B2M LIT Assay (Beta-2-Microgloblin)

Intended Use

Good Biotech Corp. Beta2-microglobulin LIT Assay (REF: KT-0202-A) is intended to be used for the quantitative determination of Beta2-microglobulin in human serum and urine by latex particle enhanced immunoturbidimetry (LIT). The measurement of Beta2-microglobulin aids in the diagnosis of renal function such as glomerular and tubular kidney disease. For In Vitro Diagnostic Use.
 

Features

The one and only IgY-based Human Beta2-microglobulin immunoassay in the world.
Application for general clinical chemistry analyzers.
Ready-to-use reagent.
No sample dilution in ordinary assay range (Serum: 0.1~20 mg/L, Urine: 0.01~8 mg/L).
No Hook effect up to 150 mg/L.
 

Performance Characteristics

For Serum Specimen
The following performance data were obtained using Hitachi 911 (7070) analyzer and the suggested parameter setting (sample/R1/R2= 4/150/100, assay range 0-20 mg/L).
Precision:

Control-H (n=10)

Control-M (n=10)

Control-L (n=10)

Mean

SD

CV%

Mean

SD

CV%

Mean

SD

CV%

17.29

0.211

1.22%

4.06

0.038

0.93%

0.50

0.010

2.06%

Detection limit: ~ 0.05 mg/L
The lower detection limit represents the lowest measurable beta2-microglobulin concentration that can be distinguished from zero.  It is calculated as the mean plus two standard deviation of 20 replicates of the lowest standard ( 0 mg/L B2M ).
Interference:
Criterion: Recovery within ± 5% of initial value.
No significant interference from bilirubin up to 60 mg/dl; no significant interference from hemoglobin up to 500 mg/dl; no significant interference from lipemia up to 10 g/L of Liposyn, (at which concentration the triglyceride readout is 1376 mg/dl ).
 

Reagent Components / Package

Reagent:
Reagent 1 (R 1): Reactive buffer solution. 1 × 30 ml (200 tests)
Reagent 2 (R 2): Latex solution.
Solution of suspended latex microparticles sensitized with duck anti-B2M IgY(ΔFc). 1 × 20 ml (200 tests)
Calibrator set:
Beta2-microglobulin Calibrator Set (REF: CA-0202-A). 6 conc. × 1 ml
Controls:
Beta2-microglobulin Control Level L (REF: CL-0202-A) 1 × 1 ml
Beta2-microglobulin Control Level M (REF: CL-0202-B) 1 × 1 ml
Beta2-microglobulin Control Level H (REF: CL-0202-C) 1 × 1 ml