Ferritin LIT Assay

Intended Use

Good Biotech Corp. Ferritin LIT Assay (REF: 7010) is intended to be used for the quantitative determination of ferritin in serum by latex particle enhanced immunoturbidimetry (LIT). The measurement of ferritin aids in the diagnosis of diseases affecting iron metabolism such as hemochromatosis (iron overload) and iron deficiency anemia. For In Vitro Diagnostic Use.
 

Features

The one and only IgY-based Human Ferritin immunoassay in the world.
Applicable for general clinical chemistry analyzers.
Ready-to-use reagent.
Accuracy in low concentration (<20ng/ml) sample.
No sample dilution in ordinary assay range (0~1,000 ng/ml).
No Hook effect up to 10,000 ng/ml.

 

Performance Characteristics

The following performance data were obtained using Hitachi 917 (7170) analyzer and the suggested parameter setting (sample/R1/R2= 20/110/70).
 
Precision:

In-house Control (n=10)

Mean

SD

CV%

27.67

1.78

6.43%

Detection limit: < 5 ng/mL
The lower detection limit represents the lowest measurable ferritin concentration that can be distinguished from zero. It is calculated as the mean plus two standard deviation of 10 replicates of the lowest standard (0 ng/mL ferritin)
 

Reagent Components / Package

Reagent:
Reagent 1 (R 1): Reactive buffer solution. 1 × 34 ml (285 tests)
Reagent 2 (R 2): Latex solution.
Solution of suspended latex microparticles sensitized with duck anti-ferritin IgY(ΔFc). 1 × 20 ml (285 tests)
Calibrator set:
Ferritin Calibrator Set (REF: 7510) 5 conc. × 1 ml
Level 1 is the ferritin-free serum and levels 2, 3, 4 and 5 contain human serum with assigned value for the specific serum protein ferritin.
Controls:
Ferritin Control Level L (REF: 8011) 1 × 1 ml
Ferritin Control Level H (REF: 8013) 1 × 1 ml
Each control contains human serum with assigned value for the specific serum protein ferritin