Donor Testing and Risk: Current Prevalence, Incidence, and Residual Risk of Transfusion-Transmissible Agents in US Allogeneic Donations

doi:10.1016/j.tmrv.2011.07.007

Transfusion Medicine Reviews

Volume 26, Issue 2, April 2012, Pages 119-128

https://doi.org/10.1016/j.tmrv.2011.07.007 Get rights and content

Over the past 20 years, there has been a major increase in the safety of the blood supply, as demonstrated by declining rates of posttransfusion infection and reductions in estimated residual risk for such infections. Reliable estimates of residual risk have been possible within the American Red Cross system because of the availability of a large amount of reliable and consistent data on donations and infectious disease testing results. Among allogeneic blood donations, the prevalence rates of infection markers for hepatitis C virus (HCV) and hepatitis B virus have decreased over time, although rates for markers of human immunodeficiency virus (HIV) and human T-cell lymphotropic virus did not. The incidence (/100 000 person-years) of HIV and HCV among repeat donors showed apparent increases from 1.55 and 1.89 in 2000 through 2001 to 2.16 and 2.98 in 2007 through 2008. These observed fluctuations confirm the need for continuous monitoring and evaluation. The residual risk of HIV, HCV, and human T-cell lymphotropic virus among all allogeneic donations is currently below 1 per 1 million donations, and that of hepatitis B surface antigen is close to 1 per 300 000 donations.

Section snippets

Demography of Donor Populations

In 2008, a total of 3 830 094 volunteer blood donors successfully made 6 638 877 blood donations to ARC Blood Services, with whole blood and apheresis components accounting for approximately 89% and 11% of the collections, respectively. Females accounted for approximately half (50.1%) of the successful donors, although they contributed slightly fewer (48.6%) of the successful donations. Repeat donors accounted for 74% of all donors and 81.9% of total donations. Female donors aged 16 to 24

Infectious Disease Marker Prevalence Among Blood Donations

Prevalence reflects the number of confirmed-positive donations as determined for a given transfusion-transmissible agent over the total number of donations tested. Prevalence among first-time donations reflects the rate of an infection among the population of eligible individuals who have never undergone blood donation testing; comparison with prevalence rates for the overall population defines the impact of donor self-deferral and donor-eligibility selection. Prevalence among repeat donations

Incidence and Window-Period Risk Among Repeat Donors

The incidence of transfusion-transmissible agents among blood donors is the number of observed new infections over the total number of person-years observed (properly termed incidence density). In the past, incidence was determined by evaluation of data from repeat donors only, but now, methods have been developed to estimate incidence for first-time donors.

Table 3 presents incidence density data observed among repeat allogeneic blood donors to ARC in 2007 to 2008 along with residual risk

Overall Incidence and Window-Period Risk Estimates

A single-sample method for estimation of incidence among first-time donors allows incidence and residual risk to be estimated for all donations. A “detuned” or less sensitive assay was developed for HIV infection, although no such assays have yet been widely used for other infections. Implementation of NAT for viral RNA (HIV RNA and HCV RNA) and thus the availability of 2 tests indicative of different stages of an infection (anti-HIV and HIV RNA or anti-HCV and HCV RNA) made it possible to

Estimated Residual Risks Versus Observed Transfusion Transmissions

Estimated residual risks do not necessarily reflect the actual number of transfusion transmissions to recipients. In fact, only the original observations on HIV window-period risk were based on transfusion-transmitted infections [17]. Residual risk estimates have been continuously updated based on measures of test sensitivity. However, the window periods used in this review are based on viral doubling periods and assumed infectious doses. Other factors contribute to the lack of reported

Acknowledgment

Edward P. Notari IV and Fatemeh Musavi managed the ARCNET database and provided the unpublished data in this review.

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Historically, human immunodeficiency virus (HIV), hepatitis B virus (HBV), and hepatitis C virus (HCV) infections were of great concern as transfusion-transmissible infections. However, with the adoption of nucleic acid testing (NAT) of donors and rigorous donor selection, the risk of HIV, HBV, or HCV transmission through transfusion has dramatically decreased, with no reported transmissions through transfusion in the United States since 2014 [11-13]. However, sepsis due to bacterial contamination of platelets continues to be a significant threat to recipient safety [14].
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Donor Testing and Risk: Current Prevalence, Incidence, and Residual Risk of Transfusion-Transmissible Agents in US Allogeneic Donations

Section snippets

Demography of Donor Populations

Infectious Disease Marker Prevalence Among Blood Donations

Incidence and Window-Period Risk Among Repeat Donors

Overall Incidence and Window-Period Risk Estimates

Estimated Residual Risks Versus Observed Transfusion Transmissions

Acknowledgment

Transfus Med Rev

Blood

Ann Epidemiol

Transfus Med Rev

Transfus Med Rev

Current prevalence and incidence of infectious disease markers and estimated window-period risk in the American Red Cross blood donor population

Transfusion

Changing age distribution of the U.S. blood donor population—more young donors recruited and retained but the overall ageing trend continued

Vox Sang

Adverse reactions to allogeneic whole blood donation by 16- and 17-year-olds

JAMA

Age related donor return patterns among first time blood donors in the United States

Transfusion

Detection of HIV-1 and HCV infections among antibody-negative blood donors by nucleic acid–amplification testing

N Engl J Med

Effectiveness of human T-lymphotropic virus (HTLV) recipient tracing (lookback) and the current HTLV-I and -II confirmatory algorithm, 1999 to 2004

Transfusion

HTLV antibody screening of blood donors: rates of false positive results and evaluation of a potential donor re-entry algorithm

Transfusion

Current incidence and residual risk of hepatitis B infection among blood donors in the United States

Transfusion

Current value of serologic test for syphilis as a surrogate marker for bloodborne viral infections among blood donors in the United States

Transfusion

Prevalence, incidence and residual risk of HIV and HCV infections among US blood donors since the introduction of nucleic acid testing

Transfusion

Prevalence, incidence and residual risk of major blood borne infections among apheresis collections to the American Red Cross Blood Services, 2004-2008

Transfusion

Strategies for testing blood donors for West Nile virus

Transfusion

Blood donor screening for Chagas disease—United States, 2006-2007

MMWR

Direct assessment of cytomegalovirus transfusion-transmitted risks after universal leukoreduction

Transfusion

A method for estimating hepatitis B virus incidence rates in volunteer blood donors

Transfusion

Duration of time from onset of human immunodeficiency virus type 1 infectiousness to development of detectable antibody

Transfusion

The risk of transfusion-transmitted viral infections. The Retrovirus Epidemiology Donor Study

N Engl J Med

A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors

Transfusion

Assessing the impact of HBV NAT on window period reduction and residual risk

J Clin Virol

A prospective study of transmission by transfusion of HTLV-I and risk factors associated with seroconversion

Int J Cancer

Prevalence of circulating Treponema pallidum DNA and RNA in blood donors with confirmed-positive syphilis tests

Transfusion

A test that won't die: the serologic test for syphilis

Transfusion

Syphilis nucleic acid testing: usefulness in syphilis confirmation?

Transfusion

Current incidence and estimated residual risk of transfusion-transmitted infections in donations made to Canadian Blood Services

Transfusion

West Nile Virus Transmission Investigation Team. Transmission of West Nile virus through blood transfusion in the United States in 2002

N Engl J Med