Dade Behring is the developer and manufacturer of high-sensitivity CRP (hsCRP) tests that can be used as a diagnostic aid for the physician for determining cardiac risk factors. This method was first approved by the FDA for marketing in the U.S. in November of 1999.
Dade Behrings CRP test can be run using either whole blood or plasma and requires nephlometric systems (such as the BNTM series produced by Dade Behring) for running analyses. The test is based on nephelometric analysis of latex particles coated with CRP monoclonal antibodies, which is much more sensitive than prior manual ELISA testing for CRP levels.
Current AHA and CDC guidelines indicate that while this test should not be used as routine screening for the general public, it can be used for screening for patients at intermediate risk (10 to 20 percent chance of having a cardiac or cerebral vascular event within the next 10 years). Using this test as an adjunct to normal lipid profiles can help identify patients at risk for CHD, MI, and peripheral vascular disease.
The high-sensitive CRP (hsCRP) is available as a variety of reagent tests from the manufacturer. These tests can detect CRP levels as low as ~0.175 mg/L (standard CRP assays cannot detect CRP levels <3.0).
The test should be conducted twice within a two-week period. The CRP looks at the inflammation level and produces a relative risk assessment, states Gary Samuel, a spokesperson for Quest Diagnostics, who provides Dade Behrings test as its Ca rdio CRP. He adds, It predicts the risk of a cardiovascular event relative to the general population, and provides this data in an easy-to-read format.
Dade Behringers hsCRP test requires 1 mL of blood or plasma serum (minimum of 0.5 mL) at room temperature when it is run. The sample can be refrigerated (for up to one week) or frozen (up to three months) during storage. It is recommended that a fasting sample be collected for best results and that the patient have any inflammatory diseases resolved for at least two weeks prior to testing.
The tests sensitivity is 0.2 mg/L.
The test is standardized against the International Chemistry and Laboratory Medicine (IFCC)/Bureau Communautaire de Rfrence (BCR)/College of American Pathologists (CAP) CRP reference preparation.
Less than 1.0 mg/L is considered low. Levels of 1.0 to 3.0 are average, and 3.1 to 10.0 is considered high. When levels are consistently greater than 10.0, the physician will want to assess for other sources of inflammation.
Currently, reimbursement by insurance companies varies. Neil Protter, a marketing manager at Dade Behringer states, There is currently a reimbursement code set up under Medicare, but its best to check with individual providers about coverage because not all providers cover testing.
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