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KMID : 0985420170390020097
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Laboratory Medicine and Quality Assurance
2017 Volume.39 No. 2 p.97 ~ p.105
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Development and Performance Evaluation of External Quality Controls for Allergen-Specific Immunoglobulin E Tests
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Choi Ae-Ran
Kim Jee-Hae
Lee Eui-Sik
Lee Hye-Young
Ryu Ji-Hyeong
Park Ki-Hyun
Lim Ji-Hyang
Oh Eun-Jee
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Abstract
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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°C. The stability of allergen-specific IgE levels was assessed on days 1, 7, and 14 at -20°C, 2°C to 8°C, and 20°C to 25°C, and then after 3 months at -80°C. 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.
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KEYWORD
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Pooled serum, Allergen-specific immunoglobulin E, Stability, External quality control
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