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Thursday, Sep. 22, 2011

Tokyo firm devises easier test for sleeping sickness


BAMIKO, Mali — People suffering the final stages of trypanosomiasis, also known as sleeping sickness, can be drowsy all day and then suffer from a fever that keeps them up at night, health experts say. The disease, however, is hard to diagnose in its early stages because symptoms associated with it — headaches, joint pains and itching — are common to many illnesses.

Tokyo-based Eiken Chemical Co. launched technology last week at a trypanosomiasis conference in Mali that they said could make testing for sleeping sickness much easier for health workers and much less painful and frightening for patients, who normally have to go through a series of punctures in their lumbar region.

"The proper diagnosis of this disease is extremely important," said Sylvain Bieler of the nonprofit Foundation for Innovative New Diagnostics (FIND) that is supporting Eiken Chemical's efforts. "Because if it is not diagnosed and treated it is always fatal."

Sleeping sickness affects poor rural communities in sub-Saharan Africa. It is transmitted by the bite of the tsetse fly and about 60 million people in 36 countries are thought to be at risk, Eiken and FIND said in a joint statement.

The World Health Organization estimates that around 30,000 people currently have the illness.

Blood is usually examined under a microscope to confirm a patient has the disease, the company says. If the result is positive, spinal fluid needs to be collected to determine how far the disease has progressed. To obtain the spinal fluid a needle is inserted into a patient's back, a procedure known as a lumbar puncture. Four further lumbar punctures are needed — one every six months — to confirm that treatment has worked.

Eiken officials said the company has created a new method of testing that eliminates the need for blood samples to be examined under a microscope and which could also eliminate the need for the four followup lumbar punctures.

The new method of testing being introduced at the International Scientific Council for Trypanosomiasis Research and Control in Bamako uses a molecular technology — loop-mediated isothermal amplification (LAMP) — which involves the use of just one machine that can be operated by staff with very basic training, the company said.

"It sounds promising, but we haven't seen yet whether it works on the ground," said Dr. Victor Kane, head of the national sleeping sickness program in Congo, where the vast majority of sleeping sickness cases are found.

If, in the longer term, LAMP's promoters could also replace the spinal fluid tests now done to confirm treatment has been successful, it would be a major step forward, he said.

"Lumbar puncture really hurts," Kane said. "What's more, African tradition means some people refuse the procedure. Men think lumbar puncture can make them impotent and pregnant women think the procedure can harm their baby."

Eiken and FIND say the test is ready to enter accelerated field trials in Congo and Uganda. If tests there go well, they said the test may be available for clinical use next year.

Sylvain Bieler of FIND said that initially the tests should cost about $5 (about ¥380) each, but the cost could come down to $3 if sales volumes are high enough.

"We don't think price is going to be an obstacle to getting this product into the field," Bieler said.

Eiken and FIND said they also hope to develop LAMP-based tests for malaria and tuberculosis as well as other neglected African diseases such as leishmaniasis and schistosomiasis.

The proper diagnosis of these diseases would prevent patients from being prescribed drugs that they don't really need, the company said.

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