First-Ever Rapid Test to Screen Malaria Infection in Asymptomatic Individuals Launched

First-Ever Rapid Test to Screen Malaria Infection in Asymptomatic Individuals Launched

Alere Inc, a global leader in rapid diagnostics has launched a highly sensitive malaria diagnostic test that will help healthcare workers detect infection in people with mild (or no) symptoms helping curb the spread of malaria within families and communities.

The new test is ten times as sensitive in the detection of histidine rich protein II (HRP-II) antigen of Plasmodium falciparum, which will enable better identification of individuals with very low parasitemia, many of whom may be without evident symptoms of malaria infection.

Dubbed Alere™ Malaria Ag P.f, this new test is a major technological breakthrough in high-sensitivity rapid testing versus the currently available malaria tests and will aid the implementation of surveillance and mass screen-and-treat programs that are critical for accelerating malaria elimination.

“Breaking the cycle of malaria transmission requires identifying all infected individuals, but until now, point-of-care diagnostic tests have not been sensitive enough to reliably detect asymptomatic infections,” said Avi Pelossof, Alere’s Global President of Infectious Disease.

The development of the Alere Malaria Ag P.f has been supported by the Bill & Melinda Gates Foundation, which has identified a test to uncover the asymptomatic reservoir as a key component of its malaria strategy.

“The Alere Malaria Ag P.f represents a game-changing tool to empower healthcare workers to identify asymptomatic individuals in even the most remote settings, contributing to a reduced malaria reservoir in communities – key strategies in eliminating this devastating disease.”

Alere and the Gates Foundation are partnering to generate field data to demonstrate the public health value of the test. Clinical evaluation and technical support was also provided by PATH and FIND. The test was granted CE marking in December 2016, and was evaluated during Round 7 of the WHO FIND Malaria RDT Evaluation Program.

“We are excited by the potential for this product to address one of the barriers identified on the path to malaria eradication – the non-acute disease reservoir that complicates efforts to stop transmission,” said Dr. Bruno Moonen, Deputy Director of the Malaria program at the Bill & Melinda Gates Foundation.

“Until now, we haven’t had a tool to tackle this challenge in low-transmission settings. Added to existing RDTs, prevention methods and treatments that reduce disease burden in high- and medium-transmission settings, this test will add a new tool to the fight against malaria.”

“Improving our ability to detect and define the transmissible reservoir of malaria in a community is critical to inform evidence-based strategies to eliminate malaria. A test that can produce immediate sensitive results even in rural and remote settings represents a significant advance in our ability to do this for Plasmodium falciparum malaria and as such is a valuable tool for malaria elimination,” said Gonzalo Domingo, lead of malaria diagnostics, PATH.  “We now have an opportunity to better understand where and how this test can best impact the reduction of the malaria burden world-wide.”

“Elimination of malaria rests on our ability to identify asymptomatic malaria infections,” noted Catharina Boehme, CEO of FIND. “This test is a valuable addition to the malaria elimination toolkit. Looking forward, we are excited to see the results of our forthcoming demonstration studies, as these will provide valuable insights into how this test can have the biggest positive impact.”