PMID- 20586624
OWN - NLM
STAT- MEDLINE
DCOM- 20100720
LR  - 20220310
IS  - 1543-2165 (Electronic)
IS  - 0003-9985 (Linking)
VI  - 134
IP  - 7
DP  - 2010 Jul
TI  - Proficiency survey-based evaluation of clinical total and allergen-specific IgE 
      assay performance.
PG  - 975-82
AB  - CONTEXT: The diagnostic algorithm for human allergic disease involves 
      confirmation of sensitization by detection of allergen-specific immunoglobulin E 
      (IgE) antibody in individuals suspected of having allergic disease because of a 
      history of allergic symptoms after known allergen exposure. Previous studies 
      showed wide disparity among clinically reported allergen-specific IgE levels from 
      different serologic assays. OBJECTIVE: To validate the relative analytic 
      performance (sensitivity, interassay reproducibility, linearity/parallelism, 
      intermethod agreement) of clinically used total and allergen-specific IgE assays 
      by using College of American Pathologists' Diagnostic Allergy "SE" Proficiency 
      Survey data. DESIGN: Data from 2 SE survey cycles were used to assess relative 
      analytic performance of the ImmunoCAP (Phadia), Immulite (Siemens 
      Healthcare-Diagnostics), and HYTEC 288 (HYCOR-Agilent Technologies) total and 
      allergen-specific IgE assays. In each cycle, 2 recalcified plasma pools from 
      atopic donors were diluted twice with IgE-negative serum and evaluated in 
      approximately 200 federally certified clinical laboratories for total IgE and IgE 
      antibody to 5 allergen specificities. Statistical analysis evaluated analytic 
      sensitivity, linearity, reproducibility, and intermethod agreement. RESULTS: 
      Interlaboratory intramethod, intermethod, and interdilution agreement of all 6 
      clinically used total serum IgE assays were excellent, with coefficients of 
      variation (CVs) below 15%. Interlaboratory intramethod, and interdilution 
      agreement of 3 clinically used allergen-specific IgE assays were also excellent 
      with CVs below 15%. However, intermethod CVs identified between-assay 
      disagreement greater than 20% in 80% of allergen-specific IgE measurements. 
      Allergen reagents and patients' immune response heterogeneity are suggested 
      probable causes. CONCLUSIONS: Clinical total and allergen-specific IgE assays 
      display excellent analytic sensitivity, precision, reproducibility, and 
      linearity. Marked variability in quantitative estimates of allergen-specific IgE 
      from clinically used automated immunoassays is a concern that may be ameliorated 
      with component allergen use.
FAU - Hamilton, Robert G
AU  - Hamilton RG
AD  - Departments of Pathology and Medicine, Johns Hopkins University School of 
      Medicine, Johns Hopkins Asthma and Allergy Center, 5501 Hopkins Bayview Circle, 
      Baltimore, MD 21224, USA. rhamilt2@jhmi.edu
LA  - eng
PT  - Evaluation Study
PT  - Journal Article
PT  - Validation Study
PL  - United States
TA  - Arch Pathol Lab Med
JT  - Archives of pathology & laboratory medicine
JID - 7607091
RN  - 0 (Allergens)
RN  - 0 (Epitopes)
RN  - 37341-29-0 (Immunoglobulin E)
SB  - IM
MH  - Allergens/*immunology
MH  - *Epitopes
MH  - Humans
MH  - Hypersensitivity/blood/*diagnosis
MH  - Immunoglobulin E/*blood/*immunology
MH  - Pathology/*methods/standards
MH  - Reproducibility of Results
MH  - Sensitivity and Specificity
MH  - Societies, Medical
MH  - United States
EDAT- 2010/07/01 06:00
MHDA- 2010/07/21 06:00
CRDT- 2010/07/01 06:00
PHST- 2010/07/01 06:00 [entrez]
PHST- 2010/07/01 06:00 [pubmed]
PHST- 2010/07/21 06:00 [medline]
AID - 10.1043/2009-0518-OA.1 [pii]
AID - 10.5858/2009-0518-OA.1 [doi]
PST - ppublish
SO  - Arch Pathol Lab Med. 2010 Jul;134(7):975-82. doi: 10.5858/2009-0518-OA.1.