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Steven Kleinman - One of the best experts on this subject based on the ideXlab platform.
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comparative analysis of triplex Nucleic Acid Test assays in united states blood donors
Transfusion, 2013Co-Authors: Susan L. Stramer, Roger Y. Dodd, David E. Krysztof, Jaye P Brodsky, Tracy A Fickett, Benjamin Reynolds, Steven KleinmanAbstract:Background This study assessed the clinical sensitivity of three fully automated, human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) triplex Nucleic Acid Test (NAT) assays by individual donation (ID-NAT) and at operational minipool (MP-NAT) sizes used worldwide. Study Design and Methods MPX, Ultrio, and Ultrio Plus were used to Test 2222 pedigreed, marker-positive samples with varying viral loads, each from a unique US blood donor. NAT-positive, seronegative yield samples (16 HBV, 156 HCV, and 23 HIV) were Tested in replicates of three; undiluted; and in 1:6, 1:8, and 1:16 dilutions (MP6, MP8, and MP16), simulating various MP sizes. Seropositive samples (1276 HBV, 488 HCV, and 263 HIV) were Tested by ID-NAT in singlet. Results MPX-MP6 and Ultrio Plus-MP16 had equivalent HCV sensitivity. Although Ultrio Plus-MP16 for HIV trended toward lesser sensitivity, this was not corroborated in a large substudy of low-viral-load samples in which Ultrio Plus-MP8/MP16 showed 100% reactivity. MPX-ID and Ultrio Plus-ID HBV clinical sensitivity were identical, but MPX-MP6 was significantly more sensitive than Ultrio Plus-MP16; the differential yield projected to one HBV NAT yield per 4.72 million US donations. Ultrio Plus HBV sensitivity did not increase at MP8 versus MP16. Ultrio Plus versus Ultrio sensitivity was significantly increased in HBV-infected donors with early acute, late acute or chronic, and occult infections. No difference in sensitivity was noted for any virus for MPX-MP6 versus Ultrio Plus-ID. Conclusions Our data support US donation screening with MPX-MP6 or Ultrio Plus-MP16 since the HBV DNA detection of Ultrio Plus was significantly enhanced (vs. Ultrio) without compromising HIV or HCV RNA detection.
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sensitivity comparison of two food and drug administration licensed triplex Nucleic Acid Test automated assays for hepatitis b virus dna detection and associated projections of united states yield
Transfusion, 2011Co-Authors: Susan L. Stramer, David E. Krysztof, Jaye P Brodsky, Tracy A Fickett, Benjamin Reynolds, Soisaange Phikulsod, Sineeart Oota, Matthew Lin, John Saldanha, Steven KleinmanAbstract:BACKGROUND: There have been no comparisons of the relative sensitivity of the two Food and Drug Administration–licensed multiplex (MPX) Nucleic Acid Test (NAT) systems (Procleix Ultrio [Gen-Probe], TIGRIS platform [Novartis]; and cobas TaqScreen MPX [Roche Molecular Systems], cobas s 201 platform [Roche Instrument Center]) for detecting hepatitis B virus (HBV)-infected donors in minipool sizes (MP) used in the United States. STUDY DESIGN AND METHODS: Routine blood samples from Thailand were obtained from plasma units from 129 hepatitis B surface antigen (HBsAg)-negative, HBV NAT–yield donations. Blinded US Testing included antibody to hepatitis B core antigen (anti-HBc), NAT using both manufacturers' systems (undiluted-individual donation [ID], in singlet and diluted 1:6 and 1:16 in triplicate), quantitative antibody to hepatitis B surface antigen, HBV DNA viral loads, and HBV genotyping. HBV yields in the United States were estimated using the incidence/window period (WP) model and compared to the calculated assay sensitivities. RESULTS: Eighty samples were classified as occult HBV (anti-HBc reactive) and 49 as WP (anti-HBc nonreactive). For US pool sizes, MPX detected significantly more samples than Ultrio (MPX MP6 vs. Ultrio MP16; p < 0.0001 for occult and WP). Ultrio MP16 results were not statistically different from Ultrio MP6 (p = 0.68 for occult; p = 0.42 for WP). There was no difference between platforms for MP sizes used in most of the world (MPX MP6 vs. Ultrio ID; p = 0.70 for occult and p = 0.34 for WP). Viral loads were higher in WP samples. Modeled yield estimates were consistent with measured assay sensitivity on the Thai donor samples. CONCLUSIONS: As used in the United States, MPX MP6 is more sensitive than Ultrio MP16, but the impact of this difference is mitigated by low numbers of HBV WP infections.
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cost effectiveness of Nucleic Acid Test screening of volunteer blood donations for hepatitis b hepatitis c and human immunodeficiency virus in the united states
Vox Sanguinis, 2004Co-Authors: Deborah A Marshall, Steven Kleinman, John B Wong, James P Aubuchon, D Grima, Nathalie A Kulin, Milton C WeinsteinAbstract:BACKGROUND AND OBJECTIVES: The aim of this study was to examine the cost-effectiveness of adding Nucleic Acid Testing (NAT) to serological (antibody and antigen) screening protocols for donated blood in the United States (US) with the purpose of reducing the risks of transfusion-transmission of hepatitis B virus (HBV), hepatitis C virus (HCV) and human immunodeficiency virus (HIV). MATERIALS AND METHODS: The costs, health consequences and cost-effectiveness of adding either minipool or individual-donor NAT to serological screening (SS) Testing were estimated using a decision-analysis model. RESULTS: With the given modelling assumptions, adding minipool NAT would avoid an estimated 37, 128 and eight cases of HBV, HCV and HIV, respectively, and save approximately 53 additional years of life and 102 additional quality adjusted life years (QALYs) compared with SS, at a net cost of $154 million. SS + minipool NAT - p24 compared with SS alone resulted in an incremental cost-effectiveness ratio of $1.5 million per QALY gained (range in sensitivity analysis $1.0-2.1 million per QALY gained) in this US analysis. CONCLUSIONS: The cost effectiveness of adding NAT screening is outside the typical range for most healthcare interventions, but not for established blood safety measures.
V Pretorius - One of the best experts on this subject based on the ideXlab platform.
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the impact of using hepatitis c virus Nucleic Acid Test positive donor hearts on heart transplant waitlist time and transplant rate
Journal of Heart and Lung Transplantation, 2019Co-Authors: Yan K Gernhofer, Michela Brambatti, Barry H Greenberg, Eric Adler, Saima Aslam, V PretoriusAbstract:Abstract BACKGROUND Previous studies suggest that direct-acting antivirals (DAAs) for treatment of hepatitis C virus (HCV) infection permits transplantation of HCV-viremic donor organs in uninfected recipients. This opportunity may expand donor pool. We assessed the impact of utilizing HCV Nucleic Acid Test-positive (NAT+) donor hearts on heart transplant (HTx) waitlist time and transplant rate. METHODS We retrospectively analyzed 156 patients who were listed for HTx from October 2015 through October 2018. Patients were stratified into 2 periods centered on April 27, 2017, when the protocol to accept HCV NAT+ donor organs for transplantation in non-HCV-infected recipients began; Period 1 (October 27, 2015 to April 26, 2017) and Period 2 (April 27, 2017 to October 26, 2018). RESULTS In Period 1, 57 of the 71 patients on HTx waitlist were transplanted, whereas in Period 2, 57 of the 85 patients were transplanted. Median waitlist time to transplant decreased from 63.1 days in Period 1 to 34.1 days in Period 2 (p = 0.002). Transplant rate increased from 168.2 per 100 patient-years in Period 1 to 280.0 per 100 patient-years in Period 2 (incidence rate ratio [IRR] 2.0, 95% confidence interval [CI] 1.2—3.3; p = 0.006). Neither waitlist mortality rate, hospital stay post-transplantation, nor post-transplant mortality differed significantly between the time periods. Nineteen patients received HCV NAT+ donor hearts. Short-term post-transplant outcomes were similar between recipients who received HCV NAT+ and HCV NAT- donor hearts. CONCLUSIONS This single-center retrospective analysis suggests that utilization of HCV NAT+ donor hearts may result in reduced HTx waitlist time and increased transplant rate. Additionally, transplanting HCV NAT+ donor hearts in non-HCV-infected recipients, followed by DAAs, can provide acceptable short-term post-transplant outcomes.
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the impact of utilizing hepatitis c virus Nucleic Acid Test positive donor heart on heart transplant waitlist time
Journal of Heart and Lung Transplantation, 2019Co-Authors: Yan K Gernhofer, Michela Brambatti, Barry H Greenberg, Eric Adler, Saima Aslam, V PretoriusAbstract:Purpose Highly effective direct-acting antiviral therapy for hepatitis C virus (HCV) allows the use of organs from viremic, Nucleic Acid Test-positive (NAT+) donors in non-HCV-infected recipients. This opportunity potentially expands donor pool and decreases waitlist time. This study aims to examine the impact of utilizing HCV NAT+ donor heart on heart transplant (HTx) waitlist time. Methods We retrospectively analyzed 126 patients who were listed for HTx from April 2016 through April 2018 at our center. These patients were separated into 2 periods centered on April 27, 2017 when transplantation of HCV NAT+ donor hearts into non-HCV-infected recipients began. Results Baseline patient characteristics were similar between both periods. In Period 1, 74 patients were on HTx waitlist with 52 of them ultimately transplanted, whereas in Period 2, 52 patients were listed and 36 of them transplanted. Fifteen patients were transplanted with HCV NAT+ donor hearts since April 27, 2017. Transplant rate increased from 0.83 person-year in Period 1 to 2.31 person-year in Period 2 (p Conclusion Our single-center analysis demonstrates that utilization of HCV NAT+ donor heart has resulted in an increase in transplant rate and a reduction in HTx waitlist time. Further extended follow-up is needed to determine long-term safety and efficacy of this strategy.
Susan L. Stramer - One of the best experts on this subject based on the ideXlab platform.
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comparative analysis of triplex Nucleic Acid Test assays in united states blood donors
Transfusion, 2013Co-Authors: Susan L. Stramer, Roger Y. Dodd, David E. Krysztof, Jaye P Brodsky, Tracy A Fickett, Benjamin Reynolds, Steven KleinmanAbstract:Background This study assessed the clinical sensitivity of three fully automated, human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B virus (HBV) triplex Nucleic Acid Test (NAT) assays by individual donation (ID-NAT) and at operational minipool (MP-NAT) sizes used worldwide. Study Design and Methods MPX, Ultrio, and Ultrio Plus were used to Test 2222 pedigreed, marker-positive samples with varying viral loads, each from a unique US blood donor. NAT-positive, seronegative yield samples (16 HBV, 156 HCV, and 23 HIV) were Tested in replicates of three; undiluted; and in 1:6, 1:8, and 1:16 dilutions (MP6, MP8, and MP16), simulating various MP sizes. Seropositive samples (1276 HBV, 488 HCV, and 263 HIV) were Tested by ID-NAT in singlet. Results MPX-MP6 and Ultrio Plus-MP16 had equivalent HCV sensitivity. Although Ultrio Plus-MP16 for HIV trended toward lesser sensitivity, this was not corroborated in a large substudy of low-viral-load samples in which Ultrio Plus-MP8/MP16 showed 100% reactivity. MPX-ID and Ultrio Plus-ID HBV clinical sensitivity were identical, but MPX-MP6 was significantly more sensitive than Ultrio Plus-MP16; the differential yield projected to one HBV NAT yield per 4.72 million US donations. Ultrio Plus HBV sensitivity did not increase at MP8 versus MP16. Ultrio Plus versus Ultrio sensitivity was significantly increased in HBV-infected donors with early acute, late acute or chronic, and occult infections. No difference in sensitivity was noted for any virus for MPX-MP6 versus Ultrio Plus-ID. Conclusions Our data support US donation screening with MPX-MP6 or Ultrio Plus-MP16 since the HBV DNA detection of Ultrio Plus was significantly enhanced (vs. Ultrio) without compromising HIV or HCV RNA detection.
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sensitivity comparison of two food and drug administration licensed triplex Nucleic Acid Test automated assays for hepatitis b virus dna detection and associated projections of united states yield
Transfusion, 2011Co-Authors: Susan L. Stramer, David E. Krysztof, Jaye P Brodsky, Tracy A Fickett, Benjamin Reynolds, Soisaange Phikulsod, Sineeart Oota, Matthew Lin, John Saldanha, Steven KleinmanAbstract:BACKGROUND: There have been no comparisons of the relative sensitivity of the two Food and Drug Administration–licensed multiplex (MPX) Nucleic Acid Test (NAT) systems (Procleix Ultrio [Gen-Probe], TIGRIS platform [Novartis]; and cobas TaqScreen MPX [Roche Molecular Systems], cobas s 201 platform [Roche Instrument Center]) for detecting hepatitis B virus (HBV)-infected donors in minipool sizes (MP) used in the United States. STUDY DESIGN AND METHODS: Routine blood samples from Thailand were obtained from plasma units from 129 hepatitis B surface antigen (HBsAg)-negative, HBV NAT–yield donations. Blinded US Testing included antibody to hepatitis B core antigen (anti-HBc), NAT using both manufacturers' systems (undiluted-individual donation [ID], in singlet and diluted 1:6 and 1:16 in triplicate), quantitative antibody to hepatitis B surface antigen, HBV DNA viral loads, and HBV genotyping. HBV yields in the United States were estimated using the incidence/window period (WP) model and compared to the calculated assay sensitivities. RESULTS: Eighty samples were classified as occult HBV (anti-HBc reactive) and 49 as WP (anti-HBc nonreactive). For US pool sizes, MPX detected significantly more samples than Ultrio (MPX MP6 vs. Ultrio MP16; p < 0.0001 for occult and WP). Ultrio MP16 results were not statistically different from Ultrio MP6 (p = 0.68 for occult; p = 0.42 for WP). There was no difference between platforms for MP sizes used in most of the world (MPX MP6 vs. Ultrio ID; p = 0.70 for occult and p = 0.34 for WP). Viral loads were higher in WP samples. Modeled yield estimates were consistent with measured assay sensitivity on the Thai donor samples. CONCLUSIONS: As used in the United States, MPX MP6 is more sensitive than Ultrio MP16, but the impact of this difference is mitigated by low numbers of HBV WP infections.
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Nucleic Acid Testing to Detect HBV Infection in Blood Donors
The New England journal of medicine, 2011Co-Authors: Susan L. Stramer, Roger Y. Dodd, Ulrike C. Wend, Daniel Candotti, Gregory A. Foster, F. Blaine Hollinger, Jean-pierre Allain, Wolfram H. GerlichAbstract:BACKGROUND The detection of hepatitis B virus (HBV) in blood donors is achieved by screening for hepatitis B surface antigen (HBsAg) and for antibodies against hepatitis B core antigen (anti-HBc). However, donors who are positive for HBV DNA are currently not identified during the window period before seroconversion. The current use of Nucleic Acid Testing for detection of the human immunodeficiency virus (HIV) and hepatitis C virus (HCV) RNA and HBV DNA in a single triplex assay may provide additional safety. METHODS We performed Nucleic Acid Testing on 3.7 million blood donations and further evaluated those that were HBV DNA-positive but negative for HBsAg and anti-HBc. We determined the serologic, biochemical, and molecular features of samples that were found to contain only HBV DNA and performed similar analyses of follow-up samples and samples from sexual partners of infected donors. Seronegative HIV and HCV-positive donors were also studied. RESULTS We identified 9 donors who were positive for HBV DNA (1 in 410,540 donations), including 6 samples from donors who had received the HBV vaccine, in whom subclinical infection had developed and resolved. Of the HBV DNA-positive donors, 4 probably acquired HBV infection from a chronically infected sexual partner. Clinically significant liver injury developed in 2 unvaccinated donors. In 5 of the 6 vaccinated donors, a non-A genotype was identified as the dominant strain, whereas subgenotype A2 (represented in the HBV vaccine) was the dominant strain in unvaccinated donors. Of 75 reactive Nucleic Acid Test results identified in seronegative blood donations, 26 (9 HBV, 15 HCV, and 2 HIV) were confirmed as positive. CONCLUSIONS Triplex Nucleic Acid Testing detected potentially infectious HBV, along with HIV and HCV, during the window period before seroconversion. HBV vaccination appeared to be protective, with a breakthrough subclinical infection occurring with non-A2 HBV subgenotypes and causing clinically inconsequential outcomes. (Funded by the American Red Cross and others.).
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Current incidence and residual risk of hepatitis B infection among blood donors in the United States.
Transfusion, 2009Co-Authors: Shimian Zou, Susan L. Stramer, Edward P. Notari, Mary C. Kuhns, David E. Krysztof, Fatemeh Musavi, Chyang T. Fang, Roger Y. DoddAbstract:BACKGROUND: This study used two approaches to estimate the current incidence of hepatitis B virus (HBV) in a US donor population. METHODS: HBV incidence was estimated through the hepatitis B surface antigen (HBsAg) yield approach and the seroconversion method. Residual risk was estimated by the incidence–window period model. HBsAg yield refers to an HBsAg confirmed-positive, antibody against hepatitis B core antigen (anti-HBc)–nonreactive donation, adjusted for false-positive neutralization results. The number of HBsAg-seroconverting repeat donors divided by total number of person-years of evaluation or the HBsAg yield rate divided by HBsAg yield window gave rise to incidence estimates. RESULTS: The seroconversion and the yield approach, respectively, gave an incidence estimate of 3.41 or 3.43 per 105 person-years. Using a revised infectious window period of 38 or 30 days for current HBsAg assays, the current residual risk for HBV was respectively estimated for 2006 to 2008 at 1 in 282,000 or 1 in 357,000 donations from the seroconversion approach and 1 in 280,000 or 1 in 355,000 donations from the yield approach. With the same database and methods, this is a decrease from 1 in 86,000 to 1 in 110,000 observed in 1997 to 1999. CONCLUSIONS: Current HBV incidence and residual risk are lower than earlier estimates, especially in the youngest donors, but remain higher in the absence of HBV Nucleic Acid Test than those for human immunodeficiency virus or hepatitis C virus (HCV). In addition to the exclusion of HBsAg false-positive donors, the reduction could reflect shortened window periods and decreased incidence rates due to vaccination or other reasons.
Yan K Gernhofer - One of the best experts on this subject based on the ideXlab platform.
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the impact of using hepatitis c virus Nucleic Acid Test positive donor hearts on heart transplant waitlist time and transplant rate
Journal of Heart and Lung Transplantation, 2019Co-Authors: Yan K Gernhofer, Michela Brambatti, Barry H Greenberg, Eric Adler, Saima Aslam, V PretoriusAbstract:Abstract BACKGROUND Previous studies suggest that direct-acting antivirals (DAAs) for treatment of hepatitis C virus (HCV) infection permits transplantation of HCV-viremic donor organs in uninfected recipients. This opportunity may expand donor pool. We assessed the impact of utilizing HCV Nucleic Acid Test-positive (NAT+) donor hearts on heart transplant (HTx) waitlist time and transplant rate. METHODS We retrospectively analyzed 156 patients who were listed for HTx from October 2015 through October 2018. Patients were stratified into 2 periods centered on April 27, 2017, when the protocol to accept HCV NAT+ donor organs for transplantation in non-HCV-infected recipients began; Period 1 (October 27, 2015 to April 26, 2017) and Period 2 (April 27, 2017 to October 26, 2018). RESULTS In Period 1, 57 of the 71 patients on HTx waitlist were transplanted, whereas in Period 2, 57 of the 85 patients were transplanted. Median waitlist time to transplant decreased from 63.1 days in Period 1 to 34.1 days in Period 2 (p = 0.002). Transplant rate increased from 168.2 per 100 patient-years in Period 1 to 280.0 per 100 patient-years in Period 2 (incidence rate ratio [IRR] 2.0, 95% confidence interval [CI] 1.2—3.3; p = 0.006). Neither waitlist mortality rate, hospital stay post-transplantation, nor post-transplant mortality differed significantly between the time periods. Nineteen patients received HCV NAT+ donor hearts. Short-term post-transplant outcomes were similar between recipients who received HCV NAT+ and HCV NAT- donor hearts. CONCLUSIONS This single-center retrospective analysis suggests that utilization of HCV NAT+ donor hearts may result in reduced HTx waitlist time and increased transplant rate. Additionally, transplanting HCV NAT+ donor hearts in non-HCV-infected recipients, followed by DAAs, can provide acceptable short-term post-transplant outcomes.
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the impact of utilizing hepatitis c virus Nucleic Acid Test positive donor heart on heart transplant waitlist time
Journal of Heart and Lung Transplantation, 2019Co-Authors: Yan K Gernhofer, Michela Brambatti, Barry H Greenberg, Eric Adler, Saima Aslam, V PretoriusAbstract:Purpose Highly effective direct-acting antiviral therapy for hepatitis C virus (HCV) allows the use of organs from viremic, Nucleic Acid Test-positive (NAT+) donors in non-HCV-infected recipients. This opportunity potentially expands donor pool and decreases waitlist time. This study aims to examine the impact of utilizing HCV NAT+ donor heart on heart transplant (HTx) waitlist time. Methods We retrospectively analyzed 126 patients who were listed for HTx from April 2016 through April 2018 at our center. These patients were separated into 2 periods centered on April 27, 2017 when transplantation of HCV NAT+ donor hearts into non-HCV-infected recipients began. Results Baseline patient characteristics were similar between both periods. In Period 1, 74 patients were on HTx waitlist with 52 of them ultimately transplanted, whereas in Period 2, 52 patients were listed and 36 of them transplanted. Fifteen patients were transplanted with HCV NAT+ donor hearts since April 27, 2017. Transplant rate increased from 0.83 person-year in Period 1 to 2.31 person-year in Period 2 (p Conclusion Our single-center analysis demonstrates that utilization of HCV NAT+ donor heart has resulted in an increase in transplant rate and a reduction in HTx waitlist time. Further extended follow-up is needed to determine long-term safety and efficacy of this strategy.
Michael P Busch - One of the best experts on this subject based on the ideXlab platform.
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associations between west nile virus infection and symptoms reported by blood donors identified through Nucleic Acid Test screening
Transfusion, 2009Co-Authors: Brian Custer, Hany Kamel, Nancy Kiely, Edward L Murphy, Michael P BuschAbstract:Author(s): Custer, Brian; Kamel, Hany; Kiely, Nancy E; Murphy, Edward L; Busch, Michael P | Abstract: BackgroundBlood collected in the United States and Canada is screened for West Nile virus (WNV) using Nucleic Acid Testing (NAT). The role that donor-reported symptoms of infection disclosed at or shortly after donation may play in enhancing blood safety has been debated. Little data are available on subsequent manifestations of WNV-specific disease outcomes in viremic donors.Study design and methodsDonors with initially reactive NAT results were informed by telephone and asked to complete symptom interviews. The questionnaires are focused on three time periods: the week before, the day of, and the 2 weeks after donation. Symptoms and risk factors were compared between confirmed-positive and false-positive donors (classified based on confirmatory NAT and serology). Additional analyses comparing confirmed-positive symptomatic and asymptomatic donors were conducted.ResultsA total of 423 of 536 initially reactive donors were interviewed between 2003 and 2006: 292 confirmed-positive for WNV and 131 false-positive. Individual symptoms were not significant predictors of WNV infection, except skin rash in the week before donation (odds ratio [OR], 3.0; 95% confidence interval [CI], 1.2-7.9) and body aches in the period after donation (OR, 2.8; 95% CI, 1.1-7.4). Specific combinations of symptoms were not good predictors of infection, but donors with three or more concurrent symptoms before donation were more likely to have WNV infection (OR, 2.5; 95% CI, 1.2-5.1). Demographic characteristics, predonation symptoms, and serology profiles in confirmed-positive donors did not predict postdonation symptom severity. Thirty-five confirmed-positive donors (12%) sought medical care for WNV infection, with two hospitalizations, but no cases of neuroinvasive disease.ConclusionThe number rather than type of symptoms is associated with confirmed WNV infection, but the overall predictive value is low. Very few infected donors develop clinically significant disease.
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prevalence incidence and residual risk of human immunodeficiency virus among community and replacement first time blood donors in sao paulo brazil
Transfusion, 2005Co-Authors: Claudia C Barreto, Ester C Sabino, Thelma T Goncalez, Megan E Laycock, Brandee L Pappalardo, Nanci A Salles, David J Wright, Dalton De Alencar Fischer Chamone, Michael P BuschAbstract:BACKGROUND: Concerted efforts have been directed toward recruitment of community rather than replacement donors in Brazil. Time trends and demographic correlates of human immunodeficiency (HIV) prevalence and incidence among first-time (FT) donors in Brazil were examined by donation type. HIV residual risk from FT-donor transfusions, and projected yield of p24 antigen and Nucleic Acid Test (NAT) screening were estimated. STUDY DESIGN AND METHODS: HIV prevalence data and seroreactive specimens were obtained at Fundacao Pro-Sangue/Hemocentro-de-Sao Paulo from 1995 to 2001. To estimate incidence, confirmed-positive samples from July 1998 through December 2001 were Tested with a less-sensitive (detuned) enzyme immunoassay to detect recent seroconversions. Incidence data were used to estimate residual risk and p24 and NAT yield based on published window periods (WPs). RESULTS: HIV prevalence was 22 percent higher among the FT community donors than replacement donors (19.6 vs. 16.1 per 10,000; p < 0.01) and 48 percent higher among men than women (19.1 vs. 12.9; p < 0.01). In the multivariable logistic regression, both variables remained significant predictors of HIV prevalence. HIV prevalence decreased from 20.4 (1995) to 13.1 per 10,000 FT donations (2001). HIV incidence was 2.7 per 10,000 person-years. The estimated rate of infected antibody-negative donations was 14.9 per 1,000,000 units (95% confidence interval, 9.8-20.0). It was estimated that addition of p24 antigen, minipool NAT, and individual-donation NAT assays would detect 3.9 (2.0-5.8), 8.3 (5.3-11.3), and 10.8 (7.1-14.5) WP units per 1,000,000 FT donations, respectively. CONCLUSION: HIV incidence and residual transfusion risk estimates are approximately 10 times higher in Brazil FT donors compared to US and European FT donors. Community FT donors had higher HIV prevalence than replacement FT donors. The yield of p24 antigen or RNA screening will be low in Brazilian donors, but substantially higher than in US donors.
