An automated immunoassay for the detection of antibodies against human T-lymphotropic virus I or II (HTLV-I/II) in donated blood and routine diagnostic samples and is now available for use by blood centers and clinical laboratories.

The Roche (Basel, Switzerland) HTLV-I/II immunoassay was designed for use on the Elecsys benchtop analyzer. This IVD instrument is powered by enhanced chemiluminescence (ECL) technology, which provides precise and reliable patient results that contribute to better patient care.

The Elecys instrument uses two electrochemically active substances, a ruthenium complex and tripropylamine (TPA). These reagents are involved in the reaction that leads to the emission of light. Ruthenium and TPA are non-isotopic and highly stable at base state. Only when voltage is applied and the labeled compound is repeatedly excited do the reactants begin emitting photons. To start the reaction, voltage is applied between the working and counter electrode, and an electrical field is created, ensuring a precisely controlled and timed reaction.

The operation is performed on a solution containing sample and reagents that are aspirated into the measuring cell. A magnetic field is applied, and the paramagnetic beads (coated with antigen/antibody complexes bound by streptavidin-biotin) are bound to the surface of the measuring cell. ProCell solution is introduced in order to separate the bound immunoassay complexes from the free remaining particles and to provide TPA, which is essential for the ECL-reaction. The test procedure requires about 18 minutes to run a single test.

“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,” said 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.”

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