Biomaterial Database

Establishment of the Ph. Eur. Hepatitis A virus RNA for NAT testing BRP batch 1. 2017

M Chudy, and C M Nübling, and J Blümel, and A Daas, and A Costanzo

Paul-Ehrlich-Institut, Paul-Ehrlich-Strasse 51-59, D-63225 Langen, Germany.

Detection of viral contamination in plasma donations is critical to prevent transmission of infectious diseases. The European Pharmacopoeia (Ph. Eur.) monograph 1646 'Human plasma (pooled and treated for virus inactivation)', requires that plasma pools used for the manufacture of this product be tested, among others, for the presence of hepatitis A virus RNA by nucleic acid testing (NAT) using a positive control containing 100 International Units (IU) of hepatitis A virus (HAV) RNA per mL. To this end, the European Directorate for the Quality of Medicines & HealthCare (EDQM, Council of Europe) organised an international collaborative study under the aegis of the Biological Standardisation Programme, for the establishment of the 1st Biological Reference Preparation (BRP) for HAV RNA for NAT testing. A freeze-dried candidate material was thus prepared and calibrated against the WHO 2nd International Standard for HAV for NAT (00/562) in a study in which thirteen European and North American laboratories including Official Medicines Control Laboratories (OMCLs), manufacturers of plasma-derived products, producers of in vitro diagnostic kits and a blood transfusion centre participated. Based on the outcome of the study, an HAV RNA content of 40 000 IU/vial (corresponding approximately to 4.6 log10 IU/vial) was assigned to the BRP, which was adopted by the Ph. Eur. Commission in March 2016 as Ph. Eur. hepatitis A virus RNA for NAT testing BRP batch 1.

UI	MeSH Term	Description	Entries
D009656	North America	The northern continent of the Western Hemisphere, extending northward from the Colombia-Panama border and including CENTRAL AMERICA, MEXICO, Caribbean area, the UNITED STATES, CANADA and GREENLAND. The term often refers more narrowly to MEXICO, continental UNITED STATES, AND CANADA.	Northern America
D010949	Plasma	The residual portion of BLOOD that is left after removal of BLOOD CELLS by CENTRIFUGATION without prior BLOOD COAGULATION.	Blood Plasma,Fresh Frozen Plasma,Blood Plasmas,Fresh Frozen Plasmas,Frozen Plasma, Fresh,Frozen Plasmas, Fresh,Plasma, Blood,Plasma, Fresh Frozen,Plasmas,Plasmas, Blood,Plasmas, Fresh Frozen
D012015	Reference Standards	A basis of value established for the measure of quantity, weight, extent or quality, e.g. weight standards, standard solutions, methods, techniques, and procedures used in diagnosis and therapy.	Standard Preparations,Standards, Reference,Preparations, Standard,Standardization,Standards,Preparation, Standard,Reference Standard,Standard Preparation,Standard, Reference
D001782	Blood Donors	Individuals supplying blood or blood components for transfer to histocompatible recipients.	Blood Donor,Donor, Blood,Donors, Blood
D005060	Europe	The continent north of AFRICA, west of ASIA and east of the ATLANTIC OCEAN.	Northern Europe,Southern Europe,Western Europe
D006801	Humans	Members of the species Homo sapiens.	Homo sapiens,Man (Taxonomy),Human,Man, Modern,Modern Man
D012367	RNA, Viral	Ribonucleic acid that makes up the genetic material of viruses.	Viral RNA
D014773	Virology	The study of the structure, growth, function, genetics, and reproduction of viruses, and VIRUS DISEASES.
D015203	Reproducibility of Results	The statistical reproducibility of measurements (often in a clinical context), including the testing of instrumentation or techniques to obtain reproducible results. The concept includes reproducibility of physiological measurements, which may be used to develop rules to assess probability or prognosis, or response to a stimulus; reproducibility of occurrence of a condition; and reproducibility of experimental results.	Reliability and Validity,Reliability of Result,Reproducibility Of Result,Reproducibility of Finding,Validity of Result,Validity of Results,Face Validity,Reliability (Epidemiology),Reliability of Results,Reproducibility of Findings,Test-Retest Reliability,Validity (Epidemiology),Finding Reproducibilities,Finding Reproducibility,Of Result, Reproducibility,Of Results, Reproducibility,Reliabilities, Test-Retest,Reliability, Test-Retest,Result Reliabilities,Result Reliability,Result Validities,Result Validity,Result, Reproducibility Of,Results, Reproducibility Of,Test Retest Reliability,Validity and Reliability,Validity, Face
D015588	Observer Variation	The failure by the observer to measure or identify a phenomenon accurately, which results in an error. Sources for this may be due to the observer's missing an abnormality, or to faulty technique resulting in incorrect test measurement, or to misinterpretation of the data. Two varieties are inter-observer variation (the amount observers vary from one another when reporting on the same material) and intra-observer variation (the amount one observer varies between observations when reporting more than once on the same material).	Bias, Observer,Interobserver Variation,Intraobserver Variation,Observer Bias,Inter-Observer Variability,Inter-Observer Variation,Interobserver Variability,Intra-Observer Variability,Intra-Observer Variation,Intraobserver Variability,Inter Observer Variability,Inter Observer Variation,Inter-Observer Variabilities,Inter-Observer Variations,Interobserver Variabilities,Interobserver Variations,Intra Observer Variability,Intra Observer Variation,Intra-Observer Variabilities,Intra-Observer Variations,Intraobserver Variabilities,Intraobserver Variations,Observer Variations,Variabilities, Inter-Observer,Variabilities, Interobserver,Variabilities, Intra-Observer,Variabilities, Intraobserver,Variability, Inter-Observer,Variability, Interobserver,Variability, Intra-Observer,Variability, Intraobserver,Variation, Inter-Observer,Variation, Interobserver,Variation, Intra-Observer,Variation, Intraobserver,Variation, Observer,Variations, Inter-Observer,Variations, Interobserver,Variations, Intra-Observer,Variations, Intraobserver,Variations, Observer