Photo Kaldowski Arnd_640

Arnd Kaldowski, Beckman Coulter Diagnostics.

Beckman Coulter Diagnostics has received CE marks for a pair of real-time polymerase chain reaction assays—the DxN Veris hepatitis C virus (HCV) assay and the DxN Veris human immunodeficiency virus type 1 (HIV-1) assay.

Available only outside the United States and now permitted to be sold in Europe and certain other markets, the assays enable rapid and reliable quantitative determination of HCV and HIV-1 RNA in human plasma. The assays are the latest additions to the growing menu of CE-marked assays for use on the company’s DxN Veris molecular diagnostics system.

“Beckman Coulter is committed to the ongoing development of assays for DxN Veris and aims to rapidly expand the DxN Veris infectious disease portfolio, delivering assays that are both cost- and time-effective,” says Arnd Kaldowski, president of Beckman Coulter Diagnostics.

As with other DxN Veris assays, the HCV and HIV assays are supplied in a single cartridge system, seeking to reduce waste and consumables costs compared to traditional batch-plate systems.

Photo Creager Richard_640

Richard Creager, Beckman Coulter Diagnostics.

“Tests can be up and running in 10 minutes and, with true single-sample random access and the shortest turnaround time available, results can be delivered to physicians faster than ever before,” says Richard Creager, senior vice president of the molecular diagnostics business unit and chief scientific officer at Beckman Coulter Diagnostics.

While the prevalence of HCV infection in different European countries ranges from 0.4% to 3.5%, the virus’ full burden is unknown due to differences in surveillance systems across Europe.1,2 HCV RNA quantification is therefore useful for assessing and monitoring patients who are undergoing antiviral treatment, helping to assess patient compliance, inform response?guided therapy, and determine sustained viral response (SVR), which corresponds to a definitive cure of HCV infection in more than 99% of cases.3,4 The DxN Veris HCV assay offers rapid, automated sample processing, amplification, and detection, and an assay run-time of less than 102 minutes. With proven sensitivity, specificity, and precision, the assay reliably detects HCV genotypes one to six, and is calibrated to the fourth World Health Organization (WHO) International Standard for HCV.5,6

In 2011, it was estimated that 2.3 million people were living with HIV throughout Europe and Central Asia, with approximately 170,000 newly diagnosed cases that year.8,9 Quantitative measurement of HIV-1 RNA viral load in plasma plays a vital role in the prognosis and management of patients infected with HIV-1, helping to decide when antiretroviral therapy should be initiated, monitor response to treatment, and predict clinical progression.10 The DxN Veris HIV-1 assay offers rapid, automated sample processing, amplification, and detection, and an assay run-time of less than 87 minutes. It also has demonstrated sensitivity and precision.11

Available for 1000 ?L and 175 ?L sample volume, the DxN Veris HIV-1 assay is traceable to the WHO International Standard for HIV-1, and reliably detects HIV-1 subtypes: Group M (A, C, D, F, G, H); Group N; Group O; CRF AE, and CRF AG.11 .

In addition to these assays, the range of CE-marked assays for use on the DxN Veris also includes assays for the quantitative determination of human cytomegalovirus in plasma and of hepatitis B virus in plasma and serum.

For more information, visit Beckman Coulter.


  1. European Centre for Disease Prevention and Control (ECDC). Hepatitis B and C in the EU neighborhood: prevalence, burden of disease, and screening policies. Technical report. Solna, Sweden: ECDC, 2010. Available at: Accessed June 15, 2015.
  1. ECDC. Hepatitis C. Fact sheet online. Available at: Accessed June 15, 2015.
  1. EASL [European Association for the Study of the Liver] clinical practice guidelines: management of hepatitis C virus infection. J Hepatol. 2014;60(2):392–420; doi: 10.1016/j.hep.2013.11.003. Epub December 9, 2013.
  1. American Association for the Study of Liver Diseases, Infectious Diseases Society of America, International Antiviral Society–USA. Recommendations for testing, managing, and treating hepatitis C. Available at: Accessed June 15, 2014.
  1. Gilfillan R, Wang Z, Xu Y, et al. Quantitative detection of hepatitis C virus (HCV) on the Veris MDx system. Poster presentation. Barcelona: European Society of Clinical Microbiology and Infectious Diseases annual meeting, 10–13 May 2014.
  1. Xu Y, Gilfillan R, Wang Z, et al. Quantitative detection of hepatitis C virus (HCV) on the Veris molecular diagnostics system. Poster presentation. Prague: European Society for Clinical Virology annual meeting, September 28–October 1, 2014.
  1. Swain MG, Lai MY, Shiffman ML, et al. A sustained virologic response is durable in patients with chronic hepatitis C treated with peinterferon alfa?2a and ribavirin. Gastroenterology. 2010;139(5):1593–1601; doi: 10.1053/j.gastro.2010.07.009. Epub July 14, 2010.
  1. Joint United Nations Program on HIV/AIDS (UNAIDS). Regional fact sheet 2012: North America, Western and Central Europe. Available at: Accessed June 15, 2015.
  1. UNAIDS. Regional fact sheet 2012. Eastern Europe and Central Asia. Available at: Accessed June 15, 2015.
  1. US Centers for Disease Control and Prevention (CDC). Revised recommendations for HIV testing of adults, adolescents, and pregnant women in health-care settings. Morbidity and Mortality Weekly Report. 2006;55(RR14):1–17. Accessed June 15, 2015.
  1. Veris HIV-1 Instructions for Use.