C-reactive Protein in Human Serum with Roche c502

Detection of C-reactive Protein in Human Serum with Roche c502

Test Name: In vitro test for the quantitative determination of C-reactive protein in human serum and plasma on Roche/Hitachi cobas c systems.
Method Name: Particle enhanced immunoturbidimetric assay. Human CRP agglutinates with latex particles coated with monoclonal anti-CRP antibodies.
Results: Technical Range: 0.3-35 mg/dL
Reportable Range: 0.32-31.94 mg/dL
Reference Ranges: Taken from Mayo Clinic.
≤8.0 mg/L
Clinical Significance: C-reactive protein is the classic acute phase protein in inflammatory reactions. It is synthesized by the liver and consists of five identical polypeptide chains that form a five membered ring having a molecular weight of 105,000 daltons. CRP is the most sensitive of the acute phase reactants and its concentration increases rapidly during inflammatory processes. Complexed CRP activates the classical complement pathway.

The CRP response frequently precedes clinical symptoms, including fever. In normal healthy individuals CRP is a trace protein with a range up to 5 mg/L. After onset of an acute phase response the serum CRP concentration rises rapidly and extensively. The increase begins within 6 to 12 hours and the peak value is reached within 24 to 48 hours.

Levels above 100 mg/L are associated with severe stimuli such as major trauma and severe infection (sepsis). CRP response may be less pronounced in patients suffering from liver disease. CRP assays are used to detect systemic inflammatory processes; to assess treatment of bacterial infections with antibiotics; to detect intrauterine infections with concomitant premature amniorrhexis; to differentiate between active and inactive forms of disease with concurrent infection, e.g. in patients suffering from SLE or Colitis ulcerosa; to therapeutically monitor rheumatic disease and assess anti-inflammatory therapy; to determine the presence of post-operative complications at an early stage, such as infected wounds, thrombosis and pneumonia, and to distinguish between infection and bone marrow rejection. Postoperative monitoring of CRP levels of patients can aid in the recognition of unexpected complications (persisting high or increasing levels). Measuring changes in the concentration of CRP provides useful diagnostic information about how acute and how serious a disease is. It also allows judgements about the disease genesis. Persistence of a high serum CRP concentration is usually a grave prognostic sign which generally indicates the presence of an uncontrolled infection.

Submission Criteria: For specimen collection and preparation, only use suitable tubes or collection containers.
Only the specimens listed below were tested and found acceptable.
Plasma: Li-heparin, K2-EDTA and K3-EDTA plasma

The sample types listed were tested with a selection of sample collection tubes that were commercially available at the time of testing, therefore not all available tubes of all manufacturers were tested. Sample collection systems from various manufacturers may contain differing materials which could affect the test results in some cases.  When processing samples in primary tubes (sample collection systems), follow the instructions of the tube manufacturer.

Storage and Stability:    14 days at 15-25 °C
21 days at 2-8°C
365 days at (-15°C) – (-25°C)

Rejection Criteria: Rejection criteria include but are not limited to:
1. Specimens containing fibrin or clots.
2. Excessive platelet clumping
3. Leaking specimens
4. Substandard mixing or collection
5. Expired or improperly stored collection tubes.
6. Improperly filled tubes based on collection tube manufacturer’s guidelines.
7. Contaminated specimens (IV fluid, foreign particles, etc.)
8. Specimens not analyzed within the appropriate time frame.
9. Samples not shipped at appropriate temperature.
10. Samples without 2 proper identifiers or samples having identifiers that do not match the electronic or paper lab requisition.
Authorization: Diagnostic testing can only be performed with approval from an authorized provider/agency.
Turn Around Time: