Roche, Basel, Switzerland, has recently announced the availability of its Elecsys HTLV-I/II immunoassay in the European Union and other regions accepting the CE mark as authorization for market entry.
The immunoassay is a diagnostic test to help detect antibodies against human T-lymphotropic virus I or II infection in donated blood and routine diagnostic samples. Designed to meet the needs of blood centers and clinical laboratories for reliable and efficient detection of HTLV-I/II infection, the test enhances Roche’s blood screening portfolio in serology testing.
“Globally, there are around 20 million people infected with HTLV-I/II, many of whom are unknown carriers. If the virus is undetected in donors, the risk of spreading the infection increases,” says Roland Diggelmann, COO of the Roche Diagnostics Division. “Roche is uniquely positioned to help blood centers improve their testing efficiency, based on our broad assay portfolio and integrated molecular and serology laboratory solutions.”
HTLV-I and II are retroviruses that can be transmitted through hetero- or homosexual intercourse, through contaminated needles or blood products, or from mother to child via breastfeeding.
HTLV-I has been directly associated with the life-threatening disease adult T-cell leukemia/lymphoma (ATLL) and the life-debilitating condition HTLV-associated myelopathy/tropical spastic paraparesis (HAM/TSP). An HTLV infection persists lifelong and there is currently no treatment to eliminate the virus from the body.
The high sensitivity of the new immunoassay is intended to minimize the likelihood of missing early or chronic HTLV infections, thereby reducing the risk of transmission. The test’s high specificity facilitates clear and consistent interpretation of results at all disease stages. The test procedure enables healthcare professionals to run a single test within 18 minutes.