Whole Blood CRP LIT Assay

Intended Use

The Whole Blood CRP kit - Whole Blood CRP LIT Assay (REF: KT-0301-W) is intended to be used as a highly sensitive assay for the quantitative determination of C-Reactive protein (CRP) in whole blood, serum and plasma by latex particle enhanced immunoturbidimetry (LIT). Whole Blood CRP LIT Assay is adapted to use whole blood as samples, hence, this feature leads Whole Blood CRP LIT Assay has its broad availability for general clinic chemistry analyzers, in particular for the small size/ bench-top POCT use analyzers. The measurement of CRP is useful for the detection and evaluation of infection, tissue injury, inflammatory disorders and associated diseases. In Vitro diagnostic point of care testing is important and can help to determine if the infection is bacterial or vial in origin. Therefore, speeding up the establishment of an appropriate treatment will be great beneficial for improved patient care and efficacies against utilization of health care resources.

Learn more about C-reactive protein

 
 
 
 

Major Features

  1. Good Biotech Corp. Whole blood CRP LIT Assay (REF: KT-0301-W) is intended to be used for the quantitative determination of C-reactive protein in whole blood, serum and plasma by latex particle enhanced immunoturbidimetry (LIT). The measurement of C-reactive protein aids in evaluation and detection of the amount of infection, tissue injury, inflammatory disorders and associated diseases.
  2. The Whole Blood CRP LIT Assay is simple, rapid, convenient and adaptable to general clinic chemistry analyzers, in particular for the applications on POCT use compact analyzers. Moreover, the use of whole blood as samples for CRP measurement is time-saving and eliminates the step of serum-sample preparation.

  3. The one and only one IgY-based Human CRP Immunoassay in the world. A novel antibody─duck IgY(ΔFc)*, has been employed in the Whole Blood CRP LIT assay. Duck anti-CRP IgY(ΔFc) is coupled to latex microparticles, which amplify the antigen-antibody reaction and thus greatly increase the detection sensitivity. Without the Fc domain, duck IgY(ΔFc) will not cross-react with the following factors which are common interferences for immunoassay: Complement, HAMA , Human IgG ,RF/ASO and Fc receptors etc. The sensitivity, precision, and accuracy of the assay can be highly improved by using duck IgY(ΔFc) as the material of immunodiagnostic reagents.

  4. The test is completed within 2-3 minutes by quantitative measurement of the degree of agglutination using a bench-top analyzer in small and medium-sized laboratories or doctors’ offices as well as an automated chemistry analyzer (e.g. Hitachi series) in central laboratories. Hence, the assay enables in-hospital immediate testing for inflammation diagnosis. Near-patient monitoring of CRP in real time is important and beneficial for improve patient care. Besides, the use of whole blood for CRP measurement eliminates the need for sample centrifugation or transportation and thus is most suitable for rapid point-of-care testing.
*The technology platform of duck IgY(ΔFc) is solely owned by Good Biotech Corp. ; the manufacturing and the applications of duck IgY(ΔFc) antibody is patent-protected worldwide including all the major and dominant markets. 

 

Specifications 

Reagent: 

Liquid stable, Ready-to-use reagent.

 

Both single-reagent and two-reagent formats are avaliable

Analyzer:

General clinical chemistry analyzer (auto & bench-top)

 

Specially for POCT devices

Measurement:

LIT (latex microparticle enhanced immonoturbidimetry)

Sample type:

Whole blood (capillary or venous whole blood), serum and plasma

Sample volume:

1μl

Wave length:

660nm, single wave length

Assay time:

120-180 seconds

Assay range:

Reliable assay range of   1.3-230 mg/L (whole blood)

 

Reliable assay range of   0.6-200 mg/L (serum/plasma)

Sensitivity:

2.0 mg/L (whole blood)

 

<1.0 mg/L (serum/plasma)

Detection limit:

1.3 mg/L (whole blood)

 

0.6 mg/L (serum/plasma)

Antigen excess:

In whole blood and serum/plasma, up to 1000 mg/L, no hook effect.

Calibrator:

Single set calibrator

Correlation:

Good correlation with other commercial latex kits.


Above mentioned results were obtained by Hitachi 917 (7170) analyzers.
 

Performance Characteristics

The following performance data were obtained using Hitachi 917 (7170) analyzer and the suggested parameter setting (sample/R1/R2= 1/250/150). Suitable for whole blood, serum and plasma specimens.

 
Whole blood specimen (contained 50% RBC)
Specimen pretreatment:  1μl of whole blood was diluted with 9μl of Lysis Buffer prior to analysis.
 
 
Assay range: 1.3-230 mg/L (whole blood)
Antigen excess:  up to 1000 mg/L, no hook effect
Functional Sensitivity: 2.0 mg/L
Detection limit: 1.3 mg/L
Precision:
Specimens (N=10)
Mean (mg/L)
SD
CV%
Whole blood 1
5.12
0.2495
4.9
Whole blood 2
7.69
0.2703
3.5
Correlation of blood CRP: Good correlation with the Triplex CRP LIT Assay (Universal mode) method.

 
Serum and plasma specimen
Assay range: 0.6-200 mg/L (serum and plasma)
Antigen excess: up to 1000 mg/L, no hook effect
Functional Sensitivity: <1.0 mg/L
Detection limit: 0.6 mg/L
Precision:
Specimens (N=10)
Mean (mg/L)
SD
CV%
Serum 1
5.21
0.2621
5.0
Serum 2
9.48
0.2614
2.8
Correlation of serum CRP: Good correlation with the Triplex CRP LIT Assay (Universal mode) method.