PMID- 36433848
OWN - NLM
STAT- MEDLINE
DCOM- 20221129
LR  - 20221228
IS  - 1399-3038 (Electronic)
IS  - 0905-6157 (Linking)
VI  - 33
IP  - 11
DP  - 2022 Nov
TI  - A singleplex IgE test to a mixture of molecules from multiple airborne allergen 
      sources: Innovating in vitro screening of respiratory allergies.
PG  - e13867
LID - 10.1111/pai.13867 [doi]
AB  - BACKGROUND: In vitro immunoglobulin E (IgE) tests can be better standardized if 
      based on molecules rather than extracts. However, singleplex screening tests for 
      respiratory or food allergies are still based on extracts only. TARGET: To 
      validate a novel singleplex IgE screening test for respiratory allergies, based 
      on a mix of major allergenic molecules Der p 1, Der p 2, Fel d 1, Can f 1, Can f 
      2, Can f 3, Can f 5, Bet v 1, Phl p 1, and Art v 1 (Molecular SX01, NOVEOS, 
      HYCOR, USA), and requiring only four microliters (mul) of serum. METHODS: We 
      examined six subsets of sera from participants of the German Multicenter Allergy 
      Study (MAS) birth cohort enrolling 1314 newborns during 1990: (1) monosensitized 
      (n = 58); (2) polysensitized (n = 24); (3) nonsensitized, with total IgE levels 
      above (n = 24) or (4) below (n = 24) 300 kU/L; (5) sensitized to milk and/or egg 
      but not to airborne allergens (n = 24); and (6) sera of children aged </=5 years at 
      their earliest IgE monosensitization to airborne allergens (n = 41). Sera were 
      analyzed with the novel molecular SX01 test (NOVEOS) and with three categories of 
      comparators: ImmunoCAP Phadiatop SX01, extracts, and molecules of 
      D. pteronyssinus, cat, dog, grass, and birch. Sensitivity, specificity, positive 
      and negative predictive values were calculated. Quantitative interrelationships 
      were determined using Spearman's rank-order correlation coefficient and 
      Bland-Altmann plots. RESULTS: The molecular SX01 test predicted the outcome of 
      IgE tests based on molecules, extracts, or Phadiatop in 188 (96.4%), 171 (87.7%), 
      and 171 (87.7%) of the 195 sera, respectively. Accordingly, sensitivity was 
      93.5%, 89.0%, and 82.4%, whereas specificity was 100%, 97.6%, and 96.1% when 
      compared with molecular, extract, and Phadiatop tests, respectively. Inconsistent 
      outcomes were largely confined to sera with IgE-Ab levels around the cutoff value 
      of 0.35 kU/L, except for 5/195 (2.5%) sera, containing high levels of IgE to Phl 
      p 5 and/or Alt a 1 only. IgE levels measured by the molecular SX01 test and with 
      IgE tests to molecules, extracts, and Phadiatop were highly correlated (rho 0.90; 
      p < .001), (rho 0.87, p < .001), (rho 0.84, p < .001), respectively. The novel 
      molecular SX01 test detected IgE-Ab in 27/28 (sensitivity 96.4%) of the sera of 
      preschool children at their earliest IgE sensitization to the same molecules. 
      DISCUSSION: Our study validates the prototype of a novel category of IgE test, 
      based on molecular mixes. The test's rather good precision and accuracy in early 
      screening IgE sensitization to airborne allergens in German children may be 
      further improved by adding a few other molecules, such as Phl p 5 and Alt a 1.
CI  - (c) 2022 The Authors. Pediatric Allergy and Immunology published by European 
      Academy of Allergy and Clinical Immunology and John Wiley & Sons Ltd.
FAU - Potapova, Ekaterina
AU  - Potapova E
AUID- ORCID: 0000-0003-4427-6335
AD  - Department of Pediatrics, Department of Pediatric Respiratory Medicine, 
      Immunology and Critical Care Medicine, Charite - Universitatsmedizin Berlin, 
      Berlin, Germany.
FAU - Panetta, Valentina
AU  - Panetta V
AUID- ORCID: 0000-0001-6058-5045
AD  - L'altrastatistica srl, Consultancy & Training, Biostatistics office, Rome, Italy.
FAU - Grabenhenrich, Linus
AU  - Grabenhenrich L
AUID- ORCID: 0000-0002-9300-6625
AD  - Institute for Social Medicine, Epidemiology and Health Economics, Charite - 
      Universitatsmedizin Berlin, Berlin, Germany.
FAU - Icke, Katja
AU  - Icke K
AUID- ORCID: 0000-0002-4170-8430
AD  - Institute for Social Medicine, Epidemiology and Health Economics, Charite - 
      Universitatsmedizin Berlin, Berlin, Germany.
FAU - Grubl, Armin
AU  - Grubl A
AD  - Department of Pediatrics, Technical University of Munich, Munich, Germany.
FAU - Muller, Christoph
AU  - Muller C
AD  - Department of Pediatrics, Allergy Working Group, University Clinic Freiburg, 
      Freiburg, Germany.
FAU - Zepp, Fred
AU  - Zepp F
AD  - Department of Pediatrics and Adolescent Medicine, University Medicine Mainz, 
      Mainz, Germany.
FAU - Schuster, Antje
AU  - Schuster A
AD  - Department of Pediatrics, Heinrich-Heine-University, Dusseldorf, Germany.
FAU - Wahn, Ulrich
AU  - Wahn U
AD  - Department of Pediatrics, Department of Pediatric Respiratory Medicine, 
      Immunology and Critical Care Medicine, Charite - Universitatsmedizin Berlin, 
      Berlin, Germany.
FAU - Lau, Susanne
AU  - Lau S
AUID- ORCID: 0000-0002-5189-4265
AD  - Department of Pediatrics, Department of Pediatric Respiratory Medicine, 
      Immunology and Critical Care Medicine, Charite - Universitatsmedizin Berlin, 
      Berlin, Germany.
FAU - Keil, Thomas
AU  - Keil T
AUID- ORCID: 0000-0002-9108-3360
AD  - Institute for Social Medicine, Epidemiology and Health Economics, Charite - 
      Universitatsmedizin Berlin, Berlin, Germany.
AD  - Institute of Clinical Epidemiology and Biometry, University of Wurzburg, 
      Wurzburg, Germany.
AD  - State Institute of Health, Bavarian Health and Food Safety Authority, Erlangen, 
      Germany.
FAU - Matricardi, Paolo Maria
AU  - Matricardi PM
AUID- ORCID: 0000-0001-5485-0324
AD  - Department of Pediatrics, Department of Pediatric Respiratory Medicine, 
      Immunology and Critical Care Medicine, Charite - Universitatsmedizin Berlin, 
      Berlin, Germany.
LA  - eng
PT  - Journal Article
PT  - Multicenter Study
PT  - Research Support, Non-U.S. Gov't
PL  - England
TA  - Pediatr Allergy Immunol
JT  - Pediatric allergy and immunology : official publication of the European Society 
      of Pediatric Allergy and Immunology
JID - 9106718
RN  - 0 (Allergens)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Humans
MH  - Dogs
MH  - Animals
MH  - Allergens
MH  - Immunoglobulin E
MH  - *Respiratory Hypersensitivity
MH  - *Food Hypersensitivity
MH  - Dermatophagoides pteronyssinus
OTO - NOTNLM
OT  - allergen-specific immunotherapy
OT  - component-resolved diagnostics
OT  - immunoglobulin E
OT  - pollen
OT  - precision medicine
OT  - seasonal allergic rhinitis
EDAT- 2022/11/27 06:00
MHDA- 2022/11/30 06:00
CRDT- 2022/11/26 08:32
PHST- 2022/09/12 00:00 [revised]
PHST- 2022/05/27 00:00 [received]
PHST- 2022/09/24 00:00 [accepted]
PHST- 2022/11/26 08:32 [entrez]
PHST- 2022/11/27 06:00 [pubmed]
PHST- 2022/11/30 06:00 [medline]
AID - 10.1111/pai.13867 [doi]
PST - ppublish
SO  - Pediatr Allergy Immunol. 2022 Nov;33(11):e13867. doi: 10.1111/pai.13867.