INTRODUCTION
A reliable and accurate lipid point-of-care test method enables healthcare professionals to easily test and immediately counsel their patients on lipid-lowering therapies, to understand their risk for developing coronary heart disease, their medication regimen, and the benefits of long-term persistence of therapy.
A new lipid panel test, PTS PANELS™ Lipid Panel Test Strips, provides lipid results (total cholesterol, HDL cholesterol, triglycerides, and calculated LDL cholesterol) from a single drop of blood, when run on the PTS CardioChek™ P·A test system. CardioChek P·A is a portable whole blood test system that uses reflectance photometry to determine three lipid concentrations on a single test strip. The system calculates LDL cholesterol levels using the Friedewald equation through the use of total cholesterol, HDL cholesterol and triglycerides levels.1 Lipid Panel Test Strips have a cholesterol measuring range from 50 to 400 mg/dL, HDL cholesterol range from 15 to 100 mg/dL, and triglycerides range from 25 to 500 mg/dL.
PTS PANELS Lipid Panel Test Strips are CLIA Waived. This classification establishes that the PTS Lipid Panel Test Strip provides accurate, reliable and timely patient test results.
These studies describe the performance characteristics of the PTS Lipid Panel Test Strips.
MATERIALS AND METHODS
Specimens
Whole blood was used for all PTS Test Strips studies. The blood was drawn in K2EDTA
tubes for all studies, except for the correlation studies. In the correlation
studies, whole blood, obtained from a fingerstick was used. Serum and whole
blood samples were used for all reference methods.
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CONCLUSION
The PTS PANELS Lipid Panel Test Strips, as run on the CardioChek P·A
system, provide
accurate and reliable results for total cholesterol, HDL cholesterol, and
triglycerides from a simple
fingerstick, whole blood sample. This new, portable, point-of-care lipid test
system provides
an alternative to bench-top systems enabling healthcare professionals greater
flexibility and
efficiency in performing routine lipid testing as well as managing their
patients.
References
1. Friedewald et al. 1972. Clin. Chem., 18:499-502.
2. Warnick, et al. 2002. Clin Chem., 48(l):11-17.