GUIDELINES

Year : 2023  |  Volume : 37  |  Issue : 3  |  Page : 1-98

Indian Guidelines for diagnosis of respiratory allergy

Raj Kumar¹, Shailendra Nath Gaur¹, Mahendra Kumar Agarwal¹, Balakrishnan Menon¹, Nitin Goel¹, Parul Mrigpuri¹, Sonam Spalgais¹, Anshu Priya¹, Kapil Kumar¹, Rahul Meena¹, N Sankararaman¹, Arvind Kumar Verma¹, Vatsal Bhushan Gupta¹, Sonal¹, Anupam Prakash¹, M Ahmed Safwan¹, Digamber Behera², Anand Bahadur Singh³, Naveen Arora¹, Rajendra Prasad⁴, Mahesh Padukudru⁵, Surya Kant⁶, Ashok Kumar Janmeja⁷, Anant Mohan⁸, Vikram Kumar Jain⁹, Komarla V Nagendra Prasad¹⁰, K Nagaraju¹¹, Mahesh Goyal^12
1 Department of Pulmonary Medicine, Vallabhbhai Patel Chest Institute, University of Delhi, Delhi-11000, India
² Department of Pulmonary Medicine & Critical Care, Postgraduate Institute of Medical Education and Research, Chandigarh, India
³ Department of Allergy Biology, Institute of Genomics and Integrative Biology, Delhi, India
⁴ Department of Pulmonary Medicine, Era's Lucknow Medical College, Uttar Pradesh, India
⁵ Allergy Asthma and Chest Centre, Mysore (Karnataka), India
⁶ CSM Medical University, Lucknow, Uttar Pradesh, India
⁷ Department of Pulmonary Medicine, Maharishi Markandeshwar Medical College and Hospital, Mullana, Ambala, Haryana, India
⁸ Department of Pulmonary Medicine, Critical Care & Sleep Disorders, All India Institute of Medical Sciences, New Delhi, India
⁹ Department of Pulmonary Medicine, Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan, India
¹⁰ Bengaluru Allergy Centre, Bengaluru, Karnataka, India
¹¹ VN Allergy and Asthma Research Centre, Kattabomman Street, Shanmugham Road,Tambaram West, Chennai (Tamil Nadu), India
¹² Department of Respiratory Medicine, C K S Hospitals, Jaipur, India

Correspondence Address:
Dr. Raj Kumar
Director, Vallabhbhai Patel Chest Institute, Delhi – 110007
India

Source of Support: None, Conflict of Interest: None

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DOI: 10.4103/0972-6691.367373

Raj Kumar, Nitin Goel, Parul Mrigpuri, Sonam Spalgais, Digamber Behera and Anand Bahadur Singh
Writing committee of the Respiratory Allergy Guideline Working Group.

Introduction and Methodology

Introduction

Methodology

Table 1: Classification of level of evidence and grading of recommendation Click here to view

Executive Summary

A: History Taking and Examination

1. Common respiratory allergic diseases



• Common respiratory allergic diseases are asthma and allergic rhinitis although the concept of one airway one disease considers them as a single disease
• Both these diseases have significant impact on the quality-of-life (QoL), social life and economy
• In a significant proportion of patients these diseases coexist, and the coexistence of both is associated with increased emergency room visits and health care utilization.



2. What are the symptoms of respiratory allergy?



• Symptoms of asthma are typically paroxysmal and include wheezing, cough, breathlessness, and chest tightness
• No single symptom is specific or more significant for asthma, although non-asthmatics rarely report frequent wheezing
• Typical symptoms of allergic rhinitis are nasal obstruction, post-nasal drip, sneezing, rhinorrhoea (clear watery secretions), and itchy nose.



3. What are the signs of respiratory allergy?



• Physical examination in asthmatics can be completely normal
• Wheezing is the most typical sign of asthma and it may be heard only on expiration or on both inspiration and expiration.
• Wheezing is classically polyphonic and usually heard throughout the chest. Children with allergic rhinitis usually exhibit mouth breathing, allergic salute, allergic nasal crease, facial grimacing, nasal snorting, and allergic shiners on general appearance
• Typical signs of allergic rhinitis on nasal and naso-pharygeal examination are clear, watery rhinorrhea, pale or bluish and boggy inferior turbinates.



4. Is age at onset of symptoms significant for diagnosis of respiratory allergy?



• The age of onset of symptoms is important for respiratory allergic diseases as these diseases have different risk factors, clinical presentation, impact on QoL and prognosis in various age groups
• Childhood onset asthma has been demonstrated to have a stronger association with family history and genetics compared to adult onset asthma
• Childhood onset asthma patients also have better lung functions, prognosis, and higher chances of going into remission or resolve altogether
• On the other hand, adult onset asthma symptoms are more associatied with occupational exposures and smoking. Obesity related phenotypes are also more common in adults
• Onset of respiratory allergic diseases in the elderly age group is associated with significant comorbidities, polypharmacy, and more severe deterioration in QoL.



5. Does family history have significance in diagnosis of respiratory allergy?



• Family history of allergic disorders is a significant risk factor for the development of respiratory allergic diseases
• Both childhood onset as well as adult onset asthma have strong association with the family history of asthma
• Although association is stronger for childhood onset asthma
• Family history of allergies is also associated with an increased risk of allergic rhinitis
• Risk is more if there is a family history of allergic rhinitis.



6. What is the importance of area of residence with regards to respiratory allergy?



• India is a vast country with varied geographical profile
• From the Himalayas to coastal regions of southern states and from arid Rajasthan to far north-eastern states different allergens predominate
• Thus, the allergen predominant in one region may lose its significance in another region
• Additionally, the dominance pattern of allergen also varies according to rural and urban area of residence
• Hence, knowledge of area-wise allergen predominance helps in identification of allergens, subsequently followed by appropriate testing and treatment.



7. What is the relevance of indoor and outdoor symptoms with regard to the respiratory allergy?



• A broader knowledge of indoor and outdoor allergens with detailed history taking of allergic patients can help in selecting appropriate allergen for testing either by skin prick test (SPT) or specific immunoglobulin-E (IgE) against a particular allergen, which in turn, will help in allergen avoidance and designing allergen specific immunotherapy.



8. What is the importance of seasonal variation in respiratory allergy?



• The knowledge about season-wise variation in allergen pattern helps a physician in relating to a typical history of seasonal symptom pattern or season-wise variation in symptom pattern of an allergic patient, which in turn, helps in appropriate testing and further treatment.



9. What is the significance of work/occupational exposure in respiratory allergy?



• The exposure assessment, including work-place allergen determination, is a cornerstone in identification of allergen type in a patient suspected to be suffering from occupation related allergies because it helps in establishing preventive measures which includes total allergen exposure avoidance or a reduction in exposure (second best option) along with its treatment.



10. What is the significance of recurrence of symptoms on repeat exposure(s) to a particular agent/antigen?



• The importance of elucidating the history of recurrence of symptoms after exposure to a specific environmental condition underlies the fact that one or more allergen(s) predominate in a particular type of environment, and hence, its knowledge helps a physician in narrowing down the possibility of a particular type of allergen which is followed by appropriate testing and adequate treatment of a patient who is suspected to be suffering from repeated allergen exposure.



11. What is the relationship of food and skin allergy with respiratory allergy?



• Variety of respiratory symptoms occurs on exposure to food allergens
• Very rarely patients may have asthma symptoms in response to inhalation of food particles
• Symptoms on exposure to food additives can infrequently involve lower respiratory tract symptoms, specifically in asthmatic patients
• In contrast, the perception of food-induced asthma is more common
• Previous history of presence of a food allergy increases the risk for the development of asthma, as well as life threatening asthma
• When food-allergy reactions involve the lower respiratory tract, the reactions tend to be more severe
• In addition, patients with underlying asthma may experience more severe and potentially life-threatening allergic food reactions.



12. What is the relationship of food and skin allergy with respiratory allergy?



• Allergic dermatitis (AD) is a prerequisite for the development of allergic rhinitis and asthma and specific sensitization
• Whether AD in the atopic march is necessary for the progression to other atopic disorders remains to be defined
• It is also important to identify infants at risk for developing lifelong chronic atopic diseases and utilize the critical window of opportunity early in the life for therapeutic intervention.



13. What is the relevance of treatment history in diagnosis of respiratory allergy?



• Asthma is seen in nearly 35% to 40% of patients with treatment history of eczema and/or atopic dermatitis
• History of skin allergy in childhood is important for the diagnosis of respiratory allergy
• History of treatment with aspirin, non-steroidal anti-inflammatory drugs (NSAIDS), angiotensin converting enzyme (ACE) inhibitors, beta-blockers and antibiotics play a major role in some individuals for making the diagnosis of respiratory allergy.

B: Allergens in Respiratory Allergy

1. What are the source/location, risk factors and clinical significance of pollen in causation of respiratory allergy?



• Allergic rhinitis and asthma are most common pollen-associated allergic respiratory diseases
• Pollen sensitization in India varies across different parts because of varied geo-climatic conditions.



2. Why is pollen calendar important in respiratory allergic diseases? Is there any standardized pollen calendar for India with reference to various geographic areas?



• Pollen calendar is important in respiratory allergic diseases for taking personal preventive measures and diagnostic and therapeutic considerations
• It also helps public health officials to assess the impact of exposure and to develop early warning systems.



3. What is the importance of pollen count in respiratory allergic diseases?



• Increase in pollen count is associated with an increased risk of allergic and asthmatic symptoms
• A rise in asthma related admissions may be seen during peak pollen season.



4. What are the source/location, risk factors and clinical significance of house dust mite in causation of respiratory allergy?



• Allergic rhinitis and asthma are most common house dust mites associated allergic respiratory diseases
• House dust mites sensitization on SPT in India varies from 11% to 88%
• The dominant genus found in India is Dermatophagoides spp.



5. What is the source/location, risk factors and clinical significance of fungal allergens in causation of respiratory allergy?



• Most common mold associated allergic respiratory diseases are allergic rhinitis and asthma. Aspergillus, Penicillium and Cladosporium are the most common indoor fungal allergens
• The common fungal allergens to which sensitivity has been elicited included: Aspergillus fumigatus, A. flavus, A. niger, A. tamari, Altenaria, Rhizopus, Cladosporium, Curvularia, Fusarium, Helminthosporium, Mucor, Epicoccum and Trichoderma.



6. What are the source/location, risk factors and clinical significance of insect allergens in causation of respiratory allergy?



• Naso-bronchial allergy and asthma are most common allergic respiratory diseases associated with insects
• Prevalence of insect allergy is variable across India ranging from 6% to 64%
• Moth, cockroach, housefly and mosquito are common among insect allergens in India.



7. What is the source/location, risk factors and clinical significance of other aeroallergens (Animal/Inhalant food allergens/Occupational allergens) in causation of respiratory allergy?



• Dander allergen sensitivity is commonly seen due to cat, cow and dog dander
• Increasing evidence suggests that allergic reactions to foods can occur following inhalation
• Occupational allergens responsible for respiratory allergy mainly include biocides, latex, flour, animals and metals.



8. How will one choose the allergens for screening of allergic diseases in adults and pediatric age group?



• Clinical history along with the knowledge about regional allergens combined with clinical correlation can help in formulating allergen panel for an individual patient
• Additional factors, such as exposure to foods and school environment should be considered in clinical history while choosing allergen for pediatric age group
• Indian studies suggest house dust mites to be the common allergen in children.

C: Diagnostic Testing (In Vivo and In Vitro)

1. What are the in vivo tests for diagnosis of respiratory allergic diseases?



• In vivo tests for the diagnosis of respiratory allergic diseases are:



1. Skin prick test
2. Intradermal test (IDT)
3. Patch test
4. Allergen provocation tests:



1. Nasal allergen provocation test
2. Bronchial allergen provocation test
3. Conjunctival allergen provocation test
4. Food allergen provocation test.



2. What are the in vitro tests for diagnosis of respiratory allergic diseases?



• In vitro tests for the diagnosis of respiratory allergic diseases are:



1. Serum immunoglobulim-E assays



1. Serum total IgE
2. Serum specific IgE



1. Single-plex
2. Multiplex



3. Cell-based assay

• Both the type of tests has certain advantages and disadvantages over each other



1. SPT is simple, inexpensive, reliable and reproducible test and can be performed with virtually any allergen. It provides quick results, but requires a certain amount of co-operation from the patient
2. SPT in collaboration with clinical history is the most accurate diagnostic test for the diagnosis of respiratory allergy.(2A)
3. IDT has higher sensitivity, but its diagnostic accuracy is limited (2A)
4. In vitro test, i. e serum specific IgE is both less sensitive and less specific compared to SPT for the diagnosis of respiratory allergy.(3A)



• Which test is considered as the gold standard test for diagnosis of respiratory allergic diseases?

• SPT is considered as the gold standard for the diagnosis of respiratory allergy.

• An allergy specialist/physician or pediatrician formally trained in allergy testing should perform in vivo allergy testing (3A)
• A nurse/technician trained in allergy testing can also perform in vivo allergy testing under the supervision of an experienced physician (3A)
• However, an experienced physician well versed in the management of anaphylactic reactions along with all the necessary requirements for the same, should be present, whenever in vivo allergy testing is being performed.(UPP)

• SPT should not be performed during acute phase of the disease/uncontrolled asthma (3A)
• SPT should be done after at least a gap of 3-4 weeks from systemic allergic reactions.(3A)

• SPT should be performed in the following indications:



1. For diagnosis of respiratory allergy by inhalant allergens (1A), food allergens (1A) and drugs.(2A)
2. As reference standard for in vitro tests for the diagnosis of respiratory allergy.(1A)
3. For determining bioequivalent potency of allergen extracts.(1A)

• SPT is contraindicated in the following conditions:



1. Pregnancy and lactation (3A)
2. Dermatographism (2A)
3. Absence of normal skin (1A)
4. Un-cooperative patient (UPP)
5. Patients who are taking drugs may hinder the action of epinephrine (if needed for anaphylaxis), e. g. beta-blockers and ACE-inhibtors (1A)
6. Patients who are taking medications (which interfere with test results) which can not be stopped before test, e. g. anti-histamines, trycyclic anti-depressants (TCA) and steroids (3A)
7. Relative contraindication. It should not be performed in young children and when needed, should be performed under the supervision of pediatrician trained in allergy.(3B)

• Based on the literature review and the experience of the expert panel it is recommended that



1. SPT should preferably be done in children >5 years of age (2A)
2. With strong clinical indications, SPT may be done in children <5 years under the supervision of a pediatrician trained in allergy testing.(3B)

• This has already been discussed in answers to question number 7 and 8 of Part B.

• The maximum permissible number of allergens that can be used for SPT in one sitting in an adult could be upto 60.(2A)
• In pediatric age group, maximum number of permissible allergens that can be tested in one sitting should be <12.(2A)
• However, a minimum number of allergens on the individualized basis-as per the clinical history, age, prevalence of aeroallergens, exposure factors and pollen calendar-should be used for SPT.(2A)

• The steps of patient preparation before SPT include:



1. The testing procedure and the risk of complications should be explained to the patient before-hand. Informed written consent should also be obtained for the same.(Consent proforma given in the detailed guidelines)
2. The test should be deferred if any contraindication to SPT is present
3. The patient should have a light breakfast at least 2 hours before the test
4. Someone should accompany the patient to help in case if the patient develops any adverse reaction, like anaphylaxis.
5. In case of male patients with hairy arms, it is required to shave the arms at least 48 hours before the procedure
6. The medications which may interfere with the SPT results and the duration for which these drugs should be withheld before performing SPT is given in the [Box 1].

• Before beginning to perform SPT, it should be ensured that emergency kit to manage anaphylaxis (if it happens) has been prepared and ready
• It should contain pre-filled adrenaline syringe, hydrocortisone, injection atropine, anti-histamine and equipment for intubation
• Also, oxygen supply should be available.



1. Reassure the patient and explain the test procedure
2. Site: The test can be performed on volar aspect of forearm, outer upper arm and back. The allergen should be applied at a site 5cm from the wrist and 3cm from antecubital fossa. The most commonly used site is volar surface of forearm
3. Clean the skin site with alcohol prior to SPT
4. Mark the positions (where allergen has to be applied) with pen. The allergens should be applied 2cm apart to avoid overlapping and false positive results
5. Apply the drop of allergen on skin with dropper without touching the dropper tip with the skin
6. A sharp instrument (lancet) is passed through the drop at an angle of 45^o-60^o or alternatively at 90^o upto a depth of 0.9mm to 1mm. Lancet with a point length of 1 mm is the preferred device as evidenced by the literature reviewed
7. After 15-20 minutes read the test results
8. Patient (particularly those with multiple positive results and history of anaphylaxis) should be observed for 20 minutes after the test for any discomfort.

• A standardized approach for reading of SPT is lacking
• It is recommended that allergen be left at the test site should be blotted immediately after skin test
• Histamine control should be read after 15 minutes of application
• Allergen prick test should be read after 15-20 minutes
• As evidenced by the literature, still mean wheal diameter is the most widely used method in practice. Format for reporting of SPT results is given in the detailed guidelines
• A mean wheal diameter of >3mm more than simultaneously performed diluent control (i. e., negative control) is taken as positive response to an allergen on SPT.(2A)

• SPT is considered a relatively safe procedure, except for a few minimal complications. The various complications which can occur during SPT include:


Local


1. Local skin swelling is seen rarely in some patients due to late phase response of IgE. It is more common in IDT. It usually resolves within 36 hours
2. Localised wheal or flare.


Systemic

Systemic reactions usually begin within 15-30 minutes


1. Anaphylaxis
2. Vaso-vagal syncope.


Non-allergic complications


1. Risk of transmission of infection. This has never been documented, although theoretically possible.
2. Headache
3. Malaise.

• The IDT can be done in the following indications:



1. Patients with strong suspicion for allergy to specific allergens and negative SPTs. (3B)
2. Venom allergy. (2A)
3. Drug allergy (beta-lactams, insulin, opiates, anesthetics, neuromuscular relaxants, proton-pump inhibitors, enzymes, chemotherapeutic agents, vaccines). (2A)

• Serum IgE levels usually higher in atopic disorders. Its relevance in respiratory allergy is summarized as:



1. Sensitivity and specificity of serum total IgE is very low for the diagnosis of respiratory allergy and it should not be considered as a reliable marker of allergy status.(2A)
2. Serum total IgE is one of the reliable markers for following disease severity and therapeutic response in allergic bronchopulmonary aspergillosis (ABPA).(1A)
3. Serum total IgE values have significance in omalizumab therapy.(1A)

• The indications for serum specific IgE testing are as follows:



1. In cases with inconclusive SPTs and high suspicion of allergy based on the history
2. Inability to temporarily discontinue skin test suppressive medication therapy (e. g., anti-histamines, anti-depressants or beta-blockers)
3. Presence of extensive skin disease (e. g., dermatographism or generalized eczema)
4. Un-cooperative patient
5. Clinical history suggestive of high risk of anaphylaxis from skin testing.

• Nasal allergen provocation test (NAPT) is of limited clinical value and is mainly indicated for research purposes.(2A)
• Under the current conditions in India, NAPT is advised in tertiary care centres only (2A).
• Unavailability of standardized allergens specific to Indian conditions further limits the utility of this test.

• FeNO is not necessary for making a diagnosis of allergic asthma (1A)
• High FeNO levels are suggestive of eosinophilic/allergic asthma (2A)
• In adults: FeNO >50 ppb (parts per billion) and in children FeNO >35 ppb signifies eosinophilic inflammation and likelihood of corticosteroids responsiveness in symptomatic asthma patients (2A)
• FeNO may be a useful tool for follow-up and assessment of the treatment response in allergic asthma (3A)
• Spirometry is an essential diagnostic modality for the diagnosis and follow-up of allergic asthma. (1A)

A: History Taking and Examination

1. Bronchial asthma
2. Allergic rhinitis/rhinosinusitis

Table 2: Signs on physical examination Click here to view

Figure 1: Photograph of the patient showing (a) Allergic shiners, (b) Allergic salute, (c) Allergic nasal crease. Courtesy: Prof.(Major) K. Nagaraju Click here to view

Figure 2: Photograph of the patient (Dennie-Morgan lines). Courtesy: Prof.(Major) K. Nagaraju Click here to view

1. Children with allergic rhinitis usually exhibit mouth breathing, allergic salute, allergic nasal crease, facial grimacing, nasal snorting, and allergic shiners on general appearance
2. Typical signs of allergic rhinitis on nasal and nasopharyngeal examination include clear, watery rhinorrhea, pale or bluish and boggy inferior turbinates
3. The physical examination in asthmatics can be completely normal
4. Wheezing is the most typical sign of asthma, and it may be heard only on expiration or on both inspiration and expiration
5. Wheezing is classically polyphonic and usually heard throughout the chest.

Figure 3: Importance of the age of onset of asthma and asthma phenotypes Click here to view

1. The age of onset of symptoms is important for respiratory allergic diseases as these diseases have different risk factors, clinical presentation, impact on the QoL and prognosis in various age groups
2. Childhood-onset asthma has been demonstrated to have a stronger association with family history and genetics compared to adult-onset asthma
3. Childhood-onset asthma patients also have better lung functions, prognosis, and higher chances of going into remission or resolve altogether. On the other hand, adult-onset asthma symptoms have more association with occupational exposures and smoking
4. Obesity-related phenotypes are also more common in adults. The onset of respiratory allergic diseases in the elderly age group is associated with significant comorbidities, polypharmacy, and more severe deterioration in the QoL
5. Importance of the age of onset of asthma and asthma-phenotypes are summarized in [Figure 3].

Table 3: Family history of allergies and allergic rhinitis Click here to view

1. Family history of allergic disorders is a significant risk factor for the development of respiratory allergic diseases.
2. Both childhood-onset and adult-onset asthma have a strong association with the family history of asthma. However, the association is stronger for childhood-onset asthma
3. Family history of allergies is also associated with increased risk of allergic rhinitis. Risk is more if there is a family history of allergic rhinitis
4. Knowledge of asthma risk might help to motivate behavioural efforts on the part of parents of children at risk (e. g., increased use of mattress covers, removal of rugs, avoidance of humidifiers, and efforts to spare children exposure to cigarette smoke). However, all family members affected by atopic diseases would potentially benefit from these efforts
5. A positive family history of asthma or other allergic diseases might also help health-care providers and parents to identify early signs of respiratory allergy and to be more proactive about treatment.

1. Atopic dermatitis is a prerequisite for the development of allergic rhinitis and asthma and specific sensitization
2. Whether atopic dermatitis in the atopic march is necessary for the progression to other atopic disorders remains to be defined
3. It is also important to identify infants at risk for developing lifelong chronic atopic diseases and utilize the critical window of opportunity early in life for the therapeutic intervention.

• The physician needs a thorough medical history to make an accurate diagnosis of respiratory allergy. Following points are needed to be enquired from the patients:



1. Is there any family history of allergies or asthma?
2. Is there personal history of any allergic conditions?
3. Under what circumstances do these symptoms occur?
4. If medications have been prescribed previously, what was the response to each of them?
5. Were there any relevant complications at birth, such as respiratorydistress?
6. Does the patient have any other medical problems, such as gastrointestinal disorders, skin problems, joint problems, or infectious diseases?

• Asthma is seen in nearly 35% to 40% of the patients with a treatment history of eczema and/or atopic dermatitis^[265]
• Nearly 33% to 38% of the patients with allergic rhinitis had a history of treatment for eczema or atopic dermatitis^[267]
• Treatment history of skin allergy in childhood is important for the diagnosis of respiratory allergy.

• Asthma and food allergy have been commonly shown to coexist with each other
• Studies have shown that food sensitization early in life (within the first 2 years of life) approximately double the chance of developing asthma and rhinitis^[234],[235]
• Rhodes et al in a study of 100 infants found that sensitization to egg and milk in the first year of life was an independent risk factor for the development of asthma in adulthood.^[229]

• Drug hypersensitivity reactions are most common in patients over 50 years of age
• Allergic reactions to drugs are predominantly observed among women
• Anaphylactic reactions are most commonly observed after history of administration of aspirin, non-steroidal anti-inflammatory agents, intravenous contrast agents, muscle relaxants and beta-lactam antibiotics
• Allergic reactions to medications usually resolve themselves after the discontinuation of the drug.

• Beta-blockers, used to treat blood pressure, heart disease and migraine headaches, glaucoma (eye drop) can trigger asthma symptoms.^[268] Aspirin and other non-steroidal anti-inflammatory drugs (NSAIDS), such as ibuprofen and naproxen, may trigger symptoms in some people with asthma. Between 8% to 20% of the adult asthmatics experience bronchospasm to these drugs^[269]
• Incidence of ACE inhibitors induced cough range from 5% to 10% of treated the patients^[270]
• Pre-natal antibiotic exposure is found to be associated with a dose-dependent increase in asthma risk.^[271]
• Allergy to drugs is diagnosed based on medical history and a number of specific tests: skin tests, blood tests. In diagnosing the causes of anaphylaxis, the basophil activation test is used to exclude false negative and false positive results of skin tests and specific IgE levels^[272]

1. Asthma is seen in nearly 35% to 40% of the patients with a treatment history of eczema and/or atopic dermatitis
2. History of skin allergy in childhood is important for the diagnosis of respiratory allergy
3. History of treatment with aspirin, NSAIDS, ACE-inhibitors, beta-blockers and antibiotics play a major role in some individuals for making the diagnosis of respiratory allergy.

History Taking and Examination: A Glance

• Common respiratory allergic diseases are asthma, and allergic rhinitis. Both these diseases pose as a substantial burden on the QoL, social life, and economy. A significant proportion of patients have both asthma and allergic rhinitis, and the co-existence of both is associated with increased emergency room visits and health-care utilization
• Symptoms of asthma are typically paroxysmal and include wheezing, cough, breathlessness, and chest tightness. Typical symptoms of allergic rhinitis are nasal obstruction, post-nasal drip, sneezing, rhinorrhoea (clear watery secretions) and itchy nose
• On physical examination, an asthmatic can be completely normal. Wheezing is the most typical sign of asthma and it may be heard only on expiration. On the other hand, children with allergic rhinitis usually exhibit a plethora of signs and symptoms, such as, sneezing, rhinorrhoea, nasal blockage with associated mouth breathing, allergic salute, allergic nasal crease, facial grimacing, and nasal snorting
• Respiratory allergic diseases have different risk factors, clinical presentation, impact on QoL and prognosis according to the age of presentation of the disease. Childhood-onset asthma has been demonstrated to have a stronger association with family history, better lung functions and higher chances of going into remission or resolving as compared to adult onset asthma. On the other hand, adult-onset asthma symptoms have more association with occupational exposures, obesity, and smoking
• Family history of allergic disorders is a significant risk factor for the development of respiratory allergic diseases. Both childhood-onset as well as adult-onset asthma have strong association with the family history of asthma. Family history of allergies is also associated with an increased risk of allergic rhinitis
• The growing prevalence of allergy and asthma in India is a cause of major concern as it is a vast country with varied geographical profile, climatic conditions, agriculture and food habits. Hence, there is a wide range of area-specific allergen predominance. The allergen which may be of importance in one region may lose its relevance in some other parts of the country. At present, more than 25% of the total population of India is sensitized with different forms of allergens and the major sources of allergens identified are the pollen grains, fungal spores, dust mites, insects and food. Also, the dominance pattern of allergen varies according to rural and urban area of residence. Thus, the knowledge of area-wise allergen predominance helps in identification of allergens, subsequently followed by appropriate testing and treatment
• Similarly, the atopic individuals are known to mount a response to the presence of allergens in his/her environment either indoor or outdoor. It can occur either in the form of allergic symptoms appearing de novo or an exacerbation of the underlying allergic condition, like rhinitis, asthma, atopic dermatitis, conjunctivitis, etc. The severity of respiratory reactions can vary from mild irritation to severe anaphylaxis reaction. In case of indoor allergen the typical history would include peremial (especially, in HDM and cockroaches), early morning and nocturnal symptom pattern with history of aggravation of symptoms while being indoors, while doing household work like dusting, blooming, opening old dusty books in home, libraries etc. Previous studies have demonstrated that the asthmatic subjects who are exposed in their homes to allergens (dust mite, cat, dog) to which they are sensitized have a more severe form of the disease, as measured on the basis of FEV₁, PEFR, bronchial reactivity (PC20), SPT and FeNO. Hence, a broader knowledge of indoor and outdoor allergens with detailed history taking of allergic patients can help in selecting appropriate allergen for testing either by skin prick test or specific IgE against a particular allergen, which will in turn, help in allergen avoidance and designing allergen-specific immunotherapy
• Like-wise, the knowledge of season-wise variation in respiratory allergy dates back to as as the fifth Century BC when Hippocrates first noted the seasonal variation in exacerbations of asthma, since then the seasonal patterns have been described for asthma mortality, hospital admissions and emergency department visits. These variations are ascribed to seasonal variations in the exposure to ambient allergens, respiratory infections and meteorological changes. The knowledge about season-wise variation in allergen pattern helps a physician in relating to a typical history of seasonal symptom pattern or season-wise variation in symptom pattern of an allergic patient, which in turn, helps in appropriate testing and further treatment
• Also, the exposure to allergens at work-place has contributed significantly in enhancing the problems of patients suffering from respiratory disorders as the quality of air is poor due to presence of large number of allergens. At present, about 200 agents have been implicated in causing occupational asthma in the work-place. Exposure-specific studies about occupational asthma have focused on substances, of high-and low-molecular weight. The exposure assessment, including work-place allergen determination, is a cornerstone in the identification of allergen type in a patient suspected to be suffering from occupation-related allergies because it helps in the establishing preventive measures which includes total allergen exposure avoidance or a reduction in the exposure (second best option) along with its treatment
• The persistent or repetitive exposure to these allergens results in chronic allergic inflammation, which in turn, produces long-term changes in the structure of the affected organs and substantial abnormalities in their function. Also, many patients who initially have a single allergic disorder, such as atopic dermatitis, eventually develop others, such as allergic rhinitis and allergic asthma called as the allergic march or atopic march. This process may be driven in part by a vicious circle in which allergic inflammation diminishes the function of the epithelial barrier. This increases the immune system's exposure to the original allergens and additional allergens, and hence, existing allergen specific IgE contributes to sensitization to new allergens
• Hence, a vicious cycle is set up and thus, the importance of elucidating the history of recurrence of symptoms after the exposure to a specific environmental condition underlies the fact that one or more allergen(s) predominate in a particular type of environment, and hence, its knowledge helps a physician in narrowing down the possibility of a particular type of allergen which is followed by appropriate testing and adequate treatment of a patient who is suspected to be suffering from repeated allergen exposure
• Food allergy is defined as an adverse immunological reaction that occurs on exposure to a food that re-occurs on repeat exposures. Food allergies and asthma are increasing in children worldwide. Egg, milk, peanut, soy, fish, shellfish, and tree nuts are the most common food allergens. The most frequently observed clinical manifestations of IgE-mediated food allergies are cutaneous and gastrointestinal symptoms. Foods can also induce a wide spectrum of respiratory symptoms that can range from rhinorrhea to life-threatening anaphylaxis with severe respiratory compromise. Other respiratory symptoms induced by food include sneezing, nasal congestion, throat swelling, coughing, shortness of breath, and wheezing. These symptoms are significantly more likely to occur in patients with underlying asthma
• Atopy is defined as a personal or familial propensity to produce IgE antibodies and sensitization in response to environmental triggers. It is used to describe asthma and allergic rhinitis. Ten years later, atopic dermatitis was added as part of the definition, giving rise to the atopic triad. Atopic dermatitis is a highly pruritic chronic inflammatory skin disease that may manifest predominantly during early infancy but may also present during childhood or adulthood. Atopic diseases, including allergic rhinitis, atopic dermatitis and asthma have increased in frequency in recent decades and now affect approximately 20% of the population worldwide. Atopic dermatitis is a prerequisite for the development of allergic rhinitis and asthma and specific sensitization. Whether atopic dermatitis in the atopic march is necessary for the progression to other atopic disorders remains to be defined. It also is important to identify infants at risk for developing life-long chronic atopic diseases and utilize the critical window of opportunity early in life for therapeutic intervention
• Medical history in respiratory allergic diseases: the physician needs a thorough medical history to make an accurate diagnosis of respiratory allergy. Following questions are needed to be asked:



• Is there any family history of allergies or asthma?
• Is there personal history of any allergic conditions?
• Under what circumstances do these symptoms occur?
• If medications have been prescribed previously, what has been the response to each of them?
• Were there any relevant complications at birth, such as respiratory distress?
• Does the patient have any other medical problems, such as gastrointestinal disorders, skin problems, joint problems, or infectious diseases?



• Asthma is seen in nearly 35% to 40% of patients with treatment history of eczema and/or atopic dermatitis. Hence, history of skin allergy in childhood is important for the diagnosis of respiratory allergy
• History of treatment with aspirin, NSAIDS, ACE inhibitors, beta-blockers and antibiotics play major role in some individuals for making the diagnosis of respiratory allergy.

B: Allergens in Respiratory Allergy

Table 4: Risk factors tor pollen allergy Click here to view

Table 5: Pollen prevalence at various places of India Click here to view

1. Allergic rhinitis and asthma are most common pollen associated allergic respiratory diseases
2. Pollen sensitization varies across different parts in India because of varied geo-climatic conditions
3. We recommend that asthma and allergic rhinitis patients in India should be tested for pollen sensitization as per relevant pollen distribution in various areas.(1A).

From Eastern India

From Western India

From Northern India

From Central India

From Southern India

1. Pollen calendar is important in respiratory allergic diseases, for taking personal preventive measure and for diagnostic and therapeutic considerations
2. Pollen calander also helps public health officials assess exposure, develop early warning systems.

1. Increase in pollen count is associated with an increased risk of allergic and asthmatic symptoms
2. A rise in asthma related admissions may be seen during peak pollen season
3. A rise in pollen count is associated with rise in allergic symptoms and emergency department visits.(2A)

Table 6: Risk factors for house dust mites Click here to view

• Allergic rhinitis and asthma are most common HDM associated allergic respiratory diseases
• HDM sensitization on SPT in India varies from 11% to 88%
• The dominant genuses found in India are Dermatophagoides spp.
• We recommend that patients with asthma and allergic rhinitis in India should be tested for HDM sensitization. (1A)

Table 7: Fungal species in different part of India Click here to view

Table 8: Skin prick test-based fungal allergen prevalence in different parts of India Click here to view

1. Most common mold associated allergic respiratory diseases are allergic rhinitis and asthma.
2. Aspergillus, Penicillium and Cladosporium are the most common indoor fungal allergens.
3. The common fungal allergens to which sensitivity was elicited included Aspergillus fumigatus, A. flavus, A. niger, A. tamari, Altenaria, Rhizopus, Cladosporium, Curvularia, Fusarium, Helminthosporium, Mucor, Epicoccum and Trichoderma.
4. We recommend that patients with asthma and allergic rhinitis in India should be tested for fungal sensitization.(1A)

Table 9: Risk factors for insect allergy Click here to view

1. Naso-bronchial allergy and asthma are the most common allergic respiratory diseases associated with the insects
2. Prevalence of insect allergy is variable across India ranging from 6% to 64%
3. Moth, cockroach, housefly and mosquito are most common among insect allergens in India
4. We recommend that asthma and allergic rhinitis patients in India should be tested for insect sensitization.(1A)

1. Dander allergen sensitivity is commonly seen due to cat, cow and dog dander
2. Increasing evidence suggests that allergic reactions to foods can occur following inhalation
3. Occupational allergens responsible for respiratory allergy mainly include biocides, latex, flour, animals and metals
4. We recommend that the asthma and allergic rhinitis patients with relevant exposure history may be tested for dander and occupational allergen sensitization. (1A)

1. Seasonality.^[700] Seasonal allergens are pollens and outdoor molds whereas perennial are animal dander, cockroaches, dust mites and indoor molds
2. Environment. Indoor environmental factors, such as presence of cockroaches, water damage, visible mold, dampness on the walls and passive smoking were independently associated with asthma in school children.^[702],[703] Cockroach-produced allergens have been identified as a major cause of childhood asthma in the home environment.^[182],[704] HDM is another important allergen^[373],[705]
3. Pet or insect exposure. The timing of the exposure to pets appears critical, with pre-natal or infancy exposure more consistently inversely associated and later exposure sometimes positively associated with allergic outcomes.^[706] Numerous studies have reported that pre-natal or early life exposures to mammals, including pets and livestock, are inversely associated with pediatric allergy
4. Familial atopy. Patients of asthma and/or rhinitis has a positive family history of atopy.^{[702],[707],[708],[709]}

1. Mode of delivery. Birth by cesarean section may increase the risk of allergic disease.^{[706],[710],[711],[712],[713],[714]} However, few studies do not support the above hypothesis^{[715],[716],[717]}
2. Maternal smoking. There was significant relationship between foetal exposure to tobacco smoke via maternal passive smoking and asthma and allergic rhinitis.^{[702],[718],[719],[720],[721]}

1. Clinical history along with the knowledge about regional allergens combined with clinical correlation can help in formulating allergen panel for individual patient
2. Additional factors like exposure to foods and school environment should be considered in clinical history while choosing allergen for pediatric age group
3. Indian studies suggest HDM to be the common allergens in children

Allergens in Respiratory Allergy: A Glance

• Pollen grains are amongst the important known allergens. A variety of host and environmental factors are implicated in the development of pollen allergy. Host factors include history of atopy, gender, ethnicity, smoking, respiratory infection and lung function. Environmental factors include meteorological factors, season, year to year variability, air pollution, rural and urban, regional variability and diurnal variation. Wide spectrum of pollen species are prevalent in various parts of India.
• Pollen calendars, defined as graphs narrating the annual dynamics of major airborne pollen types in a given location. Pollen calendars are commonly used to depict seasonal distribution of pollen in the atmosphere. Pollen calendars can be useful in a variety of ways which includes for clinical warning, to document seasonal characteristics, prevention of allergy symptoms, to predict pollen timing, to guide officials, to tour guides and to guide forensic investigators.
• Increase in pollen count is associated with an increased risk of allergic and asthmatic symptoms. A rise in asthma related admissions and emergency department visits may be seen during peak pollen season.
• HDM constitute an important source of indoor allergens. The dominant genus found in India were Dermatophagoides spp, followed by Blomia spp Risk factors for HDM include dose, source, seasonal variation, temperature, humidity, cross reactivity, high altitude, house types, air pollution, helminths, protective allele and probiotics.
• Moulds are found in all parts of India because of the favourable climatic conditions permitting their growth. The most common genera in India inducing allergy are Aspergillus spp, Alternaria spp, Cladosporium spp and Penicillium spp and epicoccum. Fungal allergens are known to cause hypersensitivity and are associated with conditions like bronchial asthma, allergic rhinitis, allergic bronchopulmonary mycoses, hypersensitivity pneumonitis, and atopic dermatitis.
• Insect inhalant allergens are found indoors, outdoors, homes, and at the work-places. All insect matters like wings, scales, saliva, dried faecal matter, and venom can cause allergic diseases, such as rhinitis, conjunctivitis, asthma, urticaria and gastric disorders. Cockroach exposure is associated with increased asthma morbidity. Moth, cockroach, housefly and mosquito are common among insect allergens in India.
• Animal products are one of the important groups of inhalant allergens which are present in indoor and outdoor environments. Young age, positive family history of allergic disorders, associated allergic disorders are the factors responsible for increased sensitization to animal allergens. Dander allergen sensitivity is commonly seen due to cat, cow and dog.
• Exposure to food allergens through inhalation can also cause food hypersensitivity reactions. Exposure to chemicals can cause exacerbation of respiratory diseases. Approximately 9% to 25% of all adult-onset asthma cases occur due to occupational exposures. Occupational allergens responsible for respiratory allergy mainly include biocides, latex, flour, animals and metals.
• The most important diagnostic test for screening of allergic diseases in adults and pediatric age group is the clinical history. Important points to be considered in history include seasonality, environment, pet or insect exposure, familial atopy, etc. Mode of delivery and maternal smoking needs to consider in paediatric population. A common standardized allergen battery is recommended for clinical use and research across Europe.

C: Diagnostic Testing (In Vivo and In Vitro)

1. Skin prick test
2. Intradermal test
3. Patch test
4. Allergen provocation test

1. Suspected respiratory allergies with negative SPT
2. Venom allergy
3. Drug allergy

1. Diffuse dermatologic conditions, like eczema, urticaria and dermographism (absence of normal skin)
2. Un-cooperative patient
3. When antihistamines or other medications interfering with the test could not be stopped.

1. Unstable bronchial asthma
2. During pregnancy
3. Infants or young children.

1. Nasal allergen provocation test
2. Bronchial allergen provocation test
3. Conjunctival allergen provocation test and
4. Food allergen provocation test

1. immediate response (10–20 min),
2. late response (after 6–8 hours),
3. dual immediate and late response, and
4. delayed response (beginning 24–32 hours, maximum at 32–36 hours, and resolving within 56 hours)

• Skin prick test
• Intradermal test
• Patch test
• Allergen provocation tests – These are of following types



1. Nasal allergen provocation test
2. Bronchial allergen provocation test
3. Conjunctival allergen provocation test
4. Food allergen provocation test

1. Serum IgE assays



1. Serum total IgE
2. Serum specific IgE



2. Cell-based assays – Basophil activation test (BAT)

1. Serum IgE assays



1. Serum total IgE
2. Serum specific IgE



1. Single-plex
2. Multi-plex



2. Cell based assay–Basophil activation test

• Skin tests, especially SPT, are the simple, convenient, reliable, cost-effective, biologically significant, reproducible and time-effective and sensitive tool for the diagnosis and management of IgE-mediated diseases
• In vivo assessment offers quick results (within 10 minutes)
• SPT can be performed with virtually any allergen^[728] and is considered as the gold standarad test.

• Technical errors that can interfere with SPT results are



1. Difficulty in reading overlapping results when tests are applied too close (<2 cm),
2. Bleeding at test site resulting in misreading it as false positive result
3. Insufficient skin penetration resulting in false negative results.



• SPT is difficult to perform in children
• Certain drugs, like anti-histamines can interfere with the results, so need to be stopped before SPT.^{[698],[728],[732]}
• Serious adverse reactions, like anaphylaxis (although rare) have been reported so, it should be conducted under proper medical supervision.
• A positive SPT does not always mean allergic disease.^[728]
• The results of skin test can differ with



1. season (more sensitive in October for seasonal allergens and in February for perennial allergens),
2. the site of application (back is more sensitive than the arm),
3. the instrument used for pricking
4. extract source (standardized versus unstandardized)
5. time of day when it is done (more sensitive in morning than evening).
6. age.^{[700],[753],[754],[755]}



7. In addition, there is a risk of cross-reactivity, especially with crude antigens.
8. The results are difficult to assess when applied on pigmented skin.^[728],[732]
9. Skin sensitivity is decreased in some conditions, like



10. renal failure,
11. malignancy,
12. diabetes,
13. spinal cord injuries
14. long-term steroid use, etc.^[701]

• Serum IgE assays can be performed by any trained laboratory technician. The results are not affected by the operator's experience.^[728]
• No risk of systemic reactions during test since the test does not require administration of potentially dangerous allergens to the patient.^[732]
• Modern sIgE results can be obtained within a couple of hours.^[732]
• These are not affected by anti-histamine drugs.^[732]
• Serum specific IgE detection offers quantitative detection of allergic disease as compared to SPT.^[701]

• The number of allergens which can be tested by in vitro tests is limited by the costs^[728],[732]
• In vitro assays done by chemiluminescence are more specific (especially, if low levels of specific IgE are present) than those done by ELISA or similar techniques
• The major drawback of sIgE assessment is the occurrence of false positive results with high total IgE levels (>300 kIU/L) due to non-specific binding to test allergens^[701]
• IgE tests are not significant at all for diagnosing various drug allergies
• Clinical detection of IgE is limited to free serum/plasma IgE (t1/2=2-3 days) which ignores the large contribution of cell-bound IgE (t1/2=several weeks).^[746]

Table 10: Studies reviwed for sensitivity and specificity of skin prick test Click here to view

Table 11: Studies reviewed for sensitivity and specificity of intradermal test Click here to view

Table 12: Studies reviewed for sensitivity and specificity of specific immunoglobulin E Click here to view

1. SPT in collaboration with clinical history is the most accurate diagnostic test for the diagnosis of respiratory allergy
2. Intradermal test has higher sensitivity, but its diagnostic accuracy is limited
3. In vitro test, i. e serum sIgE is both less sensitive and less specific compared to SPT for the diagnosis of respiratory allergy.

• Using desired skin test device, perform skin testing with positive (histamine 1–10) and negative controls (saline 1–10) in an alternate pattern on a subject's back
• Record both histamine and saline results at 15 minutes by outlining wheals with a felt tip pen and transferring results with transparent tape to a blank sheet of paper
• Calculate the mean diameter as (D + d)/2; where 'D'-largest diameter and 'd'-orthogonal or perpendicular diameter at the largest width of D.

• Calculate the mean (±SD) of each mean wheal diameter
• Determine CV = SD/mean
• Quality standard should be a CV value of less than 30%

• All negative controls should be 3mm wheals and 10 mm flares.

1. An allergy specialist/physician or pediatrician formally trained in allergy testing should perform in-vivo allergy testing(3A)
2. A nurse/technician trained in allergy testing can also perform in vivo allergy testing under the supervision of an experienced allergy physician (3A)
3. An experienced physician well versed in the management of anaphylactic reactions along with all the necessary requirements for the same should be present, whenever in-vivo allergy testing is being performed.(UPP, A)

1. SPT should not be performed during acute phase of the disease/uncontrolled asthma (3A)
2. SPT should be done after at least a gap of 3–4 weeks from systemic allergic reactions. (3A)

• Diagnose type I hypersensitivity reaction mediated allergic disease. It has been used for diagnosing sensitization to different proteins.^[805] SPT is the most common test used by an allergist for the diagnosing allergic rhinitis/conjunctivitis, food allergy, atopic dermatitis/eczema, asthma.^[758],[806] However, the role of SPT in diagnosing food allergy is still not well established, since it has both IgE and non-IgE mediated responses and also SPT has low specificity (40%–80%) in diagnosing food allergy. Oral food challenge test and component resolved diagnosis (CRD) have a promising role in diagnosing food allergy^{[698],[807],[808]}
• Identify common aeroallergens in a given region
• Measuring the sensitivity and specificity of various other diagnostic tests for allergic diseases. Allergy skin testing using the prick/puncture method is considered to be one of the best combinations of sensitivity and specificity.^{[758],[809],[810]} In most of the studies, SPT is used as the reference standarad test to identify the sensitivity and specificity of various in vitro tests, especially serum sIgE^[760],[761]
• Various guidelines/studies also suggest that SPT should be used for diagnosing type I hypersensitivity reactions caused by food allergens, aero-allergens, or certain chemicals and drugs, as a reference standard for determining the specificity of various in vitro allergy diagnostic tests and also as in epidemiologic studies to determine trends or regional differences of various allergens.^{[701],[713],[730]}

1. For the diagnosis of respiratory allergy by inhalant allergens (1A), food allergens (3B) and drugs (2A)
2. As reference standard for in vitro tests for the diagnosis of respiratory allergy (1A)
3. For determining bio-equivalent potency of allergen extracts (1A)

Table 13: Studies reviewed for contraindication of skin prick test Click here to view

1. Pregnancy and lactation (3A)
2. Dermatographism (2A)
3. Absence of normal skin (1A)
4. Un-cooperative patient (UPP, B)
5. Patients who are taking drugs which may hinder the action of epinephrine (if needed for the anaphylaxis), e. g., beta-blockers and ACE-inhibtors.(1A)
6. Patients who are taking medications (which interfere with test results) those can not be stopped before the test, e. g., antihistamines, tri-cyclic anti-depressants and steroids(3A)
7. Relative contraindication: Young children: it should not be performed in young children and when needed, should be performed under the supervision of a pediatrician trained in allergy.(3B)

Table 14: Studies reviewed to identify the lower limit of age for performing skin prick test Click here to view

1. There are increased chances of developing atopic dermatitis (upto one year of age) and other complications^{[823],[824],[834]}
2. Skin in children is hyporeactive to histamine (positive control), especially in those aged less than 6 months.^[822] Size of the wheal produced in children is small, and hence, difficult to interpret
3. Un-cooperative behaviour of the children (of age <5 years) is common.

1. SPT should preferably be done in children >5 years of age (2A)
2. With the strong clinical indications, SPT may be done in children <5 years under the supervision of a pediatrician trained in allergy testing. (3B)

Table 15: Studies reviewed to determine the maximum number of allergens that can be tested at one time during skin prick test Click here to view

Table 16: Studies reviewed to determine the maximum number of allergen that can be tested at one time during skin prick test in paediatric age groups Click here to view

1. The maximum permissible number of allergens that can be used for SPT in one sitting in adults could be upto 60.(2A)
2. In paediatric age group, maximum number of permissible allergens that can be tested in one sitting should be less than 12.(2A)
3. However, a minimum number of allergens on an individualized basis – as per the clinical history, age, prevalence of aero-allergens, exposure factors and pollen calendar – should be used for SPT.(2A)

• The testing procedure and the risk of complications should be explained to the patient before hand. Informed written consent should also be obtained for the same^[732] [Annexure I]
• Patient should be appropriately screened for the status of asthma and the presence of other contraindications to SPT as discussed in question number 9. The test should be deferred if any contraindication to SPT is present
• The patient should have a light breakfast at least 2 hours before the test
• Someone should accompany the patient to help in case if the patient develops any adverse reaction, like anaphylaxis
• In case of male patients with hairy arms, it is required to shave the arms at least 48 hours before the procedure
• Certain medications which may interfere with the test results should be stopped for a particular period of time.^{[820],[821],[844]} These medications include:



• short-term and long-term anti-histamines
• oral corticosteroids
• tri-cyclic anti-depressants and other anti-depressants with anti-histamine activity
• topical steroid ointments may interfere with the test results.

Table 17: Proposed withholding period of various drugs before skin prick test Click here to view

Table 18: Withholding period of various drugs before skin prick test as per various studies Click here to view

1. The testing procedure and the risk of complications should be explained to the patient before-hand. Informed written consent should also be obtained for the same [Consent proforma given in the detailed guidelines; Annexure I]
2. The test should be deferred if any contraindication to SPT is present
3. The patient should have a light breakfast atleast 2 hours before the test
4. Someone should accompany the patient to help in case if the patient develops any adverse reaction, like anaphylaxis.
5. In case of male patients with hairy arms, it is required to shave the arms atleast 48 hours before the procedure
6. The medications which may interfere with the SPT results and the duration for which these drugs should be withheld before performing the SPT is given in [Table 17].

1. either, the patient is taking anti-histamine or drugs with anti-histamine activity, or,
2. patient's skin is non-reactive.

Table 19: Studies reviewed to determine commonly used positive and negative control, site, device and testing time Click here to view

1. single point which includes stallergens prick lancet, ALK Spain SPT lancet and Stallerpoint
2. dual tip which includes ALK duotip
3. multi-point which includes ALK multi-test

1. Re-assure the patient and explain the test procedure.
2. Site. The test can be performed on volar aspect of the forearm, outer upper arm and back. The reactions produced on back are more than those produced on forearm.^[851] The allergen should be applied at a site 5 cm from the wrist and 3 cm from ante-cubital fossa.^[29] However, the most commonly used site is volar surface of forearm^[852]
3. Clean the skin site with alcohol prior to SPT
4. Mark the positions (where allergen has to be applied) with a pen. The allergens should be applied 2cm apart to avoid overlapping and false positive results
5. Apply the drop of allergen on skin with dropper without touching the dropper tip with the skin
6. A sharp instrument (lancet) is passed through the drop at an angle of 45-60° or alternatively at 90° upto a depth of 0.9mm to 1 mm.^[853] Multiple prick devices are not preferred now-a-days, since these are more uncomfortable and produce larger wheal, thus interfering with the results [Figure 4]^[854]
7. The test is usually read after 15–20 minutes. This is because after 20 minutes the skin response to histamine and allergen may diminish
8. The drops must always be carefully blotted from each test site prior to taking measurements so as to avoid cross-contamination of allergen test sites with the blotting tissue or the ruler used to measure the results (Method of recording and interpretation of SPT have been discussed in Q15)
9. After the test, clean the test site with alcohol
10. Patient (particularly those with multiple positive results and history of anaphylaxis) should be observed for 20 minutes for any discomfort.^[855]

Figure 4: Technique of SPT Click here to view



(Note: there is no need to observe patients with negative or mild to moderate response to SPT allergens and with no history of asthma). This is because:


• Itching subsides within 15 minutes after the test, but in case if it persists, topical creams such as urex, steroid-based creams^[856] or ice-packs may be tried. Some people prefer to use antihistamines after testing to avoid discomfort. But the evidence in support of these measures is lacking
• Patients with high positive SPT and those with previous history of anaphylaxis may develop late phase reaction and anaphylaxis, they need to be kept under observation after the test.

• A standardized approach for reading of SPT is lacking. Some authors prefer to immediately blot the allergen after SPT to minimize the risk of adverse reaction while the others leave the allergen for 20 minutes.^[857] However, keeping in view of minimal risk of adverse reactions with SPT, it is recommended that allergen be left at the test site for 20 minutes before blotting
• Histamine control should be read after 15 minutes of application (the peak time of reactivity)
• Allergen prick test should be read after 15-20 minutes (the peak time of allergen reaction)
• The outcome of the SPT can result in a variety of wheal shapes.^[858] It is implicitly assumed that the wheal may be described reasonably well by an ellipse or circle, which is not always the case in practice and this method is prone to errors^[859]
• The various methods used for reading of SPT include:^{[837],[839],[860]}
• mean wheal diameter, i. e mean value of the longest (D) and the mid-point orthogonal diameter (d) of the wheal (D+d/2)
• allergen induced wheal area
• HEP (histamine equivalent prick) index diameter, i. e allergen-induced average, diameter divided by histamine-induced average diameter, and
• HEP-index area (allergen-induced area divided by the histamine-induced average area).

Table 20: Grading for the skin prick test[796] Click here to view

Figure 5: Measurement of mean wheal diameter Click here to view

• better reproducibility,^[858]
• studies have indicated that for many allergens, a wheal size (lower cut-off) set at a larger size than 3mm of negative control would correlate better with clinical allergen reactivity,^[865],[866]
• since trauma may affect wheal size an allergen response less than 3 mm generally should not be Regarded as positive.^{[560],[866],[867]}

Table 21: Studies reviewed to determine commonly employed to interpret skin prick test Click here to view

Table 22: Studies reviewed to identify the most commonly performed method to interpret skin prick test Click here to view

• Use of ceratin drugs, like anti-histamines, long-term steroids or tri-cyclic anti-depressants may interfere with the test results, thus giving false negative response
• Age. Skin reactivity increases with age initially in the first decade and then declines. Wheal produced in children <2 years is smaller. Maximum skin reactivity is seen from puberty to 50 years
• Skin pigmentation. The test is difficult to interpret in dark skin. Although, the accuracy of interpretation in dark skin increases with the increase in the size of wheal so produced
• Short-term exposure to ultra-violet B radiation. It reduces wheal and flare intensity by as much as 50%^[869]
• Other factors, like inter-observer variation, faulty technique, type of device used for pricking and depth of the prick may also interfere with the results
• Certain skin conditions, like dermographism, eczema may also interfere with testing results
• Some diseases, like malignancy, chronic renal failure, diabetes may reduce skin test response.
• Various physiological factors, like menstrual cycle, circadian rhythm can also interfere with the results. But evidence to prove the same is lacking.
• Seasonal variation in SPT response has also been seen; the response is highly positive in the respective allergic season.

1. Local skin swelling is seen rarely in patients due to late phase response of IgE. This swelling can be painful in a few cases. It is more common in IDT. It usually resolves within 36 hours
2. Localised wheal or flare.^[732]

1. Systemic reactions usually begin within 15 to 30 minutes^[813]
2. Few fatal reactions have been reported in the literature. Very few fatalities have been reported during allergy testing till date, out of which seven were during IDT and only one child died during SPT with 90 aeroallergens^[802],[831]
3. Prevalence of systemic reactions related to SPT with inhalant and food allergens is low but not absent. It was estimated to be less than 0.05%.^[870],[871] The prevalence of systemic reactions in young children appears to be high with a reported rate of 0.12%^[7] and 6.5% in infants <6 months.

• Infants especially <6 months^[824]
• Past history of anaphylaxis to food
• Multiple allergens^[861]
• Testing with non-commercial food and latex extracts
• Extensive eczema
• Uncontrolled asthma.

1. Anaphylaxis. Accidental systemic introduction of allergen can cause generalized urticaria, angioedema including airway angioedema, bronchospasm, and hypotension. The rate of systemic allergic reaction is 0.04%.^[870]
2. Vasovagal syncope. It is important to differentiate between vasovagal syncope and anaphylaxis during SPT, since the management of the two conditions differs [Table 23].^[872]

Table 23: Difference between vasovagal reaction and anaphylaxis Click here to view

1. Risk of transmission of infection. This has never been documented, although theoretically possible
2. Headache
3. Malaise.

• Sensitization only to uncommon allergens
• Parasitic infestations
• Smoking
• HIV, Epstein-Barr Virus infection
• Multiple myeloma patients producingIgE
• Primary immunodeficiencies.



• Immune dysregulation polyendo-crinopathy enteropathy X-linked syndrome (IPEX)
• Omenn syndrome
• Wiskott-Aldrich syndrome
• Comel-Netherton syndrome
• Hyper-IgE syndrome
• Atypical complete Di-George syndrome.

Table 24: Charecteristics of various Indian studies reviwed to identify the relevance of immunoglobulin E for diagnosis of respiratoy allergy Click here to view

Table 25: Characteristics of various non-Indian studies reviewed to identify the relevance of immunoglobulin E for diagnosis of respiratoy allergy Click here to view

1. Sensitivity and specificity of serum total IgE is very low for diagnosing respiratory allergy and it should not be considered as a reliable marker of allergy status (2A)
2. Serum total IgE is one of the reliable markers for following disease severity and therapeutic response in allergic bronchopulmonary aspergillosis (1A)
3. Serum total IgE values have significance in omalizumab therapy. (1A)

1. In cases with inconclusive SPTs and high suspicion of allergy based on the history
2. Inability to temporarily discontinue skin test suppressive medication therapy (e. g., antihistaminics, antidepressants or beta-blockers)
3. Presence of extensive skin disease (e. g., dermatographism or generalizedeczema)
4. Un-cooperative patient
5. Clinical history suggestive of high risk of anaphylaxis from skin testing

1. Clinical Indications



1. Diagnosis of



1. Persistent allergic rhinitis^[724],[916]
2. Intermittent allergic rhinitis^[916],[917]
3. Local allergic rhinitis^{[918],[919],[920],[921]}
4. Occupational rhinitis^{[922],[923],[924],[925]}



2. Establishing correlation with extra-nasal symptoms with allergic rhinitis (including conjunctiva, middle ear, and sinus).^{[926],[927],[928],[929],[930]}
3. Designing allergen composition and monitoring the clinical efficacy of immunotherapy for patients with allergic rhinitis.^{[724],[931],[932],[933]}
4. Determining clinical relevance of a specific allergen in patients of allergic rhinitis with multiple positive allergy skin tests.^[934]
5. When there is discrepancy between history and SPT or sIgE result for the diagnosis of allergic rhinitis.^[724]
6. To confirm nasal reactivity before starting local nasal immunotherapy.^[935]



2. Scientific Investigations



1. To study immediate and late phase responses induced by specific allergen.^{[936],[937],[938]}
2. Correlating cellular morphological response to specific inhaled allergen using nasal lavage, biopsy, and brushing^[939],[940]
3. Detecting chemical mediators, markers of glandular exocytosis, and vascular permeability in nasal lavage following allergen provocation^[941]
4. To examine the therapeutic effects of drugs (anti-histamines, corticosteroids, cromoglycate, anti-cholinergic medications, and vasoconstrictors) on acute, late phase, non-specific, and other aspects of airway diseases^[942],[943]

1. Nasal allergen provocation test (NAPT) is of limited clinical value and is mainly indicated for research purposes.(2A)^[796],[945]
2. Under the current conditions in India, NAPT is advised in tertiary care centres only, keeping in view the possibility of anaphylactic reaction.^[946] (2A)
3. Unavailability of standardised allergens specific to Indian conditions further limits the utility of this test.

Table 26: Compilation of various studies using fractional exhaled nitric oxide with different senstivity and specificity for the diagnosis of asthma Click here to view

Table 27: Diagnostic cut-off values for diagnosis of asthma in different guidelines Click here to view

Adults

Children

1. FeNO is not necessary for making a diagnosis of allergic asthma. (1A)
2. High FeNO levels are suggestive of eosinophilic/allergic asthma. (2A)
3. In adults: FeNO >50 ppb and in children FeNO >35 ppb signifies eosinophilic inflammation and likelihood of corticosteroids responsiveness in symptomatic asthma patients. (2A)
4. FeNO may be an useful tool as follow up and assessment of treatment response in asthma. (3A)
5. Spirometry is an essential diagnostic modality for diagnosis and follow up of allergic asthma. (1A)

Diagnostic Testing for Respiratory Allergy: A Glance

• The in vivo tests for the diagnosis of respiratory allergic diseases are skin prick test, intradermal test, patch test and allergen provocation tests
• The various in vitro tests used for diagnosing respiratory allergy include serum IgE assays (serum total IgE and serum specific IgE) and cell-based assays (basophil activation test)
• SPT when combined with clinical history is the most accurate diagnostic test, and hence, is considered as the gold standard for the diagnosis of respiratory allergy
• IDT has higher sensitivity but limited diagnostic accuracy
• In vitro test, i. e serum specific IgE is both less sensitive and less specific compared to SPT
• SPT is indicated for the diagnosing of respiratory allergy (by inhalant allergens, food allergens and drugs), as reference standard for in vitro tests for the diagnosis of respiratory allergy and for determining bioequivalent potency of allergen extracts
• SPT should be performed by an allergy specialist/physician or pediatrician formally trained in allergy testing or by a trained nurse/technician under the supervision of an experienced physician, well versed in the management of anaphylactic reactions
• SPT should not be performed during acute phase of the disease/uncontrolled asthma. It should be done after at least a gap of 3-4 weeks from systemic allergic reactions
• SPT is contraindicated in pregnancy and lactation, dermatographism, in the absence of normal skin, un-cooperative patient, patients on drugs that hinder the action of epinephrine (e. g, beta-blockers and ACE-inhibtors) or drugs which might interfere with test results (like, anti-histamines, TCA and steroids) and in young children <5 years (relative contra-indication)
• SPT should preferably be done in children >5 years of age and if strongly indicated, it can be performed in <5 years children, under the supervision of a paediatrician trained in allergy testing
• A minimum number of allergens on the individualized basis – as per the clinical history, age, prevalence of aeroallergens, exposure factors and pollen calendar – should be used for SPT. The maximum permissible number of allergens that can be used for SPT in one sitting in adults is <60 and <12 in the pediatric age group
• Certain medications like short-term and long-term antihistamines, oral corticosteroids, tri-cyclic anti-depressants and other anti-depressants with anti-histamine activity, topical steroid ointments may interfere with the SPT results and should be stopped 1-2 weeks prior to the test
• The technique of performing SPT is explained in [Figure 4]:
• Lancet with a point length of 1.0 mm is the preferred device. 10 mg/mL of histamine solution and glycerinated saline buffer are the commonly used positive control and negative controls, respectively.
• A mean wheal diameter of >3 mm more than simultaneously performed diluent control (i. e., negative control) is taken as positive response to an allergen on SPT
• The various complications of SPT include local swelling, anaphylaxis, vasovagal syncope, headache, malaise etc.
• The indications of IDT include negative SPT in patients with strong suspicion for allergy to specific allergens or in cases of venom allergy and drug allergy
• Sensitivity and specificity of serum total IgE is very low for diagnosing respiratory allergy and it should not be considered as a reliable marker of allergy status
• Serum specific IgE is indicated in cases with inconclusive SPT and high clinical suspicion of allergy, inability to temporarily discontinue skin test suppressive medication therapy, presence of extensive skin disease (e. g., dermatographism or generalized eczema), un-cooperative patient, or patients at high risk of developing anaphylaxis during SPT.
• Nasal allergen provocation test is of limited clinical value due to high risk of anaphylaxis and unavailability of standardized allergens. It is mainly indicated for research purposes. Under the current conditions in India, NAPT is advised in tertiary care centres only. Unavailability of standardised allergens specific to Indian conditions further limits the utility of this test
• FeNO is not necessary for making a diagnosis of allergic asthma but it can serve as a useful tool for follow up and assessment of treatment response in asthma. High FeNO levels are suggestive of eosinophilic/allergic asthma
• In vitro test, i. e. serum specific IgE, is both less sensitive and less specific compared to SPT for the diagnosis of respiratory allergy. The indications for testing are inconclusive SPT and high suspicion of allergy based on the history, inability to temporarily discontinue skin test suppressive medication therapy, presence of extensive skin disease (e. g., dermatographism or generalized eczema), uncooperative patient and clinical history suggestive of high risk of anaphylaxis from skin testing
• Serum IgE levels usually higher in atopic disorders. Sensitivity and specificity of serum total IgE is very low for diagnosing respiratory allergy and it should not be considered as a reliable marker of allergy status. Serum total IgE is one of the reliable markers for following disease severity and therapeutic response in allergic bronchopulmonary aspergillosis. Also, serum total IgE values have significance in omalizumab therapy
• Spirometry is an essential diagnostic modality for diagnosis and follow up of allergic asthma.

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