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      History and Future of Nucleic Acid Amplification Technology Blood Donor Testing

      *

      Transfusion Medicine and Hemotherapy

      S. Karger AG

      Blood donation, Nucleic acid amplification technology, Screening, Safety, History, Future

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          Abstract

          The introduction of blood donor screening by virus nucleic acid amplification technology (NAT) in the mid to late 1990s was driven by the so-called AIDS and hepatitis C virus (HCV) epidemic, with thousands of recipients of infected blood products and components. Plasma fractionators were the first to introduce NAT testing besides pathogen reduction procedures, to reduce the virus transmission risk through their products. To achieve a similar safety standard, NAT was then also introduced for labile blood components. German transfusion centres were the first to start in-house NAT testing of their donations in pools of up to 96 samples for HCV, hepatitis B virus (HBV), and human immunodeficiency virus-1 (HIV-1). Years later the diagnostics industry provided commercial HCV and HIV-1 and later HBV NAT tests on automated platforms. NAT tests for HIV-2, hepatitis A virus, and Parvovirus B19 followed, again driven by transfusion centres with their in-house tests. When severe acute respiratory syndrome corona virus (SARS-CoV) and West Nile Virus emerged it was the NAT that enabled the manufacturers and transfusion centres to instantly introduce sensitive and specific screening tests. Subsequent automation including sample preparation has significantly reduced the costs and complexity of the procedure and made it affordable to middle income countries as well. Currently more than 60 million donations per year are NAT tested worldwide and the remaining residual risk of virus transmission by blood components and products could be reduced to almost zero. Automation rendered possible the reduction of pool size in conjunction with increased throughput and sensitivity. Thus, antibody and antigen testing may be dispensable in the long run, particularly in the combination of NAT testing with pathogen reduction. There are new technologies on the horizon like digital droplet PCR, next-generation sequencing, lab-on-a-chip, and digital antigen assays, which are comparably sensitive. However, each of these has limitations, either in throughput, costs, automation, time to result, specificity, or the need for NAT as an integral part of the technology. Thus, NAT is still the shortest and most efficient means to the result. Donor screening NAT also contributed significantly to our knowledge on how fast viruses replicate, and on the respective diagnostic window. In conjunction with animal and patient studies, we have learned more about the minimal infectious dose and the epidemics in the donor population.

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          Most cited references 51

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          Two new methods were used to establish a rapid and highly sensitive prenatal diagnostic test for sickle cell anemia. The first involves the primer-mediated enzymatic amplification of specific beta-globin target sequences in genomic DNA, resulting in the exponential increase (220,000 times) of target DNA copies. In the second technique, the presence of the beta A and beta S alleles is determined by restriction endonuclease digestion of an end-labeled oligonucleotide probe hybridized in solution to the amplified beta-globin sequences. The beta-globin genotype can be determined in less than 1 day on samples containing significantly less than 1 microgram of genomic DNA.
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            Dynamics of HIV viremia and antibody seroconversion in plasma donors: implications for diagnosis and staging of primary HIV infection.

            The characterization of primary HIV infection by the analysis of serial plasma samples from newly infected persons using multiple standard viral assays. 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. Two US plasma products companies. The timepoints of appearance of HIV-1 markers and viral load concentrations during primary HIV infection. 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. 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.
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              An assay for circulating antibodies to a major etiologic virus of human non-A, non-B hepatitis.

              A specific assay has been developed for a blood-borne non-A, non-B hepatitis (NANBH) virus in which a polypeptide synthesized in recombinant yeast clones of the hepatitis C virus (HCV) is used to capture circulating viral antibodies. HCV antibodies were detected in six of seven human sera that were shown previously to transmit NANBH to chimpanzees. Assays of ten blood transfusions in the United States that resulted in chronic NANBH revealed that there was at least one positive blood donor in nine of these cases and that all ten recipients seroconverted during their illnesses. About 80 percent of chronic, post-transfusion NANBH (PT-NANBH) patients from Italy and Japan had circulating HCV antibody; a much lower frequency (15 percent) was observed in acute, resolving infections. In addition, 58 percent of NANBH patients from the United States with no identifiable source of parenteral exposure to the virus were also positive for HCV antibody. These data indicate that HCV is a major cause of NANBH throughout the world.
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                Author and article information

                Journal
                Transfus Med Hemother
                Transfus Med Hemother
                TMH
                Transfusion Medicine and Hemotherapy
                S. Karger AG (Allschwilerstrasse 10, P.O. Box · Postfach · Case postale, CH-4009, Basel, Switzerland · Schweiz · Suisse, Phone: +41 61 306 11 11, Fax: +41 61 306 12 34, karger@karger.ch )
                1660-3796
                1660-3818
                April 2019
                5 February 2019
                5 February 2019
                : 46
                : 2
                : 67-75
                Affiliations
                GFE Blut, Frankfurt am Main, Germany
                Author notes
                *Willi Kurt Roth, GFE Blut, Altenhöferallee 3, DE-60438 Frankfurt am Main (Germany), E-Mail wkroth@ 123456wkroth.de
                Article
                tmh-0046-0067
                10.1159/000496749
                6514489
                31191192
                Copyright © 2019 by S. Karger AG, Basel
                Page count
                Figures: 1, Tables: 1, References: 58, Pages: 9
                Categories
                Review Article

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