RESUMEN
Presymptomatic plasma samples from 1596 donors reporting coronavirus disease 2019 infection or symptoms after blood donation were tested for severe acute respiratory syndrome coronavirus 2 (SARS-CoV-2) RNA and anti-S and anti-N antibodies. Prior infection and vaccination both protected from developing SARS-CoV-2 RNAemia and from symptomatic infection. RNAemia rates did not differ in the Delta and Omicron variant eras.
RESUMEN
Respiratory viruses such as influenza do not typically cause viremia; however, SARS-CoV-2 has been detected in the blood of COVID-19 patients with mild and severe symptoms. Detection of SARS-CoV-2 in blood raises questions about its role in pathogenesis as well as transfusion safety concerns. Blood donor reports of symptoms or a diagnosis of COVID-19 after donation (post-donation information, PDI) preceded or coincided with increased general population COVID-19 mortality. Plasma samples from 2,250 blood donors who reported possible COVID-19-related PDI were tested for the presence of SARS-CoV-2 RNA. Detection of RNAemia peaked at 9%-15% of PDI donors in late 2020 to early 2021 and fell to approximately 4% after implementation of widespread vaccination in the population. RNAemic donors were 1.2- to 1.4-fold more likely to report cough or shortness of breath and 1.8-fold more likely to report change in taste or smell compared with infected donors without detectable RNAemia. No infectious virus was detected in plasma from RNAemic donors; inoculation of permissive cell lines produced less than 0.7-7 plaque-forming units (PFU)/mL and in susceptible mice less than 100 PFU/mL in RNA-positive plasma based on limits of detection in these models. These findings suggest that blood transfusions are highly unlikely to transmit SARS-CoV-2 infection.
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COVID-19 , SARS-CoV-2 , Animales , Donantes de Sangre , COVID-19/diagnóstico , Humanos , Ratones , ARN Viral , SARS-CoV-2/genética , ViremiaRESUMEN
BACKGROUND: This study evaluated whether pathogen reduction technology (PRT) in plasma and platelets using amotosalen/ultraviolet A light (A/UVA) or in red blood cells using amustaline/glutathione (S-303/GSH) may be used as the sole mitigation strategy preventing transfusion-transmitted West Nile (WNV), dengue (DENV), Zika (ZIKV), and chikungunya (CHIKV) viral, and Babesia microti, Trypanosoma cruzi, and Plasmodium parasitic infections. METHODS: Antibody (Ab) status and pathogen loads (copies/mL) were obtained for donations from US blood donors testing nucleic acid (NAT)-positive for WNV, DENV, ZIKV, CHIKV, and B. microti. Infectivity titers derived from pathogen loads were compared to published PRT log10 reduction factors (LRF); LRFs were also reviewed for Plasmodium and T. cruzi. The potential positive impact on donor retention following removal of deferrals from required questioning and testing for WNV, Babesia, Plasmodium, and T. cruzi was estimated for American Red Cross (ARC) donors. RESULTS: A/UVA and S-303/GSH reduced infectivity to levels in accordance with those recognized by FDA as suitable to replace testing for all agents evaluated. If PRT replaced deferrals resulting from health history questions and/or NAT for WNV, Babesia, Plasmodium, and T. cruzi, 27,758 ARC donors could be retained allowing approximately 50,000 additional donations/year based on 1.79 donations/donor for calendar year 2019 (extrapolated to an estimated 125,000 additional donations nationally). CONCLUSION: Pathogen loads in donations from US blood donors demonstrated that robust PRT may provide an opportunity to replace deferrals associated with donor questioning and NAT for vector-borne agents allowing for significant donor retention and likely increased blood availability.
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Babesia microti , Fiebre Chikungunya , Reacción a la Transfusión , Infección por el Virus Zika , Virus Zika , Donantes de Sangre , Humanos , Reacción a la Transfusión/prevención & controlRESUMEN
BACKGROUND: In the United States, blood donor testing for hepatitis B surface antigen (HBsAg) was initiated in the early 1970s. More recently, testing for antibody to hepatitis B core antigen (anti-HBc) and hepatitis B virus (HBV) DNA have been added. The incidence of hepatitis B has been declining. This study reviews the current status of testing and questions the need for continuation of HBsAg testing. STUDY DESIGN AND METHODS: From July 2011 to June 2015, a total of 22.4 million donations were serologically tested for HBsAg and anti-HBc and for HBV-DNA by nucleic acid testing (NAT). All reactive results were evaluated and a subset of donations that were either potential NAT yield (seronegative) or serologically positive but nonreactive by HBV NAT in minipools (MPs) of 16 were further evaluated by individual donation (ID)-NAT. Samples with detectable HBV DNA were defined as actively infected and considered potentially infectious. RESULTS: Routine testing plus supplemental ID-NAT identified 2035 samples representing active infection including 1965 with anti-HBc, 1602 with HBsAg, and 1453 with HBV DNA by MP-NAT, for respective rates per hundred-thousand donations of 9.10, 8.78, 7.16, and 6.50, continuing the downward trend previously observed. There were 29 HBV DNA-yield samples (1:771,389), 35 HBsAg-yield samples (anti-HBc nonreactive), and 404 with occult hepatitis B infection. There were six samples with HBsAg and HBV DNA detectable only by ID-NAT in the absence of anti-HBc; additional testing was consistent with extremely low or negligible levels of DNA. CONCLUSIONS: Point estimates of HBV infection rates among blood donors continue to decline, as do those for incidence and residual risk. Elimination of HBsAg screening would have negligible impact, with a risk less than 1 per 4 million donations.
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Donantes de Sangre , Seguridad de la Sangre/normas , Selección de Donante/métodos , Antígenos de Superficie de la Hepatitis B/sangre , Virus de la Hepatitis B/aislamiento & purificación , Hepatitis B/diagnóstico , Viremia/diagnóstico , ADN Viral/sangre , Selección de Donante/normas , Selección de Donante/tendencias , Hepatitis B/epidemiología , Antígenos del Núcleo de la Hepatitis B/sangre , Humanos , Incidencia , Técnicas de Amplificación de Ácido Nucleico , Estudios Retrospectivos , Estados Unidos/epidemiología , Viremia/epidemiologíaRESUMEN
PURPOSE: Blood donors are considered to be one of the healthiest populations, but relatively little is known about their perceived quality of life. The objective was to examine HRQOL in donors infected with HIV, HBV, HCV or HTLV and a comparison group. METHODS: Donors with confirmed viral infection (cases) and donors who tested false-positive (controls) participated in a multicenter study of US blood donors (2010-2013), funded by the National Heart, Lung and Blood Institute (NHLBI). HRQOL was measured by the EuroQol Five Dimension (EQ-5D) instrument and EQ-5D visual analogue scale (VAS). The lower 25th of EQ-5D index or VAS score of controls was defined as a "lower HRQOL." RESULTS: A total of 1574 controls completed the HRQOL assessment with a mean EQ-5D index of 0.94 (SD = 0.10) and EQ-VAS of 87.6 (SD = 10.6). Mean EQ-5D index for 192 HIV-, 315 HCV- and 195 HTLV-positive donors were significantly lower than the controls (0.86, 0.83 and 0.87; SD = 0.18, 0.20 and 0.16, respectively, p < 0.001). HBV-positive donors (n = 290) had a similar mean EQ-5D index (0.93, SD = 0.14, p = 0.05) to controls. Anxiety/depression was reported by 34 % of cases, compared with 13 % of controls. In multivariable modeling, the odds of lower HRQOL in HIV, HBV, HCV and HTLV cases were 2.1, 1.6, 2.6 and 2.3 times that of controls, respectively (p < 0.05). CONCLUSIONS: HRQOL reported by blood donors with recent viral infections was relatively high but lower than controls. On average, HRQOL among HCV-positive donors was the lowest and HBV-positive donors reported scores similar to donors without infection.
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Donantes de Sangre/psicología , Perfil de Impacto de Enfermedad , Virosis/etiología , Adulto , Femenino , Humanos , Masculino , Persona de Mediana Edad , Factores de Riesgo , Encuestas y Cuestionarios , Adulto JovenRESUMEN
BACKGROUND: Human immunodeficiency virus (HIV)-positive blood donors pose a risk to blood safety. The Southeastern United States has the highest reported HIV infection rates. Here we calculate HIV prevalence, incidence, and residual risk in Southeastern US blood donors and report risk factors disclosed by incident donors in counseling sessions. STUDY DESIGN AND METHODS: American Red Cross donation and testing data from 2009 to 2014 for three Southeastern collection regions were used to calculate HIV prevalence, incidence, and residual risk. Incident donors had a previous HIV-negative donation within 730 days of their positive donation. Residual risk was defined as the window period multiplied by incidence. RESULTS: From 2009 to 2014, a total of 236 HIV-positive donors occurred in these regions for an overall prevalence of 8.3 per 100,000 donations. There were 56 incident donors over the 6-year period with incidence decreasing from 7.1 per 100,000 person-years (PYs) in the first two years (2009-2010) to 3.5 in the last two years (2013-2014). Residual risk decreased from 1 in 562,000 to 1 in 1,100,000. The most commonly reported risk factor behavior in male incident donors was men who have sex with men; females expressed no predominant risk factor. CONCLUSION: HIV prevalence and incidence among blood donors in the southeast are higher than other US regions, consistent with general public health surveillance. However, the overall residual risk estimates are low at less than 1 per million. Ongoing monitoring of the blood supply along with educational efforts to provide infected individuals with alternatives to donation remain important initiatives.
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Donantes de Sangre , Infecciones por VIH/sangre , Infecciones por VIH/epidemiología , Adolescente , Adulto , Anciano , Anciano de 80 o más Años , Femenino , Homosexualidad Masculina , Humanos , Masculino , Persona de Mediana Edad , Prevalencia , Factores de Riesgo , Factores Sexuales , Sudeste de Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: The frequency of positive test results for transfusion-transmitted infections (TTIs) among blood donors is an important index of safety; thus, appropriate monitoring is critical, particularly when there are changes in policies affecting donor suitability. STUDY DESIGN AND METHODS: Testing algorithms from three large blood systems were reviewed and consensus definitions for a surveillance-positive result for hepatitis B virus (HBV), hepatitis C virus (HCV), human immunodeficiency virus (HIV), and human T-cell lymphotropic virus (HTLV) established. In addition, information on each donation, including donor demographics and location, was collected. Combined data were analyzed to characterize the epidemiology of TTIs by person, place, and time. RESULTS: Data from 14.8 million donations were collected for 2011 to 2012, representing more than 50% of the US blood supply. Surveillance-positive rates per 10,000 donations were as follows: HBV, 0.76; HCV, 2.0; HIV, 0.28; and HTLV 0.34. Rates did not vary between the 2 years, although there was variation within a year. With the exception of HTLV, rates were higher among males, and all rates were higher among first-time donations. Window-period donations (those positive only in nucleic acid tests) were infrequent (HBV, 13; HCV, 60; HIV, 14) during the 2-year period. Frequencies of surveillance-positive results varied by donor age and residence location. CONCLUSIONS: We demonstrated that standardized data from multiple major US blood systems can be combined and analyzed for change. However, TTI frequencies are low, impacting their sensitivity to change. Furthermore, observed fluctuations in TTI frequencies may be secondary to changes in blood donor demographics rather than necessarily reflecting the immediate impact of policy modification.
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Donantes de Sangre , Reacción a la Transfusión , Virosis/transmisión , Bases de Datos Factuales , Monitoreo Epidemiológico , Femenino , Humanos , Masculino , Factores Sexuales , Estados Unidos , Virosis/epidemiologíaRESUMEN
BACKGROUND: Differences in motivating factors that contribute to the decision to donate blood between infected and uninfected donors may help to identify areas for improving donor education. STUDY DESIGN AND METHODS: As part of a risk factor study, confirmed-positive donors (cases) based on serology-only (human T-lymphotropic virus [HTLV]) or serology and nucleic acid testing (NAT) or NAT-only (human immunodeficiency virus [HIV], hepatitis B virus [HBV], hepatitis C virus [HCV]), and serology-unconfirmed, NAT-negative false-positive donors (controls) were asked about motivations and opinions toward blood donation. "Test seeking" was inferred if a donor answered "yes" to "I wanted to get my test results" and one of the following: "blood center testing is confidential," "free," "more accurate than other test centers," or "tests will identify problems with my blood." Cases were compared to controls using descriptive and multivariable analyses. RESULTS: Whether a case or control, the most common donation reason was "to help someone in need" (>90% in each group). After adjusting for demographic characteristics, test seeking was not significantly associated with infection status. Test seeking was more common in first-time, younger males and nonwhite, non-Hispanic donors. Of donors with HIV, 13% considered selection policies to be unfair, compared with 1, 2, 0.5, and 6% of donors with HBV, HCV, and HTLV and controls, respectively (adjusted odds ratio for HIV cases vs. controls, 3.9; 95% confidence interval, 2.3-6.7). CONCLUSIONS: Most donors give to help those in need, including HIV-positive donors. Our results establish a baseline from which additional studies can be compared focused on alternate ways to reduce noncompliance and improved messaging to ensure that high-risk potential donors understand the reasons for blood donor screening policies.
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Donantes de Sangre/psicología , Donantes de Sangre/estadística & datos numéricos , Transfusión Sanguínea/psicología , Motivación , Virosis/epidemiología , Adulto , Estudios de Casos y Controles , Femenino , Infecciones por VIH/epidemiología , Hepatitis B/epidemiología , Hepatitis C/epidemiología , Humanos , Masculino , Persona de Mediana Edad , Adulto JovenRESUMEN
BACKGROUND: Dengue is a mosquito-borne viral disease caused by the four dengue viruses (DENV-1 to 4) that can also be transmitted by blood transfusion and organ transplantation. The distribution of DENV in the components of blood from infected donors is poorly understood. METHODS: We used an in-house TaqMan qRT-PCR assay to test residual samples of plasma, cellular components of whole blood (CCWB), serum and clot specimens from the same collection from blood donors who were DENV-RNA-reactive in a parallel blood safety study. To assess whether DENV RNA detected by TaqMan was associated with infectious virus, DENV infectivity in available samples was determined by culture in mosquito cells. RESULTS: DENV RNA was detected by TaqMan in all tested blood components, albeit more consistently in the cellular components; 78.8% of CCWB, 73.3% of clots, 86.7% of sera and 41.8% of plasma samples. DENV-1 was detected in 48 plasma and 97 CCWB samples while DENV-4 was detected in 21 plasma and 31 CCWB samples. In mosquito cell cultures, 29/111 (26.1%) plasma and 32/97 (32.7%) CCWB samples were infectious. A subset of samples from 29 donors was separately analyzed to compare DENV viral loads in the available blood components. DENV viral loads did not differ significantly between components and ranged from 3-8 log10 PCR-detectable units/ml. CONCLUSIONS: DENV was present in all tested components from most donors, and viral RNA was not preferentially distributed in any of the tested components. Infectious DENV was also present in similar proportions in cultured plasma, clot and CCWB samples, indicating that these components may serve as a resource when sample sizes are limited. However, these results suggest that the sensitivity of the nucleic acid tests (NAT) for these viruses would not be improved by testing whole blood or components other than plasma.
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Virus del Dengue/aislamiento & purificación , Dengue/virología , ARN Viral/sangre , Animales , Donantes de Sangre/estadística & datos numéricos , Culicidae/virología , Dengue/sangre , Virus del Dengue/clasificación , Virus del Dengue/genética , Humanos , Puerto Rico , ARN Viral/clasificación , ARN Viral/genéticaRESUMEN
BACKGROUND: Risk factor surveillance among infected blood donors provides information on the effectiveness of eligibility assessment and is critical for reducing risk of transfusion-transmitted infection. STUDY DESIGN AND METHODS: American Red Cross, Blood Systems, Inc., New York Blood Center, and OneBlood participated in a case-control study from 2010 to 2013. Donors with serologic and nucleic acid testing (NAT) or NAT-only confirmed human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV), or serology-confirmed human T-lymphotropic virus (HTLV) infections (cases) and donors with false-positive results (controls) were interviewed for putative behavioral and demographic risks. Frequencies and adjusted odds ratios (AORs) from multivariable logistic regression analyses for each exposure in cases compared to controls are reported. RESULTS: In the study, 196 HIV, 292 HBV, 316 HCV, and 198 HTLV cases, and 1587 controls were interviewed. For HIV, sex with an HIV+ person (AOR, 132; 95% confidence interval [CI], 27-650) and male-male sex (AOR, 62; 95% CI, 27-140) were primary risk factors. For HBV, first-time donor status (AOR, 16; 95% CI, 10-27), sex with an injection drug user (IDU; AOR, 11; 95% CI, 5-28), and black race (AOR, 11; 95% CI, 6-19) were primary. For HCV, IDU (AOR, 42; 95% CI, 13-136), first time (AOR, 18; 95% CI, 10-30), and a family member with hepatitis (AOR, 15; 95% CI, 6-40) were primary. For HTLV, sex with an IDU (AOR, 22; 95% CI, 10-48), 55 years old or more (AOR, 21; 95% CI, 8-52], and first time (AOR, 15; 95% CI, 9-24) were primary. CONCLUSIONS: Despite education efforts and risk screening, individuals with deferrable risks still donate; they may fail to understand or ignore or do not believe they have risk. Recipients have potential transfusion-transmitted infection risk because of nondisclosure by donors.
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Infecciones por VIH/transmisión , Hepatitis B/transmisión , Hepatitis C/transmisión , Retroviridae/patogenicidad , Adolescente , Adulto , Donantes de Sangre/estadística & datos numéricos , Femenino , Virus de Hepatitis/patogenicidad , Humanos , Masculino , Persona de Mediana Edad , Cruz Roja , Factores de Riesgo , Reacción a la Transfusión , Adulto JovenRESUMEN
BACKGROUND: Babesia microti, a transfusion-transmissible intraerythrocytic parasite, is increasing in frequency in the United States with no available FDA-licensed donor screening assay. We utilized investigational arrayed fluorescence immunoassay (AFIA) and polymerase chain reaction (PCR) to detect B. microti antibodies and DNA in blood donors. STUDY DESIGN AND METHODS: AFIA and real-time PCR were performed on frozen paired EDTA plasma (AFIA) and EDTA whole blood (PCR) samples collected from May to September 2010 to 2011 in nonendemic (Arizona [AZ] and Oklahoma [OK]), moderately endemic (Minnesota [MN] and Wisconsin [WI]), and highly endemic (Connecticut [CT] and Massachusetts [MA]) areas of the United States. AFIA utilized B. microti piroplasm as an antigen substrate; PCR primers and probes targeted the B. microti 18S ribosomal RNA gene. Data from AZ and OK were used to calculate specificity. All AFIA- or PCR-positive or -inconclusive donors were deferred, notified, and invited to participate in a follow-up study involving repeat testing and a demographic and risk-factor questionnaire. Recipient tracing was performed for any cellular component transfused at index, at subsequent donation, or within the prior 12 months. RESULTS: Testing of 13,269 paired samples included 4022 from AZ and OK, 4167 from MN and WI, and 5080 from CT and MA. B. microti antibody and/or DNA prevalences were 0.025% (95% confidence interval [CI], 0.00%-0.14%), 0.12% (95% CI, 0.04%-0.28%), and 0.75% (95% CI, 0.53%-1.03%) in the nonendemic, mid-endemic, and high-endemic regions, respectively. Specificities were 99.95% (95% CI, 99.82%-99.99%) at a 1-in-64 AFIA cutoff and 99.98% (95% CI, 99.86%-100.00%) at a 1-in-128 cutoff. CONCLUSIONS: B. microti prevalence followed expected geographical patterns. Screening was feasible with a performance comparable or superior to other infectious disease blood donor screening assays.
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Babesia microti/patogenicidad , Donantes de Sangre/estadística & datos numéricos , Anticuerpos Antiprotozoarios/sangre , Babesia microti/genética , Babesia microti/inmunología , ADN Protozoario/sangre , Humanos , Reacción en Cadena en Tiempo Real de la Polimerasa , Estados UnidosRESUMEN
BACKGROUND: Sensitive triplex nucleic acid tests (NATs) are implemented for blood donation screening worldwide. Assays have variable ability to detect low-level hepatitis B virus (HBV) DNA. At borderline DNA detection levels, where Poisson distribution impacts results, distinguishing true-positive from false-positive results is challenging. Algorithms are needed to confirm such low-level HBV DNA-positive samples. STUDY DESIGN AND METHODS: A total of 135 blood donor samples reactive by one or more HBV markers that provided discrepant results were tested undiluted with four commercial NATs: Ultrio, Ultrio Plus, MPX, and a quantitative assay (SuperQuant). To further explore discrepancies, three additional in-house NATs including real-time polymerase chain reaction (PCR) and nested PCR and sequencing were performed. RESULTS: The numbers reactive of these 135 "difficult" samples by four commercial NATs were as follows: 39 of 107 (36%) with SuperQuant, 40 (30%) with Ultrio, 100 (74%) with Ultrio Plus, and 102 (76%) with MPX. Of the seven NATs, 109 (81%) samples were reactive by at least two assays and thus considered confirmed positive of which 67 (50%) generated a sequence. Ultrio Plus and MPX performed similarly as above (80%-85% detected of 109 and 81%-90% of 67, respectively). Older (median, 49 years), HBV core antibody-reactive donors carried predominantly Genotype A (58%) with high-frequency amino acid substitutions in the major hydrophilic region of the S-protein. Younger (median, 24 years) hepatitis B surface antigen-positive donors carried wild-type strains predominantly Genotype B (32%) and E (24%), the latter in an apparent cluster. CONCLUSIONS: Highly sensitive NATs require new confirmatory algorithms as presented optimally using different genomic regions or sequence generation. The introduction of immigration-related HBV genotypes may impact HBV epidemiology in the United States.
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Donantes de Sangre , ADN Viral/análisis , Virus de la Hepatitis B/aislamiento & purificación , Hepatitis B/sangre , Hepatitis B/diagnóstico , Reacción en Cadena de la Polimerasa/métodos , Adulto , Anciano , Biomarcadores/sangre , ADN Viral/sangre , Femenino , Virus de la Hepatitis B/genética , Humanos , Masculino , Tamizaje Masivo/métodos , Persona de Mediana Edad , Estados Unidos , Adulto JovenRESUMEN
BACKGROUND: Current Food and Drug Administration guidance specifies that all blood donors must be asked about a history of Chagas disease. STUDY DESIGN AND METHODS: We identified all American Red Cross donors deferred for Chagas disease history from January 2000 to August 2011. Attempts were made to contact all deferred donors and invite them back for anti-Trypanosoma cruzi testing. After January 2007, all accepted donors (no Chagas history) were anti-T. cruzi tested. RESULTS: Over the 12-year period (approx. 88 million donor presentations), 34 donors had a Chagas deferral. When contacted, seven reported risk (e.g., travel or residence in an endemic area, vector exposure) and six were anti-T. cruzi tested with one radioimmunoprecipitation assay (RIPA) positive. Six others had answered the question incorrectly. The remaining 21 could not be contacted but from the donor record it could be determined that 13 were Hispanic ethnicity or Spanish speaking and/or provided specific details of Chagas risk or disease. CONCLUSIONS: In 12 years, only 28 potentially infected donors were identified using the Chagas question. Limited testing data suggest that few of these would have had serologic evidence of prior infection. In contrast, nearly 5 years of anti-T. cruzi screening identified 488 RIPA-positive donors, none of whom answered "yes" to the Chagas question. According to estimates in this study, the value of retaining the questionnaire in addition to testing translates to preventing the collection of 0.4 infected donors per billion. Thus, the Chagas history question has no meaningful value.
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Enfermedad de Chagas/prevención & control , Selección de Donante , Adulto , Anciano , Animales , Seguridad de la Sangre/normas , Enfermedad de Chagas/sangre , Enfermedad de Chagas/epidemiología , Enfermedad de Chagas/transmisión , Enfermedades Endémicas , Exposición a Riesgos Ambientales , Femenino , Hispánicos o Latinos , Humanos , Insectos Vectores , América Latina/epidemiología , América Latina/etnología , Masculino , Persona de Mediana Edad , Conducta de Reducción del Riesgo , Autorrevelación , Encuestas y Cuestionarios , Viaje , Estados Unidos , United States Food and Drug Administration/normasRESUMEN
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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Donantes de Sangre , Técnicas de Amplificación de Ácido Nucleico , Recolección de Muestras de Sangre/métodos , Anticuerpos Anti-VIH/sangre , Infecciones por VIH/sangre , Infecciones por VIH/diagnóstico , Infecciones por VIH/epidemiología , VIH-1/genética , VIH-1/inmunología , Hepacivirus/genética , Hepacivirus/inmunología , Hepacivirus/aislamiento & purificación , Anticuerpos Antihepatitis/sangre , Hepatitis B/sangre , Hepatitis B/diagnóstico , Hepatitis B/epidemiología , Antígenos de Superficie de la Hepatitis B/inmunología , Virus de la Hepatitis B/genética , Virus de la Hepatitis B/inmunología , Virus de la Hepatitis B/aislamiento & purificación , Hepatitis C/sangre , Hepatitis C/diagnóstico , Hepatitis C/epidemiología , Humanos , Sensibilidad y Especificidad , Estudios Seroepidemiológicos , Pruebas Serológicas/métodos , Estados Unidos/epidemiologíaRESUMEN
BACKGROUND: Hepatitis B virus (HBV) DNA-positive yield since nucleic acid testing (NAT) implementation (minipools of 16 [MP16]) was reported for the first year. We have updated those figures, evaluated the current value of all HBV tests, calculated the HBV residual risk before and after the introduction of MP-NAT, and estimated residual risks with further improvements in HBV screening for US blood donations. STUDY DESIGN AND METHODS: All donations were screened by US-required serologic HBV tests and for HBV DNA by MP-NAT (Novartis/Gen-Probe). Further testing by individual-donation polymerase chain reaction (ID-PCR) confirmed various classes of MP-NAT-reactive or -nonreactive donations. The hepatitis B surface antigen (HBsAg)-yield method was used to calculate incidence and the incidence-window-period model used to define residual risk. RESULTS: Of approximately 12.8 million donations screened during 2009 to 2011, a total of 1368 HBV confirmed positives including 941 by MP-NAT were observed (combined 4.32% positive predictive value) of which five were seronegative NAT-yield donations (1:2.6 million) and 25 HBsAg-yield (anti-HBc-nonreactive) donations from which an incidence of 1.62/100,000 person-years (vs. 3.43 during 2006-2008) and residual risk of 1:592,000 to 1:754,000 were calculated. With the addition of MP-NAT, and resulting 8.8-day window-period reduction, residual risks decreased to 1:765,000 to 1:1,006,000. Of the 1368 positives, 99.6% were detected by serology and 68.8% by MP-NAT; ID-PCR detected 427 more infected donors than MP-NAT. CONCLUSIONS: HBV MP-NAT and decreases in HBV incidence (likely vaccine-related) in the United States have reduced residual risks to levels comparable to those of human immunodeficiency virus and hepatitis C virus and raise the question of the continued need for all three HBV markers for blood donation screening. Further reductions in residual risk will require the implementation of more sensitive HBV-NAT methods including ID-NAT.
Asunto(s)
Seguridad de la Sangre , Recolección de Muestras de Sangre/métodos , ADN Viral/análisis , Virus de la Hepatitis B/aislamiento & purificación , Técnicas de Amplificación de Ácido Nucleico , Algoritmos , Seguridad de la Sangre/métodos , Seguridad de la Sangre/normas , Reacciones Falso Positivas , Hepatitis B/sangre , Hepatitis B/epidemiología , Hepatitis B/transmisión , Anticuerpos contra la Hepatitis B/sangre , Antígenos de Superficie de la Hepatitis B/sangre , Antígenos de Superficie de la Hepatitis B/inmunología , Virus de la Hepatitis B/genética , Virus de la Hepatitis B/inmunología , Humanos , Incidencia , Tamizaje Masivo/métodos , Tamizaje Masivo/estadística & datos numéricos , Mejoramiento de la Calidad , Pruebas SerológicasRESUMEN
BACKGROUND: In 2007, a total of 10,508 suspected dengue cases were reported in Puerto Rico. Blood donations were tested for dengue virus (DENV) RNA and recipients of RNA-positive donations traced to assess transfusion transmission. STUDY DESIGN AND METHODS: Blood donation samples from 2007 were maintained in a repository and tested individually for DENV RNA by transcription-mediated amplification (TMA); a subset was further tested by an enhanced TMA (eTMA) assay. TMA-reactive samples were considered confirmed if TMA (including eTMA) was repeat reactive (RR). All TMA-RR samples were tested by quantitative, DENV type-specific reverse transcriptase-polymerase chain reaction (RT-PCR) and for anti-DENV immunoglobulin (Ig)M by enzyme-linked immunosorbent assay. Samples positive by RT-PCR were further tested for infectivity in mosquito cell culture. Patients receiving components from TMA-RR donations were followed. RESULTS: Of 15,350 donation samples tested, 29 were TMA-RR for a prevalence of 1 per 529 (0.19%). DENV Types 1, 2, and 3 with viral titers of 10(5) to 10(9) copies/mL were detected by RT-PCR in 12 samples of which all were infectious in mosquito culture. Six TMA-RR samples were IgM positive. Three of the 29 recipients receiving TMA-RR donations were tested. One recipient in Puerto Rico transfused with red blood cells containing 10(8) copies/mL DENV-2 became febrile 3 days posttransfusion and developed dengue hemorrhagic fever. The recipient was DENV-2 RNA positive by RT-PCR; both the donor and the recipient viruses had identical envelope sequences. CONCLUSIONS: High rates of viremia were detected in blood donors in Puerto Rico coupled with the first documented transfusion transmission of severe dengue disease, suggesting that further research on interventions is needed.
Asunto(s)
Donantes de Sangre/estadística & datos numéricos , Virus del Dengue/genética , Dengue , Brotes de Enfermedades/estadística & datos numéricos , ARN Viral/sangre , Viremia , Adulto , Anciano de 80 o más Años , Animales , Culicidae/virología , Dengue/sangre , Dengue/epidemiología , Dengue/transmisión , Virus del Dengue/aislamiento & purificación , Transmisión de Enfermedad Infecciosa/estadística & datos numéricos , Femenino , Humanos , Masculino , Tamizaje Masivo/estadística & datos numéricos , Filogenia , Prevalencia , Puerto Rico/epidemiología , Viremia/sangre , Viremia/epidemiología , Viremia/transmisiónRESUMEN
BACKGROUND: There have been anecdotal reports of influenza viremia since the 1960s. We present an assessment of the prevalence of seasonal and 2009 H1N1 influenza viremia (via RNA testing) in blood donor populations using multiple sensitive detection assays. METHODS: Several influenza RNA amplification assays, including transcription-mediated amplification (TMA) and 2 reverse-transcription polymerase chain reaction (RT-PCR) assays, were evaluated and used to test donor samples. Retrospective samples from 478 subjects drawn at sites with high influenza activity were tested. Prospective samples were collected from 1004 blood donors who called their donation center within 3 days of donation complaining of influenza-like illness (ILI). The plasma collected on the day of donation for these subjects was tested. RESULTS: Of the repository samples, 2 of 478 plasma samples were initially reactive but not repeat reactive by influenza TMA. Of blood donors reporting ILI symptoms postdonation, 1 of 1004 samples was TMA initially reactive but not repeat reactive; all samples were nonreactive by RT-PCR testing. CONCLUSIONS: Targeting blood donor populations most likely to have influenza infection, we failed to detect influenza RNA in 1482 donor samples, with most tested by 3 different RNA assays. Seasonal influenza does not appear to pose a significant contamination threat to the blood supply.
Asunto(s)
Donantes de Sangre , Subtipo H1N1 del Virus de la Influenza A/aislamiento & purificación , Gripe Humana/sangre , ARN Viral/sangre , Viremia/epidemiología , Animales , Estudios de Cohortes , Hurones , Humanos , Infecciones por Orthomyxoviridae/virología , Estudios Prospectivos , ARN Viral/aislamiento & purificación , Estudios Retrospectivos , Reacción en Cadena de la Polimerasa de Transcriptasa Inversa , Sensibilidad y Especificidad , Estados Unidos/epidemiología , Carga Viral , Viremia/virologíaRESUMEN
BACKGROUND: The American Red Cross implemented hepatitis B virus (HBV) minipool (MP)-nucleic acid testing (NAT) in June 2009, in addition to existing tests for hepatitis B surface antigen (HBsAg) and antibodies to hepatitis B core antigen (anti-HBc). The value of all three tests was evaluated. STUDY DESIGN AND METHODS: HBsAg, anti-HBc, and HBV DNA (Ultrio MP-NAT, Gen-Probe/Novartis) donation results were analyzed during a 12-month period (July 1, 2009-June 30, 2010). Additional testing by individual-donation (ID) polymerase chain reaction (PCR) to confirm donor infection was performed when any HBV screening test was reactive or positive, except in the case of HBsAg neutralization-positive, anti-HBc-reactive samples. Numbers of blood donations identified as reactive or positive versus nonreactive or negative were compared. RESULTS: Of about 6.5 million donations, 699 were defined as from HBV-infected donors, of which 64% (444) were reactive for all three markers. More than 99% (697) had reactivity to one or both serologic tests with 68% (477) showing reactivity by MP-NAT. Only two donations were DNA-positive, seronegative NAT-yield donations (1 per 3.23 million), fewer than expected (p = 0.0075). Among MP-NAT-reactive donors, only small numbers represented early infection (2 or 0.4% with negative serology and 10 or 2.1% who were HBsAg confirmed positive, anti-HBc nonreactive). Of the 142 occult HBV-infected donors, 85% were MP-NAT nonreactive requiring ID-PCR for detection (121 or 54.5% of all MP-NAT nonreactives vs. 21 or 4.4% of all MP-NAT reactives). CONCLUSIONS: The HBV DNA-positive yield rate from MP-NAT was lower than expected, likely representing the rarity of such findings even in very large studies. With the implementation of HBV MP-NAT, the value of maintaining anti-HBc for the detection of low-level HBV DNA-positive donors was confirmed; however, HBsAg screening showed no blood safety value.
Asunto(s)
Donantes de Sangre , Marcadores Genéticos , Virus de la Hepatitis B/genética , Hepatitis B/sangre , Hepatitis B/prevención & control , Tamizaje Masivo/métodos , Técnicas de Amplificación de Ácido Nucleico/métodos , Algoritmos , Seguridad de la Sangre , ADN Viral/análisis , ADN Viral/aislamiento & purificación , Reacciones Falso Positivas , Marcadores Genéticos/genética , Hepatitis B/diagnóstico , Hepatitis B/epidemiología , Anticuerpos contra la Hepatitis B/sangre , Antígenos del Núcleo de la Hepatitis B/inmunología , Antígenos de Superficie de la Hepatitis B/inmunología , Virus de la Hepatitis B/aislamiento & purificación , Humanos , Tamizaje Masivo/normas , Técnicas de Amplificación de Ácido Nucleico/normas , Valor Predictivo de las Pruebas , Estudios SeroepidemiológicosRESUMEN
BACKGROUND: When xenotropic murine leukemia virus-related virus (XMRV) was first reported in association with chronic fatigue syndrome, it was suggested that it might offer a risk to blood safety. Thus, the prevalence of the virus among blood donors and, if present, its transmissibility by transfusion need to be defined. STUDY DESIGN AND METHODS: Two populations of routine blood donor samples (1435 and 13,399) were obtained for prevalence evaluations; samples from a linked donor-recipient repository were also evaluated. Samples were tested for the presence of antibodies to XMRV-related recombinant antigens and/or for XMRV RNA, using validated, high-throughput systems. RESULTS: The presence of antibodies to XMRV could not be confirmed among a total of 17,249 blood donors or recipients (0%; 95% confidence interval [CI], 0%-0.017%); 1763 tested samples were nonreactive for XMRV RNA (0%; 95% CI, 0%-0.17%). Evidence of infection was absent from 109 recipients and 830 evaluable blood samples tested after transfusion of a total of 3741 blood components. CONCLUSIONS: XMRV and related murine leukemia virus (MLV) markers are not present among a large population of blood donors and evidence of transfusion transmission could not be detected. Thus, these viruses do not currently pose a threat to blood recipient safety and further actions relating to XMRV and MLV are not justified.
Asunto(s)
Seguridad de la Sangre , Infecciones por Retroviridae/sangre , Infecciones por Retroviridae/transmisión , Virus Relacionado con el Virus Xenotrópico de la Leucemia Murina/fisiología , Adolescente , Adulto , Donantes de Sangre/estadística & datos numéricos , Seguridad de la Sangre/métodos , Recolección de Muestras de Sangre/métodos , Recolección de Muestras de Sangre/normas , Recolección de Muestras de Sangre/estadística & datos numéricos , Síndrome de Fatiga Crónica/sangre , Síndrome de Fatiga Crónica/epidemiología , Síndrome de Fatiga Crónica/etiología , Síndrome de Fatiga Crónica/virología , Femenino , Humanos , Masculino , Persona de Mediana Edad , ARN Viral/sangre , ARN Viral/aislamiento & purificación , Infecciones por Retroviridae/epidemiología , Infecciones por Retroviridae/virología , Factores de Riesgo , Pruebas Serológicas , Trasplante/fisiología , Trasplante/estadística & datos numéricos , Virus Relacionado con el Virus Xenotrópico de la Leucemia Murina/genética , Virus Relacionado con el Virus Xenotrópico de la Leucemia Murina/aislamiento & purificaciónRESUMEN
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.