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Malaria test granted CE mark

Malaria-infected cell bursting

Image by Peter H. Seeberger

A malaria test called illumigene® Malaria has received the CE mark, which suggests it meets European health and safety standards.

illumigene Malaria is a molecular test that involves the use of loop-mediated isothermal amplification (LAMP) technology.

According to the test’s developers, it provides results in under an hour, doesn’t require a high level technical expertise, and is up to 80,000 times more sensitive than conventional malaria tests.

illumigene Malaria was developed by Meridian Bioscience, Inc., with technical assistance from the US Centers for Disease Control and Prevention (CDC) and Cheikh Anta Diop University in Dakar, Senegal.

“illumigene Malaria has the potential to change current practices,” said Daouda NDIAYE, PharmD, PhD, of Cheikh Anta Diop University.

“Faster and more accurate diagnosis is vital in the fight against malaria. Earlier diagnosis enables the correct treatment to be prescribed, which leads to better clinical outcomes for the person with malaria and keeps malaria treatments for the right people.”

“Because of submicroscopic parasitemia carriage among the populations, a robust, sensitive, and field-community-deployable screening tool is needed to track the malaria reservoir in pre-elimination regions.  illumigene Malaria shows this capacity.”

illumigene Malaria uses LAMP technology to amplify DNA and detect the presence of the malaria parasite.

LAMP technology is isothermal and can be used at room temperature without the need to heat reagents or the material being tested, unlike the rapid diagnostic tests currently used in malaria, which use polymerase chain reaction technology. illumigene Malaria does not require refrigeration.

Meridian Bioscience has worked with experts at the CDC and the Cheikh Anta Diop University of Dakar during the development of illumigene Malaria and collaborated with these organizations to design clinical trials.

According to Meridian, data from more than 200 patients in Senegal validated the performance of illumigene Malaria. The test demonstrated 100% sensitivity and detected infected patients that were missed by conventional testing methods.

Meridian said illumigene Malaria will be distributed in the European, Middle Eastern, and African regions by Meridian Bioscience Europe and in additional international markets by the company’s global distribution network.

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Malaria-infected cell bursting

Image by Peter H. Seeberger

A malaria test called illumigene® Malaria has received the CE mark, which suggests it meets European health and safety standards.

illumigene Malaria is a molecular test that involves the use of loop-mediated isothermal amplification (LAMP) technology.

According to the test’s developers, it provides results in under an hour, doesn’t require a high level technical expertise, and is up to 80,000 times more sensitive than conventional malaria tests.

illumigene Malaria was developed by Meridian Bioscience, Inc., with technical assistance from the US Centers for Disease Control and Prevention (CDC) and Cheikh Anta Diop University in Dakar, Senegal.

“illumigene Malaria has the potential to change current practices,” said Daouda NDIAYE, PharmD, PhD, of Cheikh Anta Diop University.

“Faster and more accurate diagnosis is vital in the fight against malaria. Earlier diagnosis enables the correct treatment to be prescribed, which leads to better clinical outcomes for the person with malaria and keeps malaria treatments for the right people.”

“Because of submicroscopic parasitemia carriage among the populations, a robust, sensitive, and field-community-deployable screening tool is needed to track the malaria reservoir in pre-elimination regions.  illumigene Malaria shows this capacity.”

illumigene Malaria uses LAMP technology to amplify DNA and detect the presence of the malaria parasite.

LAMP technology is isothermal and can be used at room temperature without the need to heat reagents or the material being tested, unlike the rapid diagnostic tests currently used in malaria, which use polymerase chain reaction technology. illumigene Malaria does not require refrigeration.

Meridian Bioscience has worked with experts at the CDC and the Cheikh Anta Diop University of Dakar during the development of illumigene Malaria and collaborated with these organizations to design clinical trials.

According to Meridian, data from more than 200 patients in Senegal validated the performance of illumigene Malaria. The test demonstrated 100% sensitivity and detected infected patients that were missed by conventional testing methods.

Meridian said illumigene Malaria will be distributed in the European, Middle Eastern, and African regions by Meridian Bioscience Europe and in additional international markets by the company’s global distribution network.

Malaria-infected cell bursting

Image by Peter H. Seeberger

A malaria test called illumigene® Malaria has received the CE mark, which suggests it meets European health and safety standards.

illumigene Malaria is a molecular test that involves the use of loop-mediated isothermal amplification (LAMP) technology.

According to the test’s developers, it provides results in under an hour, doesn’t require a high level technical expertise, and is up to 80,000 times more sensitive than conventional malaria tests.

illumigene Malaria was developed by Meridian Bioscience, Inc., with technical assistance from the US Centers for Disease Control and Prevention (CDC) and Cheikh Anta Diop University in Dakar, Senegal.

“illumigene Malaria has the potential to change current practices,” said Daouda NDIAYE, PharmD, PhD, of Cheikh Anta Diop University.

“Faster and more accurate diagnosis is vital in the fight against malaria. Earlier diagnosis enables the correct treatment to be prescribed, which leads to better clinical outcomes for the person with malaria and keeps malaria treatments for the right people.”

“Because of submicroscopic parasitemia carriage among the populations, a robust, sensitive, and field-community-deployable screening tool is needed to track the malaria reservoir in pre-elimination regions.  illumigene Malaria shows this capacity.”

illumigene Malaria uses LAMP technology to amplify DNA and detect the presence of the malaria parasite.

LAMP technology is isothermal and can be used at room temperature without the need to heat reagents or the material being tested, unlike the rapid diagnostic tests currently used in malaria, which use polymerase chain reaction technology. illumigene Malaria does not require refrigeration.

Meridian Bioscience has worked with experts at the CDC and the Cheikh Anta Diop University of Dakar during the development of illumigene Malaria and collaborated with these organizations to design clinical trials.

According to Meridian, data from more than 200 patients in Senegal validated the performance of illumigene Malaria. The test demonstrated 100% sensitivity and detected infected patients that were missed by conventional testing methods.

Meridian said illumigene Malaria will be distributed in the European, Middle Eastern, and African regions by Meridian Bioscience Europe and in additional international markets by the company’s global distribution network.

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