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The BioScanner 2000 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.
The BioScanner 2000™ home cholesterol/diabetes test 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.
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.
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.
There is evidence that some health plans such as Blue
Cross Blue Shield are paying for BioScanner home cholesterol/diabetes test
products. Please check
with your particular plan. It is best to gain pre-certification from
your health plan to ensure coverage before purchasing BioScanner home
cholesterol/diabetes test products. Medicare is covering the BioScanner system as a glucometer.
This includes associated necessary supplies to measure your blood glucose.
The amount of reimbursement or payment for the BioScanner 2000™ as a
glucometer varies by state.
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. Ketones are a bi-product of fat metabolism. In
diabetics with elevated blood sugar, acute infections or during times of
stress diabetic ketoacidosis can develop. This is a life-threatening
event that needs timely, accurate diagnosis so appropriate medical
treatment can be received. Ketones should be monitored when blood
sugar is over 240 mg/dL, during illness, when you are planning to exercise
and blood sugar is over 300 mg/dL if you are using insulin and 400 mg/dL
if you are not using insulin. Pregnant women should test for ketones
each morning before breakfast and anytime the blood sugar is over 180 mg/dL.
In addition, patients on low-carbohydrate, Atkin’s type diets; it is
recommended that they monitor their ketone levels to determine if they are
in ketosis and losing weight.
Ketones may be measured in blood and show up approximately
2-4 hours before they will be present in the urine. In addition, with
blood ketones your physician is able to get an accurate reading on your
level and know when you need medical intervention.
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.
Yes, the BioScanner is CLIA-waived. In addition by utilizing
the correct CPT coding physicians are able to receive reimbursement for
tests run on the BioScanner.
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.
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:
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