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      Evaluation of a Newly Developed Lateral Flow Immunoassay for the Diagnosis of Cryptococcosis

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          Abstract

          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.

          Abstract

          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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          Point-of-care tests for diagnosing infections in the developing world.

          R Peeling, David Mabey (2010)
          Infectious diseases continue to cause an enormous burden of death and disability in developing countries. Increasing access to appropriate treatment for infectious diseases could have a major impact on disease burden. Some common infections can be managed syndromically without the need for diagnostic tests, but this is not appropriate for many infectious diseases, in which a positive diagnostic test is needed before treatment can be given. Since many people in developing countries do not have access to laboratory services, diagnosis depends on the availability of point of care (POC) tests. Historically there has been little investment in POC tests for diseases that are common in developing countries, but that is now changing. Lack of regulation of diagnostic tests in many countries has resulted in the widespread use of sub-standard POC tests, especially for malaria, making it difficult for manufacturers of reliable POC tests to compete. In recent years increased investment, technological advances, and greater awareness about the importance of reliable diagnostic tests has resulted in rapid progress. Rapid, reliable and affordable POC tests, requiring no equipment and minimal training, are now available for HIV infection, syphilis and malaria, but POC tests for other infections are urgently needed. Many countries do not have established criteria for licensing and introducing new diagnostic tests, and many clinicians in developing countries have become disillusioned with diagnostic tests and prefer to rely on clinical judgment. Continuing advocacy and training in the use of POC tests are needed, and systems for quality control of POC tests need to be developed if they are to achieve their maximum potential.
          Article 0 comments Cited 144 times – based on 0 reviews     Review now
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            The ICT Filariasis Test: A rapid-format antigen test for diagnosis of bancroftian filariasis.

            G J Weil, P Lammie, N. Weiss (1997)
            Antigen testing is now recognized as the method of choice for detection of Wuchereria bancrofti infections. Unlike tests that detect microfilariae, antigen tests can be performed with blood collected during the day or night. However, existing enzyme-linked immunosorbent assay (ELISA) tests for filarial antigenemia are difficult to perform in the field, and this has limited their use in endemic countries. In this article, Gary Weil, Patrick Lammie and Niggi Weiss review their experience with a new rapid-format filarial antigen test. They found that the ICT card test was very easy to perform and that it was comparable with ELISA for the detection of filarial antigen in sera from people with microfilaremia. The introduction now of an antigen test suitable for use in the field is especially timely, in that it may facilitate implementation of new strategies proposed by the World Health Organization for control and elimination of lymphatic filariasis.
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              Current diagnosis of histoplasmosis.

              L. Joseph Wheat (2003)
              Histoplasmosis is a common infection endemic in many regions of America, Asia, India and Africa, with sporadic cases also occurring throughout the world. Although excellent laboratory methods for diagnosis are available, there are deficiencies that must be met by continued research. Clinicians and laboratory directors must be familiar with the uses and limitations of a battery of serologic and mycological tests to accurately diagnose histoplasmosis. Research is needed to reduce false-negative and false-positive results, and to improve the identification of the organism in tissues. Approaches to the diagnosis of histoplasmosis and areas that require further research will be reviewed.
              Article 0 comments Cited 55 times – based on 0 reviews     Review now
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                Author and article information

                Journal
                Journal ID (nlm-ta): Clin Infect Dis
                Journal ID (hwp): cid
                Journal ID (publisher-id): cid
                Title: Clinical Infectious Diseases: An Official Publication of the Infectious Diseases Society of America
                Publisher: Oxford University Press
                ISSN (Print): 1058-4838
                ISSN (Electronic): 1537-6591
                Publication date (Print): 15 August 2011
                Publication date PMC-release: 15 August 2011
                Volume: 53
                Issue: 4
                Pages: 321-325
                Affiliations
                [1 ]Mycotic Diseases Branch, Centers for Disease Control and Prevention, Atlanta, Georgia
                [2 ]National Institute of Health, Department of Medical Sciences, Ministry of Public Health, Nonthaburi, Thailand
                [3 ]International Emerging Infections Program, Thailand Ministry of Public Health–Centers for Disease Control and Prevention Collaboration, Nonthaburi, Thailand
                Author notes
                Correspondence: S. Arunmozhi Balajee, MD, PhD, Mycotic Diseases Branch, Centers for Disease Control and Prevention, Mailstop G11, 1600 Clifton Rd, Atlanta, GA 30333 ( fir3@ 123456cdc.gov ).
                Article
                DOI: 10.1093/cid/cir379
                PMC ID: 3148258
                PubMed ID: 21810743
                SO-VID: f7aa30fe-fa6f-45e5-9b7f-90757496efed
                Copyright © Published by Oxford University Press on behalf of the Infectious Diseases Society of America 2011.
                License:

                This is an Open Access article distributed under the terms of the Creative Commons Attribution Non-Commercial License ( http://creativecommons.org/licenses/by-nc/2.5/), which permits unrestricted non-commercial use, distribution, and reproduction in any medium, provided the original work is properly cited.

                History
                Date received : 4 March 2011
                Date accepted : 29 April 2011
                Categories
                Subject: Articles and Commentaries

                ScienceOpen disciplines: Infectious disease & Microbiology
                Data availability:
                ScienceOpen disciplines: Infectious disease & Microbiology

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