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 | [email protected] | 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.