Major breakthrough: LAMP test opens new paths to malaria elimination

Geneva, Switzerland – 17 May 2013 – Two articles1 published this week in the Journal for Infectious Diseases describe a highly accurate new test to detect malaria parasites in blood. The test, called LAMP2, detects malaria down to a very low threshold in people infected with the parasite, whether performed in a state-of-the-art laboratory in London or a remote clinic in rural Africa. This LAMP malaria assay is the first that is commercially available, and the first that does not require refrigeration.

Malaria remains a serious public health problem across tropical and sub-tropical areas of the globe. However, recent advances in malaria control and declining transmission have raised a real possibility of regional elimination in many areas, and the need for new, highly sensitive, diagnostic methods that can be used in remote field locations. Such diagnostics were identified as a key priority by international scientists and experts of the global MalERA initiative (Malaria Eradication Research Agenda), convened by the Bill and Melinda Gates Foundation to provide guidance for malaria elimination.

Visualizing malaria parasites under a microscope has been the standard method of malaria diagnosis for 120 years. More recently, in the 1990s, antigen-detecting tests, called rapid diagnostic tests (RDTs), became available and are now widely used in endemic areas. However, neither microscopy nor RDTs allow detection of very low levels of malaria infection. Up to now, highly sensitive detection has only been available through the use of PCR (polymerase chain reaction), a sophisticated laboratory technique for the detection of genetic material. PCR, while highly accurate, requires specialized laboratory infrastructure, costly reagents, advanced training, and several hours or even days to obtain results.

LAMP, on the other hand, achieves an accuracy similar to PCR but can be done on a simple benchtop in a clinic, with basic reagents and equipment, by personnel with only a few days’ training in the technique. Results are available just one hour after sample processing begins.

“The new ability to detect these hidden malaria infections in the field opens exciting new possibilities for malaria elimination programs, and has potential to improve screening of high-risk groups such as pregnant women,” says David Bell, Head of the Malaria and Acute Febrile Syndrome Programme at FIND. “Its simplicity compared to other highly sensitive methods also makes it possible for developing country programmes to be more independent of outside support for disease screening. The technology is already having an impact in the management of sleeping sickness in Africa; there is potential for rapidly improving the detection of many other diseases without the need for continuing, high-cost external support.”

One of the newly published studies was conducted at the Hospital for Tropical Diseases (HTD), the national reference centre for parasitic diseases in the UK, and the other in Uganda, an East African country with high levels of malaria transmission. In London, patients tested were symptomatic travellers returning from endemic areas; in Uganda, samples were taken from patients presenting with fever at a rural clinic. In both settings, samples were tested with LAMP. All samples were then sent to the HTD laboratory for testing with traditional PCR. As reported in the papers, the accuracy of LAMP performed both in the London laboratory and in the rural Ugandan clinic was equivalent to that of PCR down to very low levels of infection.

The LAMP procedure’s relative simplicity and low infrastructure costs bring high-sensitivity parasite detection within reach of national malaria control programmes, providing a new tool for diagnosis, surveillance, and screening. In endemic areas, LAMP allows investigation of ‘hot-spots’ of transmission in real-time, so that positive cases can be treated immediately and transmission can be stopped. In addition, LAMP could be used for testing in pregnancy, monitoring for antimalarial drug resistance, screening in vaccine trials, and evaluating other diagnostics. In areas outside malaria transmission zones, LAMP will provide accurate and rapid diagnosis for returning travellers.

“Patterns of malaria disease in Africa and elsewhere across the tropics are becoming much less predictable, and control of malaria needs an appropriate test to identify infected individuals, who often do not have any symptoms, in the populations at risk,” says Dr. Colin Sutherland, Clinical Scientist at HTD and Head of the Department of Immunology and Infection at the London School of Hygiene and Tropical Medicine. “We have begun using LAMP as a new tool for identifying “hot spots” of malaria infections which can be mopped up quickly through a combination of drug treatment, house spraying and distribution of bed-nets. LAMP will thus potentially contribute to saving many families and communities from the blight of malaria. It is a blight on communities because this disease keeps children from succeeding at school, prevents adults from growing food and working, holds back regional economies and exacts an annual death toll in the hundreds of thousands.”

The LAMP malaria assay was developed by the Foundation for Innovative New Diagnostics, with the Hospital for Tropical Diseases (HTD),  London, UK, the London School of Hygiene and Tropical Medicine, and Eiken Chemical Company, Ltd., Japan.

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References:

1) Scientific article on LAMP performed at HTD, London, UK:
http://jid.oxfordjournals.org/content/early/2013/04/30/infdis.jit183.abstract?keytype=ref;
Scientific article on LAMP performed in a rural clinic in Uganda, East Africa:http://jid.oxfordjournals.org/content/early/2013/04/30/infdis.jit184.abstract?keytype=ref

2) LAMP is the abbreviation for ‘loop-mediated isothermal amplification’

Eiken
Eiken Chemical Co., Ltd., has over 60 years of experience in medical diagnostics and was the first Japanese company to successfully commercialize the manufacture of powdered culture media for microbiological investigations. The company has established itself as a leader in the clinical diagnostics market and has a strong commitment to research and development toward products and technologies that fill needs at the cutting edge of contemporary medicine. The LAMP technology, developed at Eiken in 1998, is now a core technology being exploited to develop a range of products. www.eiken.co.jp/en/

London School of Hygiene & Tropical Medicine
The London School of Hygiene & Tropical Medicine is a world-leading centre for research and postgraduate education in public and global health, with 3,500 students and more than 1,000 staff working in over 100 countries. The School is one of the highest-rated research institutions in the UK and was recently cited as one of the world’s top universities for collaborative research. The School’s mission is to improve health and health equity in the UK and worldwide; working in partnership to achieve excellence in public and global health research, education and translation of knowledge into policy and practice. www.lshtm.ac.uk