Rapid cardiovascular disease test CCR-402

C-reactive proteinbloodimmunoassay

Product overview
The CRP Semi-Quantitative Rapid Test Device (Whole Blood/Serum/Plasma) is a rapid chromatographic immunoassay for semi-quantitative detection of C-Reactive Protein in whole blood, serum or plasma specimens to aid in evaluating risks of cardiovascular disease.

Principle
The device is a semi-quantitative, membrane-based immunoassay. The membrane is pre-coated with anti-CRP antibodies on the test line region. During testing, specimen reacts with particles coated with anti-CRP antibodies. The mixture migrates upward on the membrane by capillary action to react with anti-CRP antibodies on the membrane and generate a colored line. Two reference lines (R1 and R2) are present as controls and as intensity references.

Interpretation
If the intensity of the test line (T) is weaker than reference line 2 (R2), CRP level is between 1-3 mg/L.
If T is weaker than reference line 1 (R1) but stronger than R2, CRP level is between 3-10 mg/L.
If T is stronger than reference line 1 (R1), CRP level is above 10 mg/L.
Reference lines R1 and R2 will always appear to indicate proper specimen volume and membrane wicking (procedural control).

Kit components

• Test devices
• Droppers
• Buffer
• Package insert

Additional product information
Sample types accepted: whole blood, serum, plasma.
Assay format: rapid chromatographic immunoassay (semi-quantitative).
Intended use: aid in evaluating risks of cardiovascular disease by semi-quantitative CRP detection.

Technical specifications

• Analyte: C-Reactive Protein (CRP)
• Sample types: whole blood, serum, plasma
• Assay type: membrane-based lateral flow chromatographic immunoassay (semi-quantitative)
• Result categories (based on test line intensity vs reference lines): 1-3 mg/L, 3-10 mg/L, >10 mg/L
• Control/reference lines: two reference lines (R1, R2) that serve as procedural control and semi-quantitative references
• Kit contents: test devices, droppers, buffer, package insert
• Usage: point-of-care / rapid screening to assist cardiovascular risk assessment