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Original Article

Detection of HIV-1 and HCV Infections among Antibody-Negative Blood Donors by Nucleic Acid–Amplification Testing

Susan L. Stramer, Ph.D., Simone A. Glynn, M.D., M.P.H., Steven H. Kleinman, M.D., D. Michael Strong, Ph.D., Sally Caglioti, M.T. (A.S.C.P.), S.B.B., David J. Wright, Ph.D., Roger Y. Dodd, Ph.D., and Michael P. Busch, M.D., Ph.D. for the National Heart, Lung, and Blood Institute Nucleic Acid Test Study Group

N Engl J Med 2004; 351:760-768August 19, 2004

Abstract

Background

Testing of blood donors for human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) RNA by means of nucleic acid amplification was introduced in the United States as an investigational screening test in mid-1999 to identify donations made during the window period before seroconversion.

Methods

We analyzed all antibody-nonreactive donations that were confirmed to be positive for HIV-1 and HCV RNA on nucleic acid–amplification testing of “minipools” (pools of 16 to 24 donations) by the main blood-collection programs in the United States during the first three years of nucleic acid screening.

Results

Among 37,164,054 units screened, 12 were confirmed to be positive for HIV-1 RNA — or 1 in 3.1 million donations — only 2 of which were detected by HIV-1 p24 antigen testing. For HCV, of 39,721,404 units screened, 170 were confirmed to be positive for HCV RNA, or 1 in 230,000 donations (or 1 in 270,000 on the basis of 139 donations confirmed to be positive for HCV RNA with the use of a more sensitive HCV-antibody test). The respective rates of positive HCV and HIV-1 nucleic acid–amplification tests were 3.3 and 4.1 times as high among first-time donors as among donors who gave blood repeatedly. Follow-up studies of 67 HCV RNA–positive donors demonstrated that seroconversion occurred a median of 35 days after the index donation, followed by a low rate of resolution of viremia; three cases of long-term immunologically silent HCV infection were documented.

Conclusions

Minipool nucleic acid–amplification testing has helped prevent the transmission of approximately 5 HIV-1 infections and 56 HCV infections annually and has reduced the residual risk of transfusion-transmitted HIV-1 and HCV to approximately 1 in 2 million blood units.

Media in This Article

Figure 1Distribution of Alanine Aminotransferase Levels According to HCV Status.
Figure 2Follow-up Results for 67 HCV RNA–Positive, HCV Antibody–Nonreactive Donors.
Article

Screening of potential blood donors has historically relied on the use of immunoassays to detect viral antibodies or antigens. In 1999, new screening methods involving nucleic acid amplification to detect human immunodeficiency virus type 1 (HIV-1) and hepatitis C virus (HCV) RNA were implemented in the United States under an investigational new drug protocol approved by the Food and Drug Administration (FDA).1-3 This new technique was used to test multiple samples in small pools, referred to as “minipools.” The decision to implement this technique was based on its ability to identify HIV-1– and HCV-infected donors early in the infectious window period, before seroconversion,4 and the experience of plasma-derivative manufacturers showing the practicality of this approach for pooled specimens.1 Finally, it was recognized that the availability of nucleic acid–based tests would support future testing of emerging agents.5,6

The advent of nucleic acid–amplification testing has led to the discontinuation of two less effective screening tests. HIV-1 p24 antigen screening was recommended by the FDA in 1996 for the early detection of HIV-1 infection,7 and the FDA allowed this approach to be discontinued on the licensure of the HIV-1 nucleic acid–amplification test. Elevated levels of alanine aminotransferase have been used as a surrogate (nonspecific) marker for HCV infection since 1986.8 The use of this screening approach was never an FDA requirement, so blood centers have voluntarily discontinued this test. RNA-based donor screening has afforded an opportunity to study events occurring early in HIV-1 and HCV infection.9-12 To quantify the relative risk of transmission of HIV-1 and HCV from first-time blood donors and those who donated blood repeatedly, we analyzed the number of RNA-positive, antibody-nonreactive allogeneic blood donations from donors infected with HIV-1, HCV, or both that were identified in the first three years after the implementation of nucleic acid–amplification testing in the United States.

Methods

Since 1999, allogeneic blood donations in the United States have been screened for HIV-1 and HCV RNA in a minipool format with the use of one of two nucleic acid–amplification tests.1,2,13 The Gen-Probe Transcription-Mediated Amplification system uses a multiplex HIV-1 and HCV assay and minipools of 16 donor samples.14 All donation samples within a reactive minipool are tested individually to identify both the sample that was reactive and the viral cause of the reaction. The Roche Molecular Systems Cobas AmpliScreen HIV-1 and HCV tests separately detect HIV-1 and HCV RNA in minipools of 24 donor samples.11 Both assays are highly specific and sensitive, with 50 percent detection limits (i.e., the level at which 50 percent of test results would be expected to be reactive) of 14 or fewer copies of HIV-1 per milliliter and 12 or fewer copies of HCV per milliliter on the basis of probit analyses.13,14 The 95 percent detection limits as defined in the package inserts for both tests range from 30 to 60 copies per milliliter for HIV-1 and HCV. Both systems have received FDA approval for routine screening of blood donors.

All major laboratories in the United States participating in nucleic acid–amplification screening (accounting for over 98 percent of tested blood donations) participated in this study and reported data collected on cases identified between March 1999 and January 2002, and in some instances from March 1999 through April 2002. A case was defined as an allogeneic donation that was nonreactive to antibody against HIV-1, HCV, or both but that was reactive on minipool nucleic acid–amplification screening and confirmed to be positive for HIV-1 or HCV RNA. Five testing programs used the Gen-Probe assay and reported cases of HIV-1 and HCV viremia identified on screening of 27,956,758 donations. The Roche Cobas AmpliScreen was used in 13 laboratories, which tested a total of 9,207,296 donations for HIV-1 RNA and 11,764,646 donations for HCV RNA. All participating sites received approval of this study from their institutional review board. Data were contributed by the blood-collection organizations and the manufacturers of the nucleic acid assays (Roche Molecular Systems, Gen-Probe, and Chiron).

The date of donation, the donor's status as a first-time or repeat donor, and whether the unit would have qualified for transfusion if not for the result of the nucleic acid–amplification test (i.e., whether the unit was transfusable) were collected for each case. Furthermore, the results of HIV-1 p24 antigen testing were compiled for cases of HIV-1 viremia, whereas data on alanine aminotransferase levels and the presence or absence of antibody against hepatitis B core antigen (anti-HBc) were collected for cases of HCV viremia. When applicable, we also compiled the results of repeated serologic analyses, repeated nucleic acid–amplification testing of the index sample with the use of a different type of RNA method (e.g., different techniques, primers, or probes), nucleic acid–amplification testing of an independent sample from the index donation, and serologic and nucleic acid–amplification testing of samples collected from donors participating in the follow-up analysis. For HIV-1, antibody was detected with the use of enzyme immunoassays and confirmed by Western blotting; for HCV, antibodies were detected by either second- or third-generation enzyme immunoassays and confirmed by recombinant immunoblot assay (RIBA, Chiron). Laboratories that routinely used second-generation HCV-antibody tests to screen donations were also asked to report the results of third-generation HCV-antibody tests performed on the HCV RNA–positive donations. This allowed categorization of cases of HCV viremia into those in which antibodies were detectable only by the more sensitive third-generation test and those with no detectable HCV antibody on both second- and third-generation HCV-antibody tests.11 A case was considered confirmed if the index donation was reactive to HIV-1 or HCV RNA with the use of a second type of nucleic acid–amplification test, if another sample from the index donation was reactive on the nucleic acid assay, or if at least one follow-up sample was reactive on nucleic acid–amplification testing or antibody testing.

An expanded data set was developed by the largest participating program (the American Red Cross) to study the dynamics of HCV infection. This data set included follow-up of HCV RNA–positive donors identified from March 1999 through mid-June 2003, thus providing an additional 15 months of follow-up on a well-characterized group of donors with acute HCV infection. For this program, a standardized prospective protocol was used to enroll donors, with specimens collected at approximately four-week intervals through the time of seroconversion, as confirmed by third-generation HCV-antibody tests, and beyond.

To determine whether trends observed for HIV-1–positive and HCV RNA–positive donors were constant beyond this three-year study, an additional two years of data from the American Red Cross were analyzed. Data on HIV-1–positive and HCV RNA–positive donors from March 1999 through March 2002 were compared with those for the subsequent two-year period from April 2002 to April 2004.

To evaluate rates of positive nucleic acid–amplification tests for HIV-1 and HCV RNA in specific subgroups (first-time and repeat donors and donors with otherwise transfusable donations), data were included only from laboratories that routinely reported this information. These subgroups represented about 37.0 million of the 39.7 million total donations. On the basis of data from the American Red Cross for 1999 through 2002, it was estimated that 23 percent of allogeneic donations were collected from first-time donors and 1 percent of all donations were discarded owing to reactivity to another routine serologic screening test in addition to nucleic acid–amplification testing.15

Rates of positive nucleic acid–amplification tests per million donations were calculated by dividing the number of cases by the number of known donations screened (or for samples from first-time or repeat donors and samples that were otherwise transfusable, by the estimated number of donations) and multiplying by 106. When the number of donations was known, the associated 95 percent confidence interval for the rate was computed.16 When the number in a subgroup of donations was estimated, an approximate 95 percent confidence interval was computed incorporating the uncertainty around the estimated number of donations.16,17 Fisher's exact tests and Wilcoxon's tests were used to compare categorical and continuous variables, respectively. All reported P values are two-sided.

Results

Viremic, Seronegative Donations Detected by Nucleic Acid–Amplification Testing

In the three years after the implementation of minipool nucleic acid–amplification testing, 12 donations that were not reactive to HIV-1 antibody and 170 donations that were not reactive to HCV antibody were confirmed to be positive for HIV-1 RNA and HCV RNA, respectively, among approximately 37 million to 40 million donations screened (Table 1Table 1Rates of Positivity for HIV-1 and HCV RNA, March 1999 to April 2002.). Hence, 1 per 3.1 million donations screened was confirmed to be positive for HIV-1 RNA and antibody-nonreactive, whereas 1 donation per 230,000 was confirmed to be positive for HCV RNA and antibody-nonreactive. Rates did not differ significantly between users of the Gen-Probe nucleic acid–amplification test and users of the Roche test (P=0.74, data not shown).

Effect of Serologic Screening Assays on the Detection of HCV RNA

In the United States, laboratories use one of two licensed assays, which differ significantly in window-period sensitivity, to screen donations for HCV antibody.11,18 Of 156 HCV RNA–positive donations, 17 that were antibody-nonreactive on the second-generation assay would have been identified as reactive by the third-generation assay, adjusting the rate of HCV-positive donations to 1 in 270,000 donations (Table 1).

Some of the donations that were positive on minipool nucleic acid–amplification testing would not have been released for transfusion even if such testing had not been performed. Among the 12 donations that were positive for HIV-1 RNA, 2 were confirmed to be positive for HIV-1 p24 antigen (Table 1), and 33 percent of donations that were identified as positive for HCV RNA (51 of 156) by laboratories that reported subgroup information would have been deemed nontransfusable (Table 1), including 45 of 51 units (88 percent) with an elevated alanine aminotransferase level. The remaining 6 were nontransfusable owing to reactivity to other routine screening tests; none of 155 HCV RNA–positive donations evaluated for anti-HBc reactivity were reactive. Thus, HCV nucleic acid screening prevented the release of 1 viremic donation for every 350,000 donations screened.

Alanine Aminotransferase Patterns in Different Stages of HCV Infection

To compare the distribution of alanine aminotransferase levels associated with various stages of HCV infection, we evaluated donor alanine aminotransferase levels compiled by the American Red Cross from 1999 through 2002. As shown in Figure 1Figure 1Distribution of Alanine Aminotransferase Levels According to HCV Status., HCV-seronegative donors had significantly different alanine aminotransferase distributions depending on their HCV RNA status; donors confirmed to be positive for HCV RNA had higher median enzyme levels than HCV RNA–negative donors (54 vs. 21 IU per liter, P<0.001). Donors who were confirmed to be positive for HCV RNA had elevated enzyme levels independent of their HCV antibody status (median, 56 IU per liter for seropositive donors vs. 54 IU per liter for seronegative donors; P=0.99). However, enzyme elevations of 120 IU per liter or more were noted more frequently among HCV RNA–positive, seronegative donors than among HCV RNA–positive, seropositive donors (30 percent vs. 15 percent, P<0.001). Lastly, among seropositive donors, enzyme levels were again higher among HCV RNA–positive donors than among HCV RNA–negative donors (56 vs. 22 IU per liter, P<0.001).

Relative Yield of Nucleic Acid–Amplification Tests among First-Time Donors and Repeat Donors

Viremic donations were more likely to be detected from first-time rather than repeat donors. Although only marginally significant (P=0.05), the rate of positivity for HIV-1 RNA was 4.1 times as high among the former group as the latter group; this ratio was 2.7 for the donations that were nonreactive to HIV-1 p24 antigen but positive for HIV-1 RNA (Table 2Table 2Rates of Positivity for HIV-1 and HCV RNA among First-Time and Repeat Donors, March 1999 to April 2002.). The rate of positivity for HCV RNA was 3.3 times as high among first-time donors as among repeat donors (P<0.001) (Table 2); the rate among first-time donors was similarly elevated when the calculations were restricted to HCV RNA–positive donations that were nonreactive on third-generation assays (7.9 per 106 units from first-time donors vs. 2.5 per 106 units from repeat donors; rate ratio, 3.2; 95 percent confidence interval, 2.0 to 5.0).

Follow-up Investigations of RNA-Positive Donors

Follow-up studies of seronegative donors who were confirmed to be positive for viral RNA demonstrated that these donations were virtually all made in the early stage of infection when viremia is present but an antibody reaction cannot be detected. Eight of 12 donors with positive HIV-1 nucleic acid–amplification tests enrolled in follow-up. All eight seroconverted within six weeks after the positive test. The median interval between the RNA-positive index donation and the first antibody-reactive sample was 11.5 days (range, 6 to 42), and the median interval between the donation and the first confirmed seropositive sample was 20.5 days (range, 15 to 42). These intervals probably represent an overestimate of the actual time to seroconversion, since the interval between follow-up samples varied and the sample size was small. Data were available for six additional HIV-1 RNA–positive donors (identified from April 2002 through April 2004) and demonstrated a similar time to seroconversion (8.6 days to antibody reactivity and 20.5 days to confirmed positivity).

For HCV, 90 of the 139 HCV RNA–positive donors who had nonreactive third-generation assays enrolled in the follow-up study; 75 of the 90 seroconverted. In the majority of those who did not seroconvert, the duration of follow-up was too short (range, 12 to 58 days) to allow determinations of their eventual seroconversion status.

The expanded data set from the American Red Cross allowed more extensive evaluation of the dynamics of HCV seroconversion. Figure 2Figure 2Follow-up Results for 67 HCV RNA–Positive, HCV Antibody–Nonreactive Donors. provides the follow-up results for 67 HCV RNA–positive donors (48 identified from March 1999 through April 2002, plus 19 identified from May 2002 through June 2003). Of these, 7 (10 percent) discontinued follow-up before either seroconversion or three months of follow-up, the interval during which seroconversion generally occurred (Figure 2A), and 55 (82 percent) seroconverted. The median time to seroconversion (from the RNA-positive, antibody-nonreactive index donation to a reactive third-generation antibody test) was 35 days. This is likely to be an underestimate of the viremic, antibody-nonreactive window period, since the period of viremia before the index donation is unknown. Of the 55 donors who seroconverted, 47 remained viremic during continued follow-up; 3 donors had fluctuating viremia in the presence of HCV antibody, and in 5, the HCV infection resolved after seroconversion, with persistent RNA negativity for up to one year (Figure 2B). Two additional donors (3 percent) had an abortive HCV infection, in which HCV RNA could initially be repeatedly demonstrated shortly after enrollment but disappeared in the absence of HCV seroconversion. Lastly, three donors (4 percent) remained viremic without elevated alanine aminotransferase levels, but they did not seroconvert after a follow-up period ranging from 1.5 to more than 3 years (so-called immunologically silent infections) (Figure 2B). The donor with the longest immunologically silent period was infectious during this period, since his RNA-positive donation transmitted HCV to a platelet recipient early in the nucleic acid–amplification testing program before the American Red Cross began withholding all blood components until the results of such tests were available.12

HIV-1–Positive and HCV-Positive Donors Identified from April 2002 to April 2004

An additional two years of data from the American Red Cross demonstrated no changes in the rates of positivity for HCV RNA — from 1 in 251,000 for the period from March 1999 through March 2002 (79 per 19,811,809 donations screened) to 1 in 222,200 for the period from April 2002 through April 2004 (60 per 13,332,257 donations screened, P=0.49). For HIV-1, the rates were 1 in 4 million and 1 in 2.2 million, respectively. A similar number of HIV-1 RNA–positive donations were identified during the two periods (five and six, respectively). Even though the frequency of HIV-1 RNA–positive donations increased for the period from April 2002 through April 2004, this increase was not significant (P=0.37).

Discussion

Assuming that each of the 13.6 million allogeneic units of blood donated annually in the United States is converted on average to 1.45 transfusable components,19,20 our data indicate that the implementation of minipool nucleic acid screening likely prevented about 5 cases of transfusion-transmitted HIV-1 infection and 56 cases of HCV infection annually. The documented findings are consistent with the those predicted from mathematical models.4,15,21 Despite the fact that these rates are relatively low and have remained stable for five years, implementation of these tests was consistent with the goal of maximizing blood safety.1,3 It has been estimated that nucleic acid screening has reduced the residual risk of transfusion-associated infection for both HIV-1 and HCV to about 1 in 2 million blood units from repeated donors.15 This is a reduction from rates of 1 in 276,000 for HCV and 1 in 1.5 million for HIV-1 with the use of serologic testing alone.15 The residual risk after the implementation of nucleic acid–amplification testing results from the presence of virus below the limit of detection of minipool testing22; individual nucleic acid screening of each sample, rather than screening of small pools of multiple samples, would further decrease the residual risk but at a substantially greater cost.

With the licensure of nucleic acid–amplification tests, the FDA has permitted the discontinuation of HIV-1 p24 antigen testing on the basis of data showing that HIV-1 RNA screening is better able to detect infection in the window period shortly after infection and that all p24 antigen–positive donations are also RNA-positive.7,23 This policy is supported by our data, in which HIV-1 nucleic acid screening identified 12 infected donors, only 2 of whom were identified by p24 antigen testing; in contrast, there were no RNA-negative donations from HIV-1–infected donors that were identified as positive by p24 antigen testing. The detection of p24 antigen in the absence of antibody corresponds to the peak viremic period when blood donors are likely to defer donations owing to influenza-like symptoms.7,9,24

Approximately one third of the units detected by HCV nucleic acid–amplification testing would have been discarded anyway owing to elevated alanine aminotransferase levels. Because of the relative nonspecificity of this surrogate marker, the absence of evidence of additional transfusion-transmissible hepatitis agents,8,25 and the implementation of a sensitive screening method for the detection of HCV RNA, the continued use of alanine aminotransferase screening for preventing transfusion-associated hepatitis is no longer justified; consequently, many blood centers have stopped using this test. In addition, the presence of circulating HCV RNA is a direct marker of viral replication and indicates a diagnosis of HCV infection with greater sensitivity and specificity than does the presence of elevated liver enzymes.

Our data show that new HCV and HIV-1 infections occur three to four times as often among first-time donors as among repeat donors, substantiating previous observations.15,26 This finding supports the general principle that retention of repeat donors enhances both the adequacy and safety of the blood supply. Possible reasons for higher rates among first-time donors include inappropriate use of blood donation to obtain the results of viral tests; failure to understand the questions for donors and, hence, the donor-selection criteria; and self-deferral of the donor after the first donation owing to the realization that his or her donation was unsuitable.

The routine use of nucleic acid–amplification tests and serologic assays for donor screening has made possible the identification of persons in the very early stages of HIV-1 and HCV infection; this information can provide insights into risk factors associated with viral infection and potentially contribute to studies of the natural history, pathogenesis, and treatment of these infections.9,10 For example, an analysis of recent risk-related behavior among HCV-infected donors identified by nucleic acid–amplification testing may identify behavioral and demographic characteristics that could be used to improve donor-qualification criteria, provided effective questions could be designed.27 The addition of HCV RNA testing to routine HCV-antibody screening has also allowed seropositive donors to be subdivided into those with active infection (plasma RNA–positive) and those with either resolved HCV infection or intermittent viremia (plasma RNA–negative at the time of donation). Enrollment of these donors into natural-history and early-treatment trials could enhance our understanding of the pathogenesis of HCV infection, including the factors underlying the spontaneous resolution of HCV viremia.10,28

Several reports have suggested that serologic testing may miss a substantial proportion of infected persons.29-31 We found that only three seronegative donors with persistent hepatitis C viremia did not seroconvert during the expected time frame. During this same time at the American Red Cross, more than 800 HIV-seropositive donors and more than 16,000 HCV-seropositive donors were identified. Thus, persistent immunologically silent infections are extremely rare, reinforcing the continued reliance on serologic analyses for HIV-1 and HCV as the primary tools for diagnostic testing.32

Because blood centers had already implemented nucleic acid–amplification testing for HIV-1 and HCV, it was feasible in 2003, in collaboration with the Centers for Disease Control and Prevention and the FDA and with the rapid development of nucleic acid–amplification tests by manufacturers, to implement screening for West Nile virus in less than nine months.33-35 Results indicate that close to 1000 donors with West Nile virus infection were identified by nucleic acid–amplification testing in 2003 and their donations discarded, probably preventing more than 1000 transfusion-related infections.35

The relatively low yield and poor cost effectiveness of HIV-1 and HCV minipool nucleic acid–amplification testing have led some to question the value of such screening. Using somewhat different analyses and assumptions, two independent groups studying the cost-effectiveness of HIV-1 and HCV minipool nucleic acid–amplification testing, both in the context of eliminating p24 antigen screening, estimated costs of $1.5 million to $4.3 million per quality-adjusted year of life.19,36 Costs increase further if each donated blood unit is to be tested rather than combined in minipools, with yet further increases in cost for the automation required to perform large numbers of individual screening tests. Therefore, the cost of HIV-1 and HCV nucleic acid–amplification testing would need to decrease substantially to bring it in line with that of most other accepted medical practices. However, the aggregate cost-effectiveness of nucleic acid–amplification testing may have substantially improved with the implementation of such screening for West Nile virus. The rapid development and introduction of nucleic acid screening for West Nile virus and the ability to expand nucleic acid–amplification testing to include other emerging infections in the future further serve to support the adoption of this important tool for the screening of blood donations.

Supported by the individual blood programs represented as well as by contracts (N01-HB-97077 [superseded by N01-HB-47114], N01-HB-97078, N01-HB-97079, N01-HB-97080, N01-HB-97081, and N01-HB-97082) with the National Heart, Lung, and Blood Institute.

Dr. Busch reports having received consulting or lecture fees from Abbott Diagnostics, Acrometrix, Haemonetics, Navigant/Gambro, and Ortho-Clinical Diagnostics; Dr. Dodd consulting or lecture fees from Chiron and Roche Biomedical; Dr. Kleinman consulting fees from Chiron and Roche Molecular Systems; Dr. Stramer consulting fees from Chiron and Gen-Probe; and Dr. Strong consulting or lecture fees from Roche Molecular Systems. Dr. Strong also reports owning equity in Human BioSystems.

We are indebted to S. Matthew, R. McEntire, A. Snowhite, D. Todd, and Y. Xu for data collection and programming at Westat; and to E. Notari, A. Wagner, J. Paolillo, M. Beyers, M. Parcells, and K. Kane for data management and analysis of the surveillance and follow-up study.

Source Information

From the American Red Cross, Gaithersburg, Md. (S.L.S.), and Rockville, Md. (R.Y.D.); Westat, Rockville, Md. (S.A.G., S.H.K., D.J.W.); the University of British Columbia, Victoria, B.C., Canada (S.H.K.); Puget Sound Blood Center, Seattle (D.M.S.); Blood Systems Laboratory, Tempe, Ariz. (S.C., M.P.B.); Blood Systems Research Institute, Blood Centers of the Pacific, San Francisco (M.P.B.); and the University of California, San Francisco (M.P.B.).

Address reprint requests to Dr. Stramer at the American Red Cross National Testing and Reference Laboratories, 9315 Gaither Rd., Gaithersburg, MD 20877, or at .

Appendix

The National Heart, Lung, and Blood Institute Nucleic Acid Test Study involves the following sites and investigators: National Heart, Lung, and Blood Institute, National Institutes of Health — G. Nemo; Blood Centers of the Pacific and Blood Systems — M. Busch (principal investigator); Westat — G. Schreiber, M. King, S. Kleinman, S. Glynn; American Red Cross (Gen-Probe site) — S. Stramer, R. Dodd, J. Brodsky, J. Davis; America's Blood Centers (Gen-Probe sites: Blood Center of Southeastern Wisconsin, Blood Systems Laboratories, and Florida Blood Services, and Roche sites: Blood Center of Southeast Louisiana, BloodSource, Bonfils Blood Center, Central Florida Blood Bank, Community Blood Center of Greater Kansas City, Gulf Coast Regional Blood Center, LifeSource Blood Services, LifeSouth Community Blood Centers, Memorial Blood Centers of Minneapolis, New York Blood Center, Oklahoma Blood Institute, and Puget Sound Blood Center) — S. Caglioti, D.M. Strong; Association of Independent Blood Centers (Gen-Probe site) — R. Gammon; Center for Biologics Evaluation and Research, FDA — I. Hewlett; Roche — J. Gallarda, Y. Yang; Gen-Probe — L. Mimms, C. Giachetti, S. McDonough; Chiron — B. Phelps; Stanford Medical School blood bank.

References

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    S. F. O’Brien, Q.-L. Yi, W. Fan, V. Scalia, M. A. Fearon, J.-P. Allain. (2012) Current incidence and residual risk of HIV, HBV and HCV at Canadian Blood Services. Vox Sanguinisno-no
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    2011. Autologous Blood Donation and Transfusion. , 100-121.
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    Jerry E. Squires. (2011) Risks of Transfusion. Southern Medical Journal 104:11, 762-769
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    L.E. Taylor, A.K. DeLong, M.A. Maynard, S. Chapman, P. Gholam, J.T. Blackard, J. Rich, K.H. Mayer. (2011) Acute Hepatitis C Virus in an HIV Clinic: A Screening Strategy, Risk Factors, and Perception of Risk. AIDS Patient Care and STDs 25:10, 571-577
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    G. Shang, C. R. Seed, M. E. Gahan, M. S. Rolph, S. Mahalingam. (2011) Duration of Ross River viraemia in a mouse model - implications for transfusion transmission. Vox Sanguinisno-no
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    C. Zeh, B. Oyaro, H. Vandenhoudt, P. Amornkul, A. Kasembeli, P. Bondo, D. Mwaengo, T.K. Thomas, C. Hart, K.F. Laserson, P. Ondoa, J.N. Nkengasong. (2011) Performance of six commercial enzyme immunoassays and two alternative HIV-testing algorithms for the diagnosis of HIV-1 infection in Kisumu, Western Kenya. Journal of Virological Methods 176:1-2, 24-31
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    Sheila F. O'Brien, Shimian Zou, Syria Laperche, Lisa J. Brant, Clive R. Seed, Steven H. Kleinman. (2011) Surveillance of Transfusion-Transmissible Infections. Transfusion Medicine Reviews
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    Shimian Zou, Susan L. Stramer, Roger Y. Dodd. (2011) Donor Testing and Risk: Current Prevalence, Incidence, and Residual Risk of Transfusion-Transmissible Agents in US Allogeneic Donations. Transfusion Medicine Reviews
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    J. E. Levi. (2011) Current concepts in molecular testing. ISBT Science Series 6:1, 67-71
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    Jeng-Fu Yang, Ya-Yun Lin, Meng-Hsuan Hsieh, Chiu-Hung Tsai, Shu-Fen Liu, Ming-Lung Yu, Chia-Yen Dai, Jee-Fu Huang, Wen-Yi Lin, Zu-Yau Lin, Shinn-Chern Chen, Wan-Long Chuang. (2011) Performance characteristics of a combined hepatitis C virus core antigen and anti–hepatitis C virus antibody test in different patient groups. The Kaohsiung Journal of Medical Sciences 27:7, 258-263
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    K. Ellingson, D. Seem, M. Nowicki, D. M. Strong, M. J. Kuehnert, . (2011) Estimated Risk of Human Immunodeficiency Virus and Hepatitis C Virus Infection among Potential Organ Donors from 17 Organ Procurement Organizations in the United States. American Journal of Transplantation 11:6, 1201-1208
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    Adriana Weinberg, Laura Enomoto, Roland Marcus, Jennifer Canniff. (2011) Effect of menstrual cycle variation in female sex hormones on cellular immunity and regulation. Journal of Reproductive Immunology 89:1, 70-77
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    Eric Delwart, Flavien Bernardin, Tzong-Hae Lee, Valerie Winkelman, Chenglong Liu, Haynes Sheppard, Albert Liu, Ruth Greenblatt, Katryn Anastos, Jack DeHovitz, Marek Nowicki, Mardge Cohen, Elizabeth T Golub, Jason Barbour, Susan Buchbinder, Michael P Busch. (2011) Absence of reproducibly detectable low-level HIV viremia in highly exposed seronegative men and women. AIDS 25:5, 619-623
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    P. W. Hunt, H. Hatano, E. Sinclair, T.-H. Lee, M. P. Busch, J. N. Martin, J. M. McCune, S. G. Deeks. (2011) HIV-Specific CD4+ T Cells May Contribute to Viral Persistence in HIV Controllers. Clinical Infectious Diseases 52:5, 681-687
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    Stramer, Susan L., Wend, UlrikeCandotti, Daniel, Foster, Gregory A., Hollinger, F. Blaine, Dodd, Roger Y., Allain, Jean-Pierre, Gerlich, Wolfram, . (2011) Nucleic Acid Testing to Detect HBV Infection in Blood Donors. New England Journal of Medicine 364:3, 236-247
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    G. U. van Zyl, W. Preiser, S. Potschka, A. T. Lundershausen, R. Haubrich, D. Smith. (2011) Pooling Strategies to Reduce the Cost of HIV-1 RNA Load Monitoring in a Resource-Limited Setting. Clinical Infectious Diseases 52:2, 264-270
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    (2011) Nihon Toseki Igakkai Zasshi 44:6, 528-531
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    Cesar de Almeida-Neto, Jing Liu, David J. Wright, Alfredo Mendrone-Junior, Pedro L. Takecian, Yu Sun, Joao Eduardo Ferreira, Dalton de Alencar Fischer Chamone, Michael P. Busch, Ester Cerdeira Sabino, . (2011) Demographic characteristics and prevalence of serologic markers among blood donors who use confidential unit exclusion (CUE) in São Paulo, Brazil: implications for modification of CUE polices in Brazil. Transfusion 51:1, 191-197
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    Katarina Rednak Paradiž, Katja Seme, Evelin Puklavec, Darja Paro-Panjan, Mario Poljak. (2011) Prevalence of congenital cytomegalovirus infection in Slovenia: A study on 2,841 newborns. Journal of Medical Virologyn/a-n/a
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    Suganya Selvarajah, Leslie H Tobler, Graham Simmons, Michael P Busch. (2010) Host genetic basis for hepatitis C virus clearance: a role for blood collection centers. Current Opinion in Hematology 17:6, 550-557
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    A. Pruss, G. Caspari, D.H. Krüger, J. Blümel, C.M. Nübling, L. Gürtler, W.H. Gerlich. (2010) Tissue donation and virus safety: more nucleic acid amplification testing is needed. Transplant Infectious Disease 12:5, 375-386
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    Herbert A. Perkins, Michael P. Busch. (2010) Transfusion-associated infections: 50 years of relentless challenges and remarkable progress. Transfusion 50:10, 2080-2099
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    Hiroyu Hatano, Eric L Delwart, Philip J Norris, Tzong-Hae Lee, Torsten B Neilands, Colleen F Kelley, Peter W Hunt, Rebecca Hoh, Jeffrey M Linnen, Jeffrey N Martin, Michael P Busch, Steven G Deeks. (2010) Evidence of persistent low-level viremia in long-term HAART-suppressed, HIV-infected individuals. AIDS 24:16, 2535-2539
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    Keyur Patel, Hans L Tillmann, John G McHutchison. 2010. Hepatitis C. , 435-447.
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    Thelma Goncalez, Ester Sabino, Nanci Sales, Yea-Hung Chen, Dalton Chamone, Michael Busch, Edward Murphy, Brian Custer, Willi McFarland. (2010) Human immunodeficiency virus test-seeking blood donors in a large blood bank in São Paulo, Brazil. Transfusion 50:8, 1806-1814
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    Priti R. Patel, Nicola D. Thompson, Alexander J. Kallen, Matthew J. Arduino. (2010) Epidemiology, Surveillance, and Prevention of Hepatitis C Virus Infections in Hemodialysis Patients. American Journal of Kidney Diseases 56:2, 371-378
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    Shimian Zou, Kerri A. Dorsey, Edward P. Notari, Gregory A. Foster, David E. Krysztof, Fatemeh Musavi, Roger Y. Dodd, Susan L. Stramer. (2010) Prevalence, incidence, and residual risk of human immunodeficiency virus and hepatitis C virus infections among United States blood donors since the introduction of nucleic acid testing. Transfusion 50:7, 1495-1504
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    H. Schrezenmeier, E. Seifried. (2010) Buffy-coat-derived pooled platelet concentrates and apheresis platelet concentrates: which product type should be preferred?. Vox Sanguinis 99:1, 1-15
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    Shimian Zou, Fatemeh Musavi, Edward P. Notari, Susan L. Stramer, Roger Y. Dodd. (2010) Prevalence, incidence, and residual risk of major blood-borne infections among apheresis collections to the American Red Cross Blood Services, 2004 through 2008. Transfusion 50:7, 1487-1494
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    Eric Y Wong, Indira K Hewlett. (2010) HIV diagnostics: challenges and opportunities. HIV Therapy 4:4, 399-412
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    S.R. Lee, G.D. Yearwood, G.B. Guillon, L.A. Kurtz, M. Fischl, T. Friel, C.A. Berne, K.W. Kardos. (2010) Evaluation of a rapid, point-of-care test device for the diagnosis of hepatitis C infection. Journal of Clinical Virology 48:1, 15-17
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    Anke Edelmann, Ulrich Kalus, Anke Oltmann, Angela Stein, Anett Unbehaun, Christian Drosten, Detlev H. Krüger, Jörg Hofmann. (2010) TRANSFUSION COMPLICATIONS: Improvement of an ultrasensitive human immunodeficiency virus Type 1 real-time reverse transcriptase-polymerase chain reaction targeting the long terminal repeat region. Transfusion 50:3, 685-692
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    Sudha Jayaraman, Zaid Chalabi, Pablo Perel, Carla Guerriero, Ian Roberts. (2010) The risk of transfusion-transmitted infections in sub-Saharan Africa. Transfusion 50:2, 433-442
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    M. Schmidt, L. Pichl, C. Jork, M. K. Hourfar, V. Schottstedt, F. F. Wagner, E. Seifried, T. H. Müller, J. Bux, J. Saldanha. (2010) Blood donor screening with cobas s 201/cobas TaqScreen MPX under routine conditions at German Red Cross institutes. Vox Sanguinis 98:1, 37-46
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    Eleftherios C. Vamvakas. (2009) COMMENTARY: Relative safety of pooled whole blood-derived versus single-donor (apheresis) platelets in the United States: a systematic review of disparate risks. Transfusion 49:12, 2743-2758
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    Davey M Smith, Susanne J May, Josué Pérez-Santiago, Matthew C Strain, Caroline C Ignacio, Richard H Haubrich, Douglas D Richman, Constance A Benson, Susan J Little. (2009) The use of pooled viral load testing to identify antiretroviral treatment failure. AIDS 23:16, 2151-2158
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    Roger Dodd. (2009) Managing the microbiological safety of blood for transfusion: a US perspective. Future Microbiology 4:7, 807-818
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    Babak Arjmand, Seyed Hamidreza Aghayan, Parisa Goodarzi, Mohammad Farzanehkhah, Seyed Mohamadjavad Mortazavi, Mohamad Hossein Niknam, Ali Jafarian, Farzin Arjmand, Soheyla Jebelly far. (2009) Seroprevalence of human T lymphtropic virus (HTLV) among tissue donors in Iranian tissue bank. Cell and Tissue Banking 10:3, 247-252
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    Jay A. Fishman, D. Michael Strong, Matthew J. Kuehnert. (2009) Organ and tissue safety workshop 2007: advances and challenges. Cell and Tissue Banking 10:3, 271-280
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    (2009) Exposed or not exposed-that is the question: evidence for resolving and abortive hepatitis C virus infections in blood donors. Transfusion 49:7, 1277-1281
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    C. Thomas Nugent, J. Dockter, F. Bernardin, R. Hecht, D. Smith, E. Delwart, C. Pilcher, D. Richman, M. Busch, C. Giachetti. (2009) Detection of HIV-1 in alternative specimen types using the APTIMA® HIV-1 RNA Qualitative Assay. Journal of Virological Methods 159:1, 10-14
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    Soisaang Phikulsod, Sineenart Oota, Thaweesak Tirawatnapong, Tasanee Sakuldamrongpanich, Wilai Chalermchan, Suda Louisirirotchanakul, Srivilai Tanprasert, Viroje Chongkolwatana, Pimpun Kitpoka, Praphan Phanuphak, Chantapong Wasi, Chaivej Nuchprayoon, . (2009) One-year experience of nucleic acid technology testing for human immunodeficiency virus Type 1, hepatitis C virus, and hepatitis B virus in Thai blood donations. Transfusion 49:6, 1126-1135
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    Marion Vermeulen, Nico Lelie, Wendy Sykes, Robert Crookes, Johanna Swanevelder, Lilian Gaggia, Martin Le Roux, Eben Kuun, Sam Gulube, Ravi Reddy. (2009) Impact of individual-donation nucleic acid testing on risk of human immunodeficiency virus, hepatitis B virus, and hepatitis C virus transmission by blood transfusion in South Africa. Transfusion 49:6, 1115-1125
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    Shimian Zou, Edward P. Notari, Chyang T. Fang, Susan L. Stramer, Roger Y. Dodd. (2009) Current value of serologic test for syphilis as a surrogate marker for blood-borne viral infections among blood donors in the United States. Transfusion 49:4, 655-661
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    Eleftherios C. Vamvakas. (2009) Scientific Background on the Risk Engendered by Reducing the Lifetime Blood Donation Deferral Period for Men Who Have Sex With Men. Transfusion Medicine Reviews 23:2, 85-102
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    Ulrich Kalus, Anke Edelmann, Axel Pruss, Jörg Hofmann, Holger Kiesewetter, Detlev H. Krüger, Abdulgabar Salama. (2009) Noninfectious transfusion of platelets donated before detection of human immunodeficiency virus RNA in plasma. Transfusion 49:3, 435-439
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    Catherine A. Brennan, Susan L. Stramer, Vera Holzmayer, Julie Yamaguchi, Greg A. Foster, Edward P. Notari IV, Gerald Schochetman, Sushil G. Devare. (2009) Identification of human immunodeficiency virus type 1 non-B subtypes and antiretroviral drug-resistant strains in United States blood donors. Transfusion 49:1, 125-133
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    Michael P. Busch, Steven H. Kleinman, Leslie H. Tobler, Hany T. Kamel, Philip J. Norris, Irina Walsh, Jose L. Matud, Harry E. Prince, Robert S. Lanciotti, David J. Wright, Jeffrey M. Linnen, Sally Caglioti. (2008) Virus and Antibody Dynamics in Acute West Nile Virus Infection. The Journal of Infectious Diseases 198:7, 984-993
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    Lisa Jarvis, Janine Becker, Alzira Tender, Alexander Cleland, Lucinda Queiros, Ana Aquiar, Joana Azevedo, Giuseppe Aprili, Fausto Bressan, Pilar Torres, Serafin Nieto, Antonella Ursitti, Jose Montoro, Enrique Vila, Concha Ramada, John Saldanha. (2008) Evaluation of the Roche cobas s 201 system and cobas TaqScreen multiplex test for blood screening: a European multicenter study. Transfusion 48:9, 1853-1861
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    Hua Shan, Fu-rong Ren, Hai-yan Zhao, Yuan-zhi Zhang, Guo-xing Wen, Fu-zhu Yao, Guo-jing Gao, Li-xing Yan, Chao-fu Jiang, Xu-hua Bai, Mei-hei-li Tiemuer, Yuan-quan Tu, Fa-ming Zhu, You-rong Zheng, Li Cui, Chang-li Liu, Xiao-yan Gong, Qiu-shuang Lv, Peng Zheng, Rainer Ziermann, Paul Ness, Jing-xing Wang. (2007) A multi–Chinese blood center study testing serologic-negative donor samples for hepatitis C virus and human immunodeficiency virus with nucleic acid testing. Transfusion 47:11, 2011-2016
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    Niwes Nantachit, Lakkana Thaikruea, Satawat Thongsawat, Nipapan Leetrakool, Ladda Fongsatikul, Prakai Sompan, Yiu-Lian Fong, David Nichols, Rainer Ziermann, Paul Ness, Kenrad E. Nelson. (2007) Evaluation of a multiplex human immunodeficiency virus-1, hepatitisC virus, and hepatitis B virus nucleic acid testing assay to detect viremic blood donors in northern Thailand. Transfusion 47:10, 1803-1808
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    Steven H. Kleinman, Simone A. Glynn, Tzong-Hae Lee, Leslie Tobler, Leilani Montalvo, Deborah Todd, Joseph E. Kiss, Venkatakrishna Shyamala, Michael P. Busch, . (2007) Prevalence and quantitation of parvovirus B19 DNA levels in blood donors with a sensitive polymerase chain reaction screening assay. Transfusion 47:10, 1756-1764
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    Everton Hadlich, Mário Reis Álvares-Da-Silva, Rafaela Komorowski Dal Molin, Raquel Zenker, Luciano Zubaran Goldani. (2007) Hepatitis C virus (HCV) viremia in HIV-infected patients without HCV antibodies detectable by third-generation enzyme immunoassay. Journal of Gastroenterology and Hepatology 22:9, 1506-1509
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    Flavien Bernardin, Susan L. Stramer, Barbara Rehermann, Kimberly Page-Shafer, Stewart Cooper, David R. Bangsberg, Judith Hahn, Leslie Tobler, Michael Busch, Eric Delwart. (2007) High levels of subgenomic HCV plasma RNA in immunosilent infections. Virology 365:2, 446-456
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    Nicola M. Zetola, Ann Mintie, Sally Liska, Ernest Wong, Joan Dunn Williams, Michael P. Busch, Jeffrey D. Klausner. (2007) Performance of a transcription-mediated-amplification HIV-1 RNA assay in pooled specimens. Journal of Clinical Virology 40:1, 68-70
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    B. Sarov, L. Novack, N. Beer, J. Safi, H. Soliman, J. S. Pliskin, E. Litvak, A. Yaari, E. Shinar. (2007) Feasibility and cost?benefit of implementing pooled screening for HCVAg in small blood bank settings. Transfusion Medicine 0:0, 070831211632001-???
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    Mandy Whitlock, Sandra Lord, Jane A. Buxton, Patrick Doyle, Mark Bigham. (2007) Evaluating the impact of public health notification of suspected transfusion-transmissible hepatitisC virus infection and effectiveness of lookback and traceback investigations by Canadian Blood Services in British Columbia, Canada, August 2002 through February 2005. Transfusion 47:8, 1534-1539
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    Masahiro Satake, Rikizo Taira, Hisao Yugi, Satoru Hino, Kimihiro Kanemitsu, Hisami Ikeda, Kenji Tadokoro. (2007) Infectivity of blood components with low hepatitisB virus DNA levels identified in a lookback program. Transfusion 47:7, 1197-1205
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    S. Laperche, J. Pillonel. (2007) Influence of epidemiological factors on blood transfusion. ISBT Science Series 2:1, 78-84
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    Sheila F. O'Brien, Shefali S. Ram, Eleftherios C. Vamvakas, Mindy Goldman. (2007) The Canadian Blood Donor Health Assessment Questionnaire: Lessons From History, Application of Cognitive Science Principles, and Recommendations for Change. Transfusion Medicine Reviews 21:3, 205-222
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    S. Wendel. (2007) Rational testing for transmissible diseases. ISBT Science Series 2:1, 19-24
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    A. M. Caliendo, J. R. Lake. (2007) Is It Risky to Use Kidneys from CDC-Increased Risk Donors?. American Journal of Transplantation 7:6, 1437-1438
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    P. S. P. Scuracchio, M. C. C. Poli, M. M. M. Lemos, A. G. Oliveira Filho, N. A. Salles, D. A. F. Chamone, M. Magri, N. J. F. Cavalcante, R. Collela. (2007) Detection of HIV-1 infection in blood donors during the immunological window period using the nucleic acid-amplification technology. Transfusion Medicine 17:3, 200-204
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    Katja Seme, Tina Močilnik, Kristina Fujs, Dunja Z. Babič, Aleksandra Todorović, Tamara Fras-Stefan, Mario Poljak. (2007) Twenty-four mini-pool HCV RNA screening outside a blood transfusion setting: Results of a 2-year prospective study. Journal of Virological Methods 140:1-2, 218-221
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    Nicola M. Zetola, Christopher D. Pilcher. (2007) Diagnosis and Management of Acute HIV Infection. Infectious Disease Clinics of North America 21:1, 19-48
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    Juan C. Alados-Arboledas, Luis Calbo-Torrecillas, M.ª Dolores López-Prieto, José Luis de Francisco-Ramírez, Constantino de Miguel-Sastre. (2007) Evaluación de la técnica Monolisa HCV Ag-Ab ULTRA (BioRad) en un hospital general. Enfermedades Infecciosas y Microbiología Clínica 25:3, 172-176
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    G. Chamie, M. Bonacini, D. R. Bangsberg, J. T. Stapleton, C. Hall, E. T. Overton, R. Scherzer, P. C. Tien. (2007) Factors Associated with Seronegative Chronic Hepatitis C Virus Infection in HIV Infection. Clinical Infectious Diseases 44:4, 577-583
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    Silvina Alejandra Gendler, María Susana Pascuccio. (2007) Routine HIV screening among blood donors in Buenos Aires (Argentina): Results from six years’ experience and report of a single window-period donation. Enfermedades Infecciosas y Microbiología Clínica 25:2, 82-90
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    Francisco Rentas, Ronald Harman, Charlotte Gomez, Jeanne Salata, Joseph Childs, Tonya Silva, Lloyd Lippert, Joshua Montgomery, Allen Richards, Chye Chan, Ju Jiang, Heather Reddy, John Li, Raymond Goodrich. (2007) Inactivation of Orientia tsutsugamushi in red blood cells, plasma, and platelets with riboflavin and light, as demonstrated in an animal model. Transfusion 47:2, 240-247
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    Sheila F. O'Brien, Qi-Long Yi, Wenli Fan, Vito Scalia, Steven H. Kleinman, Eleftherios C. Vamvakas. (2007) Current incidence and estimated residual risk of transfusion-transmitted infections in donations made to Canadian Blood Services. Transfusion 47:2, 316-325
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    Bruce D. Spiess. (2007) Red Cell Transfusions and Guidelines: A Work in Progress. Hematology/Oncology Clinics of North America 21:1, 185-200
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    G. Zahariadis, S. S. Plitt, S. O'Brien, Q. -L. Yi, W. Fan, J. K. Preiksaitis. (2007) Prevalence and Estimated Incidence of Blood-Borne Viral Pathogen Infection in Organ and Tissue Donors from Northern Alberta. American Journal of Transplantation 7:1, 226-234
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    George J. Dawson. (2007) HCV core antigen and combination (antigen/antibody) assays for the detection of early seroconversion. Journal of Medical Virology 79:S1, S54-S58
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    L. H. Tobler, S. L. Stramer, D. Y. Chien, S. Lin, P. Arcangel, B. H. Phelps, S. L. Cooper, M. P. Busch. (2007) Antibodies to a novel antigen in acute hepatitis C virus infections. Vox Sanguinis 92:1, 1-7
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    Ewa Brojer, Piotr Grabarczyk, Grzegorz Liszewski, Maria Mikulska, Jean-Pierre Allain, Magdalena Letowska, . (2006) Characterization of HBV DNA+/HBsAg− blood donors in Poland identified by triplex NAT. Hepatology 44:6, 1666-1674
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    T.P. Leary, R.A. Gutierrez, A.S. Muerhoff, L.G. Birkenmeyer, S.M. Desai, G.J. Dawson. (2006) A chemiluminescent, magnetic particle-based immunoassay for the detection of hepatitis C virus core antigen in human serum or plasma. Journal of Medical Virology 78:11, 1436-1440
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    Shimian Zou, Karen Fujii, Stephanie Johnson, Bryan Spencer, Nicole Washington, Edward Notari Iv, Fatemeh Musavi, Bruce Newman, Ritchard Cable, Jorge Rios, Krista L. Hillyer, Christopher D. Hillyer, Roger Y. Dodd, . (2006) Prevalence of selected viral infections among blood donors deferred for potential risk to blood safety. Transfusion 46:11, 1997-2003
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    C. Micha Nübling, Michael Chudy, Peter Volkers, Johannes Löwer. (2006) Neopterin levels during the early phase of human immunodeficiency virus, hepatitisC virus, or hepatitisB virus infection. Transfusion 46:11, 1886-1891
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    Netta Beer, Eilat Shinar, Lena Novack, Jamal Safi, Hassan Soliman, Arieh Yaari, Ronit Goldman-Levi, Vered Yahalom, Arkadi Bolotin, Batia Sarov. (2006) Accuracy of hepatitisC virus core antigen testing in pools among seroconverters. Transfusion 46:10, 1822-1828
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    Michael P. Busch. (2006) Lessons and opportunities from epidemiologic and molecular investigations of infected blood donors. Transfusion 46:10, 1663-1666
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    S. L. Stramer. (2006) Impact of NAT on serological screening of transfusion-transmitted agents. ISBT Science Series 1:1, 194-202
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    Ming H. Zheng, Richard Pembrey, Silvana Niutta, Patricia Stewart-Richardson, Albert Farrugia. (2006) CHALLENGES IN THE EVALUATION OF SAFETY AND EFFICACY OF HUMAN TISSUE AND CELL BASED PRODUCTS. ANZ Journal of Surgery 76:9, 843-849
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    Dominique Challine, Fran??oise Roudot-Thoraval, Patrick Sabatier, Fabienne Dubernet, Patrick Larderie, Pierrette Rigot, Jean-Michel Pawlotsky. (2006) Serological Viral Testing of Cadaveric Cornea Donors. Transplantation 82:6, 788-793
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    Michael P. Busch, Tzong-Hae Lee, Garth H. Utter, William Reed. (2006) Application of nucleic acid amplification tests to study transfusion-associated microchimerism – a new complication of blood transfusions in trauma patients. ISBT Science Series 1:1, 185-193
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    Michael P. Busch. (2006) Transfusion-transmitted viral infections: building bridges to transfusion medicine to reduce risks and understand epidemiology and pathogenesis. Transfusion 46:9, 1624-1640
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    L. Comanor, P. Holland. (2006) Hepatitis B virus blood screening: unfinished agendas. Vox Sanguinis 91:1, 1-12
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    David S. Kauvar, John B. Holcomb, Gary C. Norris, John R. Hess. (2006) Fresh Whole Blood Transfusion: A Controversial Military Practice. The Journal of Trauma: Injury, Infection, and Critical Care 61:1, 181-184
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    M.K. McCormick, J. Dockter, J.M. Linnen, D. Kolk, Y. Wu, C. Giachetti. (2006) Evaluation of a new molecular assay for detection of human immunodeficiency virus type 1 RNA, hepatitis C virus RNA, and hepatitis B virus DNA. Journal of Clinical Virology 36:3, 166-176
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    Chyang T. Fang. (2006) Blood Screening for HBV DNA. Journal of Clinical Virology 36, S30-S32
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    Steven H. Kleinman, Susan L. Stramer, Jaye P. Brodsky, Sally Caglioti, Michael P. Busch. (2006) Integration of nucleic acid amplification test results into hepatitis C virus supplemental serologic testing algorithms: implications for donor counseling and revision of existing algorithms. Transfusion 46:5, 695-702
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    Steven H. Kleinman, Michael P. Busch. (2006) Assessing the impact of HBV NAT on window period reduction and residual risk. Journal of Clinical Virology 36, S23-S29
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    Mindy Goldman, Lindsay Patterson, Anne Long. (2006) Recent Canadian experience with targeted hepatitis C virus lookback. Transfusion 46:5, 690-694
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    Bernard Weber. (2006) Screening of HIV infection: role of molecular and immunological assays. Expert Review of Molecular Diagnostics 6:3, 399-411
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    E PIANIGIANI, M RISULO, F IERARDI, P SBANO, L ANDREASSI, M FIMIANI, C CAUDAI, P VALENSIN, M ZAZZI. (2006) Prevalence of skin allograft discards as a result of serological and molecular microbiological screening in a regional skin bank in Italy. Burns 32:3, 348-351
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    Matthias Brigulla, Thomas Thiele, Christian Scharf, Susanne Breitner-Ruddock, Simone Venz, Uwe Volker, Andreas Greinacher. (2006) Proteomics as a tool for assessment of therapeutics in transfusion medicine: evaluation of prothrombin complex concentrates. Transfusion 46:3, 377-385
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    Michael P. Busch, Simone A. Glynn, Susan L. Stramer, Jennie Orland, Edward L. Murphy, David J. Wright, Steven Kleinman, . (2006) Correlates of hepatitis C virus (HCV) RNA negativity among HCV-seropositive blood donors. Transfusion 46:3, 469-475
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    C. B. Hare, B. L. Pappalardo, M. P. Busch, A. C. Karlsson, B. H. Phelps, S. S. Alexander, C. Bentsen, C. A. Ramstead, D. F. Nixon, J. A. Levy, F. M. Hecht. (2006) Seroreversion in Subjects Receiving Antiretroviral Therapy during Acute/Early HIV Infection. Clinical Infectious Diseases 42:5, 700-708
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    Michael P. Busch, David J. Wright, Brian Custer, Leslie H. Tobler, Susan L. Stramer, Steven H. Kleinman, Harry E. Prince, Celso Bianco, Gregory Foster, Lyle R. Petersen, George Nemo, Simone A. Glynn. (2006) West Nile Virus Infections Projected from Blood Donor Screening Data, United States, 2003. Emerging Infectious Diseases 12:3, 395-402
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    S.L. Orton, S.L. Stramer, R.Y. Dodd. (2006) Self-reported symptoms associated with West Nile virus infection in RNA-positive blood donors. Transfusion 46:2, 272-277
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    Albert Farrugia. (2006) Assessing Efficacy and Therapeutic Claims in Emerging Indications for Recombinant Factor VIIa: Regulatory Perspectives. Seminars in Hematology 43, S64-S69
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    Michael S. Avidan. (2006) Perioperative Bugs, Prions, and Virions. ASA Refresher Courses in Anesthesiology 34:1, 21-29
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    J.A. Stockman. (2006) Detection of HIV-1 and HCV Infections Among Antibody-Negative Blood Donors by Nucleic Acid-Amplification Testing. Yearbook of Pediatrics 2006, 272-274
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    Eric Delwart, Mary C. Kuhns, Michael P. Busch. (2006) Surveillance of the genetic variation in incident HIV, HCV, and HBV infections in blood and plasma donors: Implications for blood safety, diagnostics, treatment, and molecular epidemiology. Journal of Medical Virology 78:S1, S30-S35
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    P. Palla, M. L. Vatteroni, L. Vacri, F. Maggi, U. Baicchi. (2006) HIV-1 NAT minipool during the pre-seroconversion window period: detection of a repeat blood donor. Vox Sanguinis 90:1, 59-62
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    Hyun Ok Kim. (2006) Guidelines for Appropriate and Safe Transfusion. Journal of the Korean Medical Association 49:5, 391
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    F. Ansaldi, B. Bruzzone, G. Testino, M. Bassetti, R. Gasparini, P. Crovari, G. Icardi. (2006) Combination hepatitis C virus antigen and antibody immunoassay as a new tool for early diagnosis of infection. Journal of Viral Hepatitis 13:1, 5-10
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    Syria Laperche, Marie-Helene Elghouzzi, Pascal Morel, Marianne Asso-Bonnet, Nadine Le Marrec, Annie Girault, Annabelle Servant-Delmas, Francoise Bouchardeau, Marie Deschaseaux, Yves Piquet. (2005) Is an assay for simultaneous detection of hepatitis C virus core antigen and antibody a valuable alternative to nucleic acid testing?. Transfusion 45:12, 1965-1972
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    D. Michael Strong, Karen Nelson, Marge Pierce, Susan L. Stramer. (2005) Preventing disease transmission by deceased tissue donors by testing blood for viral nucleic acid. Cell and Tissue Banking 6:4, 255-262
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    José M. Ballester, René A. Rivero, Rinaldo Villaescusa, Julio C. Merlín, Ada A. Arce, Dunia Castillo, Rosa M. Lam, Adalberto Ballester, Miguel Almaguer, Silvia M. Melians, José L. Aparicio. (2005) Hepatitis C virus antibodies and other markers ofblood-transfusion-transmitted infection in multi-transfused Cuban patients. Journal of Clinical Virology 34, S39-S46
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    Michael P. Busch, Simone A. Glynn, David J. Wright, Dale Hirschkorn, Megan E. Laycock, Joan McAuley, Yongling Tu, Cristina Giachetti, James Gallarda, John Heitman, Steven H. Kleinman, . (2005) Relative sensitivities of licensed nucleic acid amplification tests for detection of viremia in early human immunodeficiency virus and hepatitis C virus infection. Transfusion 45:12, 1853-1863
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    S. Aswad, N. S. Khan, L. Comanor, C. Chinchilla, L. Corado, T. Mone, R. Mendez, R. Mendez. (2005) Role of nucleic acid testing in cadaver organ donor screening: detection of hepatitis C virus RNA in seropositive and seronegative donors. Journal of Viral Hepatitis 12:6, 627-634
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    L. H. Tobler, S. L. Stramer, S. R. Lee, D. Baggett, D. Wright, D. Hirschkorn, I. Walsh, M. P. Busch. (2005) Performance of ORTHOR HCV core antigen and trak-Ctm assays for detection of viraemia in pre-seroconversion plasma and whole blood donors. Vox Sanguinis 89:4, 201-207
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    Joan D. McAuley, Gene F. Robertson. (2005) Screening Volunteer Blood Donations for Transmissible Infectious Diseases. Laboratory Medicine 36:11, 717-722
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    L. M. Jarvis, B. C. Dow, A. Cleland, F. Davidson, C. Lycett, K. Morris, B. Webb, A. Jordan, J. Petrik. (2005) Detection of HCV and HIV-1 antibody negative infections in Scottish and Northern Ireland blood donations by nucleic acid amplification testing. Vox Sanguinis 89:3, 128-134
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    Shimian Zou, Fatemeh Musavi, Edward P. Notari, Karen E. Fujii, Roger Y. Dodd, . (2005) Prevalence of selected viral infections among temporarily deferred donors who returned to donate blood: American Red Cross blood donor study. Transfusion 45:10, 1593-1600
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    Padeh, Yoram C., , Rubinstein, Arye, , Shliozberg, Jenny, . (2005) Common Variable Immunodeficiency and Testing for HIV-1. New England Journal of Medicine 353:10, 1074-1075
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    SANDRA L. BARCELONA, ALEXIS A. THOMPSON, CHARLES J. COTÉ. (2005) Intraoperative pediatric blood transfusion therapy: a review of common issues. Part I: hematologic and physiologic differences from adults; metabolic and infectious risks. Pediatric Anesthesia 15:9, 716-726
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    Fernando Cobo, Glyn N. Stacey, Charles Hunt, Carmen Cabrera, Ana Nieto, Rosa Montes, José Luis Cortés, Purificación Catalina, Angela Barnie, Ángel Concha. (2005) Microbiological control in stem cell banks: approaches to standardisation. Applied Microbiology and Biotechnology 68:4, 456-466
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    Petersen, Lyle R., Epstein, Jay S., . (2005) Problem Solved? West Nile Virus and Transfusion Safety. New England Journal of Medicine 353:5, 516-517
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    Busch, Michael P., Caglioti, Sally, Robertson, Eugene F., McAuley, Joan D., Tobler, Leslie H., Kamel, Hany, Linnen, Jeffrey M., Shyamala, Venkatakrishna, Tomasulo, Peter, Kleinman, Steven H., . (2005) Screening the Blood Supply for West Nile Virus RNA by Nucleic Acid Amplification Testing. New England Journal of Medicine 353:5, 460-467
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    Michael P Busch, Frederick M Hecht. (2005) Nucleic acid amplification testing for diagnosis of acute HIV infection: has the time come?. AIDS 19:12, 1317-1319
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    S.H. Kleinman, D.M. Strong, G.G.E. Tegtmeier, P.V. Holland, J.B. Gorlin, C. Cousins, R.P Chiacchierini, L.A. Pietrelli. (2005) Hepatitis B virus (HBV) DNA screening of blood donations in minipools with the COBAS AmpliScreen HBV test. Transfusion 45:8, 1247-1257
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    James P. AuBuchon, Louise Herschel, Jill Roger, Harry Taylor, Pamela Whitley, Junzhi Li, Rick Edrich, Raymond P. Goodrich. (2005) Efficacy of apheresis platelets treated with riboflavin and ultraviolet light for pathogen reduction. Transfusion 45:8, 1335-1341
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    Susan L. Stramer. (2005) Pooled hepatitis B virus DNA testing by nucleic acid amplification: implementation or not. Transfusion 45:8, 1242-1246
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    M Nelson, G Matthews, MG Brook, J Main, . (2005) BHIVA guidelines on HIV and chronic hepatitis: coinfection with HIV and hepatitis C virus infection (2005). HIV Medicine 6:S2, 96-106
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    Baoguang Wang, G.B. Schreiber, S.A. Glynn, Steven Kleinman, D.J. Wright, E.L. Murphy, M.P. Busch, . (2005) Does prevalence of transfusion-transmissible viral infection reflect corresponding incidence in United States blood donors?. Transfusion 45:7, 1089-1096
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    Michael J Joyce. (2005) Safety and FDA Regulations for Musculoskeletal Allografts. Clinical Orthopaedics and Related Research &amp;NA;:435, 22-30
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    Simone A. Glynn, David J. Wright, Steven H. Kleinman, Dale Hirschkorn, Yongling Tu, Charles Heldebrant, Richard Smith, Cristina Giachetti, James Gallarda, Michael P. Busch. (2005) Dynamics of viremia in early hepatitis C virus infection. Transfusion 45:6, 994-1002
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    J. Coste, H. W. Reesink, C. P. Engelfriet, S. Laperche, S. Brown, M. P. Busch, H. T. Cuijpers, R. Elgin, B. Ekermo, J. S. Epstein, O. Flesland, H. E. Heier, G. Henn, J. M. Hernandez, I. K. Hewlett, C. Hyland, A. J. Keller, T. Krusius, S. Levicnik-Stezina, G. Levy, C. K. Lin, A. R. Margaritis, L. Muylle, C. Neiderhauser, S. Pastila, J. Pillonel, J. Pineau, C. L. van der Poel, C. Politis, W. K. Roth, S. Sauleda, C. R. Seed, D. Sondag-Thull, S. L. Stramer, M. Strong, E. C. Vamvakas, C. Velati, M. A. Vesga, A. Zanetti. (2005) International Forum: 1. Vox Sanguinis 88:4, 289-298
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    M.P. Busch, L.H. Tobler, J. Saldanha, S. Caglioti, V. Shyamala, J.M. Linnen, J. Gallarda, B. Phelps, R.I.F. Smith, M. Drebot, S.H. Kleinman. (2005) Analytical and clinical sensitivity of West Nile virus RNA screening and supplemental assays available in 2003. Transfusion 45:4, 492-499
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    Steven Kleinman, Simone A. Glynn, Michael Busch, Deborah Todd, Laurie Powell, Larry Pietrelli, George Nemo, George Schreiber, Celso Bianco, Louis Katz. (2005) The 2003 West Nile virus United States epidemic: the America's Blood Centers experience. Transfusion 45:4, 469-479
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    Adeel A Butt. (2005) Hepatitis C virus infection: the new global epidemic. Expert Review of Anti-infective Therapy 3:2, 241-249
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    (2005) Insights on donor screening for West Nile virus. Transfusion 45:4, 460-462
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    Michael P. Busch, Simone A. Glynn, Susan L. Stramer, D. Michael Strong, Sally Caglioti, David J. Wright, Brandee Pappalardo, Steven H. Kleinman, . (2005) A new strategy for estimating risks of transfusion-transmitted viral infections based on rates of detection of recently infected donors. Transfusion 45:2, 254-264
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    Susan D. Roseff. (2005) Regulatory and Quality Initiatives-- Trends in Transfusion Medicine. Laboratory Medicine 36:2, 108-114
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    Girish Subba Rao, Jean Pappas Molleston. (2005) Children with hepatitis C. Current Gastroenterology Reports 7:1, 37-44
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    Harald H. Kessler. (2005) Molecular detection of human immunodeficiency virus: where do we stand? Molekularer Nachweis des humanen Immunschwächevirus: Aktueller Stand. LaboratoriumsMedizin 29:1, 44-49
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    Roger Y. Dodd. (2004) Current Safety of the Blood Supply in the United States. International Journal of Hematology 80:4, 301-305
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    Rino Rappuoli. (2004) From Pasteur to genomics: progress and challenges in infectious diseases. Nature Medicine 10:11, 1177-1185
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Letters