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Roche launches Elecsys® HIV Duo test in the U.S.

30.09.2020

  • 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. 

 

About Human Immunodeficiency Virus (HIV)

 

There are nearly 38 million people living with HIV/AIDS around the world, predominantly in Sub-Saharan Africa. In 2019, AIDS-related deaths totaled approximately 1,900 people each day.5

The human immunodeficiency virus (HIV) is the causative agent of acquired immunodeficiency syndrome (AIDS) and has been a major global burden for over three decades. HIV is transmitted through sexual contact, contaminated blood and blood products or from an HIV-infected mother to her child before, during and after birth.

 

About the Elecsys® HIV Duo Immunoassay 

 

Elecsys® HIV Duo is an advanced 4th generation HIV screening test, offering separate HIV antigen and anti-HIV antibody results, as well as a single combined result. The test has several benefits over traditional 4th generation tests, not only for the patient, but also for the laboratory and the clinician.

The total testing time is only 18 minutes, allowing rapid results in the case of emergency situations.

 

About Roche

 

Roche is a global pioneer in pharmaceuticals and diagnostics focused on advancing science to improve people’s lives. The combined strengths of pharmaceuticals and diagnostics under one roof have made Roche the leader in personalised healthcare – a strategy that aims to fit the right treatment to each patient in the best way possible.

Roche is the world’s largest biotech company, with truly differentiated medicines in oncology, immunology, infectious diseases, ophthalmology and diseases of the central nervous system. Roche is also the world leader in in vitro diagnostics and tissue-based cancer diagnostics, and a frontrunner in diabetes management.

Founded in 1896, Roche continues to search for better ways to prevent, diagnose and treat diseases and make a sustainable contribution to society. The company also aims to improve patient access to medical innovations by working with all relevant stakeholders. More than thirty medicines developed by Roche are included in the World Health Organization Model Lists of Essential Medicines, among them life-saving antibiotics, antimalarials and cancer medicines. Moreover, for the eleventh consecutive year, Roche has been recognised as one of the most sustainable companies in the Pharmaceuticals Industry by the Dow Jones Sustainability Indices (DJSI).

The Roche Group, headquartered in Basel, Switzerland, is active in over 100 countries and in 2019 employed about 98,000 people worldwide. In 2019, Roche invested CHF 11.7 billion in R&D and posted sales of CHF 61.5 billion. Genentech, in the United States, is a wholly owned member of the Roche Group. Roche is the majority shareholder in Chugai Pharmaceutical, Japan. For more information, please visit www.roche.com.

All trademarks used or mentioned in this release are protected by law.

  1. Fiebig, E.W., Wright, D.J., Rawal, B.D. et al. (2003). Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection. AIDS 17, 1871-9.
  2. Busch, M.P., Lee, L.L., Satten, G.A. et al. (1995). Time course of detection of viral and serologic markers preceding human immunodeficiency virus type 1 seroconversion: implications for screening of blood and tissue donors. Transfusion 35, 91-7.
  3. Guertler, L., Muehlbacher, A., Michl, U. et al. (1998). Reduction of the diagnostic window with a new combined p24 antigen and human immunodeficiency virus antibody screening assay. Journal of Virological Methods 75, 27-38.
  4. Alexander, T.S. (2016). Human Immunodeficiency Virus Diagnostic Testing: 30 Years of Evolution. Clinical and Vaccine Immunology; 23(4) p249-253.
  5. https://www.who.int/gho/hiv/en/