Accuracy of Nasal House Dust Mite-Specific Immunoglobulin E in Diagnosis of Local Allergic Rhinitis

 

Elsa Rosalina¹*, Dwi Reno Pawarti¹, Irwan Kristyono¹, Baharudin Abdullah²

¹Department of Otorhinolaryngology - Head and Neck Surgery, Faculty of Medicine, Universitas Airlangga - Dr. Soetomo General Academic Hospital, Mayjen Prof. Dr. Moestopo street No 6-8 Surabaya, Indonesia.

²Department of Otorhinolaryngology - Head and Neck Surgery, School of Medical Sciences,

Universiti Sains Malaysia, Kubang Kerian, Kelantan, Malaysia.

 

ABSTRACT:

Background: Local allergic rhinitis (LAR) is the symptom of allergic rhinitis in which nasal allergen-specific immunoglobulin E(IgE) is detected but has no sensitivity to systemic allergens. The gold standard test is the nasal allergen provocation test (NAPT) which requires a complicated procedure. Specific IgE in nasal mucosa test is the less invasive and easier diagnostic alternative for LAR. Aims: This review aimed to determine the validity of the nasal house dust mite - specific IgE test for LAR patients. Study designs: A meta-analysis was conducted in chronic rhinitis patients with negative skin prick test (SPT) and serum IgE. Methods: The research was using PubMed Central, Cochrane library, SAGE journals, and Science Direct were searched until July 29th, 2022. The validity of the nasal HDM - specific IgE test was compared to NAPT. Results: A total of 413 research articles were selected and five articles were included. The QUADAS-2 assessment showed minimum publication bias. The total sample was 236 patients. Pooled sensitivity 90.00%, I2= 28.95% and p=0.01. Pooled specificity 96.00%, I2= 30.28% and p=0.00. The value of the area under the curve in the SROC curve = 0.9710, statistically significant. Conclusion: The nasal HDM- specific IgE test is valid for diagnosing patients with LAR.

 

 

 

INTRODUCTION: 

Local allergic rhinitis poses a diagnostic challenge in the management of patients suffering from nasal symptoms triggered by natural exposure to aeroallergens. Local allergic rhinitis is a rhinitis phenotype with symptoms similar to AR. It is characterized by localized nasal symptoms and local production of allergen-specific IgE antibodies during exposure to aeroallergens without systemic atopy.^1–3 Patients with LAR have frequently been misdiagnosed as non-allergic rhinitis (NAR) or idiopathic rhinitis. Misdiagnosis can lead to inefficient approaches and treatment errors. Unfortunately, research on LAR and its mechanism and treatment is still lacking.⁴

 

The prevalence of LAR thus far is ambivalent. Rondon et al. reported LAR was found in 25.7% of 428 adults’ patients diagnosed with chronic rhinitis (CR).⁵ In China and Korea, LAR has been reported prevalence estimation of LAR as 7-19% and 9-10%, respectively.^6,7 Studies in Thailand reported a prevalence of 3.7% among children and 24.2% among adult patients.^8,9 The main allergen is house dust mite (HDM), followed by grass and tree pollens, weeds, and animal danders.¹⁰ The HDM especially Der p have great importance in the induction of LAR among various age groups.⁴

 

The nasal allergen provocation test is known as the gold standard method for diagnosing LAR, however, this examination requires a complex and very time-consuming process.^11,12 As an alternative, nasal-specific IgE which is less invasive and easier than NAPT can be used for diagnosing LAR. Despite the availability and the use of those diagnostic methods, LAR remains a subject of intense debate due to a lack of understanding of LAR pathophysiological mechanism and insufficient LAR studies leading to misdiagnosis and less optimal management.^13–15

 

A nasal HDM-specific IgE test is an examination to measure nasal IgE levels specific to HDM (Der p and/or Der f). This examination can be done with a swab of the nasal mucosa, nasal secretion, or a rinse on the nose and measured using a fluoroenzyme immunosorbent assay.^4,16–18 Another way to get nasal secretion can be done by using a sinus sponge pack in each nostril for about 5 minutes. The nasal HDM-specific IgE result is said to be positive if the limit value is ≥ 0.1 IU/ml.^19–21

 

The NAPT is an examination used to elicit a local allergic response of the nose after being exposed to an allergen using a metered spray containing the allergen extract Der p and/or Der f. Positive NAPT results are determined by subjective assessment based on visual analog scale (VAS) or objective measurements based on acoustic rhinometry and active anterior rhinomanometry.^22–24

 

The aim of this review was to determine the accuracy of nasal HDM-specific IgE in the diagnosis of LAR patients.

 

MATERIAL AND METHODS:

A systematic review and meta-analysis of the literature were conducted from July 13, 2022, to July 29, 2022, in accordance with a protocol published in PROSPERO with identification serial number CRD42022332594. Critical appraisal is assessed based on the 2018 Critical Appraisal Skill Program (CASP) for diagnostic research.²⁵ The methods and reporting were based on the preferred reporting items for systematic reviews and meta-analyses statements (PRISMA).²⁶

 

Eligibility Criteria:

The search was performed using the population, intervention, comparison, outcome, and study design (PICOS). The population in this study was chronic rhinitis-indicating LAR patients confirmed by negative SPT and serum IgE results at any age. The exclusion from population criteria were chronic rhinosinusitis and/or nasal polyposis or respiratory infections in the previous 4 weeks before sampling; use of antihistamines or other anti-allergic drugs within washout period; use of decongestants within 2 days; contraindications to adrenaline; and exacerbation of allergic and/or other diseases based on contraindications to performing NAPT procedure. The intervention in this study was the nasal HDM-specific IgE carried out by swabbing the nasal mucosa and taking nasal rinse fluid. The comparison of this study was the NAPT defined as a procedure where the response of the nasal mucosa was assessed by exposure to HDM allergens. The outcome of this study was the sensitivity and specificity of both investigations. All studies must have extractable outcomes data. The inclusion criteria were human studies of all diagnostic designs. There were no restrictions on study design; cross-sectional studies, case-control studies, and cohort studies were all included in this systematic review. Only full-text manuscripts published in English were included. Review articles, case reports, opinions, editorials, and perspectives were excluded.            

 

Information sources:

We systematically retrieved data from four electronic database searches comprising PubMed Central, Cochrane library, SAGE journals, and Science Direct using MeSH headings and text words. The subject headings included those related to population indicating LAR or NAR, index test (nasal HDM specific IgE), and the reference standard (NAPT). We organized the search terms using Boolean operators (AND, OR). The following key terms and search strategies were used: (local allergic rhinitis OR nonallergic rhinitis) AND (nasal IgE OR local IgE OR diagnostic) AND (provocation test OR challenge).

 

Study selection:

The search results were reviewed independently by two authors (ER and DRP) and selected according to eligibility criteria. Titles were screened by abstract review. Any uncertain abstracts were discussed between the reviewers. The eligibility of the full-text articles was assessed independently and the reasons for exclusion were documented. The articles included were cross-checked to maintain the integrity and avoid overlapping data. Any disagreements between the review authors were resolved by discussion.

 

Data collection:

An Excel standardized data sheet was used to extract the data from selected studies. Extraction of the data was done by one reviewer (ER) and checked by a second reviewer (DRP). We retrieved data by the study characteristics and the variables. The study characteristics recorded were: study information (first author, year of publication), sex, total sample, age, smoking status, family history of atopy, and the chronic rhinitis frequency of severity. The variables recorded were: study location, number of participants, study period, patient selection, nasal IgE sampling (nasal secretion/lavage/rinse or swab of the nasal mucosa), NAPT assessment (VAS score/acoustic rhinometry/ active anterior rhinomanometry). Outcomes were defined as the sensitivity and specificity of the index test (Nasal HDM-specific IgE) compared to the reference standard (NAPT). If the studies that meet eligibility criteria had missing or incomplete data, corresponding authors were contacted by email.

 

Data synthesis:

The descriptive data was presented in proportions and percentages. We report the results of the meta-analysis in a forest plot, a summary receiver operating characteristic curve with an area under curve assessment, and an assessment of the quality using the Quality Assessment of Diagnostic Accuracy Study 2 (QUADAS-2). The forest plot shows a summary of the data entered for each research article by showing the sensitivity and specificity of each article, pooled sensitivity, pooled specificity, size effect, 95% CI value, and statistical significance. Each study was calculated to retrieve the accuracy of the index test (Nasal HDM specific IgE) according to the reference standard (NAPT). Processing and analyzing data with the statistical application RevMan version 5.4 and Stata 17 using metadta command. This study has a significance level (α) of 0.05 or 5%. Heterogeneity (I²) was used to determine the discrepancy in each examination.

 

Quality assessments:

Author ER and DRP assessed the quality assessment for each study using methods adapted from the QUADAS-2. The assessment is based on 2 categories of questions, namely risk of bias and applicability concerns. The risk of bias consists of four domains: patient selection, index test, reference standard, and flow and timing. The applicability concerns consist of only three domains: patient selection, index test, and reference standard. We write the high bias values with a red symbol, unclear with a yellow symbol, and low bias values with a green symbol. Review Manager (RevMan) version 5.4 was used to assess the quality. If there was a disagreement between the two overall risks of bias assessments by the two initial assessors, IK as the third author was consulted.

 

RESULTS:

Study selection:

A systematic search identified a total of 413 articles through electronic database searches (PubMed Central, 184; Cochrane Library, 24; SAGE, 103; Science Direct, 102). We excluded 23 studies containing overlapping data or appearing in more than one database (duplicate articles). After screening the titles and abstracts, the following articles were excluded: 23 articles not available in full text, 15 articles in the form of abstracts, 224 articles not following PICOS, 3 articles in the form of systematic research studies, 13 articles in the form of case reports, 98 articles in the form of literature reviews, 5 articles in the form of editorials. One article was excluded for using operative material as a sample. The flow diagram for this study identification using PRISMA 2020 (shown in Fig. 1).Eight articles were assessed for eligibility using the CASP diagnostic study checklist where 5 articles met the criteria.^4,7,19,27,28

 

Fig. 1: Flow Diagram of studies identification using PRISMA 2020.

 

Characteristics of included studies:

The included studies consisted of five selected studies that are shown in table 1. Of the 5 included studies, all of them were published before 2020. The demographics of this study consists of various ethnicities, races, and locations. Three studies were from the European continent and two studies from the Asian continent. Half of the studies (2/5) used the ImmunoCAP system (Phadia AB, Uppsala, Sweden) for detecting nasal HDM-specific IgE, two studies used the UniCAP system (Uppsala, Sweden), and one study used the ALLERG-O-LIQ system (Fooke, Borken, Germany). All systems have different positive value cut-offs ranging from 0,1 kU/L to 0,35 kU/L. There were different systems used to perform NAPT in the studies. Two studies used Allergopharma (Reinbek, Germany), one study used the Allerkin test (Lofarma, Milano, Italy), one study used WOLWOPHARMA (Zhejiang, China), and one study did not mention the system used. All were original articles.^4,7,19,27,28

 

 

Table 1: Characteristics of included studies.

No	First author, year	Country	Number of participants	Study period	Patient selection	Nasal IgE sampling	NAPT assessment
1	Bozek et al, 2015	Poland	46	November 2013- January 2014	Chronic rhinitis more than 12 months	Nasal lavage	-VAS -acoustic rhinometry
2	Zicari et al, 2016	Italy	18	NR	Moderate-severe persistent non- allergic rhinitis with symptoms during the previous years	Nasal lavage	Active anterior rhinomanometry
3	Krajewska-Wojtys et al,2017	Poland	84	2015-2016	Moderate-severe persistent non- allergic rhinitis	Nasal lavage	-VAS -acoustic rhinometry
4	Tao et al,2018	China	15	March 2016- March 2017	LAR	Nasal secretion	-VAS -Active anterior rhinomanometry
5	Meng et al,2019	China	73	1st February 2017 – 31st August 2017	Chronic rhinitis	Nasal secretion	Active anterior rhinomanometry

 

All reviewer authors assessed the quality of five selected studies. Detection of possible bias in the five studies is described in the quality assessment based on QUADAS-2. For applicability concerns, the five included studies were matched to the review questions for three domains (patient’ selection, index test, and reference standard) and were 100% of low applicability concerns. For risk of bias, the studies were matched to the review questions for all domains (patient’ selection, index test, reference standard, and the flow and timing) were a 100% of low or unclear risk of bias. Most of the studies have low risks and low concerns on both groups of questions. Publication bias is minimal (shown in Fig. 2).

 

The total number of participants in the five studies was 236. Male consists of 116 participants (49.15%) and 120 participants were female (50.85%). The ratio between men and women is 1:1.03. The distribution of the included studies is shown in Table 2.

 

Fig. 2: Quality assessment for articles using QUADAS.

 

 

Table 2: Distribution of included studies.

No	First author, year	Sex (%)		Total sample (%) n= 236	Age (Mean)	Smoking status	Family history of atopy	Frequency of severity
		Male (n = 116)	Female (n = 120)
1	Bozek 2015	17 (7,20)	29 (12,29)	46 (19,49)	68.45	Current or former smoker 27	31	>12 months
2	Zicari 2016	9 (3,81)	9 (3,81)	18 (7,63)	8.33	NR	NR	Moderate-severe persistent rhinitis with symptoms during the previous years
3	Krajewska-Wojtys 2017	41 (17,37)	43 (18,22)	84 (35,59)	29.40	NR	33	Moderate-severe persistent non- allergic rhinitis
4	Tao 2018	7 (2,97)	8 (3,39)	15 (6,36)	34.00	0	8	Mild 3 patients Moderate-severe 12 patients
5	Meng 2019	42 (17,80)	31 (13,14)	73 (30,93)	38.00	NR	NR	NR

 

 

The sensitivity and specificity of the selected studies are shown in the forest plot (shown in Fig. 3). The highest sensitivity was 100% obtained in the study by Krajewska-Wojtys et al. and Tao et al., while the least was 57% in the study by Zicari et al.^4,7,19 The highest specificity was 100% found in the study by Bozek et al. and Krajewska-Wojtys et al., while the least was 85% in the study by Tao et al.^4,7,28

 

 

Fig. 3: Forest plotof five included studies. Sensitivity and specificity analysis of nasal HDM-specific IgE in LAR patients using Stata 17.

 

Pooled sensitivity and specificity were calculated using Stata 17. Pooled sensitivity of the five studies was 90.00% (95% CI 69.00 – 97.00%) with I2 of 28.95% and p=0.01 indicating low and significant heterogeneity. The pooled specificity of the five studies was 96.00% (95% CI 87.00 – 99.00%) with I2 of 30.28% and p=0.00 suggesting low and significant heterogeneity. The summary receiver operating characteristic curve shows the combined point estimate in the area under the curve (AUC). The AUC value in the five studies is 0.9710. This value indicates an 97.10% probability that the nasal HDM-specific IgE test is able to diagnose patients with LAR (shown in Fig. 4).

 

Fig. 4: Summary ROC plot of six included studies using Stata 17.

 

DISCUSSION:

In LAR, in which no systemic atopy but IgE is produced in the nasal mucosa, then the concept of entopy was proposed. In the absence of systemic involvement, patients with LAR often were managed as NAR or idiopathic rhinitis²⁹. The present review found five studies originating from the continents of Europe and Asia with the majority of LAR studies being from the European continent. LAR may affect patients from different ethnic groups and parts in the world, but the prevalence of LAR based on NAPT diagnosis is reported to be lower in countries in Asia compared to Europe, thought to be due to differences in genetic factors, climate, temperature, and other factors such as mucosal allergen levels and sample measurement technique³⁰.

 

Previous studies had shown that LAR is common in young adult women, but Tao, et al showed that the gender ratio was equal among Chinese patients^5,7. Bozek, et al showed that LAR can also be founded in older patients, and Zicari, et al have found LAR in children^19,28. The statement of LAR is common in young adult women is supported by the present review which found patients with LAR were mostly female, young, never or rarely smoked, had a family history of atopy or not, and presented with moderate or severe persistent rhinitis.

 

This study compares the nasal HDM-specific IgE test with NAPT which is the gold standard for diagnosing patients with LAR. Pooled sensitivity of 90.00% shows individuals who are sick from the entire population of 90.00%, this is a very good result (close to 100%). Pooled specificity of 96.00% indicates that individuals who are not sick from the entire population are 96.00%, this is a very good result (close to 100%).

 

A meta-analysis by Hamizan, et al showed that the nasal mucosa-specific IgE was detectable in patients with non-allergic rhinitis with a pooled estimate of 10.2% (95% CI 7.4-13.4)³¹. Their review included a wide range of non-allergic rhinitis patients and not only on LAR patients compared to the present review. Non-allergic rhinitis is different from LAR as such patients have nasal symptoms without any identifiable allergens as triggering factors which is usually the case in LAR. The high sensitivity and specificity of 90.00% and 96.00% respectively found in the current review suggest that the use of nasal-specific IgE is valid and reliable in the investigation of suspected patients with LAR, especially in the presence of a clear history of allergens as a triggering factor.

 

 

 

The pooled heterogeneity of sensitivity and specificity of the nasal HDM-specific IgE test was 28.95% and 30.28%, respectively. This pooled heterogeneity value is less than 50%, which indicates a low heterogeneity in the sensitivity and specificity of the nasal HDM-specific IgE test. We may relate the heterogeneity in this study to the diversity of participants from some studies.

 

Misdiagnosing patients with LAR into NAR or IR is frequently found²⁹. Improper diagnosis can lead to inappropriate LAR treatment, resulting in impaired quality of life. One cause of LAR misdiagnosis is the complexity of establishing a definite diagnosis using NAPT²⁷. Nasal-specific IgE is an alternative diagnosis in LAR patients that is easier, more comfortable for patients, and less risk of an anaphylactic reaction. This study showed high sensitivity and specificity of nasal specific IgE, showing that this test can diagnose LAR patients.

 

The limitations of this review include the small number of studies available on LAR and the specific focus on nasal HDM-specific immunoglobulin E. Thus, the findings may not represent the characteristics of all patients with LAR.

 

CONCLUSIONS:

This study was a systematic review and meta-analysis with the aim of determining the accuracy of the nasal house dust mite-specific IgE in the diagnosis of LAR patients. Our analysis included 5 studies with a total number of 236 patients. This systematic review showed that the nasal house dust mite-specific immunoglobulin E test is a valid and reliable test in the diagnosis of local allergic rhinitis. It should be part of the standard diagnostic tool in the management of allergic rhinitis to avoid misdiagnosis and mismanagement.

 

CONFLICT OF INTEREST:

The authors declare no conflict of interest.

 

AUTHOR CONTRIBUTION:

Study conceptualization, E.R., D.R.P. and I.K.; methodology, E.R. and D.R.P.; formal analysis, E.R. and D.R.P.; data curation E.R., D.R.P. and I.K.; writing—original draft preparation, E.R., D.R.P. and I.K.; writing—review and editing, E.R., D.R.P., I.K., and B.A.; manuscript supervision, B.A.; project administration, E.R. All authors have read and agreed to the published version of the manuscript.

 

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Accepted on 10.09.2023           © RJPT All right reserved

Research J. Pharm. and Tech 2023; 16(12):5650-5656.