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Eorgia Avenue Silver Spring, MD Revised January 5,2000 Summary of a Workshop on Implementation of Nucleic Acid Testing December 14,1999 Bethesda,MD Edward Tabor, M.D. A Workshop on Implementation of Nucleic Acid Testing (NAT) was sponsoredby CBER, FDA on December 14, 1999 at Masur Auditorium at the National Institutes of Health campus. Participants included IND sponsorswho are testing blood and plasma donations by NAT, representativesof blood and plasma trade organizations, foreign regulatory.
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PhaseII FAQ
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Nucleic Acid Amplification Testing (NAT) is a highly-sensitive method of testing blood that is used to detect Hepatitis C virus (HCV), Human Immunodeficiency Virus (HIV-1) and West Nile Virus (WNV) in blood. Most traditional screening tests require the presence of antibodies to trigger a positive test reaction.
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Hepatitis B Virus DNA Quantification (“viral load”) – This blood test measures the amount of hepatitis B virus DNA (or viral load) in the blood of chronically infected patients. The blood is tested using a Polymerase Chain Reaction (PCR) technique that is highly sophisticated and accurate.
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A Nucleic Acid Amplification Test, or NAAT, is a type of viral diagnostic test for SARS-CoV-2, the virus that causes COVID-19. NAATs detect genetic material (nucleic acids).
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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.
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HBV nucleic acid testing (NAT) can detect HBV DNA in the HBsAg-negative and total hepatitis B core antibody (anti-HBc)–negative window period of infection and in chronic cases.
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Specimens for HBV DNA viral load are tested using the Roche cobas® HBV Quantitative Assay on the cobas® 6800/8800 system. The cobas® HBV assay is an in vitro nucleic acid amplification test for the quantitation of HBV DNA in serum of HBV-infected individuals.
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HBV nucleic acid testing (NAT) can detect HBV DNA in the HBsAg-negative and total hepatitis B core antibody (anti-HBc)–negative window period of infection and in chronic cases. To assess the presence or absence of HBV DNA in blood donors with HBsAg negativity.
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HBV NAT is a more sensitive technology which could detect trace amounts of HBV DNA during the window period in HBsAg negative blood specimens (i.e., a potential reduction of the infectious window period of up to 40 days depending on sensitivity of the HBsAg test) (Ref.
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