cholestrak cholesterol testing guide

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Heart disease - it'sthe number one killer of adults in the United States. Eachyear, morethan a million Americans haveheart attacks and about 500,000 people die from heart disease. ln November 1985, The National Heart, Lung, and Bloodlnstitute, a division of the National Institutes of Health (NlH), launched the National Cholesterol Education Program (NCEP). The goatof NCEp is to contribute to reducing illness and death from coronary heart disease (CHD) in the United States by reducing the percentage of Americans with high blood cholesterol. Your blood cholesterol has a lot to do with your chances for CHD.CHD is a disease of the -btooO vessels of the heart that causes a heart attack. High bloodcholesterol is one of the majorrisk factors. l-n fact, the higher your blood cholesterol level. the greater your risk. We are committed to helping individuals understand theirriskfor heart disease due to highcholesterol and providing convenient and easyto-use toolsto assist you in managing your cholesterol to desirable levels. What is Gholesterol? Cholesterol is a soft, waxy substance foundin the bloodstream and in all your body's cells. Cholesterol is carried in smallpackages called lipoproteins (lip_o_ PRO-teens). Two kinds of tipoproteins (LDL a fiOf_t carry cholesterol throughout your bodyand it is important to havehealthy levels of both. Too much cholesterol in your blood can buildup in the walls of your arteries (blood vessels that carrybloodfrom the heart to otherparts of the body). This buildup of cholesterol is called plaque (PLACK), whichcan causenarrowing of the arteries. This is called atherosclerosis (ath-er-o-skler-O-sis) or "hardening of the arteries". TotalCholesterol TotalCholesterol provides a general indication of your riskfor heart disease. lf your TotalCholesterol level is too high, (over200), you are at a higher risk for CHD,whichcan leadto heart attack. High cholesterol is also a risk factorfor stroke. With total cholesterol, the lower your number, the better. LDL (low densitv lipoprotein) Oftenreferred to as "bad" cholesterol, LDL leadsto a buildup of cholesterol in your arteries. The higher your LDL level, the greater your riskfor CHD. Reducing your LDL cholesterol is the maingoalof cholesterol-loweri ng treatment. HDL (hiqh densitv lipoprotein) Oftenreferred to as "good" cholesterol, HDL carries cholesterol from other parts of your body back to your liver, whereit removes the cholesterol fromyour body. The higher your HDL cholesterol level, the lower your riskfor CHD. Triqlvcerides As a form of fat found in the bloodstream, elevated Triglycerides (over150)are often accompanied by otherfactors(suchas low HDL or a tendency towbrd diabetes) that raise the riskof CHD. A normal coronary artery. Whencholesterol levelsare low, artery wallsremain smooth and slippery, allowing bloodto flow freely. An arterywith a build up of plaque. A buildup of excess cholesterol in the arteryreduces bloodflow,which can resultin a heart attack or stroke. Cholesterol Panel Things You Should Know to Keep your Heart Healthy Brought to you by theAmerican Diabetes Association andHome Access Health Corporation Part #701 1 0675, Rev. 01/08

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CholesTrak Total Home Cholesterol Test. Read the test device just like a thermometer and refer to the result chart to interpret cholesterol level. Visit: http://myhometesting.com/home-cholesterol-tests/cholestrak-total-home-cholesterol-test.html for more information.

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Page 1: CholesTrak Cholesterol Testing Guide

Heart disease - it 's the number one kil ler of adults inthe United States. Each year, more than a mill ionAmericans have heart attacks and about 500,000people die from heart disease.

ln November 1985, The Nat ional Heart , Lung, andBlood lnstitute, a division of the National Institutes ofHeal th (NlH), launched the Nat ional CholesterolEducation Program (NCEP). The goat of NCEp is tocontribute to reducing i l lness and death fromcoronary heart disease (CHD) in the United States byreducing the percentage of Americans with highblood cholesterol.

Your blood cholesterol has a lot to do with yourchances for CHD. CHD is a disease of the

-btooO

vessels of the heart that causes a heart attack. Highblood cholesterol is one of the major risk factors. l-nfact, the higher your blood cholesterol level. thegreater your risk.

We are committed to helping individuals understandtheir risk for heart disease due to high cholesterol andproviding convenient and easyto-use tools to assistyou in managing your cholesterol to desirable levels.

What is Gholesterol?

Cholesterol is a soft, waxy substance found in thebloodstream and in all your body's cells. Cholesterolis carried in small packages called l ipoproteins (l ip_o_PRO-teens). Two kinds of t ipoproteins (LDL a fiOf_tcarry cholesterol throughout your body and it isimportant to have healthy levels of both. Too muchcholesterol in your blood can build up in the walls ofyour arteries (blood vessels that carry blood from theheart to other parts of the body). This buildup ofcholesterol is called plaque (PLACK), which cancause narrowing of the arteries. This is calledatherosclerosis (ath-er-o-skler-O-sis) or "hardening ofthe arteries".

Total CholesterolTotal Cholesterol provides a general indication ofyour risk for heart disease. lf your Total Cholesterollevel is too high, (over 200), you are at a higher riskfor CHD, which can lead to heart attack. Highcholesterol is also a risk factor for stroke. With totalcholesterol, the lower your number, the better.

LDL (low densitv l ipoprotein)Often referred to as "bad" cholesterol, LDL leads to abuildup of cholesterol in your arteries. The higheryour LDL level, the greater your risk for CHD.Reducing your LDL cholesterol is the main goal ofcholesterol-loweri n g treatment.

HDL (hiqh densi tv l ipoprotein)Often referred to as "good" cholesterol, HDL carriescholesterol from other parts of your body back to yourliver, where it removes the cholesterol from yourbody. The higher your HDL cholesterol level, thelower your risk for CHD.

TriqlvceridesAs a form of fat found in the bloodstream, elevatedTriglycerides (over 150) are often accompanied byother factors (such as low HDL or a tendency towbrddiabetes) that raise the risk of CHD.

A normal coronaryartery.

When cholesterollevels are low,artery walls remainsmooth andsl ippery, al lowingblood to flow freely. An artery with a

bui ld up of plaque.

A bui ldup of excesscholesterol in theartery reducesblood flow, whichcan result in a heartattack or stroke.

Cholesterol Panel

Things You ShouldKnow to Keep your

Heart Healthy

Brought to you bythe American Diabetes Association

and Home Access Health Corporation

Part #701 1 0675, Rev. 01/08

Page 2: CholesTrak Cholesterol Testing Guide

What Affects Cholesterol Levels?

Things you can do that wil l affect yourcholesterol levels:

DietSaturated fat and cholesterol in the foods you eatmake your blood cholesterol level go up. Reducingthe amount of saturated fat and cholesterol in yourdiet helps lower your blood cholesterol level.

Foods low in saturated fats include fat free or 1o/odairy products, lean meats, f ish, skinless poultry,whole grain foods, and fruits and vegetables. Lookfor soft margarines (l iquid or tub varieties) that arelow in saturated fat and contain l itt le or no trans fat(another type of dietary fat that can raise yourcholesterol level). Limit foods high in cholesterol suchas l iver and other organ meats, egg yolks, and full-fatdairy products.

Good sources of soluble fiber include oats, certainfruits (such as oranges and pears) and vegetables(such as brussel sprouts and carrots), and dried peasand beans.

WsrqhiBeing overweight is a risk factor for heart disease andalso tends to increase your cholesterol. Losingweight can help lower your triglyceride, LDL and totalcholesterol levels, as wel l as raise your HDL levels.

Phvsical ActivitvNot being physically active is a risk factor for heartdisease. Regular physical activity can help lower yourLDL cholesterol and raise your HDL cholesterollevels. lt also helps you lose weight. You should try tobe physically active for 30 minutes on most, if not all,days.

Things you cannot change that affect yourcholesterol levels:

Aqe and GenderAs women and men get older, their cholesterol levelsrise. Before the age of menopause, women havelower cholesterol levels than men of the same age.After the age of menopause, women's LDL levelstend to rise.

HereditvYour genes partly determine how much cholesterolyour body makes. High blood cholesterol can run infami l ies.

Know Your Numbers - Find Your Goal

Blood cholesterol is measured in mi l l igrams (mg) perdecil iter (dL). The table below outlines cholesterolcomponents and respective ranges. lt is important tonote that the National Institutes of Health guidelinesstress that physicians should focus on assistingpatients to reach their appropriate LDL cholesterolgoal as a primary coronary heart disease preventionmethod.

-For people diagnosed with CHD or diabetes; an LDL level of less than70 mg/dL may be recommended by your physician.

Total Cholesterol LevelLess than 200 mg/dl200-239 mg/dL240 mgldL and above

LDL Cholesterol LevelLess than 100 mg/dL100-129 mg/dL130-159 mg/dl160-189 mg/dl190 mg/dl and above

HDL Cholesterol LevelLess than 40 mg/dl

40-59 mg/dL60 mg/dl and above

Triqlvcerides Level150-199 mg/dl200 mg/dl and above

Total Cholesterol RiskDesirableBorderl ine HighHigh

LDL Cholesterol RiskOptimal*Near opt imal/above opt imalBorderl ine HighHighVery High

HDL Cholesterol RiskA major risk factor forheart diseaseThe higher, the betterConsidered protectiveagainsi heart ciisease

Triqlvcerides RiskBorderl ine HighHigh

My RecommendedCholesterol

Levels

Manage Your Numberslf your cholesterol levels are not at goal, follow yourdoctors advice to modify your l i festyle and/or becompliant with the drug prescription written...this canhelp you prevent coronary heart disease.

My CurrentCholesterol

Levels

TotalCholesterol

HDL

LDL

Triglycerides

Page 3: CholesTrak Cholesterol Testing Guide

Know Your Rlsk Categorv

The main goal of cholesterol-lowering treatment is tolower your LDL level enough to reduce your risk ofhaving a heart attack or other diseases caused byhardening of the arter ies. ln general , the higher yourLDL level and the more risk factors you have, thegreater your chances of developing coronary heartdisease (CHD) or having a heart attack. (A risk factoris a condition that increases your chance of getting adisease.)

Following are the risk factors that affect your LDLgoal:

Diagnosed with CHD or diabetes (automaticallyputs you at highest risk)Cigarette smokingHigh blood pressure (140/90 or higher, or onblood pressure medicine)Low HDL cholesterol (less than 40 mg/dL).Family history of early heart disease (CHD infather or brother before age 55; CHD in motheror sister before age 65)Age (men 45 years or older; women 55 years orolder)

Total Risk Factors* If your HDL cholesterol is 60 mg/dL or higher, subtract 1 from your

total count

Determine your number of r isk factors (above)to f indyour risk category (below).

] l f vou have You are in Categorv Your LDL Goal is ,Heart disease l . Highest Riskand/or diabetes

Less than '100 mg/dl

Inerapeuttc Lt testv le unanges ( ILG)

TLC includes a cholesterol-lowering diet (called theTLC Diet), physical activity, and weight management.TLC is for anyone whose LDL is above goal. TLC is aset of l i festyle changes you can make to help loweryour LDL cholesterol.

The main parts of TLC are:The TLC Diet

o Limiting the amount of saturated fat andcholesterol you eat.

. Eating only enough calories to achieve ormaintain a heal thy weight.

. Increasing the soluble f iber in your diet . Forexample, oatmeal, k idney beans, and apples aregood sources of soluble fiber.

. Adding cholesterol-lowering food.

Weiqht ManagementLosing weight if you are overweight can help lowerLDL. Weight management is especial ly important forthose with a group of r isk factors that includes hightr ig lycer ides and/or low HDL levels and beingoverweight with a large waist measurement (morethan 40 inches for men and more than 35 inches forwomen).

Phvsical ActivitvRegular phvsical act iv i ty is recommended foreveryone. lt can help raise HDL and lower LDL andis especially important for those with hightriglycerides and/or low HDL levels who areoverweight with a large waist measurement.

Druq Treatment

l f cholesterol- lowering drugs are needed, they areused together with TLC treatment to help lower yourLDL. Along with changing the way you eat andexercising regularly, your doctor may prescribemedicines to help lower your cholesterol. Even if youbegin drug treatment, you wil l need to continue TLC.Drug treatment controls but does not "cure" highblood cholesterol. Therefore, you must continuetaking your medicine to keep your cholesterol level inthe recommended range.

When trying to lower your cholesterol or keep it low, itis important to remember to follow your treatments forother condi t ions you may have such as high bloodpressure. Get help wi th qui t t ing smoking and losingweight if they are risk factors for you.Source: 2005. U.S Department of Health & Human Services, National Institutes of l.lealth,Nai ional Heart . Lung. and Blood Inst i tute, The Nat ional Cholesterol Educat ion Program(NCEP). Adul t Treatment Panel (APTl l l ) Guidei ines

'fz or more rist<

t2factors

!0 or 1 r isk.''":.::.:"-..-",_:"

l l . Moderate r isk

l l l " Low to moderate

Less than 130 mg/dL

Treatment Approaches for C holesterol Red uctionYou get cholesterol in two ways. Your body makessome of it, and the rest comes from cholesterol inproducts you eat. There are 2 treatment methods -Therapeutic Lifestyle Changes (TLC) and DrugTreatment.

A summary of both follows; however, your doctor wil lhelp you decide what combination wil l work best foryou.

Page 4: CholesTrak Cholesterol Testing Guide

Analyte Y;#JlirffiMicro-Serum Sample Total

o.,,llffiot1it^rr% cvoaerlriiioelt or

Total Cholesterol206 6.1 8 3.0

240 6.55 2.7

HDL-Cholesterol40 1.57 3.9

73 2.49 3.4

Triglycerides150 7.20 4.8

305 13.39 4.4

PrecisionFor each analyte, two micro-serum samples were assayed in duplicate in forty differentruns (n=80), 2 runs per day. The total standard deviations and coefficients of variationwere calculated and the data are presented below:

AccuracvThe results of the precision study for micro-serum testing were compared to the testingof venous blood to assess the bias and calculate total enor.

Method Comparison between finqerstick samples collected bv lav-users andvenous samplesAs part of the overall veriflcation and validation of the CheckUp America CholesterolPanel, lay-users were asked to collect a fingerstick sample for later comparison withvenous samoles collected at the same date and time,

Sample RequirementsThe CheckUp America Cholesteroi Parer requires approximately three to four (3 - 4)full drops of fingerstick blood (apprcx r':ately 75 ml to 100 ml in total). After the bloodsamplehasdr iedonthef i l tergap,e-;c.at east l5minutes, thecassetteshouldbesealed in the desiccated foil pcuc" a-C sent in the prepaid mailerto the Home AccessHealth Corporation laboraic-, '0.::sirrg. In evaluating lay-user micro-serum collectionadequacy rates, untrained aj--se.s rrere able to obtain a specimen of adequatequantity and quality 96:, as e-e::,eiy as trained phlebotomists.

Easv to UseEverything necessary to collect, package and mail a dried fingerstick sample to theHome Access Health Corporation laboratory is included with each CheckUp AmericaCholesterol Panel. Results are available within three days of receipt of the sample inthe laboratorv.

Laboratorv Results Glassification as Compared with NCEP CriteriaWhen individual results for Cholesterol, HDL-Cholesterol and Triglycerides wereclassified according to NCEP criteria, the majority of the results were correctlyclassified as identified in the chart below. When results were misclassified higher, thisindicates that a small percentage of the time your results could actually be lower thanthe reading you obtain; and when results were misclassified lower, this indicates that asmall percentage of the time your results could actually be higher than the reading youobtain.

For more information, cal l 1-800-871-6080,6:00 am to 7:00 pm, Monday through Friday,

Gentral Time, or visit our website atwww.homeaccess.com.

${*iLtHAecES$

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Home Access Health Corporation2401W. HassellRoad, Suite 1510

Hoffman Estates, lL 60169800-87 1 -6080

CLIA Certificate #1 4D0981 820CAP Accred itatio n #7 17 5083

Control 086, Rev. 01/08, #70110675

Correctly Classified 90% 90% 910/o

Misclassified Higher SYo 4Yo 6Yo

Misclassified Lower 5o/o 6Yo 3ToAnalyte $"ilJ,?:?"iiiY'l:

TotalCholestero

206 3.0 7.4 -1.5 +/- 3,0

240 2.7 6.7 1a +/- 3.0

HDt-Cholesterol

4A 3.9 9.2 '19 +/- 5.0

73 3.4 7.2 +i- 5,0

Triglycerides150 4.8 10.7 4A +/- 5.0

305 4.4 9.9 LJ +/- 5.0

Analyte Numberof 'Samples '

Linear Fit R Square

Total Cholesterol tc I Y=1.016X-4415 0 9840 127 467

HDL-Cholesterol 137 Y=0.9937X-09040 9639 22- 141

Triglycerides 141 Y=0,9798X+7.8 0.9771 33 - 591