ZYMUTEST™ HIA MonoStrip IgG

ZYMUTEST™ HIA MonoStrip IgG

Code: ARK041A

Manufacturer’s Part Number: RK041A

Product size: Kit of 32 tests

Clearance: 510(k)

Price: $549.00

Product Description

For In Vitro Diagnostic Use.

ZYMUTEST� HIA MonoStrip IgG is a flexible-format ELISA for anti-PF4/heparin IgG antibodies using breakable 8-well strips (4 strips � 8 wells = 32 tests). Same IgG specificity as the full 96-test plate (ARK040A). Designed for lower-volume laboratories or STAT HIT testing � run individual strips as needed without wasting a full plate. FDA 510(k) cleared. CE-IVD.

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

Video of Product Components
(Video can be viewed with Flash Plugin)

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 MonoStrip 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.