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Biosafe Diabetes A1c Home Test Kit

The BIOSAFE Hemoglobin A1c (HbA1c) blood test is a laboratory procedure that measures the total amount of hemoglobin A1c in your blood. Comparing the results of your initial HbA1c test to the results of subsequent tests can determine the progress you’ve made in properly managing your Diabetes. The specimen collection process is quick, easy and virtually painless. Using the special lancet included in the BIOSAFE Blood Collection Kit, a couple of drops of blood are taken from a nick of a finger and deposited onto a special collection card. The card is then sent to BIOSAFE Laboratories for analysis. BIOSAFE tests your blood sample to see how much HbA1c is present and then mails the results back to you in an easy-to-read, understandable report. Click here to view a Diabetes A1c Sample Lab Report.

Since the BIOSAFE Diabetes A1c test produces a numerical result rather than a simple "yes" or "no" answer, both testing approval and professional review of test results are required by a licensed physician. After your test analysis is completed by BIOSAFE Laboratories, the results will be reviewed by a licensed health professional before being sent back to you.

Testing Procedure

	Check the Kit Contents Laboratory Authorization Form. Blood Sample Return Bag. Blood Collection Card. Alcohol Prep. Adhesive Bandage. Sterile Gauze Pad. 2 Lancets. Preaddressed, Prepaid Mailing Envelope. Easy to Understand Instructions.
	Fill out the Lab Authorization Form Fill out the lab Authorization Form completely. Note the date and time of blood collection.
	Apply Barcode and Print Name on Blood Collection Card Remove the barcode sticker from the upper corner of the Authorization Form and place on the Blood Collection Card. Print your name on the Blood Collection Card and place on firm, clean and flat surface.
	Clean Selected Finger for Blood Collection Wash hands with warm water and dry thoroughly. Select either the middle or ring finger to collect blood sample. To increase blood flow, rub hands together for 10 seconds and then allow your selected hand to hang at your side for 30 seconds. Open the alcohol prep package and clean the selected finger and allow the skin to dry.
	Remove the Cap from the Lancet and Press against Finger Remove the plastic cap from the Lancet. Place the chosen hand palm side up on a flat surface. Place the Lancet slightly off center of your finger. Hold Lancet steady, press down firmly until it "clicks" and then release.
	Wipe away First Blood Drop and Collect Blood Sample Observe the finger to see if blood is flowing from the nick. It may be necessary to gently massage the finger from the base up to the "nick site" to produce the first drop of blood. Wipe away the first drop of blood with the Sterile Gauze Pad. Continue to gently squeeze the finger if needed to produce the drops that are needed. Wait until each drop is large and "hanging" before attempting to touch it to the Blood Collection Card.
	Fill the Three Circles on the Blood Collection Card and allow to Dry If single drop of blood does not completely fill the circle, add additional drops beside the first until the circle is filled. Completely fill each circle before proceeding to the next circle. Allow the Blood Collection Card to dry for 15 minutes. Do not allow the card to be exposed to direct sunlight or extreme temperature or humidity. Apply adhesive bandage over the small nick on your finger.
	Insert the Authorization Form and Sample into Prepaid Envelope Close Blood Collection Card and insert into the bag marked Blood Sample Return Bag. Remove pink copy of the Laboratory Authorization Form for your records. Place completed form and sealed sample bag into the preaddressed prepaid mailing envelope.
	Mail Sample Promptly Place in regular mail as soon as possible, but no later than one week after sample collection. Discard used Lancet and all other kit materials in household trash.

General Information

Diabetes

Diabetes is a complicated, chronic disease that impairs your body's ability to produce or properly use insulin, which, in turn, causes your blood sugar level to increase. This build-up of sugar, without treatment, can cause blindness, heart attack, loss of feet or legs to amputation, kidney dysfunction, and even death. There is no cure for Diabetes, but there are a number of things you can do to control it. Approximately 15 to 16 million people in the United States are known to have Diabetes. In addition, an estimated 8 million American adults have undiagnosed Diabetes. That estimate does not include people who have borderline Diabetes or pre-Diabetes. Diabetes affects both men and women.

Serious but Manageable Disease

Diabetes is a very serious disease, but it can be controlled with proper self-management. Many people affected with Diabetes lead very normal and productive lives by following a few simple guidelines:

• Proper diet

• Regular exercise

• Check your feet (daily)

• Eye examination (annual)

• Physical examination (annual)

• Total Cholesterol Panel blood test (annual)

• Hemoglobin A1c blood test (2-4 each year)

Note: For proper guidance regarding these issues, always consult with your health care professional.

HbA1c Testing is a Necessity

Periodic hemoglobin A1c testing gives you and your health care professional the most accurate picture of your overall Diabetes control. By lowering your HbA1c number (or keeping it low) you can help avoid the risk of serious Diabetes problems affecting the eyes, kidneys, and nerves.It is important to note that lowering your hemoglobin A1c level by any amount will improve your overall health. Note: Test results provide important information, but never adjust your medication(s) based on the test results alone. Always consult with your health care professional before making any changes in your treatment.

Keeping on Track

There are two basic ways a health care professional monitors the blood glucose (sugar) of a Diabetes patient:

1. Random Blood Glucose Testing - This is usually a self-monitored test, performed by the patient randomly during the day, using a blood glucose meter that measures the actual level of sugar in the blood at the time of the test. This test can also be performed by a health care professional in a clinical setting.

2. Hemoglobin A1c testing - Since blood glucose levels vary widely during the day, a single measurement of blood glucose is a poor indicator of overall Diabetes control. The hemoglobin A1c test, by comparison, measures the amount of sugar that is attached to the hemoglobin (the part of the cell that carries oxygen) in red blood cells. Once the sugar is attached, it stays there for the life of the red blood cell (about 120 days). The higher the level of blood sugar, the more sugar attaches to red blood cells. The hemoglobin A1c test measures the amount of sugar sticking to the hemoglobin in the red blood cells, showing the average blood sugar for the past several months. Results are given in percentages.

The hemoglobin A1c goal for patients with Diabetes is less than 7 percent. If you test your hemoglobin A1c routinely, you will know if your recent value is lower or higher than your last one. If the most recent value is lower, you know you are making progress. Conversely, if the recent value is higher, a change in treatment may be necessary. You will often need a change in treatment if your value is over 8 percent. Note: The important thing to remember is that if you have Diabetes, and if you lower your hemoglobin A1c by any amount, you dramatically improve your chances of staying healthy.

Testing Frequency

Everyone affected with Diabetes should have a hemoglobin A1c test at least twice a year. If you are affected with Type 1 Diabetes, if you are taking insulin, or if your blood sugars are consistently too high, you should have this test performed every 3 months. Regular hemoglobin A1c testing will help you keep your blood sugar levels on track. Diabetes is a serious disease. Regular monitoring is an important element of your care. Note: Test results provide important information, but never adjust your medication(s) based on the test results alone. Always consult with your health care professional before making any changes in your treatment.

Test Levels

Frequently Asked Questions

What are the Diabetes Categories and Risk Factors?

Most forms of Diabetes fall within two major categories:

1. Type 1 - Insulin-dependent Diabetes mellitus (IDDM) or "juvenile onset." Fortunately, only about 5 - 10% of alI diabetic patients are affected with Type 1 (insulin-dependent).

2. Type 2 - Non-insulin-dependent Diabetes mellitus (NIDDM) or "adult onset." It usually occurs in patients over 35-40 years of age but can occur in children. Type 2 patients tend to be obese, and although not dependent on insulin for survival, may require it for hyperglycemia (high blood sugar) that is resistant to other treatment.

Gestational Diabetes develops in 2-5 % of all pregnancies. Although it usually disappears when pregnancy is over, it occasionally persists in women with previously undetected Diabetes. Sometimes insulin is required. Most all women with gestational Diabetes will have a recurrence in subsequent pregnancies. With each successive pregnancy, the Diabetes has a tendency to begin sooner, become more severe, and develop into a permanent condition. Some patients have unexplained combinations of Types 1 and 2. Overlapping characteristics of the two types include patients who typically have adult onset but are near normal in body weight and are insulin-deficient (they require insulin treatment). This form of Diabetes is sometimes referred to as "Type 1 ½". Secondary Diabetes describes most forms not covered by the two main types. Causes of these include any condition that causes damage to or loss of the pancreas (blunt trauma, cancer, alcohol abuse, exposure to chemicals, pancreatitis).

What are the Major Symptoms of Diabetes? 

People with Diabetes may have some (or none) of the following symptoms:

• Frequent Urination

• Excessive Thirst

• Unexplained Weight Loss

• Extreme Hunger

• Sudden Changes in Vision

• Tingling or Numbness in Hands or Feet

• A Frequent Feeling of being Very Tired
  Very Dry Skin

• Sores that are Slow to Heal

• More Infections than Usual

How does Blood Glucose and HbA1c Testing Differ? 

Self-monitoring of blood glucose is important. A finger-stick test using a blood glucose meter measures the actual level of sugar in the blood at the time of the test. The hemoglobin A1c (HbA1c) test measures the average blood sugar over a 90 day period. HbA1c can be sampled at any time during the day. By contrast, daily blood sugars are taken at specific times, usually just before or after meals.

Together, these two tests help people with Diabetes see how food, physical activity, and Diabetes medicines affect their blood sugar. A correlation of test results helps the patient and the health care professional better manage the disease. All people with Diabetes need regular HbA1c testing. Most people with Diabetes also need to self-monitor their blood glucose to get a complete picture of blood sugar control. Note: Always consult with your health care professional before adjusting any of your medications. Never adjust your medications based on test kit results.

Laboratory Accuracy

• BIOSAFE Diabetes A1c Home Test Kit dry blood sample analysis is as accurate as EDTA whole blood analysis with a tested 99% correlation.

• Samples are analyzed in a CLIA certified Laboratory. The U.S. Congress passed the Clinical Laboratory Improvement Amendments (CLIA) in 1988 establishing quality standards for all laboratory testing to ensure the accuracy, reliability and timeliness of patient test results regardless of where the test was performed. The objective of the CLIA program is to ensure quality laboratory testing. The Centers for Medicare & Medicaid Services (CMS) is charged with the implementation of CLIA.

• BIOSAFE Laboratories are also accredited by the College of American Pathologists (CAP), the highest national standard in the U.S..

Features

• The Diabetes A1c test measures the level of Hemoglobin A1c in the blood and is the most cost effective tool available for determining the blood sugar level over the previous 90 days.

• This test allows you to monitor your blood sugar levels over time and can help evaluate the effectiveness of a control program.

• Monitoring your Hemoglobin A1c score is an important tool in reducing Diabetes related health risks and complications such as cardiovascular disease, kidney disease, stroke, blindness and poor blood circulation in the lower limbs.

• Lab report features TestTracker™ which compares previous test results on one test report to chart your progress. 

• Measures the amount of Hemoglobin A1c in the blood.

• Test is easy to perform yourself in the privacy of your home or office.

• U.S. Food and Drug Administration (FDA) approved test kit for direct consumer use.

• Test kit includes a laboratory authorization form, privacy practices statement, blood collection card, blood sample return bag, easy to understand instructions, alcohol prep, gauze pad, 2 lancets, adhesive bandage and a U.S. postage paid return mail envelope.

• Test analyzed by a Certified Clinical Laboratory Improvement Amendments (CLIA) Laboratory and is accredited through the College of American Pathologists (CAP). Lab test results are reviewed by a licensed health professional before being sent back to you.

• Lab Report mailed directly to your home usually within 3 business days of receiving the sample. Click here to view Diabetes A1c Sample Lab Report.

• No Additional Test Fees - test kit pricing includes all sample collection materials, U.S. postage paid return envelope for the sample, laboratory analysis and mailed lab results.

-- Sales of BioSafe Product has been Halted due to Issues with the Manufacturer and Customer Result Reporting. Sales will Resume once these Issues are Resolved --

Diabetes A1c Home Test

Price: $23.95

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