FDA approved tests which are exempt or waived from CLIA regulation as a result of being simple to carry out and making inaccuracy nealry impossible.
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 PA test system. CardioChek PA 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. 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.
| Cardio Chek Lipid Panel Test Strips - 15 per Pack | |
|---|---|
Analyzer |
CardioChek PA Only |
CLIA |
Waived |
Range HDL |
15-100 mg/dL (0.39-2.59 mmol/L) |
Range Total Cholesterol |
50 to 400 mg/dL |
Range Triglycerides |
25 to 500 mg/dL |
Sample Size |
35-40 uL whole blood (fingerstick or venous) |
Time |
Approximately 2 minute/test |
Cardio Chek PA Monitor Sold Separetly
This item does not come with a warranty.
This item is not returnable after the package has been opened or if the original seal is broken. An exception may be made if the product is confirmed defective by the manufacturer and the manufacturer agrees to take them back. Products requiring refrigeration may not be returned.
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