Product portfolio

Donor Screening – Serology Solutions

Keeping the blood supply safe
Bringing safety, reliability and efficiency to donor screening

Being able to recognize an infected donation regardless of when the donor was infected or where you are in the world is critical.

Elecsys® assays developed by Roche include highly specific and sensitive serology tests to detect infectious diseases based on ECL (ElectroChemiLuminescence) technology to deliver reliable results.1-10 All serology screening assays detect the major viral genotypes and variants found worldwide. They show very high seroconversion sensitivity, and their very high specificity and clear cut-off separation of positive and negative results reduces the need for retesting.1-10

Partner with a company dedicated to helping save patients' lives and leverage Roche's extensive experience in infectious disease testing for your serology donor screening solution.

Ensuring patient safety during blood transfusions

patient safety

 

 

 

  • Comprehensive variant coverage to ensure reliable detection of infectious samples 
  • Excellent sensitivity to allow for detection of window-period infections 
  • Reduction in manual handling errors due to automated sample handling solutions

Supporting a consistent and reliable blood supply

blood

 

 

 

 

  • Optimized uptime (>98 %)11 of cobas® instruments that ensure the timely release of blood products
  • Confidence in results with validated workflows for cross contamination compliance
  • Assurance in service with skilled local Roche support teams available when you need them

Improving efficiency by automating screening tests

efficiency

 

 

 

 

  • Decrease the need for retesting and minimize loss of donations due to high specificity of Elecsys® assays1-10
  • Allow your staff to focus on important tasks by achieving up to 8 consecutive hours of walkaway time12
  • Ensure efficient blood supply through total automation
 test

Serology analyzers and assays from Roche can be fully integrated with nucleic acid testing Solutions for maximum workflow efficiency. Support for full automation means increased throughput and faster turnaround times.

Nucleic Acid Testing (NAT) Solutions

Roche offers a comprehensive portfolio of NAT solutions, including instruments and assays developed using high-performance real-time PCR technology.

Easily integrated into pre- and post-analytic solutions, they enable greater overall workflow efficiency.

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Personalized Lab Automation

Personalized lab automation offered by Roche simplifies, streamlines and standardizes the screening process.

It supports seamless connectivity and traceability at all levels of throughput, allowing a reduction in errors, more consistent results and ultimately more control over your lab's processes.

 

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Donor Screening

At Roche, we are dedicated to help you save patients' lives by delivering safe, reliable and efficient blood safety solutions, today and in the future.

Roche offers a complete solution for blood and plasma screening tailored to your needs and designed to work together for maximum efficiency.

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Serology assays for blood testing

Serology assays for blood testing

Immunoassay for the qualitative determination of the human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV.  With the Elecsys® HIV Duo assay, HIV-1 p24 antigen, as well as antibodies to HIV-1 and HIV-2 (anti-HIV) can be detected in parallel with two separate determinations. On the basis of these determinations, the Elecsys® HIV Duo main result is calculated automatically by the analyzer.

Immunoassay for the qualitative determination of the human immunodeficiency virus (HIV) p24 antigen and antibodies to HIV including group O, and HIV-2 in human serum or plasma.

Chronic HCV infection may lead to cirrhosis and hepatocellular carcinoma, therefore, early detection is essential to effectively manage patients needing treatment.1 This immunoassay qualitatively determines antibodies against HCV during acute and chronic infection, and after a resolved infection.

 

  1. EASL Recommendations on Treatment of Hepatitis C 2016 (2017). Journal of Hepatology 66, 153-194.

Under selective pressure HBV may mutate, potentially leading to escape from a host’s protection after vaccination and undetectability with certain commercially available HBsAg assays.1 This assay was specifically designed to detect a multitude of such mutants.

 

  1. Gerlich, W. (2004). Intervirology 47, 310-313.

Immunoassay for the qualitative determination of total antibodies against hepatitis B core antigen (HBcAg). Due to the persistence of anti-HBc following HBV infection, screening for anti-HBc can be used to identify previously infected individuals.1 Determination of anti-HBc in association with other hepatitis B tests permits the diagnosis and monitoring of HBV infections. In the absence of other hepatitis B markers (HBsAg-negative persons), anti-HBc may be the only indication of an existing HBV infection.2,3

 

  1. WHO. Hepatitis B. WHO/CDS/CSR/LYO/2002.2:Hepatitis B. Available at: http://www.who.int/csr/disease/hepatitis/HepatitisB_whocdscsrlyo2002_2.pdf (accessed February 2012).
  2. Liaw, Y.F., Chu, C.M. (2009). Lancet 373, 582-592.
  3. Elgouhari, H.M., Abu-Rajab, Tamini, T.I., Carey W. (2008). Cleve Clin J Med. 75, 881–889.

Immunoassay for the quantitative determination of antibodies to hepatitis B surface antigen (HBsAg). Anti-HBs tests are used within the scope of hepatitis B vaccination to check the necessity and success of vaccination.1-3 In addition, Anti-HBs tests are used to monitor the course of disease following acute hepatitis B infection.4

 

  1. WHO (2009). Wkly Epidemiol Rec 84, 405-419.
  2. Caspari, G., Gerlick, W.H. (2007). Clin Lab 53, 335-343.
  3. Elgouhari, H.M., Abu-Rajab Tamini, T.I., Carey, W. (2008). Cleve Clin J Med 75, 881-889.
  4. Liaw, Y.F., Chu, C.M. (2009). Lancet 373, 582-592.

Immunoassay for the qualitative determination of total antibodies against Treponema pallidum.

Immunoassay for the qualitative determination of total antibodies to human T-lymphotropic virus (HTLV) I/II. HTLV-I is the most clinically relevant of the two viruses and 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).1,2

 

  1. Gessain, A., Mahieux, R. (2012). Rev Neurol 168, 257-69.
  2. Gonçalves, D.U. et al. (2010). Clin Microbiol Rev. 23, 577-89.

Immunoassay for the qualitative determination of antibodies to Trypanosoma cruzi.

Immunoassay for the quantitative determination of IgG-antibodies against CMV. Seroconversion in CMV IgG shows a recent infection. The detection of CMV IgG antibodies is an indicator of a past infection. The time of infection can roughly be estimated in IgM positive patients by a CMV IgG avidity test.1

 

  1. Revello, M.G. et al. (2002). Clin Microbiol Rev 15, 680-715.
Serology analytical modules and analyzers

Serology analytical modules and analyzers

Available for the cobas® 8000 modular analyzer series. This module runs up to 48 assays and has a throughput of up to 300 tests per hour.

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Available for the cobas® 8000 modular analyzer series. This module runs up to 25 assays and has a throughput of up to 170 tests per hour.

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Available for the cobas® 6000 analyzer series. This module runs up to 25 assays and has a throughput of up to 170 tests per hour.

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Available for the cobas® 4000 analyzer series. This analyzer runs up to 18 assays and has a throughput of up to 75 tests per hour.

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Products of the Roche blood safety solutions portfolio are not commercially available in all regions. Please contact your local Roche representative regarding availability.

 

References

 

  1. Mühlbacher, A., et al. (2013). Med Microbiol Immunol 202, 77–86.
  2. Mühlbacher, A., et al. (2008). Med Microbiol Immunol 197, 55–64.
  3. Esteban, J., et al. (2013). J Med Virol 85, 1362–1368.
  4. Ly, T.D., et al. (2012). J Clin Virol 55, 121–127.
  5. Louisirirotchanakul, S., et al. (2010).  J Med Virol 82, 755–762.
  6. Jia, J.D., et al. (2009). Med Microbiol Immunol 198, 263–269.
  7. Laperche, S., et al. (2017).  J. Clin. Microbiol 55, 2180-2187.
  8. Kremastinou, J., et al. (2016). J. Clin. Microbiol 54, 2330-2336.
  9. Sommese, L., et al. (2014). Scandinavian Journal of Infectious Diseases 46, 660–664.
  10. Schmidt, M., et al. (2015). Vox Sanguinis 109, 114-21.
  11. Data on file. Roche Diagnostics International Ltd.
  12. Data on file. Roche Diagnostics International Ltd.
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