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在中国哮喘患者中,将Phadiatop检测作为一线气传变应原特异性免疫球蛋白E(sIgE)筛查方法的实际益处:一项验证研究。

The practical benefit of Phadiatop test as the first-line allergen-specific immunoglobulin E (sIgE) screening of aeroallergens among Chinese asthmatics: a validation study.

作者信息

Zeng Guangqiao, Hu Haisheng, Zheng Peiyan, Wu Ge, Wei Nili, Liang Xueqing, Sun Baoqing, Zhang Xiaowen

机构信息

State Key Laboratory of Respiratory Disease, Guangzhou 510120, China.

National Clinical Research Center of Respiratory Disease, Guangzhou 510120, China.

出版信息

Ann Transl Med. 2018 Apr;6(8):151. doi: 10.21037/atm.2018.04.06.

Abstract

BACKGROUND

Phadiatop test is a variant of ImmunoCAP assay that covers a mixture of common aeroallergens. Its diagnostic efficiency in Chinese population remains so far inadequate. We validated Phadiatop testing with ImmunoCAP assays in a Chinese cohort.

METHODS

Phadiatop test was performed for serum samples from 290 asthmatics and 92 healthy controls previously tested with "classic" ImmunoCAP for house dust mix (hx2), molds and yeasts mix (mx2), tree pollen mix (tx4) and weed mix (wx5).

RESULTS

Phadiatop positivity was shown in 46.2% of 290 asthmatic patients. Using ImmunoCAP as the gold standard, the concordance rate was 91.7%; negative predictive value, 92.9%; and positive predictive value, 90.2%. The sensitivity of Phadiatop test was high for hx2 (98.2%), tx4 (100%) and wx5 (95.5%), but not for mx2 (78.4%). Yet the mx2 allergen-specific immunoglobulin E (sIgE) level in all missed cases was relatively low (0.35 to 0.90 kU/L). The total Phadiatop sIgE level was correlated with the ImmunoCAP sIgE levels for all allergen mixes combined ( =0.941, P<0.001) or each allergen mix, particularly the hx2 ( =0.924) (all P<0.001), 0.53 kU/L used as a cut-off would optimize the diagnostic performance of Phadiatop testing, yielding 89.4% sensitivity and 97.5% specificity in indentifying serums positive to any of these allergen mixes.

CONCLUSIONS

Overall, Phadiatop test may efficiently detect sensitization to common aeroallergen mixes. In light of the currently rigorous administration on crude extracts for skin tests in China, using Phadiatop as the first-line test for suspected atopy can be cost-effective.

摘要

背景

Phadiatop检测是ImmunoCAP检测的一种变体,涵盖了多种常见的气传变应原。迄今为止,其在中国人群中的诊断效率仍不足。我们在中国队列中对Phadiatop检测与ImmunoCAP检测进行了验证。

方法

对290例哮喘患者和92例健康对照的血清样本进行Phadiatop检测,这些样本之前已用“经典”ImmunoCAP检测过屋尘混合物(hx2)、霉菌和酵母菌混合物(mx2)、树木花粉混合物(tx4)和杂草混合物(wx5)。

结果

290例哮喘患者中46.2%显示Phadiatop阳性。以ImmunoCAP作为金标准,符合率为91.7%;阴性预测值为92.9%;阳性预测值为90.2%。Phadiatop检测对hx2(98.2%)、tx4(100%)和wx5(95.5%)的敏感性较高,但对mx2(78.4%)不高。然而,所有漏诊病例中的mx2变应原特异性免疫球蛋白E(sIgE)水平相对较低(0.35至0.90 kU/L)。总的Phadiatop sIgE水平与所有变应原混合物联合的ImmunoCAP sIgE水平相关(r = 0.941,P < 0.001)或与每种变应原混合物相关,特别是hx2(r = 0.924)(所有P < 0.001),以0.53 kU/L作为临界值可优化Phadiatop检测的诊断性能,在识别对任何这些变应原混合物呈阳性的血清时,敏感性为89.4%,特异性为97.5%。

结论

总体而言,Phadiatop检测可有效检测对常见气传变应原混合物的致敏情况。鉴于目前中国对皮肤试验粗提物管理严格,将Phadiatop用作疑似特应性的一线检测可能具有成本效益。

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