Triplex CRP LIT Assay

Good Biotech Corp. Triplex CRP LIT Assay (REF: KT-0301-D) is intended to be used for the quantitative determination of C-reactive protein in serum, plasma and whole blood by latex particle enhanced immunoturbidimetry (LIT). Triplex CRP LIT Assay is designed for use in two applications (Universal mode and High Sensitivity mode) by using different parameter settings. The Universal mode is characterized by extraordinary broad measuring range (up to 300 mg/L) and using a wide range of specimens, including whole blood, serum and plasma. The High Sensitivity mode is recommended for serum/plasma samples with CRP concentrations below 20 mg/L and where high precision and extremely good sensitivity is required (assay range of high sensitivity mode: 0-20 mg/L). The 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.

 

What's C-reactive protein?

 

The one and only IgY-based Human CRP immunoassay in the world.

Easy and reliable performance of the test.

Use of serum, plasma and whole blood.

Test result available in minutes.

Application for general clinical chemistry analyzers.

Quantitative results.

High sensitivity/ Low detection limit: 0.5 mg/L (Universal mode)/ 0.05 mg/L (High Sensitivity mode).

 

Universal Mode: assay range 2-250 mg/L

Antigen Excess: CRP concentration up to 1000 mg/L did not produce a false negative value.

Detection limit: ~ 0.68 mg/L

High Sensitivity  Mode: assay range 0.2-20 mg/L

Antigen Excess: CRP concentration up to 500 mg/L did not produce a false negative value.

Detection limit: ~ 0.013 mg/L

Universal Mode: assay range 1-300 mg/L

Antigen Excess: CRP concentration up to 1000 mg/L did not produce a false negative value.

Detection limit: ~ 0.34 mg/L 

High Sensitivity  Mode: assay range 0.1-20 mg/L

Antigen Excess: CRP concentration up to 500 mg/L did not produce a false negative value.

Detection limit: ~ 0.04 mg/L 

Whole Blood  Mode: assay range 2-300 mg/L

Antigen Excess: CRP concentration up to 1000 mg/L did not produce a false negative value.

Detection limit: ~ 1.4 mg/L

Reagent:

Reagent 1 (R 1): Reactive buffer solution. 1 × 14.8 ml

Reagent 2 (R 2): Latex solution. 1 × 9.9 ml

Reagent 1 (R 1): Reactive buffer solution. 1 × 72 ml (300 tests)

Reagent 2 (R 2): Latex solution. 1 × 60 ml

Solution of suspended latex microparticles sensitized with duck anti-CRP IgY(ΔFc) 1 × 18 ml (300 tests)

Calibrator set:

CRPex-HS CRP Calibrator Set (REF: 1510) 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.

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.