CRPex-BR CRP LIT Assay

Intended Use

Good Biotech Corp. CRPex-BR CRP LIT Assay (REF: 2010) is intended to be used for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). The measurement of C-reactive protein aids in evaluation of the amount of injury to body tissues. For In Vitro Diagnostic Use.
 

Features

The one and only IgY-based Human CRP immunoassay in the world.
Application for general clinical chemistry analyzers.
Resistant to common interferences (RF, Hb, Lipid, Bilirubin, etc.).
Good correlation with other commercial latex kits.
Reliable assay range of 1~300 mg/L.
Ready-to-use reagent.
 
 

Performance Characteristics

The following performance data were obtained using Hitachi 911 (7070) analyzer and the suggested parameter setting (sample/R1/R2= 2/150/150).
Precision:

Control-M (n=10)

Control-H (n=10)

Mean

SD

CV%

Mean

SD

CV%

5.35

0.14

2.7%

57.40

0.58

1.0%

Detection limit: < 0.3 mg/L
The lower detection limit represents the lowest measurable CRP 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 CRP).
Interference:
Criterion: Recovery within ± 5% of initial value.
No significant interference from bilirubin up to concentration of 60 mg/dl, hemoglobin up to concentration of 500 mg/dl, lipemia(chyle) up to concentration of 10 g/L, ( at which concentration the triglyceride readout is 1376 mg/dl).
 

Reagent Components / Package

Reagent:
Reagent 1 (R 1): Reactive buffer solution 1 × 50 ml (330 tests)
Reagent 2 (R 2): Latex solution.
Solution of suspended latex microparticles sensitized with duck anti-CRP IgY(ΔFc) 1 × 50 ml (330 tests)
Calibrator set:
CRPex-BR CRP Calibrator Set (REF: 2510) 6 conc. × 1 ml
Level 1 is normal saline solution and levels 2, 3, 4, 5 and 6 contain human serum with assigned value for the specific serum protein CRP.
Controls:
CRPex CRP Control Level L (REF: 3011) 1 × 1 ml (~1.6 mg/L)
CRPex CRP Control Level M (REF: 3012) 1 × 1 ml (~5.5 mg/L)
CRPex CRP Control Level H (REF: 3013) 1 × 1 ml (~55 mg/L)
Each control contains human serum with assigned value for the specific serum protein CRP.