- Elecsys® HIV Duo is the first 4th generation HIV testing solution in the US that allows separate detection of HIV p24 antigen and anti-HIV antibodies
- Enables earlier determination of acute infection due to higher test sensitivity and separate detection of HIV p24 antigen and anti-HIV antibodies
- Accelerates the confirmatory testing process, reducing laboratory workload
Roche (SIX: RO, ROG; OTCQX: RHHBY) today announced the launch of the Elecsys® HIV Duo immunoassay in the U.S., following FDA approval in April 2020. Through separate measurement of the HIV p24 antigen (the virus) and anti-HIV antibodies (caused by immune reaction), this test can detect an acute HIV infection earlier than current methods. This approval enables a robust, comprehensive infectious diseases menu on the cobas e 801 system and a significant step towards bringing holistic value to the U.S. market within the area of infectious diseases.
Significant progress has been made in the last forty years to diagnose and treat HIV. The number of new infections has declined in the last ten years, as access to HIV testing and treatment, especially in low- and middle-income countries, has expanded. More work still has to be done to reduce new infections of this virus,
said Thomas Schinecker, CEO Roche Diagnostics.
Having quicker and more effective diagnostic tests, like the Elecsys® HIV Duo, helps clinicians make more informed treatment decisions for their patients.
HIV screening tests have been used for many years to determine an HIV infection, through the detection of viral components like the HIV p24 antigen and anti-HIV antibodies. Diagnosis of an HIV infection can be made as early as two to three weeks after infection, based on the detection of the HIV p24 antigen in the blood.1,2 Anti-HIV antibodies are detectable from around four weeks post-infection.1,3 Most traditional screening tests combine the HIV antigen and anti-HIV antibody results, meaning they do not identify the source of reactivity.4 This leads to a need for additional confirmatory tests, and additional workload for laboratories.4
Confirmatory tests are commonly performed when screening for HIV as there might be major implications of an incorrect result.4 A false-positive could lead to a person getting unnecessary treatment and having additional stress of believing they are HIV positive. A false negative result can lead to a delayed or no treatment for someone who has HIV and further disease transmission.4
A confirmatory test often aims to confirm the presence of anti-HIV antibodies. In case of an acute infection, this will yield negative results, necessitating a further test to confirm the presence of viral components, which is less efficient and takes more time.1,3
The Elecsys® HIV Duo immunoassay detects both the HIV p24 antigen and anti-HIV antibody, in parallel, with two separate measurements. These results are then combined through an algorithm to give a combined result. This, along with the high sensitivity and specificity of the Elecsys® HIV Duo, helps to determine acute infections at an early stage, and helps to facilitate early treatment interventions and accelerates the confirmatory testing process.