Impact of changes in viral marker screening assays

Sharma, Usha; Stramer, Susan L.; Wright, David J.; Glynn, Simone A.; Hermansen, Sigurd; Schreiber, George B.; Kleinman, Steven; Busch, Michael P.

doi:10.1046/j.1537-2995.2003.00291.x

Cited by 25 publications

(23 citation statements)

References 37 publications

(90 reference statements)

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“…The reported confirmation rates for HBV in developed countries are 34% (92) and 38.8% (49); the latter rate was selected for use here. The confirmation rate selected for HCV was 50%, consistent with the median of what has been previously reported (49,92,94,106), and the confirmation rate selected for T. cruzi was 25% (31). Calculations for HIV were also adjusted on the basis of a report from Southern Brazil, with case confirmation similar to that mentioned above, indicating an estimated residual risk of 1 in 50,000 because of the window period (36).…”

Section: Vol 18 2005 Transfusion-transmitted Infectious Diseases 21supporting

confidence: 83%

“…Confirmation rates for HIV in developed countries, where repeat donors are the norm, are usually less than 10% (49,95). To put our estimates for developing countries in Latin America in a proper perspective, we used a confirmation rate of 16%, the rate which has been found among, first-time blood donors in the United States (92). The reported confirmation rates for HBV in developed countries are 34% (92) and 38.8% (49); the latter rate was selected for use here.…”

Section: Vol 18 2005 Transfusion-transmitted Infectious Diseases 21mentioning

confidence: 99%

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Safety of the Blood Supply in Latin America

2005

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Appropriate selection of donors, use of sensitive screening tests, and the application of a mandatory quality assurance system are essential to maintain the safety of the blood supply. Laws, decrees, norms, and/or regulations covering most of these aspects of blood transfusion exist in 16 of the 17 countries in Latin America that are the subject of this review. In 17 countries, there is an information system that, although still incomplete (there are no official reports on adverse events and incidents), allows us to establish progress made on the status of the blood supply since 1993. Most advances originated in increased screening coverage for infectious diseases and better quality assurance. However, in 2001 to 2002, tainted blood may have caused infections in 12 of the 17 countries; no country reached the number of donors considered adequate, i.e., 5% of the population, to avoid blood shortages, or decreased significantly the number of blood banks, although larger blood banks are more efficient and take advantage of economies of scale. In those years, paid donors still existed in four countries and replacement donors made up >75% of the blood donors in another eight countries. In addition, countries did not report the number of voluntary donors who were repeat donors, i.e., the healthiest category. In spite of progress made, more improvements are needed

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Section: Vol 18 2005 Transfusion-transmitted Infectious Diseases 21supporting

confidence: 83%

Section: Vol 18 2005 Transfusion-transmitted Infectious Diseases 21mentioning

confidence: 99%

Safety of the Blood Supply in Latin America

2005

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“…Therefore, introduction of the modified version will have clear benefits for both, users and donors. During the 1990s, several reports have raised concerns over the false-positive rates of some screening tests (Sharma et al, 2003). As shown in this study by the ARCHITECT Anti-HCV false-reactive panel, the modification of the assay diluent decreases the number of false-reactive specimens.…”

Section: Discussionmentioning

confidence: 64%

Performance characteristics of the ARCHITECT® Anti-HCV assay

Jonas

Pelzer

Beckert

et al. 2005

Journal of Clinical Virology

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“…An increase in screening test sensitivity of TTIs is highly desirable to ensure recipient safety. However, in populations with a low prevalence rate, the positive predictive value is relatively poor [31-33]. …”

Section: Discussionmentioning

confidence: 99%

Prevalence and trends of markers of hepatitis B virus, hepatitis C virus and human Immunodeficiency virus in Argentine blood donors

et al. 2014

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BackgroundTransfusion-transmitted infections are a major problem associated with blood transfusion. The aim of this study was to determine prevalence and trends of HBV, HCV and HIV in blood donors in Argentina.MethodsA retrospective study was carried out in blood donors of 27 transfusion centers covering the whole country over a period of eight years (2004-2011). Serologic screening assays for HBsAg, anti-HBc, anti-HCV, and anti-HIV were performed in all centers and nucleic acid amplification testing (NAT) was performed in 2 out of the 27 centers.ResultsThe 2,595,852 samples tested nationwide from 2004 to 2011 showed that the prevalence of HBsAg decreased from 0.336% to 0.198% (p < 0.0001), that of anti-HBc from 2.391% to 2.007% (p < 0.0001), that of anti-HCV from 0.721% to 0.460%, (p < 0.0001) and that of anti-HIV from 0.208% to 0.200 (p = 0.075). The prevalence of HBV, HCV and HIV was unevenly distributed among the different regions of the country. Two out of 74,838 screening- negative samples were positive in NAT assays (1 HIV-RNA and 1 HCV-RNA); moreover, HBV-DNA, HCV-RNA and HIV-RNA were detected in 60.29, 24.54 and 66.67% of screening-positive samples of the corresponding assays. As regards donors age, positive HBV-DNA and HCV-RNA donors were significantly older than healthy donors (46.6, 50.5 and 39.5 y respectively, p < 0.001).ConclusionsArgentina has a low prevalence of HBsAg, anti-HCV and anti-HIV in blood donors, with a decreasing trend for HBsAg, anti-HBc and anti-HCV but not for anti-HIV over the last 8 years. The uneven distribution of transfusion-transmitted infections prevalence among the different regions of the country highlights the need to implement regional awareness campaigns and prevention. The discrepancy between samples testing positive for screening assays and negative for NAT assays highlights the problem of blood donors who test repeatedly reactive in screening assays but are not confirmed as positive upon further testing. The uneven distribution of age between healthy donors and NAT-positive donors could be related to changes in risks of these pathogens in the general population and might be attributed to a longer exposure to transmission risk factors in elderly people.

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Impact of changes in viral marker screening assays

Cited by 25 publications

References 37 publications

Safety of the Blood Supply in Latin America

Safety of the Blood Supply in Latin America

Performance characteristics of the ARCHITECT® Anti-HCV assay

Prevalence and trends of markers of hepatitis B virus, hepatitis C virus and human Immunodeficiency virus in Argentine blood donors

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