CHARM cm - CHARM LDL-C Characterics

Professional healthcare settings

The CardioChek Plus test system is a small, portable analyzer and test strip system intended for multiple-patient use in professional healthcare settings. This system should only be used with single-use, auto-disabling lancing devices.

This system is for in vitro diagnostic use only The test strips are for the quantitative determination of glucose, total cholesterol, HDL (high density lipoprotein) cholesterol, and triglycerides in venous whole blood and capillary whole blood from the fingertip A Chol/HDL ratio and estimated values for LDL (low density lipoprotein) cholesterol and non-HDL cholesterol are calculated by the CardioChek Plus analyzer.

Cholesterol measurements are used in the diagnosis and treatments of disorders involving excess cholesterol in the blood and lipid and lipoprotein metabolism disorders
HDL (lipoprotein) measurements are used in the diagnosis and treatment of lipid disorders (such as diabetes mellitus), atherosclerosis, and various liver and renal diseases
Triglycerides measurements are used in the diagnosis and treatment of patients with diabetes mellitus, nephrosis, liver obstruction, other diseases involving lipid metabolism or various endocrine disorders
Glucose measurements are used in the diagnosis and treatment of carbohydrate metabolism disorders including diabetes mellitus, neonatal hypoglycemia, and idiopathic hypoglycemia, and of pancreatic islet cell carcinoma

Criteria for CRMLN Cholesterol Certification

The CRMLN established test protocols use accepted “gold standard” reference methods. In order to be CRMLN certified, results must meet the following criteria:
Table 1: CRMLN Cholesterol Certification Criteria

Parameter	Total Cholesterol	HDL Cholesterol	LDL Cholesterol
R²	>0.975	>0.975	>0.975
Bias at medical decision points	≤3% at 200 mg/dL (5.18 mmol/L) ≤3% at 240 mg/dL (6.22 mmol/L)	≤5% at 40 mg/dL (1.04 mmol/L) ≤5% at 60 mg/dL (1.55 mmol/L)	≤4% at 100 mg/dL (2.59 mmol/L) ≤4% at 130 mg/dL (3.37 mmol/L) ≤4% a t 160 mg/dL (4.14 mmol/L)
Average % bias	≤3%	≤5%	≤4%
Among-run CV	≤3%	≤4%	≤4%

NCEP Guidelines for Total Error (TE)

The National Cholesterol Education Program (NCEP) of the National Institutes of Health (NIH) has established test protocols and guidelines for acceptable deviation from “truth” (defined as the National Reference System for Cholesterol [NRS/Chol] reference value). These guidelines state that TE should be within the following limits from the reference value when these test protocols are followed:

Total Error Criteria

	Total Cholesterol	HDL Cholesterol	LDL Cholesterol
Total Error	≤8.9%	≤13%	≤12%