Skip to main content Accessibility help
×
Hostname: page-component-848d4c4894-xm8r8 Total loading time: 0 Render date: 2024-06-16T04:52:07.754Z Has data issue: false hasContentIssue false

15 - Nucleic acid testing: the US approach

from Section 2 - Selection and testing

Published online by Cambridge University Press:  12 January 2010

Susan L. Stramer
Affiliation:
Executive Scientific Officer, American Red Cross, Gaithersburg, MD, USA
John A. J. Barbara
Affiliation:
University of the West of England, Bristol
Fiona A. M. Regan
Affiliation:
HNSBT and Hammersmith Hospitals NHS Trust, London
Marcela Contreras
Affiliation:
University of the West of England, Bristol
Get access

Summary

The central goal of blood centres is to provide a safe, adequate and effective blood supply. Towards that end, the focus on infectious disease testing has resulted in a high level of blood component safety. Today, in the developed world, the risk of transfusion-transmission of a major agent has been dramatically reduced by the introduction of next generation tests for antibodies and antigens, and with the introduction of nucleic acid testing (NAT). In the USA, with the introduction of NAT, the residual risk of HIV-1 and HCV has been reduced to approximately 1:2,000,000 donations screened (Dodd and Stramer, 2000). The yield of HIV-1 infected donors detected by NAT has been reported at 1:3.1 million and that for HCV (relative to third-generation antibody screening) at 1:270,000 (Stramer et al., 2004). The low frequency of these findings reinforces the safety of the blood supply today. In addition, the specificity of HIV-1 and HCV NAT relative to providing a false-positive result to a blood donor has been exceedingly high, with lower false-positive rates than any of the serological tests used in blood donor screening (e.g. 1:40,000 for NAT for the American Red Cross, ARC).

In addition to recipient safety, another aspect of the blood donation testing process is that it serves a public health function in identifying those individuals who are infected by a disease agent, particularly at the time shortly following exposure.

Type
Chapter
Information
Publisher: Cambridge University Press
Print publication year: 2008

Access options

Get access to the full version of this content by using one of the access options below. (Log in options will check for institutional or personal access. Content may require purchase if you do not have access.)

References

Biswas, R., Tabor, E., Hsia, C. C., et al. (2003) Comparative sensitivity of HBV NATs and HBsAg assays for detection of acute HBV infection. Transfusion, 43, 788–98.CrossRefGoogle ScholarPubMed
Bower, W. A., Nainan, O. V., Han, X., et al. (2000) Duration of viremia in hepatitis A infection. J Infect Dis, 182, 12–7.CrossRefGoogle Scholar
Busch, M. P., Caglioti, S., Robertson, E. F., et al. (2005) Screening the blood supply for West Nile virus RNA by nucleic acid amplification testing. N Eng J Med, 353, 460–7.CrossRefGoogle ScholarPubMed
Centers for Disease Control and Prevention (2003a) Guidelines for laboratory testing and result reporting of antibody to hepatitis C virus. MMWR, 52 (RR-3), 1–16.
Centers for Disease Control and Prevention (2003b) Update: detection of West Nile virus in blood donations – United States, 2003. MMWR, 52, 916–9.
Centers for Disease Control and Prevention (2003c) Detection of West Nile virus in blood donations – United States, 2003. MMWR, 52, 1160.
Cyrus, S., Robertson, G., Caglioti, S., et al. (2002) Evaluation of an alternate HIV confirmatory testing algorithm. Transfusion, 43 (9S), S131–040K.Google Scholar
Dodd, R. Y. (2003) Emerging infections, transfusion safety, and epidemiology. N Eng J Med, 349, 1205–6.CrossRefGoogle Scholar
Dodd, R. Y. and Stramer, S. L. (2000) Indeterminate results in blood donor testing: what you don't know can hurt you. Transfus Med Rev, 14, 151–60.CrossRefGoogle ScholarPubMed
Dodd, R. Y., Notari, E. P. and Stramer, S. L. (2002) Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population. Transfusion, 42, 975–9.CrossRefGoogle ScholarPubMed
Kleinman, S., Busch, M. P., Hall, L., et al. (1998) False-positive HIV-1 test results in a low-risk screening setting of voluntary blood donation. JAMA, 280, 1080–5.CrossRefGoogle Scholar
Kleinman, S. H., Kuhns, M., Todd, D. S., et al. (2003) Frequency of HBV DNA detection in US blood donors testing positive for the presence of anti-HBc: implications for transfusion-transmission and donor screening. Transfusion, 43, 696–704.CrossRefGoogle ScholarPubMed
Pealer, L. N., Marfin, A. A., Petersen, L. R., et al. (2003) Transmission of West Nile virus through blood transfusion in the United States 2002. N Eng J Med, 349, 1236–45.CrossRefGoogle Scholar
Pietrelli, L., Gorlin, J., Holland, P., et al. (2003) A prospective study to evaluate the screening of plasma pools from volunteer blood donations for the presence of HBV DNA. Transfusion, 43 (9S), S86–040C.Google Scholar
Stramer, S. L., Fang, C. T., Foster, G. A., et al. (2005) West Nile virus among blood donors in the United States, 2003 and 2004. N Eng J Med, 353, 451–9.CrossRefGoogle ScholarPubMed
Stramer, S. L., Glynn, S. A., Kleinman, S. H., et al. (2004) Detection of HIV-1 and HCV infections among antibody-negative US blood donors by nucleic acid amplification testing. N Eng J Med, 351, 760–8.CrossRefGoogle Scholar
Tobler, L. H., Stramer, S. L., Kleinman, S. H., et al. (2001) Misclassification of HCV viremic blood donors as indeterminate by RIBA 3.0 because of human superoxide dismutase activity. Transfusion, 41, 1625–6.CrossRefGoogle Scholar
Young, N. S. and Brown, K. E. (2004) Parvovirus B19. N Eng J Med, 350, 586–97.CrossRefGoogle ScholarPubMed

Save book to Kindle

To save this book to your Kindle, first ensure coreplatform@cambridge.org is added to your Approved Personal Document E-mail List under your Personal Document Settings on the Manage Your Content and Devices page of your Amazon account. Then enter the ‘name’ part of your Kindle email address below. Find out more about saving to your Kindle.

Note you can select to save to either the @free.kindle.com or @kindle.com variations. ‘@free.kindle.com’ emails are free but can only be saved to your device when it is connected to wi-fi. ‘@kindle.com’ emails can be delivered even when you are not connected to wi-fi, but note that service fees apply.

Find out more about the Kindle Personal Document Service.

Available formats
×

Save book to Dropbox

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Dropbox.

Available formats
×

Save book to Google Drive

To save content items to your account, please confirm that you agree to abide by our usage policies. If this is the first time you use this feature, you will be asked to authorise Cambridge Core to connect with your account. Find out more about saving content to Google Drive.

Available formats
×