COBAS® AmpliScreen HBV Test

A PCR test for the detection of HBV in human plasma

A PCR test that detects the presence of HBV DNA in plasma or blood, organ and tissue donors. This assay screens pools of blood donations using the COBAS® AMPLICOR Analyzer — an instrument which automates amplification and detection of the PCR process.

Features and Benefits

Features

  • A high degree of sensitivity to the earliest detectable marker of HBV infection, viral DNA
  • Simplified set-up: sample pooling, sample preparation with viral enrichment step and limited reagent preparation
  • Automated amplification and detection, which may contribute to greater laboratory productivity

Benefits

  • PCR helps narrow the ‘window period’ during which the infectious agent is undetectable
  • PCR directly detects the genetic material of the virus resulting in improved blood safety

Intended Use

(US-IVD 5/2008 v5.0)
The COBAS® AmpliScreen HBV Test is a qualitative in vitrotest for the direct detection of hepatitis B virus (HBV) DNA in human plasma. The COBAS® AmpliScreen HBV Test is intended to be used to screen donors for HBV DNA in addition to the currently recommended serology tests. This product is intended for use as a donor screening test to detect HBV in plasma samples from individual human donors, including donors of whole blood and blood components, source plasma and other living donors. It is also intended for use to screen organ donors when specimens are obtained while the donor’s heart is still beating, and to detect HBV DNA in blood specimens from cadaveric (non-heart-beating) organ and tissue donors. This test is not intended for use on samples of cord blood. Plasma from all donors may be screened as individual samples. For donations of whole blood and blood components, plasma may be tested in pools comprised of equal aliquots of not more than 24 individual donations in conjunction with licensed tests for detecting hepatitis B surface antigen (HBsAg) and antibody to hepatitis B core antigen (anti-HBc). For donations of hematopoietic stem/progenitor cells (HPCs) sourced from bone marrow, peripheral blood or cord blood, and donor lymphocytes for infusion (DLI), plasma may be tested in pools comprised of equal aliquots of not more than 24 individual donor specimens. For donations of source plasma, plasma samples of the donations may be tested in pools comprised of equal aliquots of not more than 96 individual donations. The COBAS®.

AmpliScreen HBV Test can be considered a supplemental test that confirms HBV infection for specimens that are repeatedly reactive on a licensed donor screening test for hepatitis B surface antigen, and reactive on the COBAS® AmpliScreen HBV Test.

This assay is not intended for use as an aid in diagnosis.

(CE-IVD 9/2008 v5.0)
The COBAS® AmpliScreen Hepatitis B Test (HBV) is a qualitative in vitro test for the direct detection of hepatitis B virus DNA in human plasma from donations of whole blood and blood components, plasma intended for transfusion or further manufacture, and organ and tissue donors. The test is intended for use in screening individual donor samples of human plasma or pools of human plasma comprised of equal aliquots of individual donations. It is also intended for use to screen individual organ donors when plasma specimens are obtained while the donor’s heart is still beating and to detect HBV DNA in blood specimens from cadaveric (non-heart beating) organ and tissue donors. This assay may be used in conjunction with serology tests for detecting HBsAg and/or antibodies to HBV.

This assay is not intended for use as an aid in diagnosis.