Evaluation of a newly developed lateral flow immunoassay for the diagnosis of cryptococcosis.

Evaluation of a newly developed lateral flow immunoassay for the diagnosis of cryptococcosis.
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DOI:
10.1093/cid/cir379
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发表时间:
2011-08
期刊:
Clinical infectious diseases : an official publication of the Infectious Diseases Society of America
影响因子:
--
通讯作者:
Poonwan N
Poonwan N
中科院分区:
其他
文献类型:
--
作者:
Lindsley MD;Mekha N;Baggett HC;Surinthong Y;Autthateinchai R;Sawatwong P;Harris JR;Park BJ;Chiller T;Balajee SA;Poonwan N

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本研究评价了一种新型隐球菌侧流免疫测定法的性能,表明该测定法与现有诊断方法一样经济、快速且易于执行;因此可以在资源有限的环境中进行即时检测。背景:隐球菌病是人类免疫缺陷病毒(HIV)感染者常见的机会性感染,主要发生在资源有限的国家。 本研究比较了最近开发的侧流免疫测定法(LFA)与血培养和酶免疫测定法(EIA)诊断隐球菌病的性能。方法:使用EIA检测了704名因急性呼吸道疾病住院的泰国HIV感染患者的存档血清中隐球菌抗原血症。 通过LFA检测所有EIA阳性和EIA阴性血清子集,并在孵育5分钟和15分钟后记录结果。用LFA检测来自具有LFA和EIA阳性血清的患者的尿液。比较隐球菌血培养阳性患者的抗原结果。结果:在704份血清中,EIA检测92份(13%)为阳性;在LFA检测的91份EIA阳性血清中,分别有82份(90%)和87份(96%)在5分钟和15分钟后读取时为LFA阳性。 EIA和LFA对血清的Kappa一致性在5分钟后为0.923,在15分钟后为0.959。373例EIA阴性血清中有2例在两个时间点均为LFA阳性。在EIA阳性的74份尿标本中,52份(70.3%)为LFA阳性。EIA在17份血培养阳性患者血清中有16份阳性(94%敏感性),所有血清均为LFA阳性(100%敏感性)。结论:血清LFA和EIA检测之间有很高的一致性。 LFA是一种快速、易于执行的检测方法,不需要冷藏,证明了其作为资源有限国家隐球菌病诊断的即时检测方法的潜在有用性。
This study, evaluating the performance of a novel cryptococcal lateral flow immunoassay, shows that the assay performs as well as available diagnostic methods is economical, rapid, and easy to perform; and as such can be a point of care test in resource limited settings. Background. Cryptococcosis is a common opportunistic infection of human immunodeficiency virus (HIV)–infected individuals mostly occurring in resource-limited countries. This study compares the performance of a recently developed lateral flow immunoassay (LFA) to blood culture and enzyme immunoassay (EIA) for the diagnosis of cryptococcosis. Methods. Archived sera from 704 HIV-infected patients hospitalized for acute respiratory illness in Thailand were tested for cryptococcal antigenemia using EIA. All EIA-positive and a subset of EIA-negative sera were tested by LFA, with results recorded after 5 and 15 minutes incubation. Urine from patients with LFA- and EIA-positive sera was tested by LFA. Antigen results from patients with positive cryptococcal blood cultures were compared. Results. Of 704 sera, 92 (13%) were positive by EIA; among the 91 EIA-positive sera tested by LFA, 82 (90%) and 87 (96%) were LFA positive when read after 5 and 15 minutes, respectively. Kappa agreement of EIA and LFA for sera was 0.923 after 5 minutes and 0.959 after 15 minutes, respectively. Two of 373 EIA-negative sera were LFA positive at both time points. Of 74 urine specimens from EIA-positive patients, 52 (70.3%) were LFA positive. EIA was positive in 16 of 17 sera from blood culture–positive patients (94% sensitivity), and all sera were positive by LFA (100% sensitivity). Conclusions. A high level of agreement was shown between LFA and EIA testing of serum. The LFA is a rapid, easy-to-perform assay that does not require refrigeration, demonstrating its potential usefulness as a point-of-care assay for diagnosis of cryptococcosis in resource-limited countries.
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发表时间: 1997-10-01
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