The Direct LDL-C Plus second-generation test provides direct and fully automated measurement of low-density lipoprotein cholesterol (LDL-C) using nonfasting samples. The test is assayed for Cobas Integra and Roche/Hitachi analyzers.
Each lot of reagents and calibrator is evaluated according to platform-based specifications. The test has been CDC-certified for lot-to-lot consistency in meeting the new National Cholesterol Education Program (NCEP) guidelines, identifying the optimal level of LDL-C as <100 mg/dL.
The nonfasting feature of the test fosters greater compliance, particularly among the elderly, people with diabetes, and other high-risk patient groups.
CMS-published changes in reimbursement to be implemented in November 2002 reduce the number of reimbursed lipid panels from four to one in the first year and increase the number of ancillary individual tests to six. This change supports the value of direct rather than calculated LDL-C testing.
Roche Diagnostics
www.roche-diagnostics.com
Keywords: cardiac markers
