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Test ID: HSCRP
C-Reactive Protein, High Sensitivity, Serum

Secondary ID A test code used for billing and in test definitions created prior to November 2011

82047

NY State Approved Indicates the status of NY State approval and if the test is orderable for NY State clients.

Yes

Useful For Suggests clinical disorders or settings where the test may be helpful

Assessment of risk of developing myocardial infarction in patients presenting with acute coronary syndromes

 

Assessment of risk of developing cardiovascular disease or ischemic events in individuals who do not manifest disease at present

Method Name A short description of the method used to perform the test

Immunoturbidimetry

Reporting Name A shorter/abbreviated version of the Published Name for a test; an abbreviated test name

C-Reactive Protein, High Sens, S

Aliases Lists additional common names for a test, as an aid in searching

C Reactive Protein (CRP), Cardiac
C Reactive Protein, High Sensitivity
C-Reactive Prot, High Sens, Serum
C-Reactive Protein (CRP)
C-Reactive Protein, Cardio
C-Reactive Protein, Sensitive
Cardio C-Reactive Protein
CRP Cardiac
CRP, High Sensitivity
CRP, Highly Sensitive, (hs-CRP), Serum
CRP, Ultra-Sensitive, Serum
High-Sensitivity C-Reactive Protein (hs-CRP)
Protein, C-Reactive
Sensitive C-reactive protein
Ultra-Sensitive C-reactive protein (CRP)

Specimen Type Describes the specimen type needed for testing

Serum

Specimen Required Defines the optimal specimen. This field describes the type of specimen required to perform the test and the preferred volume to complete testing. The volume allows automated processing, fastest throughput and, when indicated, repeat or reflex testing.

Collection Container/Tube:

Preferred: Red top

Acceptable: Serum gel

Submission Container/Tube: Plastic vial

Specimen Volume: 0.5 mL

Specimen Minimum Volume Defines the amount of specimen required to perform an assay once, including instrument and container dead space. Submitting the minimum specimen volume makes it impossible to repeat the test or perform confirmatory or perform reflex testing. In some situations, a minimum specimen volume may result in a QNS (quantity not sufficient) result, requiring a second specimen to be collected.

0.5 mL

Reject Due To Identifies specimen types and conditions that may cause the specimen to be rejected

Hemolysis

Mild OK; Gross reject

Lipemia

Mild OK; Gross reject

Icterus

Mild OK; Gross reject

Other

NA

Specimen Stability Information Provides a description of the temperatures required to transport a specimen to the laboratory. Alternate acceptable temperature(s) are also included.

Specimen TypeTemperatureTime
SerumRefrigerated (preferred)7 days
 Frozen 30 days

Clinical Information Discusses physiology, pathophysiology, and general clinical aspects, as they relate to a laboratory test

C-reactive protein (CRP) is 1 of the most sensitive acute-phase reactants. Plasma CRP levels can increase dramatically (100-fold or more) after severe trauma, bacterial infection, inflammation, surgery, or neoplastic proliferation. Measurement of CRP has been used historically to assess activity of inflammatory disease, to detect infections after surgery, to detect transplant rejection, and to monitor these inflammatory processes. While assays for CRP have been available for many years, the traditional assays lack the sensitivity to measure basal levels of CRP.

 

In the mid-1990s, more sensitive methods for measurement of CRP were introduced. These methods, referred to as high sensitivity CRP (hs-CRP), can accurately measure basal levels of CRP throughout the currently accepted cardiovascular risk assessment range (0.20-10.0 mg/L).

 

These hs-CRP assays were used to assess outcomes in patients with unstable angina and showed that hs-CRP values in the upper tertile (>3.0 mg/L) were associated with increased risk of developing myocardial infarction (1,2). Data from prospective studies monitoring hs-CRP in apparently healthy populations also has been published. All prospective studies reported to date have been positive, with adjusted relative risks of developing cardiovascular disease or ischemic events ranging from 2.3 to 4.8 in the highest quartile or quintile of data versus the lowest quartile or quintile (3-6). It also has been shown that hs-CRP is additive with total cholesterol, LDL and HDL, as well as the Framingham 10-year risk score, with respect to risk prediction (7-8).

 

More aggressive treatment strategies may be pursued in patients determined to be at increased risk by hs-CRP values.

Reference Values Describes reference intervals and additional information for interpretation of test results. May include intervals based on age and sex when appropriate. Intervals are Mayo-derived, unless otherwise designated. If an interpretive report is provided, the reference value field will state this.

Low risk: <1.0 mg/L

Average risk: 1.0-3.0 mg/L

High risk: >3.0 mg/L

Acute inflammation: >10.0 mg/L

Interpretation Provides information to assist in interpretation of the test results

Increased high sensitivity C-reactive protein values are associated with increased risks of cardiovascular disease or cardiovascular events.

Cautions Discusses conditions that may cause diagnostic confusion, including improper specimen collection and handling, inappropriate test selection, and interfering substances

C-reactive protein (CRP) is an acute-phase reactant. A single test for high sensitivity CRP (hs-CRP) may not reflect an individual patient's basal hs-CRP level. Repeat measurement may be required to firmly establish an individual's basal hs-CRP concentration. The lowest of the measurements should be used as the predictive value.

 

Because CRP is an acute-phase reactant, measurements in apparently healthy individuals may not truly reflect the basal level if inflammation is present.

 

This hs-CRP assay should be used as a means to assess risk of cardiovascular disease or events. A different CRP test (CRP/9731 C-Reactive Protein [CRP], Serum) should be used to monitor or assess other inflammatory disorders.

Clinical Reference Provides recommendations for further in-depth reading of a clinical nature

1. Haverkate F, Thompson SG, Pyke SD, et al: Production of C-reactive protein and risk of coronary events in stable and unstable angina. European Concerted Action on Thrombosis and Disabilities Angina Pectoris Study Group. Lancet 1997;349(9050):462-466

2. Rebuzzi AG, Quaranta G, Liuzzo G, et al: Incremental prognostic value of serum levels of troponin T and C-reactive protein on admission in patients with unstable angina pectoris. Am J Cardiol 1998;82(6):715-719

3. Ridker PM, Cushman M, Stampfer MJ, et al: Inflammation, aspirin, and the risk of cardiovascular disease in apparently healthy men. N Engl J Med 1997;336(14):973-979

4. Tracy RP, Lemaitre RN, Psaty BM, et al: Relationship of C-reactive protein to risk of cardiovascular disease in the elderly. Results from the Cardiovascular Health Study and the Rural Health Promotion Project. Arterioscler Throm Vasc Biol 1997;17(6):1121-1127

5. Ridker PM, Buring JE, Shih J, et al: Prospective study of C-reactive protein and the risk of future cardiovascular events among apparently healthy women. Circulation 1998;98(8):731-733

6. Koenig W, Sund M, Frohlich M, et al: C-reactive protein, a sensitive marker of inflammation, predicts future risk of coronary heart disease in initially healthy middle-aged men: results from the MONICA (Monitoring Trends and Determinants in Cardiovascular Disease) Augsburg Cohort Study, 1984 to 1992. Circulation 1999;99(2):237-242

7. Ridker PM, Glynn RJ, Hennekens CH: C-reactive protein adds to the predictive value of total and HDL cholesterol in determining risk of first myocardial infarction. Circulation 1998;97(20):2007-2011

8. Ridker PM, Rifai N, Rose L, et al: Comparison of C-reactive protein and low-density lipoprotein cholesterol levels in the prediction of first cardiovascular events. N Engl J Med 2003;347(20):1557-1565

9. Pearson TA, Mensah GA, Alexander RW, et al: Markers of inflammation and cardiovascular disease; application to clinical and public health practice; A statement for healthcare professionals from the Center for Disease Control and Prevention and the American Heart Association. Circulation 2003;107(3):499-511

10. Ridker PM, Danielson E, Fonseca FAH, et al: Rosuvastatin to Prevent Vascular Events in Men and Women with Elevated C-Reactive Protein. N Engl J Med 2008;359(21):2195-2207

Method Description Describes how the test is performed and provides a method-specific reference

The quantitative determination of high sensitivity C-reactive protein (hs-CRP) is achieved by latex particle-enhanced immunoturbidimetric assay. Latex particles coated with antihuman CRP antibodies aggregate in the presence of serum CRP, forming immune complexes. The formed immune complexes cause increased turbidity, which is proportional to the concentration of CRP in the serum. The sample hs-CRP concentration is determined by comparison to hs-CRP standards of known concentration. (Tracy RP, Lemaitre RN, Psaty BM, et al: Relationship of C-reactive protein to risk of cardiovascular disease in the elderly. Results from the Cardiovascular Health Study and the Rural Health Promotion Project. Arterioscler Throm Vasc Biol 1997;17[6]:1121-1127)

Day(s) and Time(s) Test Performed Outlines the days and times the test is performed. This field reflects the day and time the sample must be in the testing laboratory to begin the testing process and includes any specimen preparation and processing time required before the test is performed. Some tests are listed as continuously performed, which means assays are performed several times during the day.

Monday through Saturday; Continuously

Analytic Time Defines the amount of time it takes the laboratory to setup and perform the test. This is defined in number of days. The shortest interval of time expressed is "same day/1 day," which means the results may be available the same day that the sample is received in the testing laboratory. One day means results are available 1 day after the sample is received in the laboratory.

Same day/1 day

Maximum Laboratory Time Defines the maximum time from specimen receipt at Mayo Medical Laboratories until the release of the test result

2 days

Specimen Retention Time Outlines the length of time after testing that a specimen is kept in the laboratory before it is discarded

7 days

Performing Laboratory Location The location of the laboratory that performs the test

Rochester

Test Classification Provides information regarding the medical device classification for laboratory test kits and reagents. Tests may be classified as cleared or approved by the US Food and Drug Administration (FDA) and used per manufacturer's instructions, or as products that do not undergo full FDA review and approval, and are then labeled as an Analyte Specific Reagent (ASR), Investigation Use Only (IUO) product, or a Research Use Only (RUO) product.

This test has been cleared or approved by the U.S. Food and Drug Administration and is used per manufacturer's instructions. Performance characteristics were verified by Mayo Clinic in a manner consistent with CLIA requirements.

CPT Code Information Provides guidance in determining the appropriate Current Procedural Terminology (CPT) code(s) information for each test or profile. The listed CPT codes reflect Mayo Medical Laboratories interpretation of CPT coding requirements. It is the responsibility of each laboratory to determine correct CPT codes to use for billing.

86141

LOINC® Code Information Provides guidance in determining the Logical Observation Identifiers Names and Codes (LOINC) values for the result codes returned for this test or profile.

Result IDReporting NameLOINC Code
HSCRPC-Reactive Protein, High Sens, S30522-7