Roche, the world’s largest biotech company, has launched the first fully automated Zika IgG immunoassay to help detect Zika virus infection.
The diagnostic test is called the Elecsys Zika IgG immunoassay and will be available in CE Mark countries.
Accurate diagnosis of patients infected with Zika virus, particularly pregnant women, is an urgent medical need. The virus can cause impaired neurological development, such as microcephaly, in babies whose mothers were infected during pregnancy.
As diagnostic testing enables healthcare professionals to assess the immune status of patients, Roche’s immunoassay will be of particular importance to expectant mothers, their partners and travellers in order to detect evidence of a recent Zika virus infection. By launching this serological assay, Roche says it has ‘solidified’ its commitment to providing a complete diagnostic solution for countries with a high risk of Zika infections.
This new assay is part of a significant advancement from Roche for Zika virus screening. In 2017, the US Food and Drug Administration (FDA) granted IVD status to the cobas Zika test, for use with the cobas 6800/8800 systems, for the screening of blood and plasma donations in the US.
The rapid development of assays, including cobas Zika NAT and Zika IgG antibodies, was part of the company-wide response to the World Health Organisation’s declaration of a public health emergency during the Zika epidemic in 2016.
Zika virus serological testing could be used for accurate diagnosis of Zika virus infection when the virus’ RNA is no longer detectable in patient’s blood sample. Due to the similarity of Zika virus to other viruses, such as Dengue virus, the Elecsys Zika IgG assay was developed as a highly-specific assay to limit cross-reaction and reduce the occurrence of false positive results. This assay can also be used to later determine the amount of Zika virus in different populations and countries at risk to assess the level of immune status in a country.
Roche’s head of centralised and point of care solutions Thomas Schinecker said: “Our investment and commitment to emerging infectious diseases has allowed us to fast-track the development of this new serological assay.
“Helping healthcare professionals to assess the infection status, even when ribonucleic acid (RNA) is no longer detectable is an important step in infection control.”
Dr José Eduardo Levi from the Tropical Medicine Institute at the University of São Paulo said: “All estimates of Zika virus infection incidence in dengue endemic areas are hampered by the cross-reactivity observed in virtually all immunoassays available so far. Moreover, accurate diagnosis, especially for pregnant women is an urgent unmet need.”