DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and...

8
DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A READY-TO-USE CONJUGATE AND BLOCKING AGENTS REF CAN-ALD-500

Transcript of DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and...

Page 1: DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and water retention, feeding back to suppress renin activity. 2. Renal or renovascular

384 Neptune CrescentLondon, Ontario, Canada N6M 1A1

Tel: 519-681-8731Fax: [email protected]

Manufacturing Innovative IVDfor the World Since 1973

DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A READY-TO-USE CONJUGATE

AND BLOCKING AGENTS

REF CAN-ALD-500

Page 2: DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and water retention, feeding back to suppress renin activity. 2. Renal or renovascular

significantproportionofhypertensiveindividualssufferfromresistanthyper-

tensionduetofactorssuchasnon-compliance,poornutritionalpractice(highsalt,alcohol,licorice)orsecondaryhypertension(20%ofallresistanthypertensioncases).Diagnosingthecauseofhypertensionisofparamountimportancetoselectthecorrecttherapy.

Heartfailure,stroke,renalconditionsanddementiaaresomeofthecommon

consequencesofuncontrolledhyper-tension;theoccurrenceoftheseconditionshowever,canbereducedwhentheunderlyingsourceofresistanthypertensionisidentifiedandafollowuptherapyisapplied.

Renin

Angiotensinogen

Aldosterone

Angiotensin I

Angiotensin II

ACE

THE RENIN-ANGIOTENSIN-ALDOSTERONE AXISplaysakeyroleinresistanthypertension.

Duringnormalhomeostasis,reninisreleasedunderconditionsofdehydrationorlowbloodpressure(seefigurebelow).Renin enzymatic activitythenpromotesthecleavageofAngiotensinogenandgenerationofAngiotensinI,whichinturnistransformedintoAngiotensinIIandactivatesaldosteronerelease(whichcausessaltandwaterretention,andexcretionofpotassium,magnesium,andotherions).

A 1. SpenceJD.LessonsfromAfrica:theimportanceofmeasuringplasmareninandaldosteroneinresistanthypertension.Can J Cardiol.2012;28(3):254–7.

2. SpenceJD.Physiologictailoringoftherapyforresistanthypertension:20years’experiencewithstimulatedreninprofiling.Am J Hypertens.1999;12:1077–83.

3. SpenceJD.Physiologictailoringoftreatmentinresistanthypertension.Current Cardiology Reviews.2010;6:119–123.

4. JonesES,etal.PhysiologicallyIndividualizedTherapyforResistantHypertensioninAfrica.HypertensionTeachingSeminarOrganizedbytheInternationalSocietyofHypertension(ISH)AfricaRegionalAdvisoryGroupincollaborationwiththeEuropeanSocietyofHypertension(ESH),theInternationalForumforHypertensionControlandPreventioninAfrica(IFHA)andtheMozambicanHeartAssociation(AMOCOR);April18–19,2016;Maputo,Mozambique2016.

LITERATURE

new

at a glanceCatalogue number: CAN-ALD-500Number of test wells: 96Sensitivity: 9.1 pg/mLSample Volume: 50 µLTotal assay time: 80 mins.Validated against: LC-MS/MS

Page 3: DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and water retention, feeding back to suppress renin activity. 2. Renal or renovascular

1. Primaryhyperaldosteronismcausessaltandwaterretention,feedingbacktosuppressreninactivity.

2. Renalorrenovascularcausesofhypertensionleadtoelevatedreninactivitywithsecondaryhyperaldosteronism.

3. Impairmentoftherenaltubularepithelialsodiumchannel(suchasLiddle’ssyndrome)causessaltandwaterretentionandsuppressesbothreninactivityandaldosterone.

ALDOSTERONE MEASUREMENTisthereforeanoutstandingtooltodeterminethephysiologicalcausesofresistanthypertension,permittingthephysiciantochoosethemostappropriatetherapy.1-3

Thefollowingalgorithmwasusedinastudyofresistanthypertensioninthreehyper-tensionclinicsinAfrica,inastudyfundedbyGrandChallengesCanada.Thisapproachincreasedsystolicbloodpressurecontrolfrom25%inusualcareto75%inindividualizedcarebasedonaldosterone/reninprofiling.4

PrimaryAldosteronism Liddle’sVariants,AdducinPolymorphisms

RenalorRenovascular

Aldosterone High Low High

Renin Low Low High

Primarytreatment Aldosteroneantagonists:SpironolactoneEplerenone(Amilorideformenwhereeplerenoneisnotavailable)(rarelysurgery)

AmilorideAngiotensinreceptorblockersAliskiren(rarelyrevascularization)

Thepreciseandaccuratemeasurementofaldosteronebyenzymeimmunoassaycanbeanimportanttoolforthediagnosisoftheunderlyingcauseofhypertension,leadingtoappropriatetherapy.

Thisapproachnotonlyimprovesbloodpressurecontrol,thusreducingtheriskofstroke,heartfailureandrenalfailure,butalsoreducesadverseeffectsofmedicationandmayreducethecostofmedicationbyidentifyingspecifictherapy.

When this metabolism is altered, three patterns of aldosterone and renin activity levels can be produced:

PERFORMANCE

TheRfBinternationalcontrolswereassayedwiththeDBCELISAkit(CAN-ALD-500).Theresultsforthekitarethemean±SDof4independentexperiments(pg/mL).

TheresultsmatchbothLC-MS/MSresultsfromMayoClinicandfallwithintherangeofresultsestablishedfromallmethods.

RfB lot HM 2/15 A HM 2/15 BLC-MS/MS(MayoClinic) 570 110

LC-MS/MS(RfB)

Target

634 122

Range (16P–84P)

419–764 111–172

AllMethods(RfB)

Target

529 110

Range (16P–84P)

468–658 90–144

CAN-ALD-500(DBC) 636±70 105±16

Evaluation of International Controls

Aldosteroneconcentrationrangeinthepopulationdependsontheethnicandsocialcompositionandnutritionalfactors.

Each laboratory must determine its own reference ranges!

Aldosterone (pg/mL)

Freq

uenc

y

120 Putatively healthy individuals—UprightMedian:52pg/mL

Average:70pg/mL

95%confidencerange:ND–210pg/mL

REFERENCE RANGE

Page 4: DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and water retention, feeding back to suppress renin activity. 2. Renal or renovascular

DBC has launched a new Aldosterone kit(CAN-ALD-500) that includes a ready-to-use conjugate and blocking agents that prevent interferences by sample endogenous substances.

PROCEDURE

ASSAY PRINCIPLEThenewDBCAldosteroneELISAkit(CAN-ALD-500)isacompetitiveimmunoassaythatusesinnovativechemistryandaspecificanti-aldosteroneantibodythatbindsquantitativelytoallisomersofaldosterone.

50μLcalibrators/samples

100μLofReady-to-UseConjugate

1hroomtemperature/shaking

Wash3x

150μLTMB

20minroomtemperature/shaking

50μLofstopsolution

Readinaplatereaderat450nm

Aldosterone (pg/mL)

OD

(450

nm

)

Typical Calibration CurveSamplecurveonly.

Donotusetocalculateresults.

Parameter DBC Competitor 1 Competitor 2 LC-MS/MSTotalassaytime 1h20min 1h30min Overnight+1h N/A

Readytousereagents Yes Yes No N/A

DynamicRange,pg/mL 10–1000 5.7–1000 4.7–250 40–1000

Samplesize,μL 50 50 100 600

Samplepre-treatment

Serum,Plasma No No Yes Yes

Urine No Yes Yes Yes

Sensitivity,pg/mL 9.1 5.7 4.7 40

Precision,CV%

Intra-assay 5.5–9.4 3.8–9.7 4.5–6.6

Inter-assay 7.6–12.8 8.6–11.5 10.8–16.3

ComparativeanalysisofserumsamplesresultsbetweenthenewDBCAldosteronekit(CAN-ALD-500)andLC-MS/MSperformedatMayoClinic.

LC-MS/MS Aldosterone (pg/mL)

DB

C A

ldos

tero

ne E

LISA

(pg/

mL) y=1.0578x+52.782

r=0.95,n=36

PERFORMANCE

Page 5: DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and water retention, feeding back to suppress renin activity. 2. Renal or renovascular

DBC has launched a new Aldosterone kit(CAN-ALD-500) that includes a ready-to-use conjugate and blocking agents that prevent interferences by sample endogenous substances.

PROCEDURE

ASSAY PRINCIPLEThenewDBCAldosteroneELISAkit(CAN-ALD-500)isacompetitiveimmunoassaythatusesinnovativechemistryandaspecificanti-aldosteroneantibodythatbindsquantitativelytoallisomersofaldosterone.

50μLcalibrators/samples

100μLofReady-to-UseConjugate

1hroomtemperature/shaking

Wash3x

150μLTMB

20minroomtemperature/shaking

50μLofstopsolution

Readinaplatereaderat450nm

Aldosterone (pg/mL)

OD

(450

nm

)

Typical Calibration CurveSamplecurveonly.

Donotusetocalculateresults.

Parameter DBC Competitor 1 Competitor 2 LC-MS/MSTotalassaytime 1h20min 1h30min Overnight+1h N/A

Readytousereagents Yes Yes No N/A

DynamicRange,pg/mL 10–1000 5.7–1000 4.7–250 40–1000

Samplesize,μL 50 50 100 600

Samplepre-treatment

Serum,Plasma No No Yes Yes

Urine No Yes Yes Yes

Sensitivity,pg/mL 9.1 5.7 4.7 40

Precision,CV%

Intra-assay 5.5–9.4 3.8–9.7 4.5–6.6

Inter-assay 7.6–12.8 8.6–11.5 10.8–16.3

ComparativeanalysisofserumsamplesresultsbetweenthenewDBCAldosteronekit(CAN-ALD-500)andLC-MS/MSperformedatMayoClinic.

LC-MS/MS Aldosterone (pg/mL)

DB

C A

ldos

tero

ne E

LISA

(pg/

mL) y=1.0578x+52.782r=0.95,n=36

PERFORMANCE

Page 6: DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and water retention, feeding back to suppress renin activity. 2. Renal or renovascular

1. Primaryhyperaldosteronismcausessaltandwaterretention,feedingbacktosuppressreninactivity.

2. Renalorrenovascularcausesofhypertensionleadtoelevatedreninactivitywithsecondaryhyperaldosteronism.

3. Impairmentoftherenaltubularepithelialsodiumchannel(suchasLiddle’ssyndrome)causessaltandwaterretentionandsuppressesbothreninactivityandaldosterone.

ALDOSTERONE MEASUREMENTisthereforeanoutstandingtooltodeterminethephysiologicalcausesofresistanthypertension,permittingthephysiciantochoosethemostappropriatetherapy.1-3

Thefollowingalgorithmwasusedinastudyofresistanthypertensioninthreehyper-tensionclinicsinAfrica,inastudyfundedbyGrandChallengesCanada.Thisapproachincreasedsystolicbloodpressurecontrolfrom25%inusualcareto75%inindividualizedcarebasedonaldosterone/reninprofiling.4

PrimaryAldosteronism Liddle’sVariants,AdducinPolymorphisms

RenalorRenovascular

Aldosterone High Low High

Renin Low Low High

Primarytreatment Aldosteroneantagonists:SpironolactoneEplerenone(Amilorideformenwhereeplerenoneisnotavailable)(rarelysurgery)

AmilorideAngiotensinreceptorblockersAliskiren(rarelyrevascularization)

Thepreciseandaccuratemeasurementofaldosteronebyenzymeimmunoassaycanbeanimportanttoolforthediagnosisoftheunderlyingcauseofhypertension,leadingtoappropriatetherapy.

Thisapproachnotonlyimprovesbloodpressurecontrol,thusreducingtheriskofstroke,heartfailureandrenalfailure,butalsoreducesadverseeffectsofmedicationandmayreducethecostofmedicationbyidentifyingspecifictherapy.

When this metabolism is altered, three patterns of aldosterone and renin activity levels can be produced:

PERFORMANCE

TheRfBinternationalcontrolswereassayedwiththeDBCELISAkit(CAN-ALD-500).Theresultsforthekitarethemean±SDof4independentexperiments(pg/mL).

TheresultsmatchbothLC-MS/MSresultsfromMayoClinicandfallwithintherangeofresultsestablishedfromallmethods.

RfB lot HM 2/15 A HM 2/15 BLC-MS/MS(MayoClinic) 570 110

LC-MS/MS(RfB)

Target

634 122

Range (16P–84P)

419–764 111–172

AllMethods(RfB)

Target

529 110

Range (16P–84P)

468–658 90–144

CAN-ALD-500(DBC) 636±70 105±16

Evaluation of International Controls

Aldosteroneconcentrationrangeinthepopulationdependsontheethnicandsocialcompositionandnutritionalfactors.

Each laboratory must determine its own reference ranges!

Aldosterone (pg/mL)

Freq

uenc

y

120 Putatively healthy individuals—UprightMedian:52pg/mL

Average:70pg/mL

95%confidencerange:ND–210pg/mL

REFERENCE RANGE

Page 7: DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and water retention, feeding back to suppress renin activity. 2. Renal or renovascular

significantproportionofhypertensiveindividualssufferfromresistanthyper-

tensionduetofactorssuchasnon-compliance,poornutritionalpractice(highsalt,alcohol,licorice)orsecondaryhypertension(20%ofallresistanthypertensioncases).Diagnosingthecauseofhypertensionisofparamountimportancetoselectthecorrecttherapy.

Heartfailure,stroke,renalconditionsanddementiaaresomeofthecommon

consequencesofuncontrolledhyper-tension;theoccurrenceoftheseconditionshowever,canbereducedwhentheunderlyingsourceofresistanthypertensionisidentifiedandafollowuptherapyisapplied.

Renin

Angiotensinogen

Aldosterone

Angiotensin I

Angiotensin II

ACE

THE RENIN-ANGIOTENSIN-ALDOSTERONE AXISplaysakeyroleinresistanthypertension.

Duringnormalhomeostasis,reninisreleasedunderconditionsofdehydrationorlowbloodpressure(seefigurebelow).Renin enzymatic activitythenpromotesthecleavageofAngiotensinogenandgenerationofAngiotensinI,whichinturnistransformedintoAngiotensinIIandactivatesaldosteronerelease(whichcausessaltandwaterretention,andexcretionofpotassium,magnesium,andotherions).

A 1. SpenceJD.LessonsfromAfrica:theimportanceofmeasuringplasmareninandaldosteroneinresistanthypertension.Can J Cardiol.2012;28(3):254–7.

2. SpenceJD.Physiologictailoringoftherapyforresistanthypertension:20years’experiencewithstimulatedreninprofiling.Am J Hypertens.1999;12:1077–83.

3. SpenceJD.Physiologictailoringoftreatmentinresistanthypertension.Current Cardiology Reviews.2010;6:119–123.

4. JonesES,etal.PhysiologicallyIndividualizedTherapyforResistantHypertensioninAfrica.HypertensionTeachingSeminarOrganizedbytheInternationalSocietyofHypertension(ISH)AfricaRegionalAdvisoryGroupincollaborationwiththeEuropeanSocietyofHypertension(ESH),theInternationalForumforHypertensionControlandPreventioninAfrica(IFHA)andtheMozambicanHeartAssociation(AMOCOR);April18–19,2016;Maputo,Mozambique2016.

LITERATURE

new

at a glanceCatalogue number: CAN-ALD-500Number of test wells: 96Sensitivity: 9.1 pg/mLSample Volume: 50 µLTotal assay time: 80 mins.Validated against: LC-MS/MS

Page 8: DBC’s NEW ALDOSTERONE ELISA KIT INCLUDES A ......1. Primary hyperaldosteronism causes salt and water retention, feeding back to suppress renin activity. 2. Renal or renovascular

384 Neptune CrescentLondon, Ontario, Canada N6M 1A1

Tel: 519-681-8731 Fax: [email protected]

Manufacturing Innovative IVD for the World Since 1973

DBC’s NEW ALDOSTERONEELISA KIT INCLUDES AREADY-TO-USE CONJUGATE

AND BLOCKING AGENTS

REF CAN-ALD-500