Microalbumin TIA

Intended Use

Good Biotech Corp. Microalbumin TIA (REF: 5010) is intended to be used for the quantitative determination of low level albumin in human urine by turbidimetric immunoassay (TIA). For In Vitro Diagnostic Use.
 

Features

The one and only IgY-based Human Microalbumin immunoassay in the world.
No reagent preparations such as dissolving, mixing, or dilution are needed.
No sample dilution in ordinary assay range (0 ~ 200mg /L).
Application for general clinical chemistry analyzers.
Long-term on-board stability
No Hook effect up to 20000 mg/L.
 

Performance Characteristics

The following performance data were obtained using Hitachi 911 (7070) analyzer and the suggested parameter setting (sample/R1/R2= 20/250/30).
Precision: (N=15)

Control-L

Control-M

Mean

SD

CV%

Mean

SD

CV%

16.67

0.80

4.79%

41.10

2.21

5.39%

Functional sensitivity: < 3 mg/L
The lowest measurable microalbumin concentration with a CV of less than 20% is below 3 mg/L.
Criterion: Recovery within ± 5% of initial value
 

Reagent Components / Package

Reagent:
Reagent 1 (R 1): Reactive buffer solution. 1 × 58 ml (230 tests)
Reagent 2 (R 2): Antibody solution.
Solution of duck anti-albumin antibody. 1 × 7 ml (230 tests)
Calibrator set:
Microalbumin Calibrator Set 200 (REF: 5511)   5 conc. × 1 ml
Controls:
Microalbumin Control Level L (REF: 6011) 1 × 1 ml
Microalbumin Control Level H (REF: 6012) 1 × 1 ml