA IgG (RK040A) for IgG-specific confirmation.

Pan-isotype (IgG + IgA + IgM) — maximum screening sensitivity
96-test plate format, CE-IVD and 510(k)

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.

Video of Product Components
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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.