背景:现场,快速,指尖,全血即时检验(POCT)由于其简单性,对于在初级保健中积极发现乳糜泻(CD)的病例很有吸引力.
目的:本文的目的是评估使用基于脱酰胺化麦醇溶蛋白肽抗体(IgA/IgG-DGP)的POCT在初级保健中用于CD诊断的成人病例发现的有用性和成本效益。
方法:使用易于使用的CD进行了病例发现研究,现场,350例基于IgA/IgG-DGP的指尖POCT与tTG2的全血比较。样本量基于参考人群中0.28%的患病率计算。用于组织学的十二指肠活检,如果tTG2和/或POCT阳性,则获得上皮内淋巴细胞和tTG2的原位沉积。计算了使用血清学或POCT的策略的准确性和成本效益。
结果:CD的患病率为1.14%(95%CI,0.3-3.4),几乎是以前观察到的两倍。4例患者被诊断为CD。tTG2阳性3例(0.85%),POCT阳性29例(8.2%)。POCT对CD的敏感性为100%,特异性93%,PPV14%,和NPV100%。POCT后十二指肠活检是我们设置中最具成本效益的方法(标准诊断:€13,033/例;POCT+十二指肠活检:€7360/例)。
结论:阴性POCT允许在初级保健中排除CD,使其适合案件调查。POCT战略是最具成本效益的。
BACKGROUND: An on-site, rapid, fingertip, whole-blood point-of-care test (POCT) is attractive for active
case-finding of coeliac disease (CD) in primary care because of its simplicity.
OBJECTIVE: The aim of this article is to assess the usefulness and cost-effectiveness of adult
case-finding using a POCT based on deamidated gliadin peptide antibodies (IgA/IgG-DGP) in primary care for CD diagnosis.
METHODS: A
case-finding study for CD was conducted by using an easy-to-use, on-site, whole-blood for IgA/IgG-DGP-based fingertip POCT compared with tTG2 in 350 individuals. Sample size was calculated based on 0.28% prevalence in the reference population. Duodenal biopsies for histology, intraepithelial lymphocytes and in situ deposition of tTG2 were obtained if tTG2 and/or POCT were positive. Accuracy and cost-effectiveness of strategies using serology or POCT were calculated.
RESULTS: Prevalence of CD was 1.14% (95% CI, 0.3-3.4), almost double what was previously observed. Four patients were diagnosed with CD. tTG2 was positive in three (0.85%) and POCT in 29 (8.2%). Sensitivity of POCT for CD was 100%, specificity 93%, PPV 14%, and NPV 100%. POCT followed by duodenal biopsy was the most cost-effective approach in our setting (standard diagnosis: €13,033/
case; POCT + duodenal biopsy: €7360/
case).
CONCLUSIONS: A negative POCT allows ruling out CD in primary care, making it suitable for case-finding. POCT strategy was the most cost effective.