Triplex CRP LIT Assay

Intended Use

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.
 
 

Features 

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).
 

Assay Range

Analyzer

Mode

Assay Range: CRP (mg/L)

VITROS 5,1FS

Universal Mode

0.68-250 mg/L

High Sensitivity Mode

0.013-20 mg/L

Hitachi 917(7170)

Universal Mode

0.34-300 mg/L

High Sensitivity Mode

0.04-20 mg/L

Whole Blood Mode

1.4-300 mg/L

 

Performance Characteristics

Performance on VITROS 5,1FS chemistry system 

Universal Mode: assay range 0.68-250 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 0.013-20 mg/L
Antigen Excess: CRP concentration up to 500 mg/L did not produce a false negative value.
Detection limit: ~ 0.013 mg/L

Read more about the Triplex CRP LIT Assay performance on VITROS 5,1FS.

 

Performance on Hiachi 917 (7170) chemistry analyzer

Universal Mode: assay range 0.34-300 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 0.04-20 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 1.4-300 mg/L
Antigen Excess: CRP concentration up to 1000 mg/L did not produce a false negative value.
Detection limit: ~ 1.4 mg/L

Read more about the Triplex CRP LIT Assay performance on Hiachi 917 (7170). 

 

 Reagent Components / Package

Reagent:
For VITROS 5,1FS
Reagent 1 (R 1): Reactive buffer solution. 1 × 14.8 ml (164 tests)
Reagent 2 (R 2): Latex solution. 1 × 9.9 ml
For HITACHI
Reagent 1 (R 1): Reactive buffer solution. 1 × 60 ml (250 tests)
Reagent 2 (R 2): Latex solution. 1 × 15 ml
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.