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 serum, plasma and whole blood. 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 whole blood, as well as serum and plasma.
Test result available in minutes.
Application for general clinical chemistry analyzers.
(e.g. Hitachi series, Vitro 5,1 FS etc.)
Quantitative results.
Reliable assay range of up to 300 mg/L (Universal mode with using serum/plasma specimens) or 20 mg/L (High Sensitivity mode).  
High sensitivity/ Low detection limit: 0.5 mg/L (Universal mode)/ 0.05 mg/L (High Sensitivity mode).
 

Performance Characteristics

 Universal Mode:For whole Blood specimen
Specimen pretreatment: one volume of whole blood was diluted with 9 volumes of dd-H2O prior to analysis.
The following performance data were obtained using Hitachi 911 (7070) analyzer and the suggested parameter setting (sample/R1/R2= 2/240/60, assay range 2-300 mg/L).
 Precision:

Low concentration (n=10)

High concentration (n=10)

Mean

SD

CV%

Mean

SD

CV%

13.6

0.2751

2.1%

156.9

0.9866

0.6%

 Detection limit: ~ 1.4 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 whole blood specimen (CRP concentration: 0 mg/L).
Interference:
Criterion: Recovery within ± 5% of initial value.
No significant interference from bilirubin up to 60 mg/dl; no significant interference from lipemia up to 10 g/L of Liposyn, (at which concentration the triglyceride readout is 1376 mg/dl).
 
Universal Mode:For serum/plasma specimen
Specimen pretreatment: one volume of serum/plasma was diluted with 9 volumes of dd-H2O prior to analysis.
The following performance data were obtained using Hitachi 911 (7070) analyzer and the suggested parameter setting (sample/R1/R2= 2/240/60, assay range 0-300 mg/L).
Precision:

Control-M (n=10)

Control-H (n=10)

Mean

SD

CV%

Mean

SD

CV%

5

0.1700

3.1%

56.3

0.3718

0.7%

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 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 ).
  
High Sensitivity Mode:For serum/plasma specimen
The following performance data were obtained using Hitachi 911 (7070) analyzer and the suggested parameter setting (sample/R1/R2= 2/240/60, assay range 0-20 mg/L).
Precision:

Control-L (n=10)

Control-M (n=10)

Mean

SD

CV%

Mean

SD

CV%

1.61

0.0231

1.4%

5.65

0.0309

0.6%

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 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 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:
For VITROS 5,1FS
Reagent 1 (R 1): Reactive buffer solution. 1 × 14.8 ml
Reagent 2 (R 2): Latex solution. 1 × 9.9 ml
For HITACHI
Reagent 1 (R 1): Reactive buffer solution. 1 × 72 ml (300 tests)
Reagent 2 (R 2): Latex solution.
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.