进口血清学检测试剂盒在日本人群中对幽门螺杆菌感染的诊断准确性不足。

Insufficient diagnostic accuracy of imported serological kits for Helicobacter pylori infection in Japanese population.

作者信息

Miwa H, Kikuchi S, Ohtaka K, Kobayashi O, Ogihara A, Hojo M, Nagahara A, Sato N

机构信息

Department of Gastroenterology, Juntendo University, School of Medicine, 2-1-1, Hongo, Bunkyo-ku, Tokyo, Japan.

出版信息

Diagn Microbiol Infect Dis. 2000 Feb;36(2):95-9. doi: 10.1016/s0732-8893(99)00143-1.

DOI:10.1016/s0732-8893(99)00143-1

PMID:10705050

Abstract

Although there are many reports of the high diagnostic accuracy of commercially available serologic kits for Helicobacter pylori infection in Western countries, they rarely has been investigated in oriental population. Accordingly we examined their usefulness in 492 Japanese patients with dyspeptic symptoms. Diagnostic accuracy of 4 imported serologic kits (HEL-p TEST, HM CAP, G.A.P IgG, Helico G2) was investigated using the (13)C-urea breath test as the gold standard. When intermediate results were excluded, the sensitivity, specificity and accuracy of these serologic tests ranged from 88.6% to 97.8%, 67.9% to 85.9%, and 87.9% to 91.4%, respectively, which were comparable with reported median accuracy in the Western population. However, there were many intermediate results in these tests, ranging from 5.3% to 23.0%. Their usefulness seemed to be limited in our patient population because of the large number of intermediate results.

摘要

虽然在西方国家有许多关于市售幽门螺杆菌感染血清学检测试剂盒诊断准确性高的报道，但在东方人群中对其研究甚少。因此，我们对492例有消化不良症状的日本患者检测了这些试剂盒的效用。以碳-13尿素呼气试验作为金标准，研究了4种进口血清学检测试剂盒（HEL-p TEST、HM CAP、G.A.P IgG、Helico G2）的诊断准确性。排除中间结果后，这些血清学检测的敏感性、特异性和准确性分别为88.6%至97.8%、67.9%至85.9%和87.9%至91.4%，与西方人群中报道的中位准确性相当。然而，这些检测中有许多中间结果，范围从5.3%至23.0%。由于中间结果数量众多，它们在我们的患者群体中的效用似乎有限。