Duet hs-CRP LIT Assay

Intended Use

Good Biotech Corp. Duet hs-CRP LIT Assay (REF: 4010) is intended to be used as a highly sensitive assay for the quantitative determination of C-reactive protein in serum by latex particle enhanced immunoturbidimetry (LIT). Highly sensitive measurement of C-reactive protein is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases.
For In Vitro Diagnostic Use.
 

Features

The one and only IgY-based Human hs-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 0.1~200 mg/L.
Ready-to-use reagent.
 

Performance Characteristics

Board Range Application:
The following performance data were obtained using Hitachi 917 (7170) analyzer and the suggested parameter setting (sample/R1/R2= 2/150/150).
Precision:

Control-H (n=20)

Control-M (n=20)

Control-L (n=20)

In-House Control(n=20)

Mean

SD

CV%

Mean

SD

CV%

Mean

SD

CV%

Mean

SD

CV%

61.26

0.57

0.9%

5.71

0.07

1.3%

1.59

0.07

4.2%

0.48

0.05

10.2%

Detection limit: < 0.1 mg/L
The lower detection limit represents the lowest measurable CRP concentration that can be distinguished from zero. It is calculated as 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 45 mg/dl, hemoglobin up to concentration of 800 mg/dl, lipemia(chyle) up to concentration of 10 g/L, ( at which concentration the triglyceride readout is 1376 mg/dl).
 
High Sensitivity Application:
The following performance data were obtained using Hitachi 917 (7170) analyzer and the suggested parameter setting (CRPex-HS CRP Calibrator Set ( 0- 20 mg/L), sample/R1/R2= 6/125/125).
Precision:

Control-L ( n= 10 )

Control-M ( n= 10 )

Mean

SD

CV%

Mean

SD

CV%

1.56

0.02

1.25%

5.56

0.03

0.62%

Detection limit: < 0.05 mg/L
The lower detection limit represents the lowest measurable CRP concentration that can be distinguished from zero. It is calculated as 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 45 mg/dl, hemoglobin up to concentration of 800 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 × 20 ml (133 tests)
Reagent 2 (R 2): Latex solution.
Solution of suspended latex microparticles sensitized with duck anti-CRP IgY(ΔFc) 1 × 20 ml (133 tests)
Calibrator set:
Duet hs-CRP Calibrator Set (REF: 4511) 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.