Triglyceride CardioChek Panel - 3 strips

CardioChek Analyzers FAQ

What is the CardioChek ST Analyzer?

The CardioChek ST Analyzer is a multi-test chemistry analyzer that utilizes reflectance photometry and a patented system of color-coded MEMo chips and test strips to measure a variety of important blood chemistries. Current tests include, glucose, ketone, total cholesterol, HDL cholesterol and triglycerides.

Who should purchase the CardioChek ST Analyzer?

The CardioChek ST Analyzer is ideal for people with type 1 diabetes who have difficulty getting accurate readings from urine ketone strips, type 2 diabetics who also suffer from dyslipidemia, patients on cholesterol lowering medications, patients with known cardiovascular disease and patients with family history of diabetes and/or CVD who want to monitor risk factors and general population concerned with leading longer, healthier lives.

Why do people with diabetes need to check more than their glucose?

Good glycemic control is the cornerstone for proper diabetes management; however, people who have diabetes are prone to dyslipidemia, CVD, PVD, eye disease, kidney disease and limb amputation. Cholesterol, HDL cholesterol, triglycerides, HgbA1c, ketone bodies, creatinine and microalbumin are all important to measure on a regular basis to keep on top of the complications associated with diabetes. In fact, the majority of people die from complications of the disease and not the disease itself.

Why do other people need to monitor lipids?

Coronary artery disease affects over 12 million Americans, and is the leading cause of death in the US for both men and women. (High cholesterol is the leading risk factor for heart disease). Ninety seven million Americans have elevated cholesterol levels. Studies have shown that lowering cholesterol in middle-aged men with hypercholesterolemia reduces the incidence of myocardial infarction. (A co-operative trial in the prevention of ischemic heart disease using clofibrate, The Lipid Research Clinics Coronary Primary Prevention Trial results. Helsinki Heart Study.) In addition, a 1 percent reduction in cholesterol levels offers a 2 percent reduction in risk of heart attack. One in five American men ages 30-34 may have an advanced case of clogged arteries that creates a high risk of a heart attack in the next 10 to 15 years (Source: Journal of the American Heart Association). About half of those who die suddenly of heart disease die without any warning sign like chest pain (American Heart Association). Given the fact that elevated cholesterol levels are a treatable risk factor to lower the risk of CAD and/or MI, early detection, interventions when appropriate and continual monitoring are necessary for all individuals.

Is the CardioChek ST Analyzer covered by insurance?

There is evidence that some health plans such as Blue Cross Blue Shield are paying for CardioChek products. Please check with your particular plan. It is best to gain pre-certification from your health plan to ensure coverage before purchasing CardioChek products. Medicare is covering the CardioChek system as a glucometer. This includes associated necessary supplies to measure your blood glucose. The amount of reimbursement or payment for the CardioChek ST Analyzer as a glucometer varies by state.

How often should cholesterol be monitored?

According to the American Heart Association cholesterol levels should be measured every 1-5 years in healthy adults. For people with elevated cholesterol levels every 6 months and for people on drug therapy every six weeks until stable and then at least every 6 months. With poor dietary habits, your cholesterol can increase in as little as 2 weeks.

How accurate is the CardioChek ST Analyzer?

PTS received certification from the CDC’s CRMLN lab, meeting their standards for cholesterol accuracy, demonstrating the ability to meet the NCEP’s performance criteria for accuracy and precision.

Is the CardioChek CLIA-waived?

Yes, the CardioChek is CLIA-waived. In addition by utilizing the correct CPT coding physicians are able to receive reimbursement for tests run on the CardioChek.

What is the significance of a CLIA-waiver?

In 1988, congress passed the Clinical Laboratory Improvement Amendments (CLIA) to establish quality standards for all laboratory testing to ensure accuracy, reliability and timeliness of patient test results regardless of where the test was preformed. Tests are divided into three levels of complexity; the more complicated the test, the more stringent the requirements. The three categories that are established are-- waived complexity, moderate complexity and high complexity. To obtain CLIA license, laboratories must first register by completing an application, pay fees, submit to a survey, if applicable, and become certified.

What variance is normal in cholesterol values?

Cholesterol levels can vary by 15 percent from day to day. An 8 percent difference can even be identified within the same day. According to the annual survey sponsored by the CAP (College of American Pathologist), acceptable variations for chemistries follow:

Analyte	Evaluation Limits
Cholesterol	± 10%
HDL	± 30%
Triglycerides, Glucose, whole blood Keytones	± 25%
Albumin	± 10%
Creatinine	± 0.3mg/dL