Development and Performance Evaluation of External Quality Controls for Allergen-Specific Immunoglobulin E Tests
Journal of Laboratory Medicine and Quality Assurance
; : 97-105, 2017.
Article
en Ko
| WPRIM
| ID: wpr-12374
Biblioteca responsable:
WPRO
ABSTRACT
BACKGROUND:
Many companies have developed different methods and products for allergen-specific immunoglobulin E (IgE) tests. Because there is no standardised reference method, external quality assessment (EQA) is important for allergen-specific IgE test to ensure the comparability and reliability of the results from different laboratories. We prepared specimens for EQA of allergen-specific IgE tests and evaluated their stability.METHODS:
Four pooled sera with 24 selected allergen-specific IgE levels were prepared and stored at −80℃. The stability of allergen-specific IgE levels was assessed on days 1, 7, and 14 at −20℃, 2℃ to 8℃, and 20℃ to 25℃, and then after 3 months at −80℃. Mock proficiency tests were performed with the four sets of prepared external quality controls for six laboratories, using the commercial multiple allergen simultaneous test (MAST) methodology.RESULTS:
About 150 specimens (650 µL each) for EQA were prepared; randomly selected specimens showed similar IgE levels for the 24 allergens (±1 class). The levels of allergen-specific IgE remained stable throughout the study period (P>0.05). Although mock survey results from six laboratories using four MAST assays revealed some variability with a difference (2–3 class), no consistent differences were observed through the allergens or MAST methods. Qualitative results from the mock survey showed 85.4% (cut-off of class 1) and 81.3% (cut-off of class 2) concordance with the results from ImmunoCAP (Phadia, Sweden).CONCLUSIONS:
The pooled sera prepared for allergen-specific IgE tests might be adequate and useful for EQA.Palabras clave
Texto completo:
1
Base de datos:
WPRIM
Asunto principal:
Control de Calidad
/
Inmunoglobulina E
/
Inmunoglobulinas
/
Alérgenos
/
Métodos
Tipo de estudio:
Qualitative_research
Idioma:
Ko
Revista:
Journal of Laboratory Medicine and Quality Assurance
Año:
2017
Tipo del documento:
Article