Rapid Immunochromatography Test for Serological Diagnosis of Melioidosis

Rapid Immunochromatography Test for Serological Diagnosis of Melioidosis

Department of Microbiology and Immunology, Faculty of Tropical Medicine, Mahidol University

Research Title:

Rapid Immunochromatography Test for Serological Diagnosis of Melioidosis

Researcher (s):

Phokrai P, Karoonboonyanan W, Thanapattarapairoj N, Promkong C, Dulsuk A, Koosakulnirand S, Canovali S, Indrawattana N, Jutrakul Y, Wuthiekanun V, Limmathurotsakul D, Brett PJ, Burtnick MN, Lertmemongkolchai G, Chantratita N

Melioidosis is a fatal infectious disease caused by the environmental bacterium Burkholderia pseudomallei. It is highly endemic in Asia and northern Australia but neglected in many other tropical countries. Melioidosis patients have a wide range of clinical manifestations, and definitive diagnosis requires bacterial culture, which can be time – consuming. A reliable rapid serological tool is greatly needed for disease surveillance and diagnosis. We previously demonstrated by enzyme-linked immunosorbent assay (ELISA) that a hemolysin – coregulated protein (Hcp1) is a promising target for serodiagnosis of melioidosis. In this study, we developed a rapid immunochromatography test (ICT) using Hcp1 as the target antigen (Hcp1 – ICT). We evaluated this test for specific antibody detection using serum samples obtained from 4 groups of human subjects, including the following: (i) 487 culture-confirmed melioidosis patients from four hospitals in northeast Thailand; (ii) 202 healthy donors from northeast Thailand; (iii) 90 U.S. healthy donors; and (iv) 207 patients infected with other organisms. Compared to culture results as a gold standard, the sensitivity of ICT for all hospitals was 88.3%. The specificities for Thai donors and U.S. donors were 86.1% and 100%, respectively, and the specificity for other infections was 91.8%. The results of the Hcp1-ICT demonstrated 92.4% agreement with the Hcp1-ELISA results with a kappa value of 0.829, indicating that the method is much improved compared with the current serological method, the indirect hemagglutination assay (IHA) (69.5% sensitivity and 67.6% specificity for Thais). The Hcp1-ICT represents a potential point-of-care (POC) test and may be used to replace the IHA for screening of melioidosis in hospitals as well as in resource-limited areas. A rapid Immunochromatography test (ICT) is a simple and reliable test for the detection of antibody to Hcp1 antigen produced by Burkholderia pseudomallei The test with a short turnaround time (within 15 minutes) helps to improve the speed of serological surveillance and clinical diagnosis of melioidosis. Early diagnosis is critical in the effective antimicrobial treatment and could reduce mortality from melioidosis.

Applied Research Project to Usage:

1.) A rapid immunochromatography test (ICT) is a simple and reliable diagnostic. The result can be interpreted within 15 minutes, The test with a short turnaround time helps to improve the speed of serological surveillance and clinical diagnosis of melioidosis. Early diagnosis is critical in the effective antimicrobial treatment and could reduce mortality from melioidosis.
2.) We have sold this product to microbiological laboratories in hospitals and to Thai and international companies.

Publishing:
•   1st Trop. Med. Quality Fair by Tropical Medicine, Mahidol University on 18 July 2018 at Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand.
•   The 10th International Exhibition of Inventions & 3rd World Invention and Innovation Forum on 13– 16 September 2018 at Foshan, China.
•   Inventors’ Day 2019 Bangkok International Intellectual Property, Invention, Innovation and Technology Exposition (IPITEx 2019) on 2 – 6 February 2019 at BITEC Exhibition centers, Bangkok, Thailand.
•   The Research and Innovation Sharing Market to Business Sectors on 25 February 2019 at Faculty of Public Health, Mahidol Univesity.
•   Thailand: MDA 2019 – The International Exhibition and Conference on Medical Device Technologies, Service Solutions and General Healthcare on 10 – 12 December 2019 at Impact Muengtong Thani Exhibition Center, Bangkok, Thailand.

Rapid Melioidosis Test

Intellectual Property Rights:
•   Request Patient Number 1701002552 “Rapid Immunochromatography Test for Serological Diagnosis of Melioidosis”

Award Grant related to the Project:
•   Outstanding Award from 1st TropMed Quality Fair by Faculty of Tropical Medicine, Mahidol University on 18 July 2018 at Faculty of Tropical Medicine, Mahidol University, Bangkok, Thailand
•   Gold Medal Award from the 10th International Exhibition of Inventions & 3rd World Invention and Innovation Forum on 13 – 15 September 2018 at Foshan, China
•   Outstanding Award from Citizen Innovation from Singapore, the 10th International Exhibition of Inventions & 3rd World Invention and Innovation Forum on 13 – 15 September 2018 at Foshan, China

Key Contact Person:
Assoc.Prof.Dr.Narisara Chantratita
narisara@tropmedres.ac
+668 1909 9772

Ms.Arphatsara Thamdib
arphatsara.musmee@gmail.com
+669 8987 9882

Ms.Suporn Puksanon
suporn.pak@mahidol.ac.th
+669 7131 9739