User manual

PRODUCT OVERVIEW

The CRP Test Kit enables quantitative in vitro determination of C-reactive protein (CRP) in:

• 
  Capillary whole blood (fingerstick)
  
• 
  EDTA venous blood
  
• 
  Serum
  

CRP is a well-established acute phase protein that increases rapidly (within 6 hours) in response to:

• 
  Acute bacterial infections
  
• 
  Post-operative inflammation
  
• 
  Tissue injury
  
• 
  Inflammatory disorders
  

Elevated CRP levels are also associated with increased cardiovascular risk in apparently healthy individuals.

TECHNICAL SPECIFICATIONS

Method

Immunoturbidimetric assay

Photometric measurement at:

• 
  546 nm
  
• 
  700 nm
  

Based on antigen–antibody reaction between CRP in the sample and anti-human CRP antibodies bound to polystyrene particles.

Measurement Range

Sample TypeRangeSerum0.5 – 120 mg/L (546 nm)Serum1.0 – 120 mg/L (700 nm)Whole Blood2.0 – 240 mg/L

Whole blood range may depend on lot and hematocrit.

Reference Range

• 
  Normal: < 10 mg/L
  
• 
  Elevated values indicate acute or severe inflammation.
  

Each laboratory should establish its own reference interval.

Precision

• 
  Within-run precision:
  
  
  N = 20
  
  
  Mean = 100 mg/L
  
  
  CV = 3.5%
  
  
  

Correlation Study

• 
  Compared with Cobas 6000
  
• 
  N = 50
  
• 
  r = 0.993
  
• 
  Regression: y = 0.938x + 0.32
  

SAMPLE REQUIREMENTS

Preferred Sample

Fresh fingertip capillary blood (5 µL)

Alternative Samples

• 
  EDTA venous blood
  
• 
  Serum
  

⚠️ Important:

• 
  EDTA plasma gives ~16% lower values vs serum
  
• 
  Li-Heparin plasma gives ~28% lower values vs serum
  

After pipetting into the ERS cuvette, analysis must be performed within 4 hours.

KIT CONTENTS & ORDERING OPTIONS

Order CodeDescriptionPack SizeST0102CRP with integrated capillary32 testsST0103CRP with integrated capillary16 testsST1000CRP Control Kit2 x 2 mL (Low/High)

STORAGE & STABILITY

Storage at 2–8 °C

• 
  Unopened: Until expiry date
  
• 
  Opened: 3 months
  

Storage at 18–25 °C

• 
  Unrefrigerated: 1 month
  
• 
  Refrigerated ≥16 hours/day: 2 months
  

Allow each test to warm to room temperature (20–25 °C) for at least 10 minutes before use.