Diagnosis of allergy in day to day practice€¦ · Diagnosis of allergy in day to day practice...

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Diagnosis of allergy in day to day practice Dr. Alok Ahuja ;M.D Director, dr ahujas” pathology and imaging centre

Transcript of Diagnosis of allergy in day to day practice€¦ · Diagnosis of allergy in day to day practice...

Page 1: Diagnosis of allergy in day to day practice€¦ · Diagnosis of allergy in day to day practice ðqBasic concepts of ALLERGY ðqPrinciples and Method of Allergy testing ðqApplication

Diagnosis of allergy in day today practice

Dr. Alok Ahuja ;M.DDirector,dr ahujas” pathology and imaging centre

Page 2: Diagnosis of allergy in day to day practice€¦ · Diagnosis of allergy in day to day practice ðqBasic concepts of ALLERGY ðqPrinciples and Method of Allergy testing ðqApplication

Diagnosis of allergy in day today practice

Basic concepts of ALLERGY Principles and Method of Allergy testing Application in Daily Practice

Page 3: Diagnosis of allergy in day to day practice€¦ · Diagnosis of allergy in day to day practice ðqBasic concepts of ALLERGY ðqPrinciples and Method of Allergy testing ðqApplication

Allergy is a hypersensitivity disorder ofthe immune system and allergic reactionsoccur to normally harmless environmentalsubstances known as allergens; thesereactions are acquired, predictable, andrapid.

It is a type 1 hypersensitivity reaction.

Allergy

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Allergy is a hypersensitivity disorder ofthe immune system and allergic reactionsoccur to normally harmless environmentalsubstances known as allergens; thesereactions are acquired, predictable, andrapid.

It is a type 1 hypersensitivity reaction.

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In Allergic individuals (Allergic inflammation)

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Allergy is a growing disease!

Allergy is one of the most common diseases in childrenand the incidence is increasing

At least 1out of 4 children is allergic, but…

Reference: EAACI Statement paper. Host et al. Allergy 2003

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Discovery of IgE…

The discovery of IgE was made in Uppsala in 1967 byresearchers Johansson, Bennich & Wide.

And it was from this discovery Phadia (formerly PharmaciaDiagnostics) was established.

The discovery of IgE was made in Uppsala in 1967 byresearchers Johansson, Bennich & Wide.

And it was from this discovery Phadia (formerly PharmaciaDiagnostics) was established.

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Is it IgE-mediated allergy or not? Identify/exclude allergy as a cause of the symptoms Guide optimal treatment Guide optimal referral (GPs/PCP)

Be specific – identify the offending allergen(s)! The medical history alone is not enough SPT alone is not enough (over-diagnosing)

Why test?

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Is it IgE-mediated allergy or not? Identify/exclude allergy as a cause of the symptoms Guide optimal treatment Guide optimal referral (GPs/PCP)

Be specific – identify the offending allergen(s)! The medical history alone is not enough SPT alone is not enough (over-diagnosing)

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Allergy Diagnosis– what difference does it

make?Identifying what the patient is allergic to

can:Reduce exposureReduce inflammationReduce symptomsReduce the need for medicationIncrease patient quality-of-life

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Identifying what the patient is allergic tocan:

Reduce exposureReduce inflammationReduce symptomsReduce the need for medicationIncrease patient quality-of-life

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Case history in primary care Efficiency 30-65%

IgEIgE testing improves accuracy of allergy diagnosestesting improves accuracy of allergy diagnoses

Case history by Specialists Efficiency 60-66%

Crobach MJ et al. Scand J Prim Health Care 1998;16:30-36Williams PB et al. Ann Allergy Asthma Immunol 2003;91:26-33Williams PB et al. Ann Allergy Asthma Immunol 2001;86:196-202Zethraeus N et al. Ital J Pediatrics 2010;36:61

Case history + IgE testingin primary care

Efficiency 85-97%

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MostMost allergic childrenallergic children have nonhave non--allergicallergicparentsparents

56%6%

38%Non-atopic parents 56%

One atopic parent 38%

German asthmaticchildren with:

Reference: Wahn U. Allergy 2000

The majority of prospectively affectedThe majority of prospectively affectedchildren willchildren will notnot be identified at birth bybe identified at birth byfamily historyfamily history

One atopic parent 38%

Two atopic parents 6%

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Individual allergens add up to symptoms– but which are they? Up to 80% of allergic patients are polysensitized, i.e. allergic to more than one

allergen, average in primary care is three and often more.

Triggers of allergic eczema & asthma symptoms can be both food and inhalantallergens.

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Individual allergens add up tosymptoms

12Elimination of one allergen may be enough to get the patient symptom free!

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Food allergy increases the risk ofsevere asthma6

Independent risk factors for life-threatening asthma,from a case-controlled analysis ofchildren ventilatedfor asthma exacerbation.

Independent risk factors for life-threatening asthma,from a case-controlled analysis ofchildren ventilatedfor asthma exacerbation.

Roberts G et al. J Allergy Clin Immunol 2003;112:168-174

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Food allergy estimated to 4.5% inasthma and/or rhinitis patients in Delhi

Kumar et al. Indian Chest Dis Allied Sci 2010;52:217-24

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Symptoms changes over time – “Allergy march” Test regularly to get the true & actual picture

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Who to test?

All patients with recurrent or persistent “allergy-like” respiratory,skin and gastro symptoms

Patients with uncontrolled allergy disease

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All patients with recurrent or persistent “allergy-like” respiratory,skin and gastro symptoms

Patients with uncontrolled allergy disease

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Which ones? Eczema – 1 out of 3 children is allergic

Rhinitis – 7 out of 10 children are allergic

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Rhinitis – 7 out of 10 children are allergic

Wheezing – 2 out of 3 children are allergic

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Blood tests will help you increase the number of correctdiagnoses

References:1. Duran-Tauleria E et al. Allergy 2004;59:35-41,2. Niggeman B et al. Pediatr Allergy Immunol 2008;19:325-31

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Basic concepts of ALLERGY

Principles and Method of Allergy testing

Application in Daily Practice

Basic concepts of ALLERGY

Principles and Method of Allergy testing

Application in Daily Practice

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Allergy Diagnosis: Physical Examination and review ofHistory of patient’s symptoms.

SPT Immunocap:In Vitro Testing

IgE

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Blood sIgE versus SPT

Why ImmunoCAP… Totally safe Standardized and reproducible No patient/procedure variation No drug interactions Not dependant on skin condition Quantitative - Decision points possible Better patient’s acceptance

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Why ImmunoCAP… Totally safe Standardized and reproducible No patient/procedure variation No drug interactions Not dependant on skin condition Quantitative - Decision points possible Better patient’s acceptance

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Value ofValue of ImmunoCAPImmunoCAP®® resultsresults

Show patients’ baseline/profile of IgE antibodies Evaluate which allergens are the most probable for causing symptoms Evaluate if specific immunotherapy (SIT) is an option Follow changes over time to:

reflect the effect of and compliance with allergen avoidance/reduction optimize medical strategies evaluate tolerance development (food allergy, SIT) avoid unnecessary food challenges

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Show patients’ baseline/profile of IgE antibodies Evaluate which allergens are the most probable for causing symptoms Evaluate if specific immunotherapy (SIT) is an option Follow changes over time to:

reflect the effect of and compliance with allergen avoidance/reduction optimize medical strategies evaluate tolerance development (food allergy, SIT) avoid unnecessary food challenges

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“ImmunoCAP is in worldwideuse, and is a de factostandard to which othermethods are compared.”Ref: Dolen WK, Allergy 2003;58:717-23.

ImmunoCAP® allergy blood testing

“ImmunoCAP is in worldwideuse, and is a de factostandard to which othermethods are compared.”Ref: Dolen WK, Allergy 2003;58:717-23.

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ImmunoCAP® blood testing

Can be performed irrespective of: Age Symptom Disease activity/or severity (e.g. active eczema) Antihistamine/steroid medication Pregnancy (hormone influence)

Is calibrated to WHO ref. preparation for IgE Gives true quantitative levels (kUA/l) Shows consistency of results between laboratories Offers Molecular Allergology (CRD)

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Can be performed irrespective of: Age Symptom Disease activity/or severity (e.g. active eczema) Antihistamine/steroid medication Pregnancy (hormone influence)

Is calibrated to WHO ref. preparation for IgE Gives true quantitative levels (kUA/l) Shows consistency of results between laboratories Offers Molecular Allergology (CRD)

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IMMUNOCAP-GOLD STANDARDTECHNOLOGY

It is the only specific IgE assay to receive USFDA approval toquantitatively report its detection limit 0.1kU/l.This is based onCLSI/NCCLS-17A limits of detection and quantificationguidelines of October 2004.

WHO recommends cut off limit 0.35 kU/l and it is the onlydevice which follows WHO calibration norms.

It is the only specific IgE assay to receive USFDA approval toquantitatively report its detection limit 0.1kU/l.This is based onCLSI/NCCLS-17A limits of detection and quantificationguidelines of October 2004.

WHO recommends cut off limit 0.35 kU/l and it is the onlydevice which follows WHO calibration norms.

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More than 40 years of market leadership- important milestones:

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Facts:Extremely low serumconcentration of specific IgE

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Design: Solid PhaseImmunoCAP®

ImmunoCAP

Extremely high binding capacity

Tubepassive coating

Paper discactivated

Cellulose foamactivated

1 50 150

3-dimensional cellulosepolymer.

Covalent coupling throughCNBr-activation

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ImmunoCAP Used in over 4000 publicationsaddressing clinical questions in allergy: : “…not all serum IgE assays are the same. Most of the studies cited use the

Pharmacia CAP or ImmunoCAP assay….” Lieberman J. et al. 2011.

“…the majority of research performed to date on the predictive power ofquantitative food-specific IgE antibody levels has been performed using theImmunoCAP system.” Eckman J. et al. 2009.

“Today, there are mainly 3 methods: Turbo RAST, Immulite andImmunoCAP. ImmunoCAP is the assay that has been most extensivelystudied.” Cox L. et al. 2008.

“Testing should be performed using a validated laboratory method, such asImmunoCAP (Phadia AB, Uppsala, Sweden)….” Bacharier L.B. et al. 2008.

: “…not all serum IgE assays are the same. Most of the studies cited use thePharmacia CAP or ImmunoCAP assay….” Lieberman J. et al. 2011.

“…the majority of research performed to date on the predictive power ofquantitative food-specific IgE antibody levels has been performed using theImmunoCAP system.” Eckman J. et al. 2009.

“Today, there are mainly 3 methods: Turbo RAST, Immulite andImmunoCAP. ImmunoCAP is the assay that has been most extensivelystudied.” Cox L. et al. 2008.

“Testing should be performed using a validated laboratory method, such asImmunoCAP (Phadia AB, Uppsala, Sweden)….” Bacharier L.B. et al. 2008.

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Established clinical decision points has beendeveloped from trials with ImmunoCAP:

“The published predictive values in the literature to date have been generated withthe ImmunoCAP system…” Hamilton RG. et al. 2011.

“To date, however, the reported IgE anti-food values leading to the generation ofpredictive cutpoints have been exclusively measured by using 1 of 3 clinicallyavailable IgE antibody assays, namely, the ImmunoCAP.” Hamilton RG. 2010.

“To date, the ImmunoCAP (Phadia, Uppsala, Sweden) has been the only clinicallyused IgE antibody immunoassay that has been systematically evaluated for itspredictive value in food allergy studies.” Eckman J. et al. 2009.

“Clinicians rely on these decision points, which were originally established usingthe ImmunoCAP assay, to determine when oral food challenges are appropriate. “Wang J. et al. 2008.

“The published predictive values in the literature to date have been generated withthe ImmunoCAP system…” Hamilton RG. et al. 2011.

“To date, however, the reported IgE anti-food values leading to the generation ofpredictive cutpoints have been exclusively measured by using 1 of 3 clinicallyavailable IgE antibody assays, namely, the ImmunoCAP.” Hamilton RG. 2010.

“To date, the ImmunoCAP (Phadia, Uppsala, Sweden) has been the only clinicallyused IgE antibody immunoassay that has been systematically evaluated for itspredictive value in food allergy studies.” Eckman J. et al. 2009.

“Clinicians rely on these decision points, which were originally established usingthe ImmunoCAP assay, to determine when oral food challenges are appropriate. “Wang J. et al. 2008.

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Anti-Histamine has no effect on Immunocap testing Adverse skin conditions, again- do not effect our

testing(but does effect in Skin Prick Test) And testing can be done during pregnancy as well(but is

contraindicated during Skin Prick) We do have Lab Community & Quality Club So, true accuracy, high precision and outstanding

quality; makes IMMUNOCAP league apart.

Anti-Histamine has no effect on Immunocap testing Adverse skin conditions, again- do not effect our

testing(but does effect in Skin Prick Test) And testing can be done during pregnancy as well(but is

contraindicated during Skin Prick) We do have Lab Community & Quality Club So, true accuracy, high precision and outstanding

quality; makes IMMUNOCAP league apart.

Page 32: Diagnosis of allergy in day to day practice€¦ · Diagnosis of allergy in day to day practice ðqBasic concepts of ALLERGY ðqPrinciples and Method of Allergy testing ðqApplication

Basic concepts of ALLERGY

Principles and Method of Allergy testing

Application in Daily Practice

Basic concepts of ALLERGY

Principles and Method of Allergy testing

Application in Daily Practice

Page 33: Diagnosis of allergy in day to day practice€¦ · Diagnosis of allergy in day to day practice ðqBasic concepts of ALLERGY ðqPrinciples and Method of Allergy testing ðqApplication

Is it allergy or not?

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Suggested test procedure

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Total IgE – clinical performance Sensitivity only ~50% in adults, better in children

Only 60% of allergic asthmatics have increased IgE Only 40 % of allergic rhinitis patients have increased IgE

Specificity ~80 % Increased total IgE due to other reasons than allergy e.g.:

Atopic dermatitis Parasites (e.g. Ascaris, Schistosoma) Virus & bacterial infections (e.g. RSV, Staph.) Graft Versus Host Disease (GVHD) Hyper-IgE Syndrome

Performance not good enough for screening!

Sensitivity only ~50% in adults, better in children Only 60% of allergic asthmatics have increased IgE Only 40 % of allergic rhinitis patients have increased IgE

Specificity ~80 % Increased total IgE due to other reasons than allergy e.g.:

Atopic dermatitis Parasites (e.g. Ascaris, Schistosoma) Virus & bacterial infections (e.g. RSV, Staph.) Graft Versus Host Disease (GVHD) Hyper-IgE Syndrome

Performance not good enough for screening!

Reference: GLORIA module 9, 2006:Diagnosis of allergic diseases/Diagnosis of allergy sensitization.

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Two age-depending versions

1. Phadiatop (≥ 5 years of age)– Measures IgE abs to common inhalant allergen for the age

2. Phadiatop Infant (0-4 years)– Measures IgE abs to common food & inhalant allergens for the age

1. Phadiatop (≥ 5 years of age)– Measures IgE abs to common inhalant allergen for the age

2. Phadiatop Infant (0-4 years)– Measures IgE abs to common food & inhalant allergens for the age

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A blood test designed to differentiate between atopic andnon-atopic patients

Demonstrates the presence of IgE antibodies to commoninhalant allergens

Acts as an objective and reliable first step when screening forallergy

Sensitivity & specificity >90%

A positive test has to be followed-up with suspected allergen-specific tests or panels

Phadiatop®/Phadiatop® Infant- atopy grading

A blood test designed to differentiate between atopic andnon-atopic patients

Demonstrates the presence of IgE antibodies to commoninhalant allergens

Acts as an objective and reliable first step when screening forallergy

Sensitivity & specificity >90%

A positive test has to be followed-up with suspected allergen-specific tests or panels

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Interpretation of IgE ab results

Quantitative result IgE ab level Symptom relation<0.1 Undetectable Unlikely

0.1 – 0.5 Very low Uncommon0.5 – 2 Low Low2 – 15 Moderate Common

15 – 50 High High>50 Very high Very high

Quantitative result IgE ab level Symptom relation<0.1 Undetectable Unlikely

0.1 – 0.5 Very low Uncommon0.5 – 2 Low Low2 – 15 Moderate Common

15 – 50 High High>50 Very high Very high

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Value of low IgE antibody levels?

The degree of sensitization is very low & relation to symptoms is uncommon, but lowlevels … identify sensitization earlier than before are of interest in order to follow the development of sensitization may appear even before symptoms have developed may predict which allergens could cause problem in the future more important for small children more relevant in drug & venom allergy

0.1 - 0.5 kUA/l

The degree of sensitization is very low & relation to symptoms is uncommon, but lowlevels … identify sensitization earlier than before are of interest in order to follow the development of sensitization may appear even before symptoms have developed may predict which allergens could cause problem in the future more important for small children more relevant in drug & venom allergy

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Efficiency of Phadiatop (21 external studies)

Anichini et al.Betti et al.Biot et al.Bonini et al.Carrodus & TiernanCrimi et al.Duc et al.Ebner et al.ErikssonGuillou et al.Guillou et al.Gustafsson et al.Herkert et al.Herold et al.Loidolt et al.

11098

109100118121100

73100105212100133100101

98185201248

88200

0.880.870.880.930.911.000.940.980.920.960.880.950.840.940.720.930.940.950.960.750.92

0.910.07

0.901.000.880.970.980.931.000.830.981.000.821.001.000.960.810.930.830.921.000.910.95

0.930.07

0.890.920.880.960.940.980.960.930.950.980.850.970.910.960.750.930.930.940.990.850.94

0.920.06

Ribeiro et al.Segalen et al.Treden et al.Wever et al.Wüthrich et al.Zetterström et al.

MeanSD

NumberAuthors Sensitivity Specificity Efficiency

Anichini et al.Betti et al.Biot et al.Bonini et al.Carrodus & TiernanCrimi et al.Duc et al.Ebner et al.ErikssonGuillou et al.Guillou et al.Gustafsson et al.Herkert et al.Herold et al.Loidolt et al.

11098

109100118121100

73100105212100133100101

98185201248

88200

0.880.870.880.930.911.000.940.980.920.960.880.950.840.940.720.930.940.950.960.750.92

0.910.07

0.901.000.880.970.980.931.000.830.981.000.821.001.000.960.810.930.830.921.000.910.95

0.930.07

0.890.920.880.960.940.980.960.930.950.980.850.970.910.960.750.930.930.940.990.850.94

0.920.06

Ribeiro et al.Segalen et al.Treden et al.Wever et al.Wüthrich et al.Zetterström et al.

MeanSD

NumberAuthors Sensitivity Specificity Efficiency

Reference: Eriksson NE. Allergy 1990;45:285-292

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Suggested test procedure

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Allergy MarchA changeable march of symptoms & allergens over time

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Michael, 3 months old

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Peter, 7 years old & his “allergymarch”

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ImmunoCAP® Symptom profilesFew allergens responsible for majority of allergies

10 allergens being responsible for 95% of allergies in children in UKReference: Symptom Profile Meeting London 2004(G lack, H Cox, C Doyle, S Leech, M Levy, J Hourihane, G Roberts, M Borres)

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Symptom panels/profiles Should help GPs (non-specialists) to select the right

allergens Should identify the allergic patient or exclude the non-

allergic A panel will not/should not cover “everything”; only

common relevant allergens Should be reasonably priced for patients A positive panel could always be followed-up with extra

tests according to patient history (and not included) alt.a comprehensive allergen panel

Should help GPs (non-specialists) to select the rightallergens

Should identify the allergic patient or exclude the non-allergic

A panel will not/should not cover “everything”; onlycommon relevant allergens

Should be reasonably priced for patients A positive panel could always be followed-up with extra

tests according to patient history (and not included) alt.a comprehensive allergen panel

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Which are the common Indianallergens?

SPT results from Kolkata – foods & respiratory allergy

>20%

Common food allergens among the respiratorypopulation in Calcutta

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Reference: Mandal et al. WAO Journal January 2009

<20%

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Skin test positivityMumbai

3,389 patients tested 2003-2007

Shaikh and Shaikh. J Indian Med Assoc 2008;106:220-226

3,389 patients tested 2003-2007

Shaikh and Shaikh. J Indian Med Assoc 2008;106:220-226

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Skin test positivity in Calcutta

Mandal et al. WAO Journal 2009;2:9-12

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Which are the important local allergens?

(with focus on Dehradoon)

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Allergic Rhinitis

Allergic Rhinitis is defined as symptomaticdisorder of nose, induced after allergen exposureby an IgE mediated inflammation of the nasalmembrane.Major symptoms -Rhinorrhea,Nasalobstruction,nasal itching,sneezing.

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Allergic Rhinitis is defined as symptomaticdisorder of nose, induced after allergen exposureby an IgE mediated inflammation of the nasalmembrane.Major symptoms -Rhinorrhea,Nasalobstruction,nasal itching,sneezing.

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Case history and physical examination alonemay lead to uncertain diagnoses

• Approx. 65% of patient diagnosed as having allergic rhinitis andprescribed antihistamine are not allergic

• Allergic rhinitis is often confused with recurrent infectious cold,leading to unnecessary use of antibiotics

Misdiagnosed rhinitis has a significant impacton patient well-being

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• Approx. 65% of patient diagnosed as having allergic rhinitis andprescribed antihistamine are not allergic

• Allergic rhinitis is often confused with recurrent infectious cold,leading to unnecessary use of antibiotics

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Food Allergy

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Individual allergens add up to symptoms

Elimination of one allergen may be enoughto get the patient symptom free!

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Reasons to quantify allergen-specific IgE antibodies

Sensitization and common allergic disorders may develop intosevere conditions later in life (”the allergy march”)

Diagnosis: Identifying the offending allergens is essential foravoidance/elimination and quantification of IgE ab helps to pick out themost probable ones

Prognosis: Early sensitization can be predictive of future allergies, thehigher the IgE ab level, the higher the risk.

Follow-up: Quantification helps monitoring patient’s allergic status overtime such as avoidance/elimination effects anddevelopment of tolerance or disease deterioration

Sensitization and common allergic disorders may develop intosevere conditions later in life (”the allergy march”)

Diagnosis: Identifying the offending allergens is essential foravoidance/elimination and quantification of IgE ab helps to pick out themost probable ones

Prognosis: Early sensitization can be predictive of future allergies, thehigher the IgE ab level, the higher the risk.

Follow-up: Quantification helps monitoring patient’s allergic status overtime such as avoidance/elimination effects anddevelopment of tolerance or disease deterioration

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ConclusionDetection of IgE antibodies➢ Provides information that the sensitization process has beeninitiated.➢ Along with symptoms and a positive case history,confirms the causative allergen.➢Without symptoms may predict later development of allergicdisease.➢ Allows careful avoidance strategies for treatment.Treatment strategies with rapid and consistent positiveresult include: preventive actions

close observationallergen avoidanceguides SIT

Detection of IgE antibodies➢ Provides information that the sensitization process has beeninitiated.➢ Along with symptoms and a positive case history,confirms the causative allergen.➢Without symptoms may predict later development of allergicdisease.➢ Allows careful avoidance strategies for treatment.Treatment strategies with rapid and consistent positiveresult include: preventive actions

close observationallergen avoidanceguides SIT

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Allergy is nothing to sneezeat!

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Better patient management needsthe best tools

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ConclusionImmunoCAP is the first choice in allergy diagnosis andcan be safely and reliably used in all patients and in allclinical settings.

IgE

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Atopy grading withPhadiatop®/Phadiatop® Infant

• A blood test designed to differentiate between atopic andnon-atopic patients.

• Demonstrates the presence of IgE antibodies to commoninhalant allergens.

• Acts as an objective and reliable first step when testing forallergy.

• A blood test designed to differentiate between atopic andnon-atopic patients.

• Demonstrates the presence of IgE antibodies to commoninhalant allergens.

• Acts as an objective and reliable first step when testing forallergy.