COBAS® AmpliScreen HIV-1 Test, v1.5

PCR test that detects the presence of HIV-1 RNA in plasma of blood, organ and tissue donors

A polymerase chain reaction (PCR) test for the detection of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma

The COBAS® AmpliScreen assays have been designed for screening 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 HIV-1 infection, viral RNA
  • 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 significantly decreases 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 7/2007 v1.0)
The COBAS® AmpliScreen HIV-1 Test, version 1.5 (v1.5) is a qualitative in vitro test for the direct detection of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma. The COBAS® AmpliScreen HIV-1 Test, v1.5 is intended to be used for detection of HIV-1 RNA in conjunction with licensed tests for detecting antibodies to HIV-1. This product is intended for use as a donor screening test to detect HIV-1 RNA in plasma specimens 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 HIV-1 RNA in blood specimens from cadaveric (non-heart-beating) organ and tissue donors.

This test is not intended for use on samples of cord blood. This test is not intended for use as an aid in diagnosis. Plasma from all donors may be screened as individual specimens. 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. 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 may be tested in pools comprised of equal aliquots of not more than 96 individual donations. This assay may be used as an alternative to licensed HIV-1 p24 antigen tests for screening human plasma from donors. The COBAS® AmpliScreen HIV-1 Test, v1.5 can be considered a supplemental test that confirms HIV-1 infection for specimens that are repeatedly reactive on a licensed donor screening test for antibodies to HIV-1, and reactive on the COBAS® AmpliScreen HIV-1 Test, v1.5.

(CE-IVD 4/2008 v4.0)
The COBAS® AmpliScreen HIV-1 Test, version 1.5 (v1.5) is a qualitative in vitro test for the direct detection of human immunodeficiency virus type 1 (HIV-1) RNA in human plasma from donations of whole blood, blood components, plasma intended for transfusion or further manufacture, and organ and tissue donors. The COBAS® AmpliScreen HIV-1 Test, v1.5 is intended for use in screening of 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 HIV-1 RNA in blood specimens from cadaveric (non-heart beating) organ and tissue donors. This assay may be used as an alternative to licensed HIV-1 p24 antigen tests for screening human plasma from donations of whole blood and blood components.

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