Data extraction tables

Marie Westwood; Bram Ramaekers; Shona Lang; Nigel Armstrong; Caro Noake; Shelley de Kock; Manuela Joore; Johan Severens; Jos Kleijnen

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Westwood M, Ramaekers B, Lang S, et al. ImmunoCAP® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis. Southampton (UK): NIHR Journals Library; 2016 Sep. (Health Technology Assessment, No. 20.67.)

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ImmunoCAP^® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis.

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Appendix 2Data extraction tables

A Baseline details (studies of change to management, treatment or diagnostic classification)

Study details	Selection criteria	Participant details (allergic)	Participant details (healthy controls)
Gay-Crosier 2010³⁶ Country: NR Funding: NR Study design: Observational before-and-after study Recruitment: Participants undergoing subcutaneous immunotherapy. No further details reported No. of participants: 9	Inclusion criteria: Participants undergoing subcutaneous immunotherapy Exclusion criteria: None reported	n: 9 Mean age, years (SD): NR Male (%): NR Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with gastrointestinal symptoms (%): NR n with respiratory symptoms (%): NR n with urticaria (%): NR n with atopic eczema (%): NR n with anaphylaxis (%): NR	NA
Heaps 2014,³⁹ 2010³⁵ Country: UK Funding: Reagents and consumables provided by Thermo Fisher Scientific Study design: Prospective, observational before-and-after study Recruitment: Participants recruited from five specialist allergy centres. No further details reported No. of participants: 110	Inclusion criteria: Adult patients diagnosed with idiopathic anaphylaxis Exclusion criteria: None reported	n: 110 Mean age, years (range): 42 (20–76) Male (%): 37 (33.6) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with gastrointestinal symptoms (%): NR n with respiratory symptoms (%): NR n with urticaria (%): NR n with atopic eczema (%): NR n with anaphylaxis (%): 110 (100)	NA
Hermansson 2014³³^,³⁴ Country: Finland Funding: NR Study design: Prospective, observational Recruitment: Database of 2317 primary school children used to identify 199 children who were on restrictive diets, of whom 85 agreed to participate in the study and were still classified as allergic following nurse interview No. of participants: 85	Inclusion criteria: Children who were on a restrictive diet in school catering Exclusion criteria: Coeliac disease	n: 85 Mean age, years (range): NR Male (%): NR Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with gastrointestinal symptoms (%): NR n with respiratory symptoms (%): NR n with urticaria (%): NR n with atopic eczema (%): NR n with anaphylaxis (%): NR	NA
Luengo 2010³⁷ Country: Spain, ‘Mediterranean population’ Funding: NR Study design: observational before-and-after study Recruitment: No details reported No. of participants: 55	Inclusion criteria: Well characterised, multisensitised, allergic patients Exclusion criteria: None reported	n: 55 Mean age, years (range): NR Male (%): NR Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with gastrointestinal symptoms (%): NR n with respiratory symptoms (%): NR n with urticaria (%): NR n with atopic eczema (%): NR n with anaphylaxis (%): NR	NA
Noimark 2012⁴⁰ Country: UK Funding: NR Study design: Case series, abstract only, no details reported Recruitment: Selected participants from a specialist allergy centre. No further details reported No. of participants: 12	Inclusion criteria: Children with moderate to severe eczema and multiple food allergies Exclusion criteria: None reported	n: 12 Mean age, years (range): NR Male (%): NR Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with gastrointestinal symptoms (%): NR n with respiratory symptoms (%): NR n with urticaria (%): NR n with atopic eczema (%): 12 (100) n with anaphylaxis (%): NR	NA
Passalacqua 2013³⁸ Country: Italy Funding: Phadia AB/Thermo Fisher Scientific Study design: Prospective, observational before-and-after study Recruitment: Participants recruited from six allergy centres. No further details reported No. of participants: 409 (318 allergy patients and 91 healthy controls)	Inclusion criteria: Patients referred for respiratory allergic diseases who had at least two positive SPTs. Controls had negative SPTs Exclusion criteria: None reported	n: 318 Mean age, years (range): 37 (12–78) Male (%): 148 (46.5) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): 51 (16) n with gastrointestinal symptoms (%): 14 (4.4) n with respiratory symptoms (%): 318 (100) n with urticaria (%): 36 (11.3) n with atopic eczema (%): 4 (1.3) n with anaphylaxis (%): 6 (1.9)	n: 91 Mean age, years (range): 40 (15–83) Male (%): 19 (20.9) Median duration of allergy, years (range): NA n with oral allergy syndrome (%): 0 (0) n with gastrointestinal symptoms (%): 0 (0) n with respiratory symptoms (%): 0 (0) n with urticaria (%): 0 (0) n with atopic eczema (%): 0 (0) n with anaphylaxis (%): 0 (0)
Sastre 2012³⁰^–³²^,⁵⁹ Country: Spain Funding: CIBER de Enfermedades Respiratorias and Instituto de Salud Carlos III of the Ministry of Science and Information, Spain Study design: Observational before-and-after study Recruitment: Participants attending an outpatient allergy clinic. No further details reported No. of participants: 141	Inclusion criteria: Patients with allergic rhinoconjunctivitis and/or asthma who were sensitised to pollen, with or without concomitant food allergy Exclusion criteria: None reported	n: 141 Mean age, years (SD): 31 (13.6) Male (%): 58 (41) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with gastrointestinal symptoms (%): NR n with respiratory symptoms (%): 141 (100) n with urticaria (%): NR n with atopic eczema (%): NR n with anaphylaxis (%): NR	NA

: NA, not applicable; NR, not reported; SD, standard deviation.

B Baseline accuracy study details (diagnostic case–control)

Study details	Selection criteria	Participant details (allergic)	Participant details (tolerant)
Alessandri 2011⁴² Country: Italy Funding: Italian Ministry of Health, Programma Ricerca Corrente 2008–2010 Recruitment: January 2008 to September 2010 No. of participants: 68	Inclusion criteria: Children referred for suspected hen’s egg allergy (based on history of reactions after ingestion and positive SPT or IgE to hen’s egg white extracts). All patients were following a hen’s egg elimination diet Exclusion criteria: Steroid treatment Recruitment site: Centre for Molecular Allergology, IDI-IRCCS, Rome, Italy	n: 19 Median age, years (range): 4.3 (NR) Male (%): 15 (79) Median duration of allergy, years (range): NR n with atopic eczema (%): NR n with oral allergy syndrome (%): 3 (16)^a n with asthma (%): 7 (37)^a n with anaphylaxis (%): 1 (5) n with gastritis/vomiting (%): 11(58) n with skin symptom (%): NR n with respiratory symptoms (%): NR	n: 14 (tolerant to boiled, not raw) 35 (tolerant to raw and boiled) Median age, years (range): 3.17 (NR) (tolerant to boiled, not raw) 4.42 (NR) (tolerant to raw and boiled) Male (%): 9 (64) (tolerant to boiled, not raw) 23 (66) (tolerant to raw and boiled) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): 3 (21) (tolerant to boiled, not raw)^a 0 (0) (tolerant to raw and boiled)^a n with asthma (%): 3 (21) (tolerant to boiled, not raw)^a 0 (0) (tolerant to raw and boiled)^a n with anaphylaxis (%): 0 (0) (tolerant to boiled, not raw)^a 0 (0) (tolerant to raw and boiled)^a n with gastritis/vomiting (%): 10 (71) (tolerant to boiled, not raw)^a 0 (0) (tolerant to raw and boiled)^a n with atopic eczema (%): NR n with skin symptom (%): NR n with respiratory symptoms (%): NR
Cabrera-Freitag 2011,⁴³ 2010,⁹⁴ 2011⁴⁸ Country: Spain Funding: Spanish Society of Allergy and Clinical Immunology Foundation; Spanish Research Network on Adverse Reactions to Allergens and Drugs Recruitment: March 2008 to May 2009 No. of participants: 173	Inclusion criteria: Allergic patients had (1) an allergen-specific history (rhinitis, rhinoconjunctivitis and/or bronchial asthma) during the season of pollinisation of grass pollen and/or cypress pollen and (2) a positive SPT to the corresponding pollen, P. pratense and/or C. arizonica. Controls had no pollen allergen-specific history and had negative SPT to the corresponding pollen Exclusion criteria: Patients showing clinical history during the season of pollinisation of grass pollen and showing SPT-positive to grass pollen and to other pollen that pollinated in the same season (i.e. olive) Recruitment site: Clínica Universidad de Navarra, Pamplona, Spain	n: 43 (grass), 12 (cypress) Mean age, years (25th–75th percentile): Grass 29 (20–37) Cypress 32 (21–44) Male (%): Grass 21 (49) Cypress 4 (33.3) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with asthma (%): Grass 15 (35) Cypress 3 (25) n with anaphylaxis (%): NR n with gastritis/vomiting (%): NR n with atopic eczema (%): NR n with skin symptom (%): NR n with respiratory symptoms (%): NR	n: 26 (grass), 92 (cypress) Control definition: Negative history and SPT Mean age, years (25th–75th percentile): Grass 27 (17–35) Cypress 29 (20–38) Male (%): Grass 10 (39) Cypress 46 (50) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with asthma (%): Grass 7 (27) Cypress 2 (35) n with anaphylaxis (%): NR n with gastritis/vomiting (%): NR n with atopic eczema (%): NR n with skin symptom (%): NR n with respiratory symptoms (%): NR
De Swert 2012⁴¹ Country: Belgium Funding: NR Recruitment: NR No. of participants: 15	Inclusion criteria: Subjects with birch pollen allergy (typical allergic symptoms during the birch pollen season in combination with a positive IgE response to birch or rBet v1), suspected of also being soy allergic Exclusion criteria: NR Recruitment site: Outpatient allergy clinic, Paediatric Department, University Hospital Gasthuisberg, Leuven, Belgium	n: 8 Median age, years (range): 10.3 (4.8–15.6) Male (%): NR Median duration of allergy, years (range): tree 3.7 (1–9) n with oral allergy syndrome (%): 7 (88) n with asthma (%): NR n with atopic eczema (%): NR n with anaphylaxis (%): NR n with gastritis/vomiting (%): NR n with skin symptom (%): NR n with respiratory symptoms (%): NR	n: 7 Median age, years (range): 10.1 (4.7–16) Male (%): NR Median duration of allergy, years (range): tree 3.5 (1–10) n with oral allergy syndrome (%): 4 (57) n with asthma (%): NR n with atopic eczema (%): NR n with anaphylaxis (%): NR n with gastritis/vomiting (%): NR n with skin symptom (%): NR n with respiratory symptoms (%): NR
Sokolova 2009⁴⁶ Country: Portugal Funding: Phadia, Portugal Recruitment: NR No. of participants: 41	Inclusion criteria: Patients from Food Allergy Outpatient Clinic who, at the time of diagnosis, had a clinical picture compatible with IgE-mediated CMPA, documented by SPT and positive specific IgE (> 0.35 kU/l) to whole milk and/or its protein fractions (α-LA, β-LG and casein). Control group consisted of four atopic individuals with no history of CMPA and who ingested cow’s milk daily Exclusion criteria: NR Recruitment site: Food Allergy Outpatient Clinic, Centro Hospitalar Lisboa Norte, Lisbon, Portugal	n: 17 Mean age, years (range): 9.25 (2–19) Male (%): 10 (58.5) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with asthma (%): NR n with anaphylaxis (%): NR n with gastritis/vomiting (%): NR n with atopic eczema (%): 2 (12) n with skin symptom (%): NR n with respiratory symptoms (%): NR	n: 20 Control definition: Negative OFC Mean age, years (range): 6.15 (2–22) Male (%): 7 (65) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with asthma (%): NR n with anaphylaxis (%): NR n with gastritis/vomiting (%): NR n with atopic eczema (%): 6 (30) n with skin symptom (%): NR n with respiratory symptoms (%): NR

: CMPA, cow’s milk protein allergy; kU/l, kilo International Unit per litre; NR, not reported.
a: After oral challenge.

C Baseline accuracy study details (diagnostic cohort studies)

Study details	Selection criteria	Participant details
Albarini 2013⁴⁷ Country: NR Funding: NR Recruitment: April 2007 to May 2012 No. of participants: 35	Inclusion criteria: Children with immediate reaction to hazelnut ingestion Exclusion criteria: NR Recruitment site: NR	n: 35 Median age, years (range): 8.3 (2.2–14.2) Male (%): 26 (74) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with asthma (%): NR n with anaphylaxis (%): NR n with gastritis/vomiting (%): NR n with atopic eczema (%): NR n with skin symptom (%): NR n with respiratory symptoms (%): NR
D’Urbano 2010⁴⁴ Country: Italy Funding: IRCCS Children’s Hospital Bambino Gesù Recruitment: NR No. of participants: 104 (58 cow’s milk and 46 hen’s egg)	Inclusion criteria: Infants and children referred for evaluation of suspected IgE-mediated food hypersensitivity (history related to cow’s milk or hen’s egg consumption, of severe and/or immediate reactions) Exclusion criteria: Atopic eczema as the only indication for suspected allergy Recruitment site: Department of Paediatric Medicine–Allergy Unit, IRCCS Children’s Hospital Bambino Gesù, Rome, Italy	n: 104 Median age, years (range): 4.9 (0.7–15.1) Male (%): 62 (60) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with asthma (%): NR n with atopic eczema (%): NR n with skin symptom (%): 44 (42) n with respiratory symptoms (%): 6 (96) n with gastrointestinal symptoms (%): 33 (32) n with anaphylaxis (%): 4 (4)
Ott 2008⁴⁹ Country: Germany Funding: START programme of the Medical Faculty of the Rheinisch-Westfälische Technische Hochschule (RWTH) Aachen Recruitment: NR No. of participants: 130	Inclusion criteria: Children referred for evaluation of suspected IgE-mediated food hypersensitivity Exclusion criteria: NR Recruitment site: Charité Allergy Center, Universitätsmedizin Berlin, Germany	n: 130 Median age, months (range): NR [total = 14 (5–150)] Male (%): 70 (54) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with asthma (%): NR n with atopic eczema (%): NR n with anaphylaxis (%): NR n with vomiting (%): 23 (16) n with skin symptom (%): NR n with respiratory symptoms (%): NR
Wohrl 2006⁴⁵ Country: Austria Funding: ISAC and IgE were performed in the laboratories of VBC-GENOMICS, Vienna, Austria Recruitment: September to October 2004 No. of participants: 120 patients with allergic rhinitis	Inclusion criteria: Adults at the end of the pollen season Exclusion criteria: Total serum IgE > 1000 kU/l (to minimise non-specific binding in the ImmunoCAP system) Recruitment site: Allergy Outpatient Clinic of the Division of Immunology, Allergy and Infectious Diseases, Medical University of Vienna, and at a private outpatient allergy clinic FAZ–Floridsdorf Allergy Center, Vienna	n: 120 Mean age, years (SD): 35.9 (14.4) Male (%): 50 (42) Median duration of allergy, years (range): NR n with oral allergy syndrome (%): NR n with asthma (%): NR n with atopic eczema (%): NR n with skin symptom (%): NR n with respiratory symptoms (%): NR n with gastrointestinal symptoms (%): NR n with anaphylaxis (%): NR

: CMPA, cow’s milk protein allergy; kU/l, kilo International Unit per litre; NR, not reported; SD, standard deviation.

D Index test and comparator details (studies of change to management, treatment or diagnostic classification)

Study details	Index test details	Standard care details
Heaps 2014³⁹	Version: ImmunoCAP ISAC 103 Manufacturer: Phadia/Thermo Fisher Scientific, Milan, Italy Method: ‘According to the manufacturer’s instructions.’ Slides were scanned using a GenePix 4000B microarray scanner (Molecular Devices, Sunnyvale, CA, USA). Image analysis was performed using the Microarray Image Analyser (MIA: Thermo Fisher Scientific/Phadia, Uppsala, Sweden). All new positive ISAC results were retested for confirmation Allergens (components) assessed: NR Definition of a positive result: ‘According to the manufacturer’s instructions’ ISU > 0.3 Positive control: NR Negative control: NR	Method: SPT and clinical history, and sIgE and MCT SPT: NR sIgE and MCT: FEIA auto-analyser, ImmunoCAP 250 platform (Thermo Fisher Scientific/Phadia AB, Uppsala, Sweden), ‘according to the manufacturer’s instructions’
Hermansson 2014³³^,³⁴	Version: ImmunoCAP ISAC 112 Manufacturer: NR Method: NR Allergens (components) assessed: NR Definition of a positive result: NR Positive control: NR Negative control: NR	Method: Clinical history/parental report, and sIgE sIgE: RAST
Luengo 2010³⁷	Version: ImmunoCAP ISAC 103 Manufacturer: NR Method: NR Allergens (components) assessed: NR Definition of a positive result: NR Positive control: NR Negative control: NR	Method: SPT and sIgE SPT: NR sIgE: NR
Noimark 2012⁴⁰	Version: ImmunoCAP ISAC unspecified version Manufacturer: NR Method: NR Allergens (components) assessed: NR Definition of a positive result: NR Positive control: NR Negative control: NR	Method: SPT and/or sIgE SPT: NR sIgE: NR
Passalacqua 2013³⁸	Version: ImmunoCAP ISAC 103 Manufacturer: Thermo Fisher Scientific, Milan, Italy Method: According to the manufacturer’s instructions. Slides were read automatically using a Laser Scan Confocal microarray reader (LuxScan 10K/A, CapitalBio, Beijing, China) Allergens (components) assessed: NR Definition of a positive result: ≥ 0.35 ISU Positive control: NR Negative control: NR	Method: SPT and clinical history, with sIgE as required SPT: Standard panel of commercial extractive preparations (ALK-Abelló, Milan, Italy), including mites, grass, olive, Parietaria, birch, cypress, ragweed, mugwort, cat and dog dander, Alternaria and Aspergillus. A positive result was defined as a weal reaction of ≥ 3 mm in diameter. 1% histamine was used as a positive control and diluent as a negative control sIgE: Commercial immunoenzymatic method (Thermo Fisher Scientific/Phadia AB, Uppsala, Sweden). A positive result was defined as > 0.35 kU/l
Sastre 2012³²	Version: ImmunoCAP ISAC 96 Manufacturer: Phadia, Sweden Method: ‘According to the manufacturer’s instructions’ Allergens (components) assessed: Olive (Ole 1); cypress (Cup s 1); plane (pla a1, Pla a2); grass (Phl p1, phl p5); cynodon (Cyn d1) Definition of a positive result: ‘According to the manufacturer’s instructions’ Positive control: NR Negative control: NR	Method: SPT and clinical history, taking into consideration the time of year of respiratory symptoms and European Academy of Allergy and Clinical Immunology guidelines SPT: Standard panel of commercial inhalants (ALK-Abelló, Madrid, Spain), including Olea e, Platanus a, Cupressus a, grass mix, Cynodon d, Phragmites c, Artemisia v, Salsola k, and Plantago l. A positive result was defined as a weal reaction ≥ 3 mm more than negative control. Histamine (10 mg/ml) was used as a positive control and glycerol–saline solution as a negative control

: FEIA, fluoroenzyme immunoassay; kU/l, kilo International Unit per litre; NR, not reported; RAST, radioallergosorbent test.

E Index test and reference standard details (accuracy studies)

Study details	Index test details			Reference standard details: oral challenge
Study details	ImmunoCAP/Microtest	Specific IgE tests	SPT	Reference standard details: oral challenge
Albarini 2013⁴⁷	Version: ImmunoCAP ISAC unspecified version Manufacturer: NR Method: NR Definition of positive result: NR Positive control: NR Negative control: NR	Version: ImmunoCAP Manufacturer: NR Method: NR Definition of positive result: > 0.35 kUI/l Positive control: NR Negative control: NR	Method: NR Allergen: NR Positive result: Mean weal diameter > 3 mm Positive control: NR Negative control: NR	DBPCFC
Alessandri 2011⁴²	Version: ImmunoCAP ISAC 103 Manufacturer: Phadia AB, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of a positive result: Thresholds for each allergen/component derived from ROC analyses, but not reported Positive control: NR Negative control: NR	Version: ImmunoCAP Manufacturer: Phadia AB, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of a positive result: Thresholds for each allergen/component derived from ROC analyses, but not reported Positive control: NR Negative control: NR	Method: Performed in duplicate on the volar surface of the forearm by the same investigator, following European Academy of Allergy and Clinical Immunology recommendations, using 1-mm-tipped lancets. Weal reactions were recorded after 15 minutes, by outlining with pen onto paper sheets, which were scanned to digitally measure areas Allergen: Commercial extracts (Allergopharma, Reinbek, Germany) and freshly prepared egg reagents Positive result: Mean weal diameter of ≥ 7 mm Positive control: Histamine diphosphate (10 mg/ml) Negative control: Glycerol–saline solution	Double-blind placebo-controlled hen’s egg challenges were carried out using commercially available eggs Boiled egg: Administering an initial dose of 0.1 ml, and, in case of no reactions in the next 20 minutes, by progressively increasing the egg amount by a factor 5 (0.5, 2, 10 and 50 ml) up to the ingestion of one egg (approximately 6 g) Patients tolerating boiled egg were then challenged with raw egg in a similar way
De Swert 2012⁴¹	Version: ImmunoCAP ISAC unspecified version Manufacturer: Phadia AB, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of a positive result: ≥ 0.3 ISU, ≥ 1.0 ISU for rGly m4 Positive control: NR Negative control: NR	Version: ImmunoCAP FEIA Manufacturer: Phadia AB, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of a positive result: ≥ 0.10 kU/l, ≥ 17.6 kU/I for rGly m4 Positive control: NR Negative control: NR	Method: Performed using a microlance. Weal reactions were recorded after 15 minutes; orthogonal diameters were measured and mean diameters were calculated Allergen: 1/10 w/v dilution of soy flour (Sojameel, Biofresh, Genk, Belgium) Positive result: Mean weal diameter ≥ 3 mm, (cut-off point ≥ 7 mm rGly m4) Positive control: Histamine diphosphate (1 mg/ml) Negative control: Coca solution in 50% glycerol	Subjects were on a soy-free diet for at least 8 weeks Challenge performed with Alpro soya natural drink; one drop of soy drink at the inner side of the lower lip If no reaction occurred within 15 minutes, increasing doses of 1, 2, 5, 10, 20, 40 and 80 ml of soy drink were given at 20-minute intervals, until appearance of objective allergic symptoms (or until 158 ml) If no symptoms after 2 hours, the parents were asked to give the child daily volumes of 120 ml of soy drink in the next 2 weeks, while continuing their diet otherwise unchanged Re-evaluation was provided after 2 weeks or earlier if required
D’Urbano 2010⁴⁴	Version: ImmunoCAP ISAC 89 Manufacturer: Phadia AB, Uppsala, Sweden Method: ‘according to the manufacturer’s instructions’ Definition of positive result: NR Positive control: NR Negative control: NR	Version: ImmunoCAP Manufacturer: Phadia AB, Uppsala, Sweden Method: ‘according to the manufacturer’s instructions’ Definition of positive result: NR Positive control: NR Negative control: NR	Method: The response was read 15 min after puncture and results were expressed as the mean weal diameter (mm) Allergen: Natural food and commercial natural extracts to milk, α-lactalbumin, β-lactoglobulin, casein, egg white, egg yolk (Lofarma, Milan, Italy) Positive result: Mean weal diameter of > 3 mm with erythema Positive control: Histamine hydrochloride Negative control: Sodium chloride (0.9%)	Performed in an open fashion The material was pasteurised cow’s milk and cooked egg (boiled for 10 minutes) or raw egg in the case of negative result to cooked egg When the patient tolerated the first dose, the subsequent doses were given every 15 minutes until objective symptoms developed or when the entire dose was ingested (equivalent to one egg; or up to 250 ml of milk) Positive result was scored if anaphylactic shock or two or more of the following objective clinical reactions were noted: bronchial asthma, lips/periorbital oedema, urticaria/angioedema, rhinitis, conjunctivitis, diarrhoea and repetitive vomiting
Ott 2008⁴⁹	Version: ImmunoCAP ISAC 51 Manufacturer: VBC Genomics Bioscience Research, Vienna, Austria Method: ‘According to the manufacturer’s instructions’ Definition of positive result: Cut-off points used for analyses derived from ROC analyses Positive control: NR Negative control: NR	Version: UniCAP^® Manufacturer: Phadia AB, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of positive result: > 0.35 kU/l (derived from ROC analyses) Positive control: NR Negative control: NR	Method: One drop of either milk or native hen’s egg was applied to the patient’s forearm with 1-mm single-peak lancets (ALK, Copenhagen, Denmark) Allergen: Fresh cow’s milk (3.5% fat) or native hen’s egg (whisked white of egg and yolk). Definition of positive result: Mean weal diameter > 3 mm, or greater than negative control. Cut-off points used for analyses derived from ROC analyses Positive control: Histamine hydrochloride (1%) Negative control: Saline	OFCs with either cow’s milk and/or hen’s egg The food challenges were scored as positive by a paediatric allergologist if one or more of the following objective clinical reactions were noted: urticaria, flushing, pruritus, angioedema, exacerbation of AE, vomiting, diarrhoea, stridor or other respiratory symptoms

: FEIA, fluoroenzyme immunoassay; kU/l, kilo International Unit per litre; w/v, weight/volume.

Study details	Index test details		Reference standard details
Study details	ImmunoCAP^®/Microtest	Specific IgE tests	Oral challenge
Sokolova 2009⁴⁶	Version: ImmunoCAP ISAC NR Manufacturer: VBC Genomics Bioscience Research, Vienna, Austria Method: ‘According to the manufacturer’s instructions’ Definition of positive result: Cut-off points NR Positive control: NR Negative control: NR	Version: UniCAP Manufacturer: Phadia, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of positive result: > 0.35 kU/l Positive control: NR Negative control: NR	Patients complaining of anaphylaxis after accidental ingestion of milk or its derivatives were considered persistent A diagnosis of persistent CMPA was confirmed in the remaining patients via a positive oral challenge test, performed following current recommendations. The initial dose administered was 0.1 ml with posterior duplication of the doses and administration at 30-minute intervals. It was considered positive if cutaneous (urticaria/angioedema), respiratory or gastrointestinal (vomiting, diarrhoea) symptoms occurred. A negative open oral challenge to cow’s milk was defined as a cumulative dose of 200 ml The control group consisted of four atopic individuals with no history of CMPA and who ingested cow’s milk daily

: CMPA, cow’s milk protein allergy; FEIA, fluoroenzyme immunoassay; kU/l, kilo International Unit per litre; NR, not reported; w/v, weight/volume.

Study details	Index test details		Reference standard details: SPT + allergen-specific history
Study details	ImmunoCAP/Microtest	Specific IgE tests	Reference standard details: SPT + allergen-specific history
Cabrera-Freitag 2011⁴³	Version: ImmunoCAP ISAC 103 Manufacturer: Phadia, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of positive result: ≥ 0.3 ISU. Thresholds for each allergen/component derived from ROC analyses, but not clearly reported Positive control: NR Negative control: NR	Version: ImmunoCAP FEIA Manufacturer: Phadia, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of positive result: > 0.35 kU/l. Thresholds for each allergen/component derived from ROC analyses, but not clearly reported Positive control: NR Negative control: NR	Method: 1-mm-tip lancet (ALK-Abelló) on the volar side of the forearm. Read after 20 minutes. Performed by the same experienced nurses Allergen: Commercial, natural extracts (ALK-Abelló, Madrid, Spain) Definition of positive result: Mean weal diameter of > 3 mm Positive control: Histamine hydrochloride (10 mg/ml) Negative control: Sodium chloride (0.9%) Allergen history: Rhinoconjunctivitis and/or bronchial asthma Controls had no pollen allergen-specific history and had negative SPT to the corresponding pollen
Wohrl 2006⁴⁵	Version: ImmunoCAP ISAC CRD 50 Manufacturer: Genomics Bioscience Research, Vienna, Austria Method: ‘According to the manufacturer’s instructions’. Slides were scanned in an Affymetrix 428 microarray scanner (Affymetrix, Santa Clara, CA, USA). Images were analysed using the GenePix image analysis software (version 3.0.6.89; Axon Instruments, Union City, CA, USA) Definition of a positive result: Thresholds for each allergen/component derived from ROC analyses, but not reported Positive control: NR Negative control: NR	Version: ImmunoCAP Manufacturer: Phadia, Uppsala, Sweden Method: ‘According to the manufacturer’s instructions’ Definition of a positive result: Thresholds for each allergen/component derived from ROC analyses, but not reported Positive control: NR Negative control: NR	Method: SPTs were read after 20 minutes. Weals and flares were pen-marked, transferred to a paper with transparent adhesive tape and analysed with an investigator-independent system calculating the weal size in mm² Allergen: Commercial extracts (HAL Allergie GmbH, Germany, and ALK, Hørsholm, Denmark) Positive result: Mean weal area of ≥ 7 mm² or > 3 mm diameter Positive control: Histamine hydrochloride (ALK) Negative control: Sodium chloride (0.9%) Allergen history: Obtained in all subjects using a questionnaire that gave special regard to the clinical relevance of the sensitisation to each allergen (e.g. clinical relevance of the sensitisation to birch pollen was affirmed by asking for an oral allergy syndrome to apple and other Rosaceae fruits) All subjects without allergen-specific history (atopics) and those with additional negative SPTs (non-allergic) served as controls

: FEIA, fluoroenzyme immunoassay; kU/l, kilo International Unit per litre; NR, not reported.

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Westwood M, Ramaekers B, Lang S, et al. ImmunoCAP® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis. Southampton (UK): NIHR Journals Library; 2016 Sep. (Health Technology Assessment, No. 20.67.) Appendix 2, Data extraction tables.
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Data extraction tables - ImmunoCAP® ISAC and Microtest for multiplex allergen te...
Data extraction tables - ImmunoCAP® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis
Heuchera hallii isolate Folk 58 trnK-rps16 intergenic spacer, partial sequence; ...
Heuchera hallii isolate Folk 58 trnK-rps16 intergenic spacer, partial sequence; and ribosomal protein S16 (rps16) gene, partial cds; chloroplast
gi|1072897984|gb|KT755768.1|
Nucleotide

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ImmunoCAP® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis.

Appendix 2Data extraction tables

A Baseline details (studies of change to management, treatment or diagnostic classification)

B Baseline accuracy study details (diagnostic case–control)

C Baseline accuracy study details (diagnostic cohort studies)

D Index test and comparator details (studies of change to management, treatment or diagnostic classification)

E Index test and reference standard details (accuracy studies)

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ImmunoCAP^® ISAC and Microtest for multiplex allergen testing in people with difficult to manage allergic disease: a systematic review and cost analysis.