혈청 알레르기항원특이 IgE 정량 검사에 있어서 ImmunoCAP과 HYTEC 288의 비교
Performance Comparison of ImmunoCAP and HYTEC 288 in the Quantitative Tests of Allergen-specific IgE
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배경: 알레르기항원특이 IgE 정량검사는 알레르기 질환의 진단을 위해서 중요한 검사이다. 국내에 처음으로 소개되는 HYTEC 288 system은 검사의 전 과정이 자동화된 알레르기항원특이 IgE 정량검사이다. 이에 저자들은 HYTEC 288 system을 기존에 국내에 널리 사용되고 있는 ImmunoCAP system과 비교하여 그 유용성을 평가하고자 하였다. 방법: HYTEC 288 system의 재현성을 평가하기 위해 50개의 혈청검체로 Dermatophagoides pteronyssinus (d1)와 D. farinae (d2)에 대한 알레르기항원특이 IgE를 측정하였다. 또한 ImmunoCAP 과 HYTEC 288 system의 일치도를 평가하기 위해 56개의 혈청으로 d1, d2 이외의 21종류의 항원에 대한 알레르기항원특이 IgE를 측정하였다. 결과: 재현성 평가에서 HYTEC 288 system은 정량측정범위 내에서 d1과 d2항원에 대한 두 번의 측정값 사이에 의미있는 차이를 보이지 않았으며. ImmunoCAP 결과와의 일치도는 반정량적으로는 1 class 이내에서 d1, d2 알레르기항원에 대해 각각 80%, 90%를 나타내었다. 항원에 상관없이 정량 구간 내에 속한 84개의 결과쌍을 비교한 상관계수는 0.90으로 높은 상관성을 나타내었고, 각각 1개씩의 이탈치(outlier)를 제외한 d1, d2 항원별 특이 IgE 정량 결과의 상관계수(r)도 각각 0.91, 0.98로 나타났다. ImmunoCAP과 HYTEC 288 system의 검사소요시간은 한 검체당 각각 약 4.6분, 약 5.5분으로 나타났다. 결론: HYTEC 288 system은 ImmunoCAP 결과와 높은 일치도를 보였으며 전 자동화된 알레르기항원특이 IgE의 정량검사로서 임상검사실에서 효과적으로 사용될 수 있을 것으로 판단하였다.
Abstract
Background: In vitro measurement of allergen-specific IgE has become an important part of allergy diagnoses. HYTEC 288 system (Hycor Biomedical Inc., USA), which was recently introduced in Korea, is a fully automated immunoassay for quantitative measurements of allergen-specific IgE. In this study, we compared the clinical utility of this in vitro allergy test with that of ImmunoCAP assay (ImmunoDiagnostics, Sweden). Methods: To evaluate the reproducibility of HYTEC 288 system, 50 serum samples were tested in duplicate each for Dermatophagoides pteronyssinus (d1) and D. farinae (d2) specific IgE. To assess the agreement between ImmunoCAP and HYTEC 288 assays, 56 serum samples were tested for the other 21 allergen-specific IgE. Results: No significant differences within the range of quantitative analysis were observed between HYTEC 288 and ImmunoCAP assays for d1 and d2 (P=0.65 and 0.55, respectively). The agreements of HYTEC allergen-specific IgE assay with ImmunoCAP within ±1 class grade were 80% and 100% for d1 and d2, respectively. The correlation coefficients between HYTEC 288 and ImmunoCAP results within the range of quantitative analysis were overally 0.90, regardless of allergen, for d1 and d2 specific IgE, 0.91 and 0.98, respectively. Running times for the HYTEC 288 and Phardia 100 were 5.5 and 4.6 min per test, respectively. Conclusions: Hycor HYTEC 288 showed a favorable agreement with ImmunoCAP and can be used for fully automated quantitative measurements of allergen-specific IgE in the clinical laboratory
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