Hepatitis E virus genotypes 1+2+3+4 RNA [Presence] in Serum or Plasma from Donor by NAA with probe detection

HEV 1+2+3+4 RNA SerPl Donr Ql NAA+probe

Definition

An in vitro nucleic acid amplification assay for the direct qualitative detection of hepatitis E virus (HEV) genotypes 1-4 RNA in human plasma or serum. This is a blood screening assay to detect HEV RNA. Plasma from whole blood, blood components, or collections by apheresis can also be used. Plasma from all donors or manufacturing pools may be tested as separate specimens or in pools composed of aliquots of individual specimens. This assay is not meant for use on cord blood nor for use as an aid in diagnosis. This term was created for, but not limited in use to, the Cobas® HEV assay.

3 Self-Sustaining Sequence Replication; 3SR SR; Amplif; Amplification; Amplified; DNA NUCLEIC ACID PROBE; DNA probe; Donr; Hep; Hep E; Hepatis; Hepatit; Hepatology; HEV; HEV 1+2+3+4; HEV 1-4 RNA; i; ID; II; III; Infectious Disease; InfectiousDisease; LAT; LCR; Ligase chain reaction; Ligation-activated transcription; Liver; Microbiology; NAA+probe; NAAT; NASBA; Nucleic acid sequence based analysis; Ordinal; PCR; Pl; Plasma; Plsm; Point in time; Polymerase chain reaction; PR; Probe amp; Probe with ampification; Probe with target amplification; QBR; QL; Qual; Qualitative; Random; Ribonucleic acid; Screen; SDA; SerP; SerPl; SerPlas; Serum; Serum or plasma; SR; Strand Displacement Amplification; TMA; Transcription mediated amplification

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