HS CRP Rapid Test

Product information

High Sensitivity (HS) C-Reactive Protein (CRP) test is a rapid semi-quantitative screening test for the detection of CRP in serum, plasma or whole blood samples.

Advantages of HS CRP test

• Easy to perform
• No complex sample collection needed
• Semi-Quantitative result
• Accurate test result

General information

C-reactive protein (CRP) is a nonspecific, acute-phase reactant used to diagnose bacterial infectious disease and inflammatory disorders, such as acute rheumatic fever and rheumatoid arthritis. Published studies suggest that cardiovascular disease (CVD) and peripheral vascular disease (PVD) are inflammatory processes due to myocardial necrosis and can result in low levels of inflammatory markers such as C-reactive protein. Therefore, the determination of CRP level can be helpful to predict a healthy person’s risk of cardiovascular disease, heart attacks and strokes.

The level of CRP correlates with peak levels of the MB isoenzyme of creatine kinase, but CRP peaks occur 1 to 3 days later. Failure of CRP to normalize may indicate ongoing damage to the heart tissue. Levels are not elevated in patients with angina. The measurement of CRP does not indicate where is occurring the inflammation which may come from cells in the fatty deposits in arterial walls reflecting the process of atherosclerosis. The American Heart Association (AHA) and Centers for Disease Control (CDC) have defined risk groups as follows:

Low risk : less than 1.0 mg/L.
Average risk : 1.0 – 3.0 mg/L.
High risk : above 3.0 mg/L.

Studies conducted, in the United States and in Europe, on subjects who did not have CVD at entry but may have had other risk factors (eg, hypercholesterolemia, hypertension, diabetes, tobacco use) have identified CRP as a strong, independent risk factor for CVD. CRP is classically measured using latex agglutination and nephelometric or turbidimetric methods.

The HS CRP semi-quantitative screening test for the detection of CRP in serum, plasma or whole blood samples. The method relies on competitive binding between CRP fixed on the dye conjugate and free CRP present in the sample. When CRP is present in the sample, it competes with the CRP dye conjugate for a limited antibody sites on the test membrane. A sample that contains sufficient level of CRP will reduce or even prevent the formation of a line in the test region. A negative sample will allow the formation of a clearly visible line in the test region. The colour intensity of the control line is used to quantify the CRP concentration in the sample.

Test procedure

1. Allow specimen and HS CRP Rapid Test and components to come to room temperature prior to testing.
2. Remove the reaction device from its protective wrapper by tearing along the split.
3. Label device with the patient ‘s name or control number.
4. Fill the dropper with specimen (serum or plasma) and by holding it vertically, dispense one drop (25 μL) into sample well. If the whole blood is used as a sample, dispense two drops (50 μL) into the sample well and wait for the whole blood sample to be completely absorbed before adding diluent.
5. Add exactly 5 or 6 full drops of diluent (200 μL) in the sample well.
6. Read the results after 10 minutes.

Interpretation of the results

Positive result: The color intensity of the control line is stronger than the test line (CRP concentration is higher than 3 mg/L). In case of very high CRP concentration, the test line can completely disappear.

Borderline : The color intensity of the control and test lines are equivalent (CRP concentration is between 1 mg/L and 3 mg/L).

Negative result: The color intensity of the test line is stronger than the control line (CRP concentration is lower than 1 mg/L).