Press release

pLDH recombinant panels for malaria diagnostic tests

Bernried am Starnberger See, Germany & Geneva, Switzerland – 08 January 2018 – Microcoat Biotechnologie GmbH and FIND are pleased to announce the commercial launch of the Plasmodium falciparum and P. vivax lactate dehydrogenase (pLDH) recombinant panels for malaria diagnostic tests. The recombinant panels are being made commercially available to facilitate the assessment of malaria rapid diagnostic tests (RDTs) available on the market.

Malaria, which is caused by Plasmodium parasites, is one of the four most burdensome infectious diseases globally. In 2016, the disease caused an estimated 216 million cases and 445,000 deaths (World Malaria Report 2017). Malaria RDTs present a reliable malaria diagnosis method and allow for the discrimination between the two most common and fatal Plasmodium species: P. falciparum and P. vivax.

The two malaria antigens P. falciparum pLDH (Pf pLDH) and P vivax pLDH (Pv pLDH) are present at high levels in the blood of infected individuals and thus represent good markers for the detection of malaria infection by RDTs. However, variability in RDT performance has been documented.

Product and lot quality are already assured through independent quality control programmes coordinated by the World Health Organization (WHO) at international reference laboratories to ensure that only high-quality malaria RDTs are procured.

In collaboration with FIND, Microcoat has developed three recombinant panels, which can complement existing quality control measures based on whole parasite samples. The HRP2 panels have been commercially available since September 2017, while the Pf pLDH and Pv pLDH recombinant panels have recently completed development. These newly available recombinant panels are made of protein dilutions that have been proven to react with most of the malaria RDTs on the market. These panels are displayed in a 96-well format, each containing 12 strips of 8 wells, with 6 wells containing standardized serially diluted concentrations of the malaria antigens, and 2 wells containing negative controls.

To order the new recombinant panels, please visit www.microcoat.de

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About Microcoat 
Microcoat Biotechnologie GmbH is a biotechnology company with over two decades of experience in diagnostic testing, kit manufacturing and coating of solid phases. Microcoat offers a wide range of individual and specialized services for the diagnostic and pharmaceutical industry.

About FIND 
FIND was established in 2003 as a global non-profit dedicated to accelerating the development, evaluation and delivery of high-quality, affordable diagnostic tests for poverty-related diseases, now including malaria, tuberculosis, HIV/AIDS, sleeping sickness, hepatitis C, leishmaniasis, Chagas disease, Buruli ulcer, non-malarial fever and diseases with outbreak potential, such as Ebola. FIND has partnered in the delivery of 22 new diagnostic tools and created an enabling environment for numerous others through the provision of specimen banks, reagent development and better market visibility. FIND also supports better access to new diagnostics through implementation, quality assurance and lab strengthening work. FIND has over 200 partners globally, including research institutes and laboratories, health ministries and national disease control programmes, commercial partners, clinical trial sites, and bilateral and multilateral organizations.

Media contacts
Microcoat Biotechnologie GmbH: Dr Nadine Uhlig, Manager, Contract Manufacturing
E-mail: n.uhlig@microcoat.de
Tel: +49 (0) 8158-9981-0; Fax: +49 (0) 8158-9981-10

FIND: Sarah-Jane Loveday, Head of Communications
Email: sarah-jane.loveday@finddx.org
T: +41 (0) 22 710 27 88; M: +41 (0) 79 431 62 44