Provide annual testing with HemoCue® Albumin 201

Patients Who Should Be Tested Annually for Albuminuria

Diabetics: 25.8 million people, or 8.3% of the US population1

High blood pressure patients: 31% of US adults2

Patients at risk for nephrosis or cardiovascular disease (CVD)4

The only CLIA-waived device for

diagnosing and monitoring

albuminuria at the Point-of-Care

The only CLIA-waived device

providing rapid, quantitative results

to support adjusting patient

medications during a visit

The only objective, quantitative

Point-of-Care urine albumin test

that allows for billable positive

and negative results

How Can I Most Confidently Monitor Albuminuria in My Patients With Diabetes and Hypertension?

HemoCue® Albumin 201

HemoCue® Albumin 201 Analyzer 120623

HemoCue® Urine Albumin Individually Packaged Microcuvettes (50/box) 110608

Albu Trol, Level 1 (2x1 ml) 189001002

HemoCue Albumin and Products

Albuminuria is detected in:

• 1ofevery3peoplewithdiabetes6

• 1ofevery7peoplewithhighbloodpressure,

without diabetes3

• 1ofevery6peopleolderthan60years3

Screening patients with diabetes,

hypertension, and other CVD risk

factors for albuminuria is easy and

inexpensive but is often overlooked

in clinical practice.4

Early Detection: Albuminuria Rapid Diagnosis and Monitoring

Because albuminuria has no signs or symptoms in the early stages, screening individuals at risk offers an accurate method for early detection, allowing appropriate treatment for improved prognosis.

HemoCue® Albumin 201 System

ACR - LAB Clinitek ACR Micral Strips

Sensitivity, % 92 73 100 70

Specificity, % 98 96 81 83

PV(+), % 92 85 66 55

PV(–), % 98 92 100 90

Sensitivity: The probability of a positive test among patients with disease Specificity: The probability of a negative test among patients without disease Positive predictive value (PV(+)): The proportion of positive test results that are true positives (such as correct diagnoses) Negative predictive value (PV(-)): The proportion of subjects with a negative test result who are correctly diagnosed

Predictive Values for Diagnosis of Elevated Urinary Albumin Excretion Values of HemoCue®Albumin201ComparedWithOtherMethods.5

Ease of use with minimal training

Lab-accurateresultsin90seconds

Factory-calibrated, quantitative testing

Added efficiency in office workflow

High reimbursement revenues

HemoCue® Albumin201Offers:

Point-of-Care Testing for Albuminuria

Intended Use Screen, diagnose, and monitor

Instrument Calibration No need for calibration. Self-testing occurs at start-up

Packaging Individually wrapped disposable cuvettes available

Connectivity Yes. Basic Connect software is available for connectivity to LIS, HIS, or EHR

CLIA-waived Yes. Can be operated by any trained healthcare professional

Precision Standard deviation ≤ 3 mg/L (according to Albumin 201 package insert, at the concentration range from 7-30mg/L)

Higher Reimbursement Revenues

Additional reimbursements from the increased number of clinical applications (screening, diagnosing, and monitoring) and billable positive screening results

Reimbursement* CPT Code: 82043; 2014 National Limit: $7.89

Description Quantitative measurement of albumin in urine by immunoassay

Testing Guidelines for Microalbuminuria

TYPE 1 Diabetics: Annually, beginning 5 years after diagnosis and older than 10 yrs.6,7 TYPE 2 Diabetics: Annually after diagnosis6,7 HYPERTENSIVES: Annually8,9

HemoCue Albumin Clinitek ACR Micral Strips

Screen Yes Yes Yes

Diagnose Yes No No

Quantitative Yes No. Semi-quantitative No. Qualitative

Monitor Disease or Therapy Yes No No

Pos. Screening Results Billable Non-billable Non-billable

Gender Influences No Yes** No

Ethnicity Influences10 No Yes** No

Age Influences No Yes** No

Muscle Mass Influences No Yes** No

Liquid Influences Yes*** No Yes***

*2014 CPT-code Reimbursement National Limit. The CPT codes provided are based on AMA guidelines and are for informational purposes only. CPT cod-ing is the sole responsibility of the billing party. Please direct any questions regarding coding to the payer being billed.

**Creatinine concentrations vary among different groups of people. As a result, a creatinine-standardized urine albumin concentration may underesti-mate microalbuminuria in patients with higher-than-normal muscle mass (e.g., men) and those of certain race/ethnicity (e.g., non-Hispanic blacks and Mexican Americans) OR overestimate microalbuminuria in patients with lower-than-normal muscle mass (e.g., women or the elderly). (Mattix, et al. Use of the Albumin/Creatinine Ratio to Detect Microalbuminuria: Implications of Sex and Race. JASN. 2002;13(4):1034-1039.

***Effects on urine concentrations resulting from drinking large volumes of water or being dehydrated before testing will influence the results. Although this may be an uncommon occurrence, before measuring albumin, a history of recent fluid intake may be documented.

Comparing HemoCue®Albumin201WithClinitekandMicral

ACR test results require objective interpretation to account for influencers suchasgender,ethnicity,age,andmusclemass.

HemoCueAlbumin201quantitativeresultscanbeusedformonitoringdiseaseor therapiesorfordiagnosingalbuminuria,andprovidereimbursablenegativeresults.

HemoCue America | California, USA Phone 800.881.1611 | Fax 800.333.7043 | info@hemocue.com | hemocue.com

Hemoglobin | Glucose | Urine Albumin | WBC

HemoCue has been a leader in Point-of-Care medical diagnostics for over 30 years. We specialize in giving healthcare providers lab-quality accuracy with results comparable to those of a clinical lab.

©2014 HemoCue America. All rights reserved. LIT 3047 Rev 140331

RefeRences:

1. AmericanDiabetesAssociation.Factsheet.January26,2011.

2. CentersforDiseaseControlandPrevention.Vitalsigns:prevalence,treatment,andcontrolofhypertension—UnitedStates, 1999-2000and2005-2008.MMWR.2011;60(4):103-108.

3. CentersforDiseaseControlandPrevention.NationalCenterforHealthStatistics.TheNationalHealthandNutritionExamination Survey(NHANES)study.www.cdc.gov/nchs/nhanes.htm.

4. BakrisGL.Microalbuminuria:MarkerofKidneyandCardiovascularDisease.London:CurrentMedicalGroupLtd;2007.

5. SarafidisPS,RiehleJ,BogojevicA,BastaE,ChughA,BakrisGL.Acomparativeevaluationofvariousmethodsformicroalbuminuria screening.AmJNephrol.2008;28(2):324-329.

6. NationalKidneyFoundation.KidneyDiseaseOutcomesQualityInitiative™ClinicalPracticeGuidelinesandClinicalPractice RecommendationsforDiabetesandChronicKidneyDisease.AmJKidneyDis.2007;49(suppl2):S1-S180.

7. AmericanDiabetesAssociation.StandardsofMedicalCareinDiabetes,2008.DiabetesCare.2008;31(suppl1):S12-S54.

8. ChovanianAV,BakrisGL,BlackHR,etal.SeventhReportoftheJointNationalCommitteeonPrevention,Detection,Evaluation, andTreatmentofHighBloodPressure.Hypertension.2003;42:1206-1252.

9. ManciaG,DeBackerG,DominiczakA,etal.GuidelinesfortheManagementofArterialHypertension:TheTaskForceforthe ManagementofArterialHypertensionoftheEuropeanSocietyofHypertension(ESH)andtheEuropeanSocietyofCardiology(ESC). JHypertens.2007;256:1105-1187.

10.CentersforDiseaseControlandPrevention.Racial/ethnicandsocioeconomicdisparitiesinmultipleriskfactorsforheartdisease andstroke—UnitedStates,2003.MMWR.2005;54(5):113-117.

“The National Kidney Foundation recommends that routine check-ups include testing for excess protein in the urine, especially for people in high-risk groups.”6 Kidney disease is one of the most serious complications of diabetes.