乳児のミルクアレルギー診断のための安価で高精度な検査(Cheaper and more accurate test to diagnose milk allergy in children)

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2025-08-14 英国研究イノベーション機構 (UKRI)

UKRI(英国の研究資金機関)配信によると、King’s College LondonとGuy’s and St Thomas’ NHS Foundation Trustの研究チームが、子どもの牛乳アレルギー(特に2歳未満)の診断において、従来よりも正確で手軽な血液検査「好塩基球活性化試験(BAT)」を検証しました。BATは皮膚プリックテストや特異的IgE測定より優れた診断精度を示し、特に焼いた牛乳への耐性と生牛乳への反応を見分ける精度が高いことが確認されました。BATを単独で使用すれば、診断の確定に必要な経口負荷試験(OFC)の実施件数を大幅に削減でき、OFCに必要な時間や負担、コストも抑制可能です。実際、BATは経口負荷試験より約5倍安価で実施できるとされ、誤診による不要なミルク除去や栄養不良、家族の負担を軽減する期待が寄せられています。この研究成果はアレルギー専門誌『Allergy』に発表された大規模診断調査に基づいています。

<関連情報>

好塩基球活性化試験は、経口食物負荷試験中に加熱した牛乳と生乳に対するアレルギー反応を予測する最も正確な試験である The Basophil Activation Test Is the Most Accurate Test in Predicting Allergic Reactions to Baked and Fresh Cow’s Milk During Oral Food Challenges

Irene Bartha, Holly Boyd, Ru-Xin Foong, Marta Krawiec, Andreina Marques-Mejias, Hannah F. Marshall, Suzana Radulovic, Faye Harrison, Grammatiki Antoneria, Zainab Jama, Matthew Kwok …
Allergy  Published: 13 August 2025
DOI:https://doi.org/10.1111/all.16675

Graphical Abstract

The BAT had larger areas under the receiver-operator-characteristic curve to identify BM (0.90) and FM (0.81) allergies compared to SPT (0.70 and 0.78) and sIgE (0.79 and 0.74) to cow’s milk. Using optimal cut-offs for BM allergy, sensitivity and specificity were 80/90% for BAT, 70/64% for SPT, and 90/66% for sIgE to cow’s milk. Using 100% sensitivity and 100% specificity cut-offs followed by OFC to BM led to 100% diagnostic accuracy, with BAT requiring the lowest number of OFC (49%, 24% positive) compared to SPT (100%, 14% positive) and sIgE (88%, 16% positive). BAT, basophil activation test; BM, baked milk; FM, fresh milk. OFC, oral food challenge; SPT, skin prick test; sIgE, specific IgE.

乳児のミルクアレルギー診断のための安価で高精度な検査(Cheaper and more accurate test to diagnose milk allergy in children)

ABSTRACT

Background

Cow’s milk is the most common cause of food allergy and related fatalities. Consumption of baked milk (BM) has been associated with better prognosis, nutrition and quality-of-life.

Methods

The BAT 2 milk study (NCT03309488) was a diagnostic study of cow’s milk allergy designed according to STARD guidelines. All children had an oral food challenge (OFC) to BM, and those who tolerated BM were offered an OFC to fresh milk (FM). The diagnostic performance of the basophil activation test (BAT), skin prick test (SPT) and specific IgE (sIgE) was assessed in comparison with OFC.

Results

Out of the 150 children studied, 85% tolerated BM and 56% also tolerated FM. BAT had the best diagnostic accuracy (area under the receiver operator characteristic curve 0.90 for BM and 0.81 for FM) compared with the other tests for both BM (sIgE: 0.79 and SPT: 0.70) and FM (sIgE: 0.74 and SPT: 0.78) allergies. Using 100% sensitivity and 100% specificity cut-offs to select patients for OFC would have led to the following proportion of children having OFC (and positive OFC) to BM: 99% (13%) for SPT to baked milk, 82% (17%) for sIgE to boiled milk, and 49% (24%) for BAT to baked milk. In children younger than 2 years, only 27% required an OFC following BAT to BM (compared to 100% and 81% following SPT or sIgE to milk extract, respectively), with 100% diagnostic accuracy.

Conclusions

BAT was the best test to identify children who reacted on OFC to BM or FM. Using 100% sensitivity and 100% specificity cut-offs, BAT ensured the lowest need for OFC and 100% diagnostic accuracy.

Trial Registration

clinicaltrials.gov identifier: NCT03309488

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