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Biomedical subjects

Michael P Busch

Publications and source records attributed to Michael P Busch.

At least 73 records · Page 4Linked to original sources
PubMed2004

Mammalian brain consumption by blood donors in the United States: brains today, deferred tomorrow?

BACKGROUND: Theoretical concerns of possible variant CJD (vCJD) transmission by transfusion have led to deferral of US donors potentially exposed to the bovine spongiform encephalopathy agent. Although the efficacy of these policies is unknown, impact on blood collections has been substantial. Under the precautionary principle, deferral of donors consuming bovine (or other mam-malian) brains, possibly contaminated with the vCJD agent, might be considered. Blood donors were surveyed to determine lifetime mammalian brain consumption. STUDY DESIGN AND METHODS: The Retrovirus Epidemiology Donor Study (REDS) conducted an anonymous mail survey of 92,581 donors from eight US blood centers. RESULTS: Responses were received from 52,650 donors (57%). Of these, 6.4 percent reported lifetime brain consumption; bovine (3.6%) and hog brains (1.7%) were the most common. Bovine brain consumption varied fourfold by center (1.7-7.0%) and was highest among male (4.5%), older (age 55+, 6.5%), foreign-born (9.2%), Asian (7.2%), and Hispanic (8.6%) donors. Among bovine brain consumers, 67 percent engaged in the practice 4 times or less, 79 percent were repeat donors, and 61 percent reported giving at least 11 donations in the past 10 years. CONCLUSION: Following the precautionary principle, further steps to reduce the theoretical vCJD risk could include deferring donors who eat bovine (or other mammalian) brains. The impact of such a policy would not be trivial, especially in areas with older, foreign-born, Asian, or Hispanic donors. Cautious implementation and periodic evaluation of deferral policies is warranted.

Adolescent↗
PubMed2004

Clinical investigation of posttransfusion Kidd blood group typing using a rapid normalized quantitative polymerase chain reaction.

BACKGROUND: Accurate typing of a patient's RBCs in the setting of prior transfusion or a hemolytic transfusion reaction is crucial in the selection of compatible blood but is time consuming, technically difficult, and sometimes impossible. To address this problem, a simple, rapid, and inexpensive quantitative PCR method was developed to identify the single nucleotide polymorphism (SNP) of the Kidd blood group. We applied this method in a clinical investigation of 54 multiple-transfusion patients. STUDY DESIGN AND METHODS: Patients were eligible if they had received at least one RBC transfusion within 30 days and had a sample referred to our regional reference lab for assistance with compatibility testing requiring reticulocyte separation, hypotonic saline treatment, or chemical modification to remove IgG. We compared serologic result to the normalized quantitative PCR. For discrepants, or where no serologic type could be assigned, DNA sequencing characterized the patient's Kidd SNP. RESULTS: Of the 54 patients, the reference lab could assign a serologic Kidd type for 33. Quantitative PCR assigned a Kidd type for 53 of the 54. In three cases, where serology and PCR were discrepant, and for all cases where serology could not assign a Kidd type, DNA sequencing verified the Kidd typing assigned by PCR. CONCLUSION: A simple, rapid, and accurate technique has been developed. The assay performs well in the clinical setting. With further study, and inclusion of other blood group systems, this may become an important supplemental technique for selected patients in the immunohematology reference laboratory.

Calibration↗
PubMed2004

Estimating blood donor loss due to the variant CJD travel deferral.

BACKGROUND: The FDA recommended new travel deferrals in May 2002 to prevent the potential transmission of variant CJD (vCJD). The predicted impact of such deferrals on the blood supply was controversial. STUDY DESIGN AND METHODS: We distributed anonymous, self-administered questionnaires to donors over 2 weeks in April 2002. Two thousand surveys were allocated to each of five geographic groupings of blood centers in the western and central US. Results were analyzed with chi-squared tests and logistic regression. RESULTS: Of 9800 surveys, 7405 (76%) were returned and analyzed. Overall, 257 (3.47%; 95% CI, 3.05-3.89) donors responding to the survey met the expanded May and November 2002 FDA vCJD travel criteria for deferral. Deferral rates ranged from 1 percent or less in Northern and Southern centers, 3 to 4 percent in San Francisco, California, and Scottsdale, Arizona, to over 13 percent in El Paso, Texas (p < 0.0001). Service at a European military base was the most common reason for deferral, whereas in San Francisco most deferrals were for UK and European travel or residence. The vCJD deferral was also associated with ages 30 through 49 years and with male gender. During June through September 2002, observed deferral rates were 1.6 percent at the same centers. CONCLUSIONS: Predicted deferrals due the new vCJD travel criteria depend upon the number of military donors at a blood center, as well as on the age and gender of donors. Actual deferrals were lower than predicted by an anonymous survey.

Adolescent↗
PubMed2004

The donor notification process from the donor's perspective.

BACKGROUND: Despite large numbers of blood donors being notified of abnormal infectious disease screening results, there has been little scientific study of the effects of this process. STUDY DESIGN AND METHODS: With a 28-item questionnaire, an anonymous mail survey was conducted of 4141 blood donors notified of 15 distinct categories of abnormal infectious disease screening and confirmatory test results. RESULTS: The survey had a 42 percent response rate, and 10 percent of the respondents did not recall being notified of their results. Of the 1556 respondents who recalled being notified, 27 percent contacted the blood center for further information, 60 percent discussed their results with a health care provider, and 73 percent of permanently or indefinitely deferred donors correctly understood their deferral status. Confusion and emotional upset were reported in 81 and 75 percent of notified donors, respectively. CONCLUSIONS: The notification process appears to achieve most of its aims in the majority of donors. Nevertheless, some donors did not understand that they were ineligible for future donation, and many donors were confused and upset. These data indicate that the adverse impact of notifying donors about abnormal test results needs to be considered when new blood donor screening tests and confirmatory algorithms are being licensed and implemented. Further studies of the effectiveness of newer revised donor notification materials are needed.

Adult↗
PubMed2004

Lack of correlation between HBsAg and HBV DNA levels in blood donors who test positive for HBsAg and anti-HBc: implications for future HBV screening policy.

BACKGROUND: Studies showing a significant correlation between hepatitis B surface antigen (HBsAg) and hepatitis B virus (HBV) deoxyribonucleic acid (DNA) levels have focused on the HBV seroconversion window period. STUDY DESIGN AND METHODS: HBsAg levels relative to HBV DNA results in 200 HBsAg-positive, anti-hepatitis B core antigen (HBc)-reactive blood donations were analyzed using quantitative polymerase chain reaction (PCR) (detection limit 400 copies/mL), two research PCR assays with increasing sensitivities (65 copies/mL and 1.3 copies/mL, respectively), and a quantitative HBsAg assay; HBsAg and HBV DNA levels were correlated with HBV serologic profiles; and the potential for replacing HBsAg screening with nucleic acid testing (NAT) was analyzed. RESULTS: Serologic profiles for over 90 percent of the donor samples were consistent with chronic HBV infection. Correlation between HBsAg and HBV DNA concentrations was weak (correlation coefficient = 0.33). Thirty-six percent (72/200) of donor samples had DNA levels under 400 copies per mL. Retesting of the 72 samples by more sensitive PCR assays showed that 60 out of 200 (30%) were positive by PCR with sensitivity of 65 copies per mL, whereas 6 out of 200 (3%) required PCR sensitivity of 1.3 copies per mL for positivity. Three percent (6/200) were negative by all three NAT assays. CONCLUSIONS: HBV DNA levels in HBsAg-positive, anti-HBc-reactive blood donations can be extremely low. About 6 percent of donations would be negative by current minipool HBV NAT methods. About 3 percent of donations would remain undetected by sensitive single-donor NAT. These results indicate caution in any consideration of dropping HBsAg screening.

Adult↗
PubMed2004

Quantifying losses to the donated blood supply due to donor deferral and miscollection.

BACKGROUND: Donors are deferred for multiple reasons. Losses related to disease marker rates are well established. Donor and donation losses for other reasons, however, have not been extensively quantified. STUDY DESIGN AND METHODS: To quantify these losses, three data sets from the Blood Centers of the Pacific were combined, permitting detailed analysis of year 2000 allogeneic whole-blood donations. RESULTS: During 2000, 13.6 percent of 116,165 persons who presented for donation were deferred at presentation. Short-term deferral accounted for 68.5 percent (hematocrit was most common at 60%); long-term deferral accounted for 21 percent (travel to a malarial area and tattoo or other nonintravenous drug use needle exposure were most common at 59 and 29%, respectively); and multiple-year or permanent deferral accounted for 10.5 percent (UK travel [variant Creutzfeldt-Jakob disease] risk and emigration from a malarial area were most common at 38 and 11%, respectively). Disease-marker-reactive donations represented 0.9 percent of donor outcomes. The prevalence of deferral and also miscollection (under- and overweight units) varied by age, sex, and first-time versus repeat donor status. Overall, miscollection led to a loss of 3.8 percent of 100,141 collections, ranging from 1.9 percent in repeat male donors 40 to 54 years of age to 10.7 percent in first-time female donors 16 to 24 years of age. CONCLUSION: Loss of units from both first-time and repeat donors due to temporary deferral and loss of units from miscollection are more common events than losses due to disease marker testing. Some of these losses may be avoidable and could increase the blood supply without having to recruit new donors.

Adolescent↗
PubMed2003

Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection.

OBJECTIVES: The characterization of primary HIV infection by the analysis of serial plasma samples from newly infected persons using multiple standard viral assays. DESIGN: A retrospective study involving two sets of archived samples from HIV-infected plasma donors. (A) 435 samples from 51 donors detected by anti-HIV enzyme immunoassays donated during 1984-1994; (B) 145 specimens from 44 donors detected by p24 antigen screening donated during 1996-1998. SETTING: Two US plasma products companies. MAIN OUTCOME MEASURES: The timepoints of appearance of HIV-1 markers and viral load concentrations during primary HIV infection. RESULTS: The pattern of sequential emergence of viral markers in the 'A' panels was highly consistent, allowing the definition and estimation of the duration of six sequential stages. From the 'B' panels, the viral load at p24 antigen seroconversion was estimated by regression analysis at 10 000 copies/ml (95% CI 2000-93 000) and the HIV replication rate at 0.35 log copies/ml/day, corresponding to a doubling time in the preseroconversion phase of 20.5 h (95% CI 18.2-23.4 h). Consequently, an RNA test with 50 copies/ml sensitivity would detect HIV infection approximately 7 days before a p24 antigen test, and 12 days before a sensitive anti-HIV test. CONCLUSION: The sequential emergence of assay reactivity allows the classification of primary HIV-1 infection into distinct laboratory stages, which may facilitate the diagnosis of recent infection and stratification of patients enrolled in clinical trials. Quantitative analysis of preseroconversion replication rates of HIV is useful for projecting the yield and predictive value of assays targeting primary HIV infection.

Biomarkers↗
PubMed2003

Development of a new less-sensitive enzyme immunoassay for detection of early HIV-1 infection.

The sensitive/less-sensitive (S/LS) enzyme immunoassay (EIA) testing strategy for discriminating "early" from "longstanding" HIV infection has been widely applied for detecting recent seroconverters and estimating HIV incidence rates. The originally developed assay (3A11-LS EIA; Abbott Laboratories, Abbott Park, IL) involved performance of LS EIAs using a bead-based assay that required specialized equipment and reagents of limited availability. In contrast, 96-microwell-based EIAs are more universally applied for HIV serodiagnosis throughout the world. The authors report development and preliminary validation of an LS protocol using an EIA in a 96-well format: the Vironostika HIV-1 MicroElisa System (Vironostika-LS EIA; Bio Merieux, Raleigh, NC). The results with samples from recent HIV-1 seroconverters, persons with longstanding HIV-1 asymptomatic infection, patients on highly active antiretroviral therapy, and AIDS patients show a high degree of correlation between the Vironostika-LS EIA and 3A11-LS EIA. The authors also demonstrate that the Abbott 3A11-LS EIA and Vironostika-LS EIA performed comparably on HIV-1-positive samples from persons infected with non-B HIV-1 subtypes. These results support the potential use of the Vironostika-LS EIA for detection of recent HIV-1 infections for incidence projections and for other epidemiologic, clinical, and molecular surveillance applications.

Acquired Immunodeficiency Syndrome↗
PubMed2003

Effect of a national disaster on blood supply and safety: the September 11 experience.

CONTEXT: An understanding of characteristics of blood donors donating in times of crisis may help predict blood supply safety and donor return patterns. OBJECTIVES: To characterize the volume of donations and prevalence of infectious disease markers in blood donated by US donors responding to the September 11, 2001, terrorist attacks, and to evaluate return rates in those who donated for the first time. DESIGN: Cross-sectional survey data from the National Heart, Lung, and Blood Institute Retrovirus Epidemiology Donor Study for 4 weeks before and 4 weeks starting with September 11, 2001, and the corresponding 8-week period in 2000. SETTING AND PARTICIPANTS: A total of 327065 volunteer blood donors making 373628 allogeneic donations at 5 large regional US blood centers. MAIN OUTCOME MEASURES: Changes in number of donations overall and by first-time and repeat status, prevalence of infectious disease markers, estimated risks of transfusion-transmitted viral infections, and first-time donor return rates. RESULTS: About 20000 allogeneic donations were collected weekly in the 4 weeks preceding September 11, whereas approximately 49 000 (2.5-fold increase) and approximately 26000 to 28000 (1.3-fold to 1.4-fold increases) donations were made per week in the first and in the second through fourth weeks starting with September 11, respectively. All demographic groups donated more than usual after the attacks, and after adjusting for seasonal and annual variation there was a 5.2-fold (95% confidence interval, 5.0-5.4) increase in the number of first-time donations vs a 1.5-fold (1.4-1.5) increase in the number of repeat donations made in the first week starting on September 11 vs the 4 weeks before. The weekly proportion of repeat donors returning after not donating for 10 or more years increased from 2% before September 11 to 6% in the first week starting with September 11. Donations confirmed positive for human immunodeficiency virus (HIV), hepatitis C virus (HCV), and hepatitis B surface antigen nearly tripled between 1 week before September 11 (0.1%) and 1 week after the attacks (0.3%), largely explained by the increase in first-time and lapsed repeat donors. Estimated viral residual risks increased slightly after the attacks (HIV, 1/1.5 million vs 1/1.8 million donations; HCV, 1/1.3 million vs 1/1.6 million; hepatitis B virus, 1/140000 vs 1/170000). First-time donor 12-month return rates for 2000 and 2001 were similar, approximately 28% (P =.37) for donors in the first week starting with September 11 (or September 12, 2000) and 30% (P =.69) for the second to fourth weeks. CONCLUSIONS: The September 11 events resulted in an influx of first-time donors without substantial increase in absolute risk of transfusion-transmissible viral infections. First-time donor return rates were equally relatively low before and after the attacks, suggesting that those donating in times of crisis have return behaviors similar to those of other first-time donors. Their relatively low return rates reinforce the need for education about the importance of donating regularly.

Blood Banks↗
PubMed2003

Risk factors for incident HIV infection among anonymous HIV testing site clients in Santos, Brazil: 1996-1999.

OBJECTIVES: To determine temporal trends in HIV infection and risk factors among persons seeking anonymous HIV testing in Santos, Brazil. METHODS: Data and sera from persons testing for HIV from 1996 to 1999 were used. Exposures were abstracted from HIV testing risk assessments. Stored HIV-positive sera were tested to identify recently acquired HIV infection using a serologic testing algorithm for detecting recent HIV seroconversion (STARHS). Independent associations between exposures and recently acquired HIV infection were determined using multivariate analyses. RESULTS: Overall, estimated HIV incidence was 2.0% (95% CI: 1.1-3.5) for the 4-year period: 1.2% (95% CI: 0.5-2.6) in women and 2.7% (95% CI: 1.3-5.0) in men. Incidence increased among women but remained stable among men. Exposures independently associated with incident infection included a history of sex work (OR= 5.4, 95% CI: 1.5-18.7), concurrent syphilis infection (OR =4.1, 95% CI: 1.4-11.9), anal sex (OR = 3.0, 95% CI: 1.3-7.1), and having an HIV-positive sexual partner (OR= 1.4, 95% CI: 1.1-1.9). CONCLUSIONS: This study further demonstrates the public health utility of using the STARHS for the assessment of emerging trends in the HIV epidemic. Results from this study will help to target appropriate prevention strategies directed toward at-risk populations in Santos.

Adult↗
PubMed2003

Residual WBC subsets in filtered prestorage RBCs.

BACKGROUND: New-generation RBC filters reduce WBC concentrations by 4 to 5 logs and may prevent or decrease transfusion complications such as HLA alloimmunization, nonhemolytic febrile reaction, and transfusion-transmitted infections. The residual level of WBC subsets may influence efficacy of WBC reduction for preventing various complications. This study analyzed subsets of residual WBCs in WBC-reduced RBC components prepared for a large, multicenter prospective study. STUDY DESIGN AND METHODS: The Viral Activation Transfusion Study (VATS) assessed the impact of WBC reduction in HIV-1-infected patients undergoing RBC transfusion. WBC-reduced RBC from 11 clinical sites with variable filtration practices were sorted into "low,""middle," and "high" groups based on residual WBC concentration. Subsets were isolated from units by immunocapture (anti-CD4-, anti-CD8-, anti-CD15-, and anti-CD19-coated magnetic beads) and quantified by PCR amplification. RESULTS: After validation studies confirming test methodology, 105 VATS WBC-reduced RBC samples were analyzed. Concentrations of subsets in low and middle residual WBC groups were very low in contrast to relatively high concentrations in the high group. Although highly significant differences were identified between the middle and high groups for total WBCs and all subsets, no single subset predominated. CONCLUSION: These results suggest that overall efficacy of WBC filtration correlates with removal of WBC subsets.

Blood Component Removal↗
PubMed2003

Impact of changes in viral marker screening assays.

BACKGROUND: Monitoring the performance of routinely used infectious disease serologic tests is necessary to evaluate their effectiveness in identifying true-positive units and erroneously disqualifying safe blood donors. METHODS: With two large screening test data sets collected between 1991 and 1998 and between 1997 and 2000, the impact of changes in screening assays for HIV, HCV, and HBsAg was analyzed with regard to the prevalence of confirmed-positive, indeterminate, and confirmed-negative results and the deferral of donors with an indeterminate or negative results (donor loss). RESULTS: The prevalence of indeterminate results and donors loss increased significantly in the 6 months after introduction of an HIV-1/2 EIA. A second-generation HCV EIA increased the detection of confirmed-positive donations in repeat donors (p < 0.001) and increased the prevalence of indeterminate donations. Implementation of a third-generation HCV EIA resulted in a significant decrease in indeterminate results in first-time donors. Nonspecific test results increased when HBsAg test kits from a different manufacturer were introduced or different lots of HIV antibody screening test kits from the same manufacturer were used. CONCLUSION: Introduction of newly licensed versions of assays, switching kit manufacturers, and lot-to-lot variations have an impact on rates of deferrals of safe donors as well as sensitivity of routine screening. Before considering changes in screening tests, blood centers should be aware of, and evaluate, the potential impact on donor loss.

Antigens, Viral↗
PubMed2003

CMV DNA is rarely detected in healthy blood donors using validated PCR assays.

BACKGROUND: Although serologic screening or WBC reduction of blood components can reduce the incidence of transfusion-transmitted CMV (TT-CMV) infection, 'breakthrough' cases of TT-CMV still occur and may produce serious sequelae. NAT of blood components for CMV DNA has been proposed to further reduce the risks of TT-CMV. However, large-scale studies to determine the utility of validated CMV NAT assays for donor screening have not been reported. STUDY DESIGN AND METHODS: Coded whole-blood samples (n=1000) were tested for the presence of CMV DNA using two CMV PCR assays previously validated in a multicenter trial (a nested PCR assay directed at the CMV UL93 open-reading frame and the Roche Monitor assay). Corresponding plasma samples were tested in parallel for the presence of anti-CMV using other assays (Abbott CMV EIA and Fujirebio/Olympus CMV particle agglutination assays). RESULTS: In total 416 and 514 of the samples tested as CMV-seropositive and -seronegative, respectively, by both antibody assays. The remaining 70 samples had discrepant serology results. Only 2 of the 1000 samples (both seropositive) had reproducibly detectable CMV DNA (positive in at least three of four replicates). CMV DNA was not reproducibly detected in seronegative samples or in samples with discrepant serology results. CONCLUSIONS: Although previous investigations showed frequent detection of CMV DNA in healthy CMV-seropositive (and some seronegative) blood donors, these studies were relatively small and the performance characteristics of their assays were difficult to evaluate. In contrast, the present large cross-sectional study of US donors utilized two previously validated PCR assays and demonstrated that CMV DNA is only rarely detectable in seropositive donors. Thus, the use of CMV PCR assays with optimal performance characteristics did not increase the detection of potentially infectious blood components beyond that provided by current serologic screening assays.

Antibodies, Viral↗
PubMed2003

Frequency and duration of plasma CMV viremia in seroconverting blood donors and recipients.

BACKGROUND: Both CMV-seronegative blood and unscreened, filtered blood carry a low but definite risk of transmitting CMV infection. To explain this residual risk, evidence of cell-free viremia was sought in seroconverting and seroprevalent blood donors and seroconverting transfusion recipients by means of a plasma-based assay for CMV DNA. STUDY DESIGN AND METHODS: A CMV DNA PCR assay (COBAS Amplicor CMV Monitor, Roche) was used to detect CMV DNA in 384 paired plasma samples from 192 donors who seroconverted to anti-CMV, 488 anti-CMV EIA-positive samples from 60 seroprevalent donors, and 113 serial samples from 11 seroconverting recipients with posttransfusion CMV hepatitis. RESULTS: Three of 384 samples from 192 seroconverting donors had low levels of plasma CMV DNA (400-1600 copies/mL); one donor was positive before seroconversion, and the other two, after seroconversion. None of the 488 serial samples from 60 anti-CMV- positive donors contained CMV DNA in plasma. Three of 11 recipients demonstrated transient plasma viremia that temporally coincided with seroconversion. CONCLUSIONS: Plasma CMV DNA was detected in a small percentage of seroconverting blood donors and a larger percentage of recipients but was undetectable in seroprevalent donors. Plasma viremia in seroconverting donors may partially explain the low residual risk of CMV transmission by both CMV-seronegative and WBC-reduced seropositive blood.

Antibodies, Viral↗
PubMed2003

Absence of HBV and HCV, HTLV-I and -II, and human herpes virus-8 activation after allogeneic RBC transfusion in patients with advanced HIV-1 infection.

BACKGROUND: The Viral Activation Transfusion Study was a prospective, randomized, double-blind comparison of transfusion with WBC-reduced versus non-WBC-reduced RBCs to HIV+ patients. The primary study characterized the effect of transfusion on HIV and CMV activation by monitoring viral load changes. The present study analyzed HBV, HCV, HTLV-I and -II, and human herpes virus-8 (HHV-8) viral load before and after transfusion to evaluate the further hypothesis that global immune stimulation following allogeneic RBC transfusion results in activation and increased viral proliferation of chronic viral infections other than HIV and CMV. STUDY DESIGN AND METHODS: Baseline samples from 519 to 523 subjects were screened for HBV, HCV, HTLV-I and -II, and HHV-8 infection, and baseline, serial weekly, and quarterly blood samples from infected subjects in the non-WBC-reduced arm were evaluated for changes from baseline in viral nucleic acid and ALT levels. RESULTS: Seroprevalence of HBV, HCV, HTLV-I and -II, and HHV-8 was 68, 25, 5, and 30 percent, respectively. No significant induction of HBV, HCV, HHV-8, or HTLV-I and -II viral replication following allogeneic transfusion of non-WBC-reduced blood was observed. A significant, albeit small, association was observed between transfusion and ALT. CONCLUSIONS: Based on these results and our previous finding that no adverse effect on HIV and CMV viral load and disease progression results from allogeneic transfusion, no evidence is found to support the selective use of WBC-reduced blood components for HIV-infected patients.

Acquired Immunodeficiency Syndrome↗
PubMed2003

Fluctuation of HCV viral load before seroconversion in a healthy volunteer blood donor.

BACKGROUND: Newly implemented NAT has been shown to be able to effectively identify HCV-positive blood donated during the preseroconversion period. STUDY DESIGN AND METHODS: EDTA-plasma pools of 24 donations were tested using an HIV-1/HCV multiplex NAT under an FDA-approved IND application. Samples in a positive pool were retested individually. Positive samples were further tested by two discriminatory assays to determine specific viral reactivity. Upon obtaining informed consent, seronegative donors with positive NAT results were enrolled into a follow-up study for risk factor analysis and laboratory testing. RESULTS: A donation by a 29 year old female was identified as HCV NAT-positive with negative serology and an elevated ALT. Her two previous donations, 5 and 12 months earlier, were both seronegative and with normal ALT. Her husband tested positive for HCV RNA. The donor remained seronegative for at least 36 days. The index donation had a viral RNA concentration of >500,000 copies per mL while the first seropositive sample was NAT-negative. Laboratory data on serial follow-up samples showed 100- to 1,000-fold fluctuations in viral load during a period of 48 days prior to seroconversion. CONCLUSIONS: This case suggests that, at least in some newly infected individuals, the HCV viral load can fluctuate dramatically prior to seroconversion, and that NAT, even on individual samples, will not totally prevent HCV transmission.

Adult↗