Company CrisBio

Algenex and Global DX announce positive evaluation of Herdscreen® ASFV antibody test for African Swine Fever

Jul 21 2020

Analysis of this new rapid test at the ​European Union Reference Laboratory for African Swine Fever ​(CISA-INIA) shows 100% specificity and higher sensitivity than a commercial ELISA test for the detection of specific antibodies in field and experimental samples frominfected animals.

This new pen-side diagnostic test for African Swine Fever will be commercially availablein 2020. Discussions are ongoing with distributors in various territories.

Algenex SL, a private biotechnology company delivering disruptive technologies for recombinant biologics production, and Global DX Ltd., a company dedicated to improving the quality of animal care by facilitating accurate diagnosis for veterinarians worldwide, today announce results of a positive evaluation of the Herdscreen® ASFV Antibody Test.

The Herdscreen® ASFV Test is a point-of-care rapid diagnostic test to identify pigs who have been exposed to the African Swine Fever Virus (ASFV). It uses a carefully selected ASFV protein, which confers high sensitivity to the new test. The recombinant version of this antigen is produced through CrisBio® technology, Algenex’ proprietary and patent protected Baculovirus vector-mediated expression platform that harnesses the power of insects to act as natural single-use bioreactors. The test is simple and easy to use and does not require complex technical training or sophisticated equipment.

Analysis conducted at Centro de Investigación en Sanidad Animal (CISA-INIA) as a European Union Reference laboratory for African swine fever (EURL-ASF), in a validation study using 282 serum and blood samples from ASFV positive animals, showed the test to have analytical specificity of 100% and analytical sensitivity of 86%. Importantly, the sensitivity was greater than that shown by a commercial ELISA test. The Herdscreen® ASFV Test has been considered appropriate as a front-line diagnostic test for African Swine Fever (ASF) in field conditions for both serum and blood samples.

“Rapid detection of infected animals, as in any other infectious disease, is essential to avoid and mitigate the global dissemination of this dangerous virus, and helps sanitary authorities take rapid decisions when an infection is determined,” said Dr. José Escribano, founder and CSO of Algenex and one of the world leading experts on ASF.

“Our collaboration with Algenex, combining their expertise in protein expression and deep understanding of ASFV and our experience in developing best-in-class rapid diagnostic tests has resulted in a much needed diagnostic product for the simple and accurate detection of ASFV-infected pigs. We look forward to bringing this rapid test to the market as soon as possible,” said Andrew Shepherd, Founder and CEO of Global DX.

African Swine Fever is a severe viral disease for which there is currently no available vaccine. It affects domestic pigs and wild boars and causes high mortality, approaching 100% in less than 10 days in acute cases. This represents possibly the most serious threat that the global veterinary industry has had to face in the last decades. Serological diagnostic tests, like the Herdscreen® ASFV Test, are essential tools for the eradication of ASF, as the detection of chronic, subacute or
subclinical infected animals is extremely important to stop the dissemination of the virus in the domestic pig and wild boar populations.