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      Development and usefulness of an immunochromatographic device to detect antibodies for rapid diagnosis of human gnathostomiasis

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          Abstract

          Background

          Human gnathostomiasis is a serious tropical disease, which is often overlooked. There is an urgent need to improve tools to aid the potential diagnosis of the disease in endemic regions. To overcome this, we produced the immunochromatographic test (ICT) kit for a rapid and simple diagnosis of human gnathostomiasis.

          Findings

          The recombinant protein (named rGslic18) was applied to ICT kit as the antigen. The diagnostic value of ICT kit was evaluated using serum samples from parasitologically proven and clinically suspected gnathostomiasis patients, healthy volunteers and patients with other parasitic diseases. The ICT kit exhibited quite high sensitivity (93.75 %) and specificity (97.01 %).

          Conclusions

          The ICT kit is simple, convenient and easy to implement and expected to provide reliable diagnostic results for human gnathostomiasis. It also will be a promising diagnostic tool not only for large-scale epidemiological surveys in endemic or remote areas where diagnostic facilities are poor but also for a rapid clinical diagnosis in the bedside laboratory.

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          Most cited references6

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          Evaluation of a rapid device for serological in-clinic diagnosis of canine angiostrongylosis

          Background Angiostrongylus vasorum is a potentially fatal canine nematode. Due to the high variability of clinical signs and the often chronic and subtle course of the infections, the diagnosis is particularly challenging. A rapid in-clinic assay (Angio Detect™ Test, IDEXX Laboratories, Westbrook, Maine, USA) for the serological detection of circulating antigen and intended for routine in-clinic diagnosis has been evaluated. Methods Sensitivity was calculated with sera from 39 naturally infected dogs confirmed by Baermann-Wetzel analysis, while sera of 38 experimentally infected dogs were used for follow-up analyses, of which 10 were treated with imidacloprid/moxidectin. Cross-reactivity was tested with a total of 123 samples from dogs with proven parasitic infections with Toxocara canis (n = 21), Ancylostoma caninum (n = 4), Crenosoma vulpis (n = 18), Oslerus osleri (n = 3), Eucoleus aerophilus, (n = 6), Dirofilaria immitis (n = 28), Dirofilaria repens (n = 20), Acantocheilonema reconditum (n = 10) or Dipetalonema dracunculoides (n = 10) or multiple infections (n = 3). All sera were tested with the Angio Detect™ Test and with an ELISA for detection of circulating antigen of A. vasorum. Results The sensitivity of the Angio Detect™ Test was 84.6% (95% C.I. 69.5 - 94.1%), while specificity was 100% (95% C.I. 97.6 - 100%). The sensitivity of the ELISA (94.9%, 95% C.I. 82.7 – 99.3%) was comparable with previous evaluations. In experimentally infected dogs, earliest positive results with the Angio Detect™ Test were observed 9 weeks post inoculation and 5 weeks later all sera were Angio Detect™ Test positive. After anthelmintic treatment, seropositive dogs turned negative again within 3 to 7 weeks after treatment. The evaluation of the colour intensity of the test strips confirmed the delay of approximately 3-4 weeks for antigen detection by the Angio Detect™ Test compared to the ELISA and its correlation with the time after infection. Conclusions This study provided evidence of a good sensitivity and a very high specificity of the rapid device Angio Detect™ Test for detection of circulating A. vasorum antigen in dogs with suspected canine angiostrongylosis, representing a very simple and useful tool to be broadly applied in veterinary practices. The rapid detection of infected dogs is a key point for initiating an indispensable and urgent therapy.
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            Immunoblot diagnostic test for neurognathostomiasis.

            Neurognathostomiasis is a rare but severe form of human gnathostomiasis. Diagnosis of neurognathostomiasis is made presumably by using clinical manifestations. Serologic tests for neurognathostomiasis are not widely available and limited. We studied 12 patients with diagnoses of neurognathostomiasis at Srinagarind Hospital, Khon Kaen University, Thailand. There were three types of neurognathostomiasis (five patients with intracerebral hemorrhage, one patient with subarachnoid hemorrhage, and six patients with myelitis). All patients were tested for antibodies against Gnathostoma spinigerum by an immunoblotting technique. The sensitivity and specificity of the 21-kD and 24-kD diagnostic bands were 83.3% and 100%, and 91.7% and 100%, respectively. The sensitivity, specificity, positive predictive value, and negative predictive value for the 21-kD and 24-kD diagnostic bands were all 100%. Both diagnostic bands are a helpful diagnostic tool for neuro gnathostomiasis and show good diagnostic properties.
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              A comparative evaluation of the performance of commercially available rapid immunochromatographic tests for the diagnosis of visceral leishmaniasis in Bangladesh

              Background Accurate and early diagnosis of Visceral Leishmaniasis (VL) is a prerequisite for proper treatment and restricting disease propagation in enldemic foci. An rK39 antigen-based immunochromatographic test is now recommended for its diagnostic accuracy and operational feasibility at point of care. In endemic regions of Bangladesh, rK39 or rKE16 antigen-based Rapid Diagnostic Tests (RDTs) are routinely performed on whole blood for diagnosis of VL. However, manufacturer’s instructions require use of serum. Therefore, we wanted to assess whether the diagnostic accuracy of these RDTs is as good on whole blood as on serum. Methods We evaluated and compared the sensitivity and specificity of five different commercially available RDTs on whole blood and on serum. We enrolled 30 VL patients, 35 endemic healthy controls and 30 Tuberculosis (TB) patients in our study from Mymensingh, a hyper-endemic region in Bangladesh. Results The sensitivity of all RDTs ranged between 96.67 % (95 % CI: 82.72-99.44 %) and 100 % (95 % CI: 96.34-100 %). The specificity ranged between 93.85 % (95 % CI: 84.97-98.26 %) and 98.46 % (95 % CI: 91.69-99.74 %), except for the Onsite leishmania Ab (Rev B) kit which showed markedly lower specificity (31.25-58.46 %). There was no significant difference in sensitivity and specificity between blood and serum. The Cohen kappa index (k >0.97) indicated excellent agreement. Conclusions We conclude from the study that the use of blood for RDT in lieu of serum is appropriate for diagnosis of VL in peripheral endemic regions provided the manufacturer recommendations are followed and the RDT is of good quality.
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                Author and article information

                Contributors
                pair.wu@gmail.com
                pewpan@kku.ac.th
                hyamasak@niid.go.jp
                rutchanee5020@gmail.com
                porlau@kku.ac.th
                thanchomnang@yahoo.com
                sanpoolor@yahoo.com
                k-kobayashi@adtec-inc.co.jp
                k-takayama@adtec-inc.co.jp
                y-kobayashi@adtec-inc.co.jp
                wanch_ma@kku.ac.th
                Journal
                Parasit Vectors
                Parasit Vectors
                Parasites & Vectors
                BioMed Central (London )
                1756-3305
                12 January 2016
                12 January 2016
                2016
                : 9
                : 14
                Affiliations
                [ ]Research and Diagnostic Center for Emerging Infectious Diseases, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002 Thailand
                [ ]Department of Medical Technology, School of Allied Health Sciences and Public Health, Walailak University, Nakhon Si Thammarat, 80161 Thailand
                [ ]Department of Parasitology, Faculty of Medicine, Khon Kaen University, Khon Kaen, 40002 Thailand
                [ ]Department of Parasitology, National Institute of Infectious Diseases, Tokyo, 162-8640 Japan
                [ ]Faculty of Medicine, Mahasarakham University, Mahasarakham, 44000 Thailand
                [ ]Division of Research and Development, Adtec Inc., Oita, 879-0471 Japan
                Article
                1294
                10.1186/s13071-016-1294-y
                4710017
                26754616
                8ea835cd-4e53-4093-b44d-eb5a8f98182c
                © Janwan et al. 2016

                Open AccessThis article is distributed under the terms of the Creative Commons Attribution 4.0 International License ( http://creativecommons.org/licenses/by/4.0/), which permits unrestricted use, distribution, and reproduction in any medium, provided you give appropriate credit to the original author(s) and the source, provide a link to the Creative Commons license, and indicate if changes were made. The Creative Commons Public Domain Dedication waiver ( http://creativecommons.org/publicdomain/zero/1.0/) applies to the data made available in this article, unless otherwise stated.

                History
                : 24 December 2015
                : 30 December 2015
                Funding
                Funded by: FundRef , the Higher Education Research Promotion and the National Research University Project of Thailand, Office of the Higher Education Commission, Thailand through the Health Cluster (SHeP-GMS);
                Funded by: FundRef , the Faculty of Medicine, Khon Kaen University;
                Award ID: RRU57201
                Award Recipient :
                Funded by: FundRef , the Thailand Research Fund through the Royal Golden Jubilee Ph.D. Program;
                Award ID: PHD/0053/2556
                Award Recipient :
                Funded by: FundRef , the Postdoctoral Training Program Graduate School and Khon Kaen University, Khon Kaen University;
                Award ID: 58101
                Award Recipient :
                Funded by: FundRef , the TRF Senior Research Scholar Grant, Thailand Research Fund;
                Award ID: RTA5880001
                Award Recipient :
                Funded by: FundRef , the TRF Senior Research Scholar Grant, Thailand Research Fund;
                Award ID: RTA5880001
                Award Recipient :
                Funded by: FundRef , the TRF Senior Research Scholar Grant, Thailand Research Fund;
                Award ID: RTA5880001
                Award Recipient :
                Funded by: FundRef , Grants-in-Aid for Scientific Research from the Ministry of Health, Labour and Welfare, Japan (H25~H26-Shinko-Ippan-009) and Research Program on Emerging and Re-emerging Infectious Diseases from Japan Agency for Medical Research and Development;
                Categories
                Short Report
                Custom metadata
                © The Author(s) 2016

                Parasitology
                gnathostoma spinigerum,human gnathostomiasis,immunochromatographic test kit,serodiagnosis,recombinant protein

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